http://www.actavis.comRSS feed of www.actavis.com60http://www.actavis.com/en/media+center/newsroom/articles/atorvastatin_day_one_launch_europe.htm Actavis today announced the launch of Atorvastatin, the generic equivalent of Pfizer’s Lipitor®/Zarator® the world’s top selling drug. Atorvastatin efficiently regulates the blood cholesterol levels and is one of the most effective drugs used in the therapy of primary hypercholesterolemia. The day one launch of Atorvastatin, one of Actavis’ biggest launches, involves more than 100 million tablets. Actavis launched Atorvastatin immediately after the patents expired this week in Germany, Denmark, France, the UK, Ireland, Italy, Netherlands and Sweden. Additionally, Austria started the price reimbursement phase on patent expiry. Atorvastatin Actavis was developed by Actavis in Iceland and is manufactured by the Company’s zero-carbon-footprint Hafnarfjordur manufacturing site. Atorvastatin Actavis has been marketed by Actavis in Iceland and more than fifteen other patent-free European countries for more than four years. Brand sales of Atorvastatin were more than EUR9.1bn worldwide in 2011, according to IMS Health data, while European sales were about EUR2bn for the same period. Enquiries Actavis GroupHjordis ArnadottirDirector – External CommunicationsTel: +41 41 462 7300E-mail: harnadottir@actavis.comProductThu, 10 May 2012 11:19:00 GMT{7CDCC29D-AC08-4C46-A9F0-3A57707E6CBF}http://www.actavis.com/en/media+center/newsroom/articles/candesartan_patent_europe.htm Actavis has launched Candesartan and Candesartan HCT on many of Europe‘s biggest pharmaceutical markets, immediately after the patents expired. Candesartan, the generic equivalent of AstraZeneca‘s Atacand® / Takeda‘s Blopress® is an angiotensin II receptor blocker, indicated for the treatment of hypertension (high blood pressure). Sales of the brand products were about EUR1.1 billion in Europe in 2011. Candesartan Actavis reached 11 European markets on day one: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden and the UK, while Candesartan HCT was launched in Germany, Finland, France and Ireland at the same time. Actavis had already launched Candesartan and Candesartan HCT in Bulgaria and Iceland, where no patents were in place.ProductMon, 07 May 2012 21:04:00 GMT{ED93B57B-96E9-43A7-8393-945321CC6CA2}http://www.actavis.com/en/media+center/newsroom/articles/statement_thor.htm Stepping-stone Today marks yet another stepping-stone in the history of Actavis and an opportunity for the good people of Actavis to continue to thrive and prosper. Two strong and ambitious pharmaceutical companies, Watson and Actavis, will be merged into the third largest generic company in the world. I am immensely proud to have participated for the past 13 years in the adventurous build-up of this great company and look forward to take part in its future. When I first became a major shareholder in Actavis the company was a local distributor of pharmaceuticals in Iceland. But the opportunity for growth was there. Not only because the international market for pharmaceuticals was rapidly changing and growing but because the company always had the good fortune to attract the best and the brightest of talents. A company is only as good as the people who work there. You made this all possible, expanding the Actavis family to over 10.000 employees in over 40 countries. We all know it has not always been easy. The rapid growth brought many challenges, but we managed to overcome every hurdle. This strong international company of today is a testament of your great work, persistence, endurance and vision through the years. I have never faltered in my belief in this great company and its future. This is why I decided to receive my payment in Watson shares as I am still convinced that Actavis will continue to make history. Björgólfur Thor BjörgólfssonOtherThu, 26 Apr 2012 13:15:00 GMT{42F88AAB-3B34-413C-947E-C51136155E78}http://www.actavis.com/en/media+center/newsroom/articles/watson_to_acquire_actavis.htm Creates 3rd largest global generics company $8.0 billion anticipated pro forma combined revenue in 2012 Significantly increases scale of Watson’s ex-U.S. generic business Accelerates revenue and earnings growth Immediately accretive to non-GAAP earnings, before synergies Greater than $300 million annual synergies anticipated within 3 years Strong combined cash flow allows for rapid pay-down of debt Additional earnout contingent on Actavis 2012 performance Watson Pharmaceuticals, Inc. (NYSE: WPI) and Actavis Group today jointly announced that Watson has entered into a definitive agreement to acquire privately held Actavis for approximately EUR4.25 billion upfront. As a result of this acquisition, Watson will become the third largest global generics company with 2012 anticipated pro forma revenue of approximately $8 billion. Download press release (pdf, 57kb) Actavis, which as a stand-alone company was positioned for strong growth, has a commercial presence in more than 40 countries and markets more than 1,000 products globally. Actavis has approximately 300 projects in its development pipeline and manufactured more than 22 billion pharmaceutical doses in 2011. Actavis has more than 10,000 employees worldwide and had 2011 revenues of approximately $2.5 billion. “The acquisition of Actavis will create the 3rd largest global generics company, substantially completing Watson’s expansion as a leading global generics company. Actavis dramatically enhances our commercial position on a global basis and brings complementary products and capabilities in the United States,” said Paul M. Bisaro, President and CEO of Watson. “In a single, commercially compelling transaction, we more than double Watson’s international access and strengthen our commercial position in key established European markets as well as exciting emerging growth markets, including Central and Eastern Europe and Russia,” Bisaro continued. “The transaction achieves Watson’s stated strategic objective of expanding and diversifying our business into a truly global company. Once the transaction is completed, approximately 40% of our generic revenues will come from markets outside of the U.S.” “This transaction is financially compelling, accelerating Watson’s top and bottom-line growth profile for the foreseeable future. It will be immediately accretive to non-GAAP earnings before synergies, and we estimate that annual synergies of greater than $300 million can be achieved within three years. Between now and closing, we will work closely with Actavis’ management to prepare for a rapid and seamless integration so that Watson can maximize the benefits of this acquisition and capitalize on the significant potential to ensure long-term growth for our shareholders.” “Today marks a milestone in the history of Actavis. For two years I have had the pleasure of working together with the newly formed Actavis management team and our stakeholders who have led the company into a new phase,” said Claudio Albrecht, Executive Chairman and CEO of Actavis. “We have successfully placed Actavis in a strong position to meet the future growth opportunities in the generic pharmaceutical industry.” “Building on this strong foundation, the combination of Watson and Actavis will result in a company of the size required to position itself as a strong player in the generic pharmaceutical industry. The two companies are an ideal complementary fit that will enable the combined company to enhance its position among the industry leaders. Additionally, together Watson and Actavis will be well placed in the fast-paced and dynamic biosimilars market,” Albrecht added. Key Benefits of the Transaction Commercially Compelling TransactionDramatically Enhances Watson’s International Presence• The acquisition combines two growing, successful and profitable companies into a stronger global player that will benefit from sustainable revenue and earnings growth, and strong cash flow. With this transaction, Watson’s international revenues are expected to increase from approximately 16% of total generic net revenues at the end of 2011 to approximately 40%. Expanded Global Market Presence• The combined company will hold a top 3 position in 11 markets and a top 5 market position in 15 markets. The combined company will have commercial operations in more than 40 countries. Actavis’ exceptional global strength, including leading market positions in key established commercial markets and emerging markets in Central and Eastern Europe and Russia, complements Watson’s position in established markets including the UK, France and Australia. Expanded Portfolio and Pipeline• The acquisition will expand Watson’s core leadership position in modified release, solid oral dosage and transdermal products into semi-solids, liquids and injectables. The result will be a broader and more diversified global product portfolio, and an expanded development pipeline. When combined the company will have 45 First-to-Files and 30 exclusive First-to-Files in the U.S. Financially Compelling TransactionSignificantly and Immediately Accretive • The transaction is expected to be immediately accretive to non-GAAP earnings, before synergies. Including synergies, Watson anticipates the acquisition will be greater than 30% accretive to 2013 Watson non-GAAP EPS, with accretion accelerating in 2014 through organic growth and additional synergies. Synergies Provide Added Benefits• Watson expects to achieve annual synergies of $300 million within three years following transaction close, predominantly consisting of SG&A, R&D and corporate cost synergies. • Watson expects additional longer-term cost synergies related to optimizing the supply chain and additional longer-term revenue synergies derived from product launches in new markets. Watson also expects to benefit from a lower pro forma effective tax rate of approximately 28%. Strong Combined Cash Flow Allows for Rapid Debt Repayment• Cash flow of the combined business is anticipated to permit Watson to pay down debt quickly to achieve a leverage ratio of below 3.0x debt to adjusted EBITDA in 2013 and approximately 2.0x debt to adjusted EBITDA in 2014. Watson expects to maintain its investment grade rating from all three rating agencies following the close of the transaction. Additional Capabilities, Global Management/Employee StrengthStrengthens 3rd Party Business• The combination of Watson’s Specifar Pharmaceuticals third-party business, with Actavis’ MEDIS third-party business will result in the creation of the largest out-licensing company with a broader range of products. Experienced, International Management Team• The combination of Watson and Actavis dramatically expands the management expertise necessary to drive international growth in established and emerging markets. Actavis also brings considerable integration experience to the combination, having focused extensively on integration of historical acquisitions since going private in 2007, including consolidating corporate functions, merging CEE and Western Europe operations and implementing project management across the value chain. Expanded Global Team• Combined, Watson will have more than 17,000 employees globally. The Company at acquisition close will have approximately 20 manufacturing facilities and more than a dozen R&D centers. With enhanced size and scale, the combined company will be well positioned to capitalize on its commercial, R&D, manufacturing and customer service capabilities. Transaction Terms Under the terms of the agreement, Watson will acquire Actavis for approximately EUR4.25 billion. The total consideration will include a cash payment of approximately EUR4.15 billion, as well as the assumption of a maximum of EUR100 million in revolver debt, which is to be repaid at closing. Actavis stakeholders could also receive additional consideration, contingent upon the company achieving negotiated levels of 2012 results. The contingent payment, if fully earned would result in the delivery of up to 5.5 million shares of Watson common stock. This contingent payment was valued during the negotiations at EUR250 million, based on a per share price of $60, using a Euro to U.S. dollar exchange rate of $1.32. The shares granted, if any, would be issued in 2013. Watson intends to fund the cash portion of the transaction through a combination of term loan borrowings and the issuance of senior unsecured notes. Watson currently has bridge loan commitments from BofA Merrill Lynch and Wells Fargo Bank, N.A. pending execution of its final financing plans. Watson anticipates that the combined company will generate substantial free cash flow, enabling Watson to pay down debt quickly to below 3.0x debt to adjusted EBITDA by 2013 and to achieve a level of approximately 2.0x debt to adjusted EBITDA in 2014. Approvals and Timing The acquisition will be subject to customary conditions, including review by the U.S. Federal Trade Commission (FTC) under the provisions of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR Act"), as well as approvals outside of the United States. Pending approvals, Watson anticipates closing the transaction in the fourth quarter of 2012. BofA Merrill Lynch is acting as exclusive financial advisor and Latham & Watkins LLP is acting as legal advisor to Watson in connection with this transaction. Press contacts Actavis contact:Frank Staud, Executive Vice President, Corporate Communications+41 41 462 7370 Watson contacts: Investors: Lisa Defrancesco +1 862 261-7152 Patty Eisenhaur +1 862 261-8141Media:Charlie Mayr+1 862 261-8030 Conference CallThe Company will host a conference call, with supporting slides available via webcast, beginning at 4:30 p.m. Eastern Daylight Time on April 25, 2012 to discuss the proposed acquisition. The dial-in number to access the call is U.S./Canada (877) 251-7980; International +1 706 643-1573 and the Conference ID is 67192051. To access the slides go to Watson’s Investor Relations Web site at http://ir.watson.com/, or directly at http://www.videonewswire.com/event.asp?id=85954. A taped replay of the conference call will be available beginning approximately two hours after the call’s conclusion and will remain available through 12:00 midnight Eastern Daylight Time on May 7, 2012. The replay may be accessed by dialing (855) 859-2056 and entering the same Conference ID above. From international locations, the replay may be accessed by dialing +1 404 537-3406. About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. Watson is engaged in the development, manufacture and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. The Company is also developing biosimilar products in Women’s Health and Oncology. Additionally, we distribute generic and branded pharmaceuticals through our Anda Distribution business. In 2011, Watson was the third largest generic pharmaceutical company in the United States. We also have commercial operations in key international markets including Canada, Western Europe, Asia/Pacific, South Africa and Latin America. Watson distributes approximately 8,500 stock-keeping units in the U.S. directly to more than 60,000 customers through our Anda Distribution Division. For press release and other company information, visit Watson Pharmaceuticals' Web site at www.watson.com. About ActavisActavis is one of the world’s leading generic pharmaceutical companies, specializing in the development, manufacture and sale of generic pharmaceuticals. The company has operations in more than 40 countries, with over 10,000 employees. At present, Actavis has a portfolio which includes more than 1,000 medicines present on the market and registered in more than 70 countries. # # # Forward-Looking Statement Statements contained in this press release that refer to Watson's estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. For instance, the statements in this press release relating to expected or anticipated benefits of the Actavis acquisition, the future financial performance of the combined company, cost synergies, future tax rates, the pay down of debt obligations, and the closing of the transaction are forward-looking statements. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business, Actavis’ business and risks associated with acquisition transactions. These factors include, among others, the inherent uncertainty associated with financial projections; successful close and subsequent integration of the Actavis acquisition and the ability to recognize the anticipated synergies and benefits of the Actavis acquisition; the anticipated size of the markets and continued demand for the Watson’s and Actavis’ products; the impact of competitive products and pricing; the receipt of required regulatory approvals for the transaction (including the approval of antitrust authorities necessary to complete the acquisition); access to available financing (including financing for the acquisition) on a timely basis and on reasonable terms; risks of fluctuations in foreign currency exchange rates; the risks and uncertainties normally incident to the pharmaceutical industry, including product liability claims and the availability of product liability insurance; the difficulty of predicting the timing or outcome of pending or future litigation or government investigations; periodic dependence on a small number of products for a material source of net revenue or income; variability of trade buying patterns; changes in generally accepted accounting principles; risks that the carrying values of assets may be negatively impacted by future events and circumstances; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; market acceptance of and continued demand for Watson's and Actavis’ products; costs and efforts to defend or enforce intellectual property rights; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Watson's and Actavis’ facilities, products and/or businesses; changes in the laws and regulations, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. All trademarks are the property of their respective owners. OtherWed, 25 Apr 2012 20:57:00 GMT{89BAE9B3-7ED4-44C8-844E-320A14A0450A}http://www.actavis.com/en/media+center/newsroom/articles/Important+role+for+generics+in+todays+healthcare+services+actavis+bulgaria.htm Actavis CEO meets Bulgarian Prime Minister for talks on generic pharmaceuticals The advantages of high quality generic pharmaceuticals for publicly funded healthcare systems formed the main topic of discussion between the Bulgarian Prime Minister Boyko Borisov and Actavis CEO Claudio Albrecht. The two men met when the Actavis leader visited Bulgaria recently. At a time when resources for healthcare services in most countries are either stagnant or declining, the role of generics is becoming increasingly important. And the generics industry can have a significant social impact according to Albrecht. “The wide usage of generics, which are of proven quality and produced by proven companies, can help to reduce the Bulgarian state’s expenditure on medicines. These savings mean that there is the potential to treat more Bulgarian citizens,” Albrecht pointed out. The importance of the role of generics has been underlined by many of the world’s largest economies, which have implemented pro-generic policies in their healthcare systems for many years now. “The shift to generics is a pragmatic and positive step, especially against a backdrop of diminishing social funds,” said Albrecht. “The medicines produced by Actavis provide value for money, which helps to ensure wider access to effective products. Actavis has always been a committed partner of the Bulgarian state in its efforts to ensure affordable and good quality treatments for the people of this country,” he added. Actavis is the biggest pharmaceutical company in Bulgaria. It has the broadest product portfolio within the Bulgarian market, with almost 280 products covering all the main therapeutic groups.Actavis BulgariaOtherWed, 04 Apr 2012 16:47:00 GMT{31B8408D-30B2-4ECD-99DF-6F845515AD01}http://www.actavis.com/en/media+center/newsroom/articles/quetiapine_europe.htm Actavis Group today announced the launch of Quetiapine, the generic equivalent of AstraZeneca’s Seroquel®, immediately after the patents expired in Denmark, the UK, Germany, Italy, Ireland, the Netherlands and Romania. The product will also be launched in Sweden, on 1 April when the next tender is due. Quetiapine is an anti-psychotic drug used in the treatment of depressive and bipolar disorders, as well as schizophrenia. It is manufactured at Actavis’ site in Malta in a variety of strengths (25, 100, 150, 200, 300mg). European sales of branded Quetiapine conventional tablets were about EUR499 million in 2011, according to IMS Global.ProductThu, 29 Mar 2012 11:43:00 GMT{D0150493-291A-4F0B-BC14-E69D506A2CF5}http://www.actavis.com/en/media+center/newsroom/articles/migraine_zolmitriptan_eu.htm Actavis Group today announced the launch of Zolmitriptan tablets immediately after the patents expired in a number of European countries. Used to treat severe migraine headaches, Zolmitriptan Actavis is the generic equivalent of the brand product Zomig® from AstraZeneca. Actavis launched Zolmitriptan immediately after the patents expired. The Company’s conventional film coated tablets were first to market in the UK, France, Italy, Denmark, Norway and Sweden and also launched in Finland. At the same time, Zolmitriptan Actavis orodispersible tablets (ODT) were first to market in the UK, France, Netherlands, Ireland, Denmark, Norway and Sweden. The product was also brought to market in Finland. Actavis had already marketed Zolmitriptan ODT in a number of countries including Malta, Romania and Ukraine. Zolmitriptan Actavis is produced at the Company’s manufacturing site in Malta. According to IMS, Zolmitriptan conventional and ODT branded sales in Europe were about EUR117m in 2011.ProductWed, 21 Mar 2012 13:50:00 GMT{660206E7-EFED-4E1B-A62C-8F0703202673}http://www.actavis.com/en/media+center/newsroom/articles/moxduo_loa.htm Actavis Inc in the United States and QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) have announced the execution of their License and Option Agreement (LOA) which finalized the legal terms and conditions to commercialise MOXDUO® IR in the US acute pain market. The LOA completion follows a 20 December 2011 signing of a binding Letter of Intent (LOI) secured by a USD6 million non-refundable upfront signing fee to QRxPharma. “Actavis is proving to be an exceptional partner. The strategic synergies between our companies and our collaboration at the joint steering committee level are critical success factors going forward,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “With the LOA now complete, we are focusing our ongoing energies towards supporting Actavis as we approach our PDUFA date and prepare for the anticipated launch of our first product, MOXDUO® IR, in the third quarter.” Actavis’ Chief Executive Officer for the US, Doug Boothe, added: “Our launch plans for MOXDUO IR are on track and we remain convinced MOXDUO® IR is very well suited to the experience and expertise of our marketing and sales teams. We are very optimistic about the opportunity for MOXDUO® IR to successfully penetrate the USD2.2 billion acute pain opioid market in the US.” About MOXDUO® IR MOXDUO® is a patented 3:2 ratio fixed dose combination of morphine and oxycodone. In head-to-head comparisons with morphine, oxycodone, Percocet® and placebo, more than 800 patients have been treated with MOXDUO® IR in seven clinical trials over QRxPharma’s successful Phase 3 programme. About QRxPharma QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) is a commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. QRxPharma’s lead product candidate, immediate release MOXDUO®, has a PDUFA date of 25 June, 2012 when the New Drug Application review by the US Food and Drug Administration (FDA) will be completed. The Company recently signed a strategic partnership agreement with Actavis, Inc. to commercialise MOXDUO® IR in the US acute pain market, with product launch anticipated in 3Q, CY2012. QRxPharma may co-promote its products in the U.S. and plans to seek strategic partnerships for worldwide markets. Additionally, the Company’s clinical pipeline includes an intravenous (IV) and continuous release (CR) formulation of MOXDUO®. For more information, visit www.qrxpharma.com ProductTue, 20 Mar 2012 15:35:00 GMT{906D6C2A-5136-4A2C-947D-DB0B09DEB450}http://www.actavis.com/en/media+center/newsroom/articles/donepezil_patent_eu.htm Actavis today announced the launch of Donepezil in some of Europe’s biggest markets, immediately after the patents expired. The conventional tablets were launched in Germany, France, Italy, Spain, the UK, Denmark, Sweden and Austria this week. Donepezil tablets were developed by Actavis R&D and manufactured by Actavis in Malta. Actavis is also bringing Donepezil oro-dispersible tablets to market following patent expiry in the UK and Sweden. Actavis has already launched Donepezil in a number of patent-free markets. Donepezil is indicated for the treatment of mild to moderately severe Alzheimer’s disease. Donepezil Actavis is the generic equivalent of the brand product Aricept® from Pfizer. The Brand product had sales in the EU of approximately EUR 475.6mln for the 12 months ending September 2011, according to IMS Health. Enquiries Actavis GroupHjordis ArnadottirDirector – External CommunicationsTel: +41 41 462 7300E-mail: harnadottir@actavis.comProductThu, 16 Feb 2012 13:20:00 GMT{80DB183D-DB89-4555-BD45-DFF73510421B}http://www.actavis.com/en/media+center/newsroom/articles/irinotecan_japan.htm ASKA has announced the launch of Irinotecan, the first oncology product from Actavis in Japan. This product is the anticancer agent which inhibits the topoisomerase I, and ASKA obtained the marketing approval on 15 July 2011 and the NHI listing on 28 November 2011. This product is supplied from the Swiss based pharmaceutical company Actavis which is marketing the generic products in oncology field globally and is distributed through Takeda Pharmaceutical Company Limited. Actavis has already launched Irinotecan in more than 35 countries. Irinotecan Actavis is produced by the Company’s Romanian facility, which is approved by the FDA (US), EMEA (EU) and the Japanese regulatory authorities. By launch of this product, ASKA and Actavis will contribute to the restraining of medical expenses, reducing of patient burden and hospital management. Through this partnership ASKA and Actavis will make the contribution to the treatment in oncology area. Enquiries Actavis GroupFrank StaudEVP Corporate CommunicationTel: +41 79 230 95 78E-mail: fstaud@actavis.comProductWed, 08 Feb 2012 10:21:00 GMT{CD1657FE-A539-431A-8D7A-DA79DB7CEA83}http://www.actavis.com/en/media+center/newsroom/articles/actavis_bioton_alliance.htm Global managed-care offering to help bring down treatment costs for 366 million diabetics Actavis and Bioton (WSE:BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia & Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company. The announcement, at a press conference in Warsaw today, was made jointly by Ryszard Krauze, Chairman of the Supervisory Board of Bioton, and Claudio Albrecht, CEO of the Actavis Group and Chairman of the Actavis Board of Directors. Actavis has agreed to remunerate Bioton with the aggregate amount of EUR 55.5 million, of which EUR 22.25 million at signing today. The remainder (EUR 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI). Based on the sales volumes estimated by the parties, Actavis’ revenues from the sale of the Insulins by Actavis into the markets in the initial period of 7 years from launch are expected to exceed EUR 1.5 billion. Pursuant to the agreement, the parties will share on an equal ‘50/50’ basis the profits from the sale of the insulins performed by Actavis, as well as the development and registration costs related to Bioton insulins. In addition to the above, the Bioton Group have also signed memoranda of understanding with Actavis for the sale of insulins in 24 additional territories, including Turkey and Australia. Actavis will pay an additional consideration of up to EUR 1,900,000, including EUR 1,000,000 at signing. Both parties expect that sales of Bioton’s recombinant human insulin by Actavis into some of the additional territories shall commence on the turn of 2012 and 2013. The profits from the sale of the insulins in these additional territories will again be shared on an equal basis (50/50). Formal documentation of these arrangements is expected to be concluded in the following weeks. Actavis CEO Claudio Albrecht believes the new alliance will create tremendous value for Actavis and Bioton and their respective shareholders. “The recombinant- and analogue insulins alone should add around EUR 900 million (USD 1.2 billion) to our enterprise value. Thanks to the collaboration agreement with Bioton, we will be among the leading manufacturers of insulin, including analogue insulins," predicted Albrecht.Chairman of the Supervisory Board of Bioton S.A. Ryszard Krauze commented, “The cooperation with Actavis has a strategic importance for Bioton. We will jointly introduce modern insulins, including analogue insulins. For the last two years, we have been consistently increasing the sales of our products based on collaborations with leading global pharmaceutical firms such as Bayer HealthCare in China and GlaxoSmithKline in Russia. Today, we are pleased to welcome another large pharmaceutical firm to our group of partners – Actavis.” Diabetes - A global epidemicNew data released by the International Diabetes Federation (IDF) indicates that more than 366 million people worldwide are living with diabetes. Due to poor diet and sedentary lifestyles, diabetes is rapidly becoming a global epidemic, and the number of diabetes patients is expected to rise to a figure in excess of 550 million by 2030. The World Health Organisation (WHO) projects that the global insulin market will grow from the present level of approximately USD 14 billion to USD 54 billion over that same period. On average, a patient with diabetes type 2 takes almost 30 different medicines over the course of the disease. In light of that fact, the collaboration with Bioton represents a more fundamental and strategic concept in terms of treating diabetes, according to Claudio Albrecht. “The diabetes idea for us is a much wider one than just promotion and sale of recombinant human insulin or insulin analogues", he said. “We are encountering competitor giants when it comes to insulin and we have to maximise the competitive advantages that we clearly have. Bioton’s insulin products have a market presence of more than 10 years’ standing, with an excellent safety and efficacy profile. This puts us in a situation where we can overcome more easily any potential doubts that key opinion leaders might have when it comes to biosimilars. “Furthermore, we differ in one aspect very strongly in comparison with the originators,” Albrecht added, highlighting the extensive range of generic type-2 oral diabetes drugs that Actavis already offers. Actavis’ pipeline also includes high-value ‘gliptin’ products” and several fixed dose combinations with Metformin. Comprehensive care offeringAlbrecht noted that the opportunity to market a much broader portfolio in the context of diseases related to diabetes is a great one. “Actavis is the only company that can offer such a broad diabetes- and related diseases portfolio. We can tell payers that we cover the whole diabetes segment for a cost that is probably considerably less than they have been paying to date.” CEO of Bioton SA Slawomir Ziegert said, “For Bioton, the collaboration with Actavis will, in addition to bringing direct financial benefits, fuel faster expansion into high-margin markets, while supporting the implementation of our product synergy strategy and further growth in the area of cardio diabetology. Patients value highly the unique and comprehensive care offered by Bioton, a package which includes insulin, injectors, glucometers, oral diabetes medicines and an educational programme. All these elements provide an opportunity to extend our collaboration with Actavis in many markets around the world.” About Actavis GroupActavis is one of the world’s leading generic pharmaceutical companies, specialising in the development, manufacture and sale of generic pharmaceuticals. The company has operations in more than 40 countries, with over 10,000 employees. At present, the Actavis Group has a portfolio, which includes approximately 830 medicines present on the market and registered in more than 70 countries. About BiotonBioton is the Polish manufacturer of modern recombinant human insulin, which is on offer to patients on almost 20 markets worldwide, including Poland, Russia, China, Thailand, Vietnam and India. With respect to the sale of insulins, Bioton cooperates with GlaxoSmithKline and Bayer HealthCare, as well as other local foreign distributors, leading on particular markets. Bioton’s insulin are manufactured in a modern biotechnology facility in Macierzysz near Warsaw. In addition to insulins, Bioton offers to patients also own-brand injectors for administration of insulin and a range of other medicines used in the treatment of diabetes and other metabolic disorders. Currently Bioton also is seeking registration in the European Union of a new sustained release growth hormone developed in collaboration with LG Life Science. Enquiries Actavis GroupFrank StaudEVP Corporate CommunicationTel: +41 79 230 95 78E-mail: fstaud@actavis.com Any statements contained in this press release that refer to Actavis’ and Bioton’ estimated or anticipated future results or future activities are forward-looking statements which reflect Actavis’ and Bioton’ current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors. OtherMon, 30 Jan 2012 10:30:00 GMT{A3E5B718-A908-4A2E-BC86-1D95D9C0496A}http://www.actavis.com/en/media+center/newsroom/articles/latanoprost_timilol_europe.htm Actavis Group has launched Latanoprost eye drops in seven major European markets, immediately after the patents expired in January. In addition to the UK, France, Sweden, Ireland, Denmark, Germany and the Netherlands, the product will be available in Finland at market formation on 1 February, while Italy, Spain, Iceland, Switzerland, Hungary, Bulgaria and the Czech Republic have already launched the Actavis product. At the same time, Actavis has launched Latanoprost / Timolol eye drops in Denmark, Finland and Ireland, immediately after patent expiry. The product will be marketed in Hungary and the Baltics later this month with more countries set to follow suit later this year. Latanoprost and timolol are active pharmaceutical ingredients used to treat hypertension of the eye and certain kinds of glaucoma. Latanoprost Actavis is the generic equivalent Pfizer’s brand product Xalatan®, while Latanoprost / Timolol is the generic equivalent of Pfizer’s Xalacom® / Xalcom®. European sales for the brand products were about EUR335 million (latanoprost) and EUR112 million (latanoprost/timolol), for the year ending September 2011, according to IMS Health. Enquiries Actavis GroupHjordis ArnadottirDirector – External CommunicationsTel: +41 41 462 7300E-mail: harnadottir@actavis.comProductWed, 25 Jan 2012 09:51:00 GMT{15D94FE1-3CE5-41D1-B978-00C81821254E}http://www.actavis.com/en/media+center/newsroom/articles/actavis+aska+sign+legal+agreement.htm Following the signature of a preliminary agreement last November, Actavis Group and ASKA Pharmaceutical have now formally signed an agreement establishing a joint company: Actavis ASKA K.K. The joint company will enter the Japanese generic pharmaceutical market in April 2009. ASKA will hold 55% of shares in the joint venture; Actavis 45%. Sigurdur Oli Olafsson, CEO, Actavis:“We are convinced this is the best way to enter the Japanese market. We bring the power of a global generic pharmaceutical company to the table, while ASKA is an experienced local partner. We are very much looking forward to a long and successful partnership. The government’s policy to increase the share of generics during the next few years is key to our decision to enter at this time.” About ASKALocated in Tokyo, Japan, ASKA Pharmaceutical is a research and development (R&D) oriented company, which contributes to society by developing and providing innovative pharmaceutical products, concentrating its management resources to the specific therapeutic areas. Additional information about ASKA is available through its corporate website. Summary of joint companyName: Actavis ASKA K.K.Head Office: TokyoCapital: 200 million Yen (planned)Investment ratio: ASKA: 55%, Actavis: 45%Establishment: 1 April 2009 (planned)OtherThu, 12 Mar 2009 04:00:00 GMT{09032FA3-554A-4F70-BB72-D4AC04979E3E}http://www.actavis.com/en/media+center/newsroom/articles/edda_order_of_falcon_iceland.htm Gudbjorg Edda Eggertsdottir, President of Actavis Iceland and the Company’s Strategic Projects lead, has been recognised for her remarkable contribution to healthcare and the national economy in Iceland’s New Year’s Honours. President of Iceland Olafur Ragnar Grimsson presented Eggertsdottir with the Order of the Falcon at his official residence Bessastadir on 1 January. Among other recipients at the distinguished investiture ceremony were pioneers who have made important contributions to the arts, farming and seafaring safety. Active in the field of generic pharmaceuticals for over 30 years, Eggertsdottir has recently brought her impressive industry experience to an additional international role. As President of the European Generic medicines Association (EGA) she represents the generics industry in Europe and champions better value in healthcare for its people. The Order of the Falcon is the highest honour that the Icelandic state can bestow upon its citizens and is awarded twice a year (in January and June). Halldor Gudmundsson was also recognised at the state ceremony for his impact on Icelandic literature. A renowned writer, Gudmundsson recently directed Iceland's participation in the Frankfurt Book Fair, where Actavis was one of the main sponsors.OtherThu, 05 Jan 2012 15:18:16 GMT{7AF2307C-65CE-4CDF-8236-8476EA658B8E}http://www.actavis.com/en/media+center/newsroom/articles/clobetasol_shampoo_lotion_us.htm Actavis has begun shipping Clobetasol Propionate Shampoo and Clobetasol Propionate Lotion, generic equivalents to Galderma’s Clobex® Shampoo and Clobex® Topical Lotion. The FDA has granted Actavis a 180-day marketing exclusivity, due to Actavis’ first-to-file status. According to IMS Health, combined annual brand sales of Clobex Shampoo and Clobex Topical Lotion were USD89.9 million for the 12 months ending 30 September 2011. Doug Boothe, CEO of Actavis US, said: “The launch of Clobetasol Propionate Shampoo and Clobetasol Propionate Lotion displays our continuing commitment to introduce new, high quality generic products to the marketplace, as well as highlights our expertise in developing and manufacturing a wide range of dosage forms. Actavis’ drive to be a leader in generic pharmaceuticals is supported by one of the largest product development pipelines in the industry.”ProductTue, 03 Jan 2012 15:54:00 GMT{33CFBDCD-4162-4920-A802-994ECB693A86}http://www.actavis.com/en/media+center/newsroom/articles/loi_qrxpharma_moxduo.htm Actavis today announced that its US subsidiary, Actavis Inc, has entered into a binding letter of intent (LOI) with QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) to commercialize MoxDuo® IR in the United States. Under the terms of the LOI, Actavis gets exclusive rights to launch and market MoxDuo® IR, a patented 3:2 ratio fixed dose combination of morphine and oxycodone for the USD2.5bn US acute pain market. The product launch in the US is expected in Q3 2012. Pre-launch preparations will begin immediately. Claudio Albrecht, CEO Actavis:“This partnership represents a major step in our strategy to further strengthen our position as one of the major players in the segment of pain management in the US. Furthermore, as this latest development highlights, Actavis is serious in its quest to be ahead of the changing generic pharmaceutical industry. In the future, there will not be such a clear difference between innovator and generic companies. The lines between the two models are blurring. The generics business as we know it today will be gone within the next ten years.” Strategic partnership with QRxPharma to commercialise MoxDuo® IR for the USD2.5 Billion US acute pain marketActavis intends for MoxDuo® IR to be a flagship product in the Company’s growing pain management franchise. This transaction builds on Actavis success with the currently marketed Kadian® Extended Release Morphine Sulfate capsules, and a broad array of generic scheduled narcotics offerings. Kadian® has been manufactured by the Company for 15 years and marketed by Actavis since 2008. The Company’s analgesic sales force for its branded products will expand significantly and have MoxDuo® IR as a primary focus in the US pain market. Actavis’ CEO for the US, Doug Boothe: “Actavis Inc. is a company with deep experience and solid results in pain management. Building on the success of Kadian®, we believe the QRxPharma partnership offers significant opportunity to leverage the talent of our team to establish MoxDuo® IR as a preferred option in the US acute pain marketplace. We believe MoxDuo® IR has tremendous sales potential.” As one of the world’s largest manufacturers of branded and generic opioids, Actavis may serve as a contract supplier for MoxDuo® IR in the US market. Under the terms of the LOI, QRxPharma retains full flexibility to market MoxDuo® IR outside the US. Dr. John Holaday, Managing Director and CEO, QRxPharma: “After analysis of several other licensing proposals, it was clear Actavis was the strategic choice for the Company. Their experience in the manufacturing, distribution, marketing and sales of both patented and generic opioid products enabled a partnership structure with QRxPharma that will accelerate revenues and maximise shareholder value.” The agreement also provides Actavis with an option for US marketing and sales rights of QRxPharma’s chronic pain controlled release Dual-Opioid, MoxDuo® CR, as well as its hospital based intravenous formulation, MoxDuo® IV. The exercise of the option for MoxDuo® CR by Actavis is contingent upon the achievement of certain sales milestones for MoxDuo® IR. The option for MoxDuo® IV will lapse on a date certain if not exercised by Actavis. EnquiriesGerard FarrellActavis US Press LineTel: (+1) 973 889 6689E-mail: media@actavis.com About QRxPharmaQRxPharma Limited (ASX: QRX and OTCQX: QRXPY) is a commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management and central nervous system (CNS) disorders. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company intends to co-promote its products in the U.S. and seeks strategic partnerships for worldwide markets. QRxPharma’s lead product candidate, immediate release MoxDuo®, now awaits approval by the US Food and Drug Administration (FDA). Additionally, the Company’s clinical pipeline includes an intravenous (IV) and continuous release (CR) formulation of MoxDuo®, as well as other pipeline technologies in the fields of pain management, neurodegenerative disease and venomics. For more information, visit www.qrxpharma.com.ProductWed, 21 Dec 2011 14:01:00 GMT{C693A5A4-47D1-494E-B7EB-F91A1FB2307B}http://www.actavis.com/en/media+center/newsroom/articles/valsartan_europe_nov2011.htm Actavis Group, the international generic pharmaceuticals company, launched Valsartan and Valsartan HCT in nine European countries immediately after the patents expired on 12 and 13 November. The angiotensin II inhibitor, used to treat high blood pressure, was marketed in Austria, Germany, Denmark, UK, Ireland, Italy, Netherlands, Sweden, and France – many of Western Europe’s biggest markets. Valsartan is the generic equivalent of the Diovan® brand product from Novartis. The generic drug from Actavis has already been launched in various other markets where the patents expired earlier. According to IMS Health data, Valsartan branded sales in Europe were more than EUR548 million for the year ending June 2011, while Valsartan HCT branded sales for the same period were over EUR701 million. Valsartan is manufactured by Actavis in Malta and Dupnitza, Bulgaria. EnquiriesActavis GroupHjordis ArnadottirDirector – External CommunicationsTel: +41 41 462 7300E-mail: harnadottir@actavis.comProductFri, 18 Nov 2011 16:12:00 GMT{397BD413-90E6-466C-9784-465E9A6E0C3C}http://www.actavis.com/en/media+center/newsroom/articles/oncology_turkey.htm Actavis is planning to increase its presence in Turkey next year and make a real difference within the country’s oncology sector. Drawing on the Company’s expertise in affordable, high quality and technologically advanced oncology products, Actavis Turkey will launch a range of oncology medicines in 2012, along with various other new products. Supporting more than one million patients every yearActavis CEO and Chairman Claudio Albrecht believes there is huge potential for growth within the Turkish oncology market. “Actavis helps more than one million oncology patients every year around the world, with medicine that’s made at our flexible, high capacity and high quality EU manufacturing sites. Actavis Turkey can offer added value in oncology, delivering great quality for patients at affordable prices.” Leading generic pharmaceuticals specialist announces 14 new product launches in Turkey for 2012, with a strong emphasis on oncology. Outlining the Company’s plans for 2012, Actavis Turkey Country Manager Serdar Sozeri confirmed that a major oncology offering would be launched in 2012. “The new molecules available to the Turkish market will include Docetaxel, Irinotecan, Gemcitabine, Vinorelbine, Fludarabine, Etoposide and Topotecan. These new oncology products will help support Turkish people in the battle against cancer, and for healthcare professionals there is the added advantage of Actavis’ innovative safety-enhancing developments. Building on detailed consultation in more than 40 markets, Actavis continues to develop new and often unique oncology presentations. Recent developments include ready-to-use mini-bags and reformulations of old powder-form cytotoxic pharmaceuticals. The world’s fourth biggest player in the industry, Actavis specialises in the development, manufacture and sale of first-class generic pharmaceuticals. Revenues for Actavis Group are expected to top EUR2bn in 2012, with the Turkish market forecast to contribute around EUR38m. Globally, Actavis’ hospital business ranks amongst the top 10 hospital generics players, with 630 dedicated hospital employees present in more than 30 markets and two high-quality manufacturing sites in Italy and Romania. It has manufacturing capacity for 42 million vials and markets in excess of 150 hospital products, a number that is set to increase rapidly with hundreds of applications currently pending and an ambitious development pipeline. EnquiriesFrank StaudEVP Corporate CommunicationsTel: +41 (0)79 230 9578E-mail: fstaud@actavis.comProductTue, 29 Nov 2011 09:00:00 GMT{5ADBB5B2-E501-4C9C-AEF1-337C918C4959}http://www.actavis.com/en/media+center/newsroom/articles/pharmapack_acquisition.htm Actavis Group, the international generic pharmaceuticals company, has acquired 100% of the shares in PharmaPack International B.V. for an undisclosed amount. PharmaPack is based in Zoetermeer, the Netherlands, and is a specialist in packaging pharmaceutical as well as biotechnological products. The company has extensive experience with product, organisational and country-specific packaging requirements and has been involved in the pharmaceutical service industry for almost 30 years. CEO Claudio Albrecht: “This brings us more flexibility and has a very positive cost impact for Actavis” "I have known this professional company for a long time and I am very proud that the owners decided to choose Actavis as their new partner. It is obvious that they had other opportunities as well," said Actavis CEO and Chairman Claudio Albrecht. “This acquisition gives Actavis much greater flexibility in tender markets and allows for minimum order quantities for smaller markets.” Actavis buys a considerable amount of tablets from third-party manufacturers. "The lead times are sometimes between six and nine months and therefore much too long. With the acquisition of PharmaPack International we are able to reduce these lead times by more than 50 per cent,” added Albrecht. One of the Dutch company’s future roles will be the bulk packaging of pharmaceuticals produced in the Actavis facility in Alathur (India). Another advantage of this packaging centre will be a significant reduction in freight costs. In summary, PharmaPack International will increase the Group's cost competitiveness and have a very positive impact on Actavis’ working capital. Gerard Stevers, Director and owner of PharmaPack International, said he is convinced that the important and well-considered decision to sell the company will secure the future of the employees of PharmaPack. "PharmaPack will benefit from the global organisation of Actavis and have a great opportunity to grow within this international group." He added that Actavis has very dynamic growth plans for the future and this expansion will have very positive effects for PharmaPack. "Actavis will need even more capacity for their packing processes and are thinking about expanding this facility." About Actavis Group:Actavis is the world's fourth largest generic pharmaceutical company. It specialises in the development, manufacture and sale of generic pharmaceuticals. The Company has operations in more than 40 countries, with over 10,000 employees. Actavis operates 14 manufacturing sites in 12 different countries with a total manufacturing capacity of 24 billion tablets/capsules per annum. About PharmaPack International:PharmaPack International has been involved in the pharmaceutical service industry for almost 30 years. In 1983, the company started out as a pharmaceutical contract packager in Rijswijk, the Netherlands. Thanks to their efficient production process, good price-quality ratio and great delivery performance, PharmaPack international developed into one of the largest pharmaceutical packers in Europe, as well as a market leader in the Netherlands. In 1998, successful growth necessitated a move to larger premises in Zoetermeer, where the company is able to provide optimum service in a well-equipped business environment. PharmaPack supports its customers by means of the "one-stop shopping" principle, offering a complete solution – from bulk sampling and storage, to the sourcing of packaging materials and release of end products for transport. PharmaPack’s services in brief:Primary packaging: blisters, containers, hospital packages (unit dose), buckets, bulk packaging, deblisteringSecondary packaging: vials, inhalers, kitting, manual packaging, repackaging, labellingPurchase of all necessary packaging componentsBulk sampling and quarantine storagePackaging and storage of opiates class 1 and 2Climate controlled storage and worldwide distributionPackaging for clinical trialComplete (cold) supply chain solutionsSecondary packaging of cytostatics and (anti-)hormones# # # # EnquiriesActavis GroupFrank StaudEVP Corporate CommunicationTel: +41 79 230 95 78E-mail: fstaud@actavis.comOtherFri, 02 Dec 2011 07:50:00 GMT{A201BB9F-C5A3-464C-BA12-D1FE33580798}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+launches+three+new+generic+products+in+Europe.htmActavis today announces the market launch of the prostate drug Finasteride in Spain, Portugal and Slovenia, the antidepressant Mirtazapine smelt in France and the antiepileptic drug Topiramate in Portugal. Finasteride, the generic equivalent of Merck’s Proscar, is used for treatment of benign prostatic hyperplasia and is sold in 5 mg tablets. Annual brand product sales amounted to EUR600m worldwide in 2006. Mirtazapine smelt, generic equivalent of Organon’s Remeron is used to treat mental depression and is sold in orally disintegrating tablets of 15mg, 30mg and 45mg. Annual brand product sales were about EUR200m worldwide in 2006. Topiramate is the generic equivalent of Janssen-Cilaq´s Topimax and is used to treat epilepsy and will be sold in tablets of 25mg, 50mg, 100mg and 200mg.Each of these products will be marketed by Actavis’ European sales force and through Medis, Actavis’ third party sales division, who will distribute the drugs to their customers in Europe. ProductMon, 22 Jan 2007 10:52:17 GMT{00924952-85EE-4462-B7F6-C9F241A56287}http://www.actavis.com/en/media+center/newsroom/articles/milan+roundtable+bulgaria.htm Milan Todorovic, Actavis’ EVP of Central Eastern Europe Sales, was keynote speaker at the Eight Business Roundtable with the Government of Bulgaria organized by the Economist magazine, held on 8 December 2009 in Sofia. His presentation highlighted the importance of Actavis Bulgaria within the Group and as the biggest pharmaceutical company in Bulgaria. Other participants at the conference included the Prime Minister of Bulgaria, the Minister of Economy, the Minister of Regional Development and Public Works, the Minister of Transport and Information Technology and the Deputy Governor of the Bulgarian National Bank. OtherThu, 10 Dec 2009 10:51:00 GMT{01D0DBDB-F67B-4186-89F1-1A34EF94AC41}http://www.actavis.com/en/media+center/newsroom/articles/olanzapine+actavis.htm Actavis Group today announced the launch of Olanzapine tablets in Germany. The product is sold via Actavis’ third party division, Medis, to other pharmaceutical companies who market the product under their own label. Medis’ customers are the first to market a generic version of this product in Germany. Olanzapine, the generic equivalent of Eli Lilly’s Zyprexa, is used in the treatment of schizophrenia and bi-polar disorder. The Actavis product is available as tablets containing 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg. Annual branded product sales were about EUR3.3 billion globally with the German market accounting for about EUR140 million . Zyprexa, which is Lilly’s top selling brand, was the fourth highest selling pharmaceutical product in Europe, and in Germany, in 2006. Generic Olanzapine was developed at Actavis’ principal research and development site in Iceland, and is manufactured in Actavis’ production plant in Malta for the German market. Gudbjorg Edda Eggertsdottir, Executive Vice President of Third-party sales, said:“Olanzapine represents a very important addition to Medis’ portfolio, and is expected to be one of the third-party sales division‘s top ten products this year. This is the most important new product launch for the division in 2007. The fact that Actavis completed its development of the product very early, five years prior to patent expiry, made it possible for the company to seize this opportunity. The company’s regulatory affairs staff and the production staff in Malta have worked very hard on making this launch possible at this early stage.” The patent for Olanzapine will in most cases expire in September 2011, but a German Patent Court ruled earlier this year that Lilly’s patent is invalid, making the launch of a generic version possible now. The first Marketing Authorisations for the product were granted in Germany on 19 October, 2007. ProductWed, 07 Nov 2007 09:50:00 GMT{03216FB7-EFC5-4996-BB8D-4A8D1859034B}http://www.actavis.com/en/media+center/newsroom/articles/sertraline+us.htmActavis today announced that it has received approval from the U.S. Food & Drug Administration to market Sertraline Hydrochloride tablets. Distribution of the product will commence immediately. Sertraline Hydrochloride tablets, the generic equivalent of Pfizer’s Zoloft® tablets, are available in 25mg, 50mg and 100 mg strengths. Sertraline Hydrochloride tablets are indicated for the treatment of major depressive disorder, obsessive-compulsive disorder and panic disorder. Annual brand sales of Sertraline Hydrochloride tablets in the U.S. were approximately US$3.1 billion for the twelve months ending June 2006 according to IMS Health data. More information about Actavis in the US can be found at www.actavis.usProductWed, 07 Feb 2007 12:30:00 GMT{032350E4-F851-40C3-98A3-353429764EA9}http://www.actavis.com/en/media+center/newsroom/articles/actavis+changes+balkan+region.htm New management appointments at Zdravlje - Actavis are part of the company's overall strategy for expansion and development in the Balkan region. Milan Todorović, Regional Director Actavis Balkan Milan Todorović, General Manager of Zdravlje - Actavis Company, has been promoted to Regional Director for the Balkans starting December 1 2004. According to the new organisational structure the Balkans region now include the markets of Serbia and Montenegro, Bosnia and Herzegovina, Macedonia, Romania and Albania. The main goal of this regional branch office of Actavis in the Balkans, which is based in Belgrade, will be the consolidation of the Balkan market and a strategic expansion of Zdravlje’s product sales and marketing, along with the introduction of Actavis group products into these markets. Milan graduated from the Faculty of Philosophy in Belgrade and holds a BA in Industrial Psychology. Before joining Zdravlje in January 2004 he held various regional managerial positions in the Balkans, with the Coca Cola Company, Whirlpool and Glaxo Smith Kline. Milan will report to Per Edelmann, Chief Executive of Sales and Marketing Own Brand Division. Goran Stojilković to be General Manager of Operations at Zdravlje Actavis Company Goran Stojilković will take the position of Plant Manager of Zdravlje – Actavis Company in Leskovac, heading the manufacturing operation there. Goran graduated from the Faculty of Technology with a BSc in Chemical Engineering. He has been with the company since graduation, last serving as site manager. Goran will report to Gerry Connelly, Operations Division Actavis Group. The new organisational and management structure in the Balkan region has the objective of improving and increasing product sales of both Zdravlje and Actavis on those markets, through more active marketing and sales activities, and by achieving the investment programme by the end of 2007. In order to enhance flexibility, pro-activeness and efficiency the current changes being made at the Actavis group site in Serbia are designed to: · Align the structure in Serbia with the new Actavis Group’s structural design · Enhance focus through more manageable size of the business units · Clarify responsibilities and accountability · Create a strong focus on bottom-line results but with the overall picture clearly in mind. "The main idea of the organisational change means that both the Regional Office for the Balkans and Zdravlje have global and local responsibility to make the new structure fully functional. This new Zdravlje Actavis system will take steps to foster teamwork and have clear leadership strategy that will enable them to be essential part of the Actavis Group", said Robert Wessman, CEO of Actavis Group. Zdravlje – Actavis Company Since privatization at the end of 2002, when the company from Leskovac became a part of the Actavis Group, Zdravlje - Actavis Company has achieved significant business results. During 2004 a total of 6.9 million EURO will be invested in new production equipment, reconstruction of the factory and other sectors, installation of a modern IT system and quality control, as well as improvement of work conditions. The position of Zdravlje – Actavis Company has been consolidated on the local market, as have export activities, the trust of buyers and business partners has been regained, and a 10% sales increase of medical drugs has been recorded compared to the previous year. OtherThu, 02 Dec 2004 09:48:00 GMT{0436FFFB-5721-47EC-8B9A-B81B50B43698}http://www.actavis.com/en/media+center/newsroom/articles/actavis+harvard+business+school+case+study.htm Harvard Business School has published a case study on Actavis and its President and CEO. The study, entitled "Robert Wessman and Actavis’ ‘Winning formula’" was presented in an MBA class in international entrepreneurship at Harvard Business School. The case will be made available to business schools around the world. Dr. Daniel Isenberg, Senior lecturer of Business administration at Harvard Business School, expressed interest in creating a case study of how what started as a relatively small Icelandic pharmaceutical company has today gone on to become one of the most important players in the generic pharmaceutical business internationally, lead by its 39 year-old CEO Robert Wessman. Robert Wessman participated in extensive interviews with Dr. Isenberg to develop the study, providing financial data and historical information, as well as engaging in in-depth personal interviews. The case study also features quotations from interviews with senior management, including the Deputy to the CEO, the Vice president of Human Resources and Organisational Development and the Director of Corporate Branding. Robert Wessman also joined Dr. Isenberg as a class guest for the case debut at Harvard Business School on 22 April and answered numerous questions from the students, who asked about a variety of topics, including the Actavis way of doing business and the CEO’s leadership style. Commenting, he said: "I really enjoyed the experience. We are delighted that Harvard Business School is interested in Actavis’ growth story and our Winning formula. It's a great honour for Actavis and for me personally to be part of the Harvard Business School curriculum." The case takes a look at the company culture and the CEO’s management style. It details the Actavis story from 1999, when the company had about a hundred employees, all located in Iceland, to the end of 2007 when the employees of the very successful global company numbered more than 11,000 in 40 countries. During this period Robert Wessman led the company through 26 acquisitions and extensive integration of the acquired companies. Daniel Isenberg is Senior Lecturer of Business Administration at the Harvard Business School in the Entrepreneurial Management Unit, where he teaches classes on International Entrepreneurship and The Entrepreneurial Manager: “Actavis has grown from a small domestic player to one of the world leaders within 7 years, an accomplishment which is very unusual, to say the least, especially given the extremely competitive nature of the generics industry. The fact that Actavis has simultaneously globalized its supply chain, its markets, its research and development, and, to a lesser extent, its management, is an achievement which speaks for itself. “ The case study method forms the basis of learning at Harvard Business School, with more than 80% of classes built on the method. It is also used at many other universities around the world. Case discussions introduce students to the reality of decision making in business situations, including time constraints, conflicting goals and incomplete information.OtherThu, 24 Apr 2008 07:50:00 GMT{081046F5-3652-437C-919C-04C340B043E4}http://www.actavis.com/en/media+center/newsroom/articles/actavis+amide+fda+approval+mirtazapine.htm Actavis Group hf.(“ACT”) today announces that Amide Pharmaceutical Inc., a subsidiary of Actavis Group in New Jersey USA, has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mirtazapine orally disintegrating tablets (ODT) 15 mg, 30 mg and 45 mg. Mirtazapine ODT is the generic version of Organon’s Remeron SolTab® and is indicated for the treatment of major depressive disorder. As one of the first two applicants to file an ANDA containing a paragraph IV certification, Amide has been awarded 180 days of shared marketing exclusivity for the 45 mg dosage strength. An authorized generic version of the 45 mg strength was launched in October 2004. Annual U.S. sales of Mirtazapine ODT tablets are approximately US$100 million. Amide will manufacture, market, sell and distribute Mirtazapine ODT in the U.S. and will begin shipping Mirtazapine ODT 15 mg, 30 mg and 45 mg tablets shortly. Amide Pharmaceutical, Inc., located in Little Falls, New Jersey, develops, manufactures and markets a select line of high quality pharmaceuticals. The company was acquired by Actavis Group hf. in May 2005.The product is expected to have insignificant material effect on Actavis’ financials for 2005.ProductMon, 05 Sep 2005 16:23:00 GMT{09518CFC-B345-4450-8900-F969654EF492}http://www.actavis.com/en/media+center/newsroom/articles/elizabeth-manufacturing.htm Actavis U.S., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group, on Friday announced plans to consolidate all New Jersey manufacturing operations at its Elizabeth, N.J. facility, a move that will enhance the leading generic manufacturer’s efficiency and focus. “As a company, we are constantly evolving and seeking ways to improve operational and other efficiencies that will enhance our competitiveness,” said Actavis Inc. CEO Doug Boothe. “Consolidating our New Jersey operations at our Elizabeth site will help us achieve significant savings to allow us to continue delivering best value pharmaceuticals at competitive prices to our customers. Ultimately, this will benefit U.S. consumers.” The company will cease its current operations in Passaic County, with some employees transferring to Elizabeth or other Actavis sites. Others will be let go beginning in May. Employees were notified of the company’s plans today. “This was not an easy decision, especially in its impact on these valued employees,” Boothe said. “But it was determined that continuing to operate those facilities did not align with our long-term strategy and, as such, would not be in the best interest of Actavis, our employees or our customers.” EnquiriesMedia Linefor Actavis U.S.Tel: +1 973 889-6689E-mail: media@actavis.comOtherFri, 23 Apr 2010 18:30:00 GMT{0A1E93D7-0266-42F9-A7EF-340FC466AEC8}http://www.actavis.com/en/media+center/newsroom/articles/oslo+joins+youth+in+europe.htm Silvi Lysthaug vice-mayor of Oslo has signed a Letter of Intent for the City of Oslo to become the 11th city to formally join the programme, Youth in Europe – A drug prevention programme, which is based on using social research to build best prevention practices. The agreement was signed at the 13th Annual Mayors’ meeting of ECAD, European Cities Against Drugs in the presence of President Olafur Ragnar Grimsson of Iceland, who is the patron of the programme. The programme is based on Icelandic research oriented preventions, spanning the last two decades, documenting risk and preventive factors. The city of Reykjavík chairs the steering committee, and the programmes’ sponsor is Actavis.CommitmentFri, 02 Jun 2006 00:21:00 GMT{0A3BCFF9-0641-4D70-BA8F-3F781CD32DE2}http://www.actavis.com/en/media+center/newsroom/articles/icelandic+investor+relation+award.htm Group receives award for "the best large and mid-cap Icelandic investor relations". Actavis Group hf., the international generic pharmaceuticals company, was last night recognised as having "the best large and mid cap Icelandic company investor relations" at the prestigious IR Magazine Awards. Presenting the award, the magazine highlighted Actavis as ‘a highly visible company with excellent disclosure and accessible management.’ Each year, across eleven regions, the IR Magazine conducts a survey among over 5,000 investment professionals and more than 3,000 retail investors to establish what companies are considered to have excelled in investor relations. The results are widely regarded as the definitive measure of outstanding performance and provide the corporate world with solid benchmarks for their IR programs. Halldór Kristmannsson, Head of Corporate Communications at Actavis, said: "We are delighted to receive this award, especially as it follows a year in which Actavis has been very active and seen a significant amount of change. Strong communications with all our stakeholders is very important to us, and we will improve our investor relations further still to keep the investment community well informed about Actavis’ continued progress and development.”OtherThu, 27 May 2004 11:06:00 GMT{0C591833-EEBC-4DC1-BBBA-CFBFFCF3C9E2}http://www.actavis.com/en/media+center/newsroom/articles/valaciclovir_switzerland.htm Actavis has launched Valaciclovir in Switzerland on day one after the patent expired on 27 June. Valaciclovir is used to treat herpes virus infections. Valaciclovir Actavis has already been launched in a number of markets í Europe, including France and the UK, and will soon be entering other European markets. In Switzerland, it was launched under the Actavis brand as well as by customers of Medis - Actavis’ Third-party sales division. Valaciclovir is marketed by GlaxoSmithKline under the brand names Valtrex® / Zelitrex®. The equivalent generic drug from Actavis is available in Switzerland in 500mg tablets. Valaciclovir (also spelt valacyclovir) is used to treat herpes virus infections, including cold sores, shingles and genital herpes in adults as well as chickenpox and cold sores in children. Valaciclovir Actavis was developed by Actavis R&D and is manufactured by Actavis in Iceland.ProductWed, 30 Jun 2010 21:45:00 GMT{0E449062-F3F4-490B-85D5-7BC04BD9B0DB}http://www.actavis.com/en/media+center/newsroom/articles/pramipexole_uk_germany_day_one.htm Actavis Group, one of the world’s leading generic pharmaceuticals companies, has launched Pramipexole, a generic version of Boehringer Ingelheim’s brand Sifrol®/Mirapexin® in Germany and the United Kingdom. The product was launched under Actavis’ own brand on day one, immediately after the patent expired, in both markets. Pramipexole is used for Parkinson's disease and the treatment of Restless legs syndrome. The Brand product had sales in the EU of approximately EUR339 million for the 12 months ending 30 September 2010, according to IMS Health.ProductMon, 20 Dec 2010 13:46:00 GMT{11071733-7663-4D90-B59C-4F08327E0127}http://www.actavis.com/en/media+center/newsroom/articles/symposium+sweden.htm Actavis is hosting a symposium on alcohol problems at an annual doctors’ meeting (“Riksstämman”) in Gothenburg, Sweden. Speakers at the symposium, “Patients with alcohol problems – what can primary care do?” include three well-known Swedish doctors within the field. Actavis has, together with one of the speakers, prepared supporting material for doctors to use when talking about alcohol with patients. This will be launched during the meeting and made available to all primary care centres in Sweden. In its booth at the Riksstämman exhibition, held 26-28 Nov, Actavis will present its broad product portfolio, its OTC products and launch its latest business area in Sweden – hospital products.OtherWed, 26 Nov 2008 13:54:06 GMT{11F9E709-D481-4A04-A162-9D63267FD11A}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+First+Market+Isotretinoin.htmActavis has launched its Isotretinoin under the brand name Decutan into the United Arab Emirates and Iran. Decutan is currently the only generic isotretinoin available in both markets. Decutan is a prescription drug and is indicated for the treatment of severe acne, which does not respond to other treatments. It contains the active substance isotretinoin, which belongs to the group of drugs called retinoids, which are structurally related to vitamin A. It reduces the activity of sebaceous glands, which produce fat in the skin. Decutan was launched to Dermatologists in Abu Dhabi and Dubai at the end of January. Both events were well attended by leading dermatologists as well as high profile members from the Ministry of Health, who were also interested to listen to a presentation made by Dr. Joseph Pace, a leading Maltese dermatologist, entitled “Management of Acne – Past, Present & Future”. The launch of Decutan marks the entry of Actavis onto the Middle East markets. The company has also launched Ciprofloxacine and Cetirizine and has a number of products currently under registration. Following the acquisition of Alpharma in December 2005, the Actavis portfolio in the Middle East is set to increase to over ten products by the end of 2006.ProductMon, 06 Feb 2006 14:18:00 GMT{1248B800-58AB-418E-ACAB-C632612F9C6C}http://www.actavis.com/en/media+center/newsroom/articles/leskovac+eu+gmp+approval.htm Following a period of intensive modernisation, Zdravlje Actavis has been officially ‘EU GMP’ certified by the Danish Medical Products Agency. The European Good Manufacturing Practice (EU GMP) standard represents the highest quality assurance in the generic pharmaceutical sector in Europe. The EU GMP certification will further intensify the ongoing transfer of products from Actavis' broad portfolio of first-class generic pharmaceuticals to the Leskovac facility. It has increased the scope of annual turnover in Serbia from 45 to 71 million Euros and will raise the company’s current export rate of 16% to around 46% by the end of 2009. Commenting on the historic milestone, Managing Director of Zdravlje Actavis Goran Stojilkovic said: “This EU approval represents the crowning of our efforts to completely modernise our operations and is the result of a very complex process of organisational change. “The first half of 2008 saw the start of significant product transfers to our Leskovac site. This process has now speeded up and will see annual production at Zdravlje Actavis increase from 500 million tablets in 2008 to 1.9 billion tablets by 2010. “Zdravlje Actavis is now an important gateway to European and global markets, ultimately supplying Actavis customers on three continents with high quality generics. With this latest recognition of our manufacturing standards we have created value for our many stakeholders and added a new perspective on the future development of this company.” Within the past three years Zdravlje Actavis has implemented: • the SAP operative system • ISO 14001 • ISO 9001:2000 • OHSAS 18001 It has also re-certificated the CE Mark and completely modernised its Microbiological and Physical and Chemical Laboratories to comply with the most stringent standards of Good Laboratory Practice.OtherThu, 06 Nov 2008 10:38:00 GMT{13237D69-AA49-4190-9203-B802CBBE3A54}http://www.actavis.com/en/media+center/newsroom/articles/actavis+medis+cphi+madrid+2009.htm Employees from Actavis Group's diverse departments worldwide will be present at this year's annual CPhI conference, held in Madrid, Spain on 13-15 October, 2009. Medis – Actavis' third party sales division — had its own stand at the CPhI exhibition for 8 years, but has shared the floor with Actavis Group for the past couple of years. Employees from Actavis and Medis will participate in this year's CPhI conference, the world’s leading pharmaceutical trade conference, now in its 20th year. Our location this year: Hall 4 booth 4D16 CPhI Worldwide was launched in 1990 as an international convention on pharmaceutical ingredients and intermediates. The first CPhI Worldwide in 1990 attracted 250 visitors for the 16 exhibitors. This year about 25,000 industry professionals are expected, visiting about 1,400 exhibiting companies from more than 125 countries. CPhI websiteMedis websiteOtherTue, 25 Aug 2009 15:44:00 GMT{133FF2F1-E648-4457-8A28-8BC5A159BCF5}http://www.actavis.com/en/media+center/newsroom/articles/businessallianceJapan.htmActavis Group and ASKA Pharmaceutical (Tokyo Stock Exchange: 4514) announce that the companies have concluded a preliminary agreement concerning the establishment of a joint company: Actavis ASKA Co., Ltd. - planning to enter the Japanese generic pharmaceutical market in April 2009. ASKA will hold 55% of shares in the joint venture; Actavis 45%. Strategic RationaleJapanese government policy requires an increase in the generic share of the total pharma market (in volume) so that this share grows to more than 30% by 2012. Measures - for example, the re-amendment of the prescription form in April 2008 - are being taken to facilitate this policy objective and, therefore, increase the usage of generic products. Through this business alliance, ASKA will have the ability to enter the market with the benefit of Actavis’ product portfolio and in addition will have the possibility of exploring the export potential for its new products and value-added formulations via Actavis’ global marketing channels. Actavis has the opportunity to enter the Japanese market and utilize its wide product portfolio, both existing and in the pipeline, in co-operation with an experienced and resourceful partner. Takashi Yamaguchi, CEO, ASKA Pharmaceutical:“This business alliance will enable ASKA to combine the benefits of its expertise in developing and marketing pharmaceutical products in Japan with Actavis’ broad range of products marketed globally. Thus, the new joint company will be able to maximize the different and complementary strengths of its founders, and will aim to become a leading company in the Japanese generic products’ market.” Sigurdur Oli Olafsson, CEO, Actavis Group:“This is an excellent opportunity for Actavis to enter the Japanese market - the second biggest pharmaceutical market in the world. The government’s policy to increase the share of generics during the next few years is key to our decision to enter the Japanese market at this time. We are very much looking forward to a long and successful partnership with ASKA, a strong partner with an excellent local network.” About ASKALocated in Tokyo, Japan, ASKA Pharmaceutical is a research and development (R&D) oriented company, which contributes to society by developing and providing innovative pharmaceutical products, concentrating its management resources to the specific therapeutic areas. Additional information about ASKA, is available through its corporate website. Summary of joint companyName: Actavis ASKA Co., Ltd.Head Office: TokyoCapital: 200 million Yen (planned)Investment ratio: ASKA: 55%, Actavis: 45%Establishment: April 2009 (planned)OtherTue, 11 Nov 2008 08:10:00 GMT{156E3487-5710-41A2-AB45-7DBB635B27EC}http://www.actavis.com/en/media+center/newsroom/articles/international+generics+conference+malta.htm Actavis is proud to have been a principal sponsor of the eighth annual conference of the International Generic Pharmaceutical Alliance (IGPA). This year’s conference location was Malta and from 19-22 June the new Malta Hilton Conference Centre played host to the biggest global gathering of the generic pharmaceutical industry. The welcoming speech of the conference was made by Actavis CEO, Robert Wessman. In his speech he talked about his future vision of the generic pharmacuetical industry stating: “We will see more consolidation and I strongly believe that within the next 4-5 years we will see only a few global players controlling the generics market.” Associated sectors such as technical, banking and industry organisations were also in attendance at the event, which was opened by the Maltese Prime Minister. Actavis also sponsored dinner and an evening cruise around the historical Valletta harbour. Coupled with the conference was a major exhibition. The Actavis subsidiary Medis, which handles sales to third parties, participated in the exhibition and took the opportunity to show customers around Actavis’ newly upgraded, state-of-the-art manufacturing facilities in Malta.OtherMon, 20 Jun 2005 09:51:00 GMT{158BB5AC-E8A5-41CB-9C06-3401ED7EAAFF}http://www.actavis.com/en/media+center/newsroom/articles/bucharest+youth+in+europe.htm Actavis supports the „Youth in Europe” initiative Actavis, Bucharest City Hall and European Cities against Drugs (ECAD) have signed a partnership agreement which see Bucharest City Hall become an ECAD member and an active partner in the drug prevention programme: “Youth in Europe”, which aims to prevent drug consumption amongst young people. “Youth in Europe” was started in 2005. It compares drug prevention strategies and identifies best practice in ECAD member-cities across Europe. In this way, it provides valuable information for all those involved in the ongoing task of protecting young people from the harmful effects of drugs. “Drug abuse has become a serious matter in Bucharest during recent years. In order to offer citizens a safe city in which to live and work, the City Hall is signing this partnership with ECAD for the development of a successful programme, with a great impact in other European cities. We are happy that we can support the young and contribute to a decrease in drug abuse”, says Adriean Videanu, mayor of Bucharest. From September 2007, having signed the partnership agreement, Bucharest City Hall becomes an ECAD member-city and a partner to the Youth in Europe Programme. European cities already participating in the scheme include Reykjavík, Vilnius, Sofia, Moscow, St. Petersburg, Istanbul, Oslo, Helsinki, Stockholm, Kaunas, Klaipeda and others are expected to join soon. The programme is chaired by the City of Reykjavík. The President of Iceland, Mr. Olafur Ragnar Grimsson, is its patron. Actavis, international generics pharmaceutical company headquartered in Iceland, is the main sponsor of this ambitious project. Its support is driven by its social responsibility programme which it carries out within the communities in which it operates. “We are happy to see more and more cities joining “Youth in Europe”. It is important that leading pharmaceutical companies involve themselves in social programmes related to the health sector. We are delighted to contribute to the development of the communities in which we conduct our operations. Romania is just such a place - a very important area for us where we are eager to make a positive contribution”, confirms Robert Wessman, President and CEO Actavis Group.“Youth in Europe” was launched in Bucharest on an official visit of Iceland’s president to Romania. The partnership agreement bears the signatures of the mayor of Bucharest, Adriean Videanu, ECAD representative, Dagur B. Eggertsson, and Actavis President and CEO, Robert Wessman. CommitmentWed, 19 Sep 2007 20:10:00 GMT{16D66FE3-0782-4273-9C1C-36B8F06CD5ED}http://www.actavis.com/en/media+center/newsroom/articles/zdravlje+actavis+internet+cafe.htm In July 2004 Mr. Milan Todorović, Managing Director of Zdravlje – Actavis Group, generously provided the town of Leskovac in Serbia with a fully equipped Internet Café. This café presents a unique and rare gift to Leskovac town and its inhabitants, and it has become very popular in a short period of time. The Internet Café Zdravlje (is technically equipped to meet the requirements of all internet and personal computers users, therefore special groups of people have been formed in a short time, accordingly to their fields of interests. While the Internet Café is open, ten personal computers are active all the time and all of them are constantly occupied – says Mr. Igor Nikolić, the Internet Administrator. The Internet Café users are all ages, from the youngest to the oldest citizens, but the most frequent users are teenagers and students. More than a thousand students attend various Faculties in Leskovac. Therefore, the internet represents a rich library and an archive of boundless opportunities, and the Café is the place which can offer its users the necessary communication. Hence, the essence of the Internet Café, is not only important for the purpose of Zdravelje – Actavis Group marketing, but it also has significance within educational, social and other spheres. CommitmentTue, 31 Aug 2004 10:35:00 GMT{171DC442-1FB3-496F-8807-13FC03C999E3}http://www.actavis.com/en/media+center/newsroom/articles/actavis+acquires+ophtha+denmark.htm Actavis Group has acquired Ophtha, an independent Danish medical company specialised in ophthalmology. Financial details were not disclosed. Ophtha, located in Copenhagen, is family owned and founded in 1998. Ophtha A/S markets a broad range of basic ophthalmic products in Denmark, and Norway. Ophtha holds 10 Marketing Authorisations in Denmark and 5 in Norway. Furthermore they market sporadic export to Sweden and Estonia. Ophtha has 4 employees. Commenting on the acquisition, Robert Wessman, President and CEO of Actavis said: “Actavis has been strengthening its sales and marketing network for own-label products through a series of acquisitions in central and eastern Europe. The acquisition of Ophtha is in line with our strategy to strengthen the distribution of own-label products in Northern Europe.” The acquisition is not expected to have any material effect on Actavis' financial results in 2005. Actavis has a sales and marketing office in Hoersholm in Denmark handling sales and marketing in Denmark and an office coordinating the sales and marketing activities in Northern Europe. The company holds 39 Marketing Authorisations in Denmark and 15 in Norway. OtherThu, 27 Oct 2005 15:36:00 GMT{180CC410-551A-40F6-9214-5B90259AD74B}http://www.actavis.com/en/media+center/newsroom/articles/formal_opening_zug.htm Company to address future challenges with new ‘think smart medicine’ approach Actavis today formally opened its new management offices in Zug, Switzerland. At a press conference to mark the opening of the new headquarters, CEO Claudio Albrecht stated that the generic industry “needs to change.” Payors, he said, need modern approaches to cope with exploding health care costs. Albrecht presents Actavis’ answer to this in the form of a new tagline for the Company: “think smart medicine”. The tagline, he says, relates to a bundle of concepts which should help to cope with this challenge. “This means that we have to come up with more clever concepts, for example offerings in managed care regarding dose dispensing.” Actavis must try to be ahead of the generic industry finding new and innovative solutions. With ‘think smart medicine’ we will address our customers’ future needs. Actavis aims to become a global player in diabetes by building an international diabetes franchise around recombinant and analogue insulins. “There are 230 million diabetes patients worldwide. We will be the first company in the future to offer the broadest diabetes portfolio.” By challenging traditional thinking Actavis wants to offer direct-to-consumer concepts in the area of dermatology and female health. “Intelligent strategic partnerships will give us the possibility to be one step ahead of our competitors”, Albrecht stated. Albrecht explained that the global pharmaceutical landscape will change once many of the current top-sellers lose patent protection over the next few years. “In 2016, out of the top 20 drugs, more than half will be biologics, others will be hard-to-develop generics, such as inhalers.” The CEO added that he’s not sure there will be such a clear difference between innovator and generic companies in the future. “The lines between the two models are blurring. The generics business as we know it today will be gone within the next ten years. A key challenge for the generic industry – which was used to substitution and key accounting for many years – will also be the required scientific detailing of the new generation of products.” Albrecht also commented on the location of the Company’s new headquarters. “Zug is centrally located in Switzerland, and close to Zurich, one of Europe’s major crossroads. We chose Switzerland because of the outstanding pharmaceutical environment, the availability of qualified personnel, the international atmosphere and the centrally located Zurich Airport.” Today around 100 Actavis employees from 29 different countries are based in Zug. By the end of Q2 2011, the Company expects all six floors of the 4,000 sq m building will be fully occupied, with 150 people on site. Actavis is an Icelandic company, founded in 1956. Following a number of acquisitions over the past decade, members of Actavis’ top management team were located in Iceland, as well as in various cities in Europe, amongst which were London and Copenhagen. Actavis also evaluated Copenhagen, London and Amsterdam as possible locations before deciding on Zug. OtherMon, 09 May 2011 10:33:00 GMT{192383FB-E4F7-423D-999F-B59FA937621E}http://www.actavis.com/en/media+center/newsroom/articles/three+products+turkey.htmActavis today announces the launch of three new products in Turkey, all of which will be marketed under the Group's own label.The three products include: Xetanor (Paroxetine), an antidepressant under the class type SSRI. Xetanor is the first generic version of this drug available in Turkey. It is the generic equivalent of Paxil® (GSK) and Seroxat® (Novartis). Xetanor is produced in one strength, 20 mg tablets, with 30mg tablets scheduled for launch later this year. Blockace / Blockace Plus (Ramipril), the generic equivalent of Delix® and Delix® Plus, products of Aventis Pharma, is an antihypertensive agent under ACE Inhibitors class. Blockace is produced in three strengths, 2.5mg, 5mg and 10 mg tablets. Actavis is also launching the drug's plus form with diuretic (HCT) additive as Blockace Plus. It is available in 2.5/12.5 mg and 5/25 mg tablets. Blockage Plus is the first generic version of this drug on the Turkish market. Vivafeks (Fexofenadine), an agent used as an anti histaminic. It is the generic equivalent of Telfast, a product of Aventis Pharma's. Vivafeks is produced in two different strengths - 120 mg and 180 mg tablets. ProductMon, 23 Oct 2006 15:48:00 GMT{1A44441B-8288-410F-82E2-D032E5FC9FCF}http://www.actavis.com/en/media+center/newsroom/articles/approvalofLevetiracetam.htm Actavis has received approval from the US Food & Drug Administration (FDA) to market Levetiracetam Oral Solution. Distribution of the product has commenced. Levetiracetam Oral Solution is available in the 100mg/mL strength and is the generic equivalent of Keppra® Oral Solution by UCB, Incorporated. Levetiracetam Oral Solution is used in the treatment of partial onset seizures in adults and children with epilepsy. Annual U.S. sales of Keppra® Oral Solution were US$95.9 million for the 12 months ending September 2008 according to IMS Health data. Commenting on the new approval, Doug Boothe, CEO of Actavis in the United States said: “The approval of Levetiracetam Oral Solution demonstrates our continuing commitment to introduce new generic products to the marketplace, as well as highlights our expertise in developing and manufacturing a wide range of dosage forms. Actavis’ drive to be a leader in generic pharmaceuticals is supported by one of the largest product development pipelines in the industry. ”ProductWed, 21 Jan 2009 13:05:41 GMT{1A5F9818-1A13-4587-9F89-A4886A1C3EB5}http://www.actavis.com/en/media+center/newsroom/articles/actavis+donates+medicine+to+Asia.htm In response to the disaster and humanitarian crisis in S.E. Asia, Actavis is donating medicines to the affected areas. The contribution will be in the form of antibiotics and analgesics. The shipments which originate from Actavis' operations in Malta, Turkey and Bulgaria will be flown to the affected areas over the next few days. The Government of Sri Lanka will handle the allocation and distribution of the medicine from Bulgaria and Turkey, in Sri Lanka. Actavis in Malta will donate medicine to the Red Cross in Malta, which will distribute the medicine to the victims. "We are horrified and very saddened to see the human disaster that has taken place and want to make a contribution to help ease the suffering in the region" said Guðbjörg Edda Eggertsdóttir, Chief Executive Sales & Marketing, third party sales.CommitmentThu, 30 Dec 2004 16:24:00 GMT{1A728CA1-10A6-4D0A-B1FB-F4A8A7BCA56B}http://www.actavis.com/en/media+center/newsroom/articles/clamelle+nicholas+hall+award.htm Actavis’ OTC product Clamelle has been awarded the prestigious Nicholas Hall European New Product of the Year Award. Awarded for the most innovative and successful new product launch or ‘Pom to P’ (prescription to OTC/without prescription) switch, Clamelle from Actavis was a clear winner as the first OTC oral antibiotic (azithromycin 500mg), as well as being supplied as part of a professional service and a diagnostic test. Accepting the award, Richard Hollies, Actavis’ OTC Marketing Director, paid tribute to the hard work and dedication of the Actavis UK team in steering through this unique switch. Since their creation, the Nicholas Hall Marketing & Creative Awards have highlighted and rewarded outstanding achievements in European OTC marketing, and have done much to spur ever higher standards of innovation and execution in the industry. This award builds on Clamelle’s success earlier in the year when the Clamelle Chlamydia Service was awarded ‘Best POM to P switch of the Year’ at the SMaRT Awards and ‘Most Innovative New OTC Product’ at the OTC Marketing Awards.Websites: Nicholas Hall Marketing & Creative Awards Clamelle Chlamydia Service ProductTue, 05 May 2009 10:53:00 GMT{1A879522-F8EC-49D6-B9F5-3D89CD49DF96}http://www.actavis.com/en/media+center/newsroom/articles/oxycodone+reintroduced+US.htm Little Falls facility resumes production with FDA approval of critical pain solution Actavis today announced the reintroduction by its subsidiary in the United States of Oxycodone 15 mg and 30 mg tablet products to pharmacies and customers. Oxycodone is the first product to be manufactured at Actavis’ Little Falls, NJ facility following a recently completed FDA inspection. In December 2008, Actavis Inc. in the US announced that it reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company’s Actavis Totowa LLC subsidiary. This Decree only impacted operations at Actavis Totowa’s three facilities in the US: two in Totowa, NJ and one in Little Falls, NJ. Actavis agreed to not distribute any products from the Actavis Totowa facilities until it certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities. “Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging – and we re-qualified and revalidated all methods used to release products from our Totowa facilities,” said Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis. “This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the Consent Decree.” The FDA completed its inspection and approved the release of the first two products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets. Subsequent inspections, also as outlined in the Decree, will follow. “Our customers come first,” said Doug Boothe, CEO of Actavis Inc. in the US. “We are sorry for the inconvenience the recall caused for some but as a company, we are committed to producing high quality pharmaceuticals, and that’s what we will continue to do.” Actavis, a leading manufacturer of generic pharmaceuticals, announced a voluntary product recall in August 2008 after determining that three of its facilities did not meet the highest standards for quality manufacturing. Following the recall, the company enacted a comprehensive remediation program and engaged an outside firm to assess Actavis Totowa facilities. “Our long and successful history with Oxycodone made it the right medication to produce first,” added Boothe. “It is one of the many quality products that Actavis will have back on the market in the coming months and we are pleased that our customers have responded so positively to its reintroduction.” EnquiriesMedia Linefor Actavis U.S.Tel: (973) 889-6689E-mail: media@actavis.comProductFri, 17 Apr 2009 14:42:00 GMT{1A94389A-2059-4164-BDC5-4AF3ED64D169}http://www.actavis.com/en/media+center/newsroom/articles/docetaxel_single_vial_europe_patent_launch.htm Actavis today announced the launch of a Docetaxel single vial, immediately after the patent expired in major European markets. The cancer drug was launched by Actavis under its own brand in Germany, the Netherlands, UK and Sweden, as well as by Medis ― the company’s sales division to third-party clients ― in the UK and Germany. Actavis has also launched the Docetaxel single vial in Ireland, Finland, Portugal and Austria which were patent-free. The product will be launched across Europe – patents permitting - during 2010 and 2011. Furthermore, Actavis has launched a Docetaxel twin vial in Romania, the Ukraine and in the Balkans. Docetaxel is used to treat a range of different cancers including advanced breast cancer, lung cancer, prostate cancer and stomach cancer. The Docetaxel single vial is produced by Actavis in 20mg, 80mg and 140mg vial sizes. Docetaxel Actavis is the generic equivalent of the Taxotere® brand product from Sanofi Aventis. The brand product, Taxotere® had sales across 29 countries in Europe of approximately EUR800 million for the 12 months ending 30 June 2010, according to IMS Health The Docetaxel single vial is manufactured by Actavis in Romania. Jonathan Ody, Vice President, Actavis Hospital business Unit:“Actavis is delighted to be able to bring to the market a high quality single vial formulation of Docetaxel, the largest oncology product ever to go off patent in Europe, and we are launching it the day after patent expiry. Actavis also brings to market the unique 140mg vial size which is designed to be more convenient and reduce wastage.”ProductMon, 29 Nov 2010 09:04:00 GMT{1B3E85F9-7DFD-4726-BC4D-BEA8E3D809E2}http://www.actavis.com/en/media+center/newsroom/articles/Actavis_acquires_Italian_manufacturing_site.htm Significant increase in Actavis’ oncology products manufacturing capability Actavis has signed an agreement with Pfizer to acquire a manufacturing site specialising in the production of oncology products. The site, which covers an area of 300,000 square metres, is located in the township of Nerviano, approximately 30km from Milan, and employs around 340 permanent staff. Separately, Actavis has entered into a multi-year exclusive agreement with Pfizer for the supply of oncology products. The Nerviano site was originally developed and founded by Farmitalia in 1965. It is approved by the US Food and drug administration (FDA), European Union (EU) and Japanese regulatory authorities, and has broad manufacturing capabilities serving 70 markets around the world. Commenting, Robert Wessman, CEO and President of Actavis said:“This transaction will enable us to meet the exciting growth projections we see for our oncology product portfolio over the coming years. The site is truly world-class, with outstanding facilities and a highly skilled and experienced workforce, and has a proven track record as a supplier of high quality products over many years. Most importantly, there is significant capacity to support our future plans, together with space for new investment in complementary development and manufacturing activities.” Actavis plans to develop new products and transfer existing products into Nerviano over the coming years and the site will work very closely with Actavis’ Bucharest operation which also develops and manufactures oncology products. The transaction is expected to be completed by the end of January 2008. OtherFri, 18 Jan 2008 10:12:00 GMT{1D6B08E4-3481-4F7D-91F3-8E80765D687A}http://www.actavis.com/en/media+center/newsroom/articles/bulgarian+launches+1q+2008.htm Actavis Bulgaria launched 29 new products during the first three months of the year. The company plans to launch a total of 43 new products in Bulgaria during 2008. The newly launched products include Fosinopril HCT (cardiovascular) and Lisinopril HCT (cardiovascular), both of which were first to market in Bulgaria; Irinotecan (oncology), which Actavis has also recently marketed in the United States; Sertraline (antidepressant) and Bicalutamide (oncology). Of the 29 products, 23 are nutritional supplements (ActaVit® vitamins; Doctor Mom and ActaStyle dietary supplements) and products from the Decubal cosmetics line. More information can be found on the local website, in BulgarianProductFri, 28 Mar 2008 10:00:00 GMT{1ECB7F45-C44B-42C6-8438-4E5F15ACDBE9}http://www.actavis.com/en/media+center/newsroom/articles/finasteride+5mg+us.htm Actavis has received approval from the U.S. Food & Drug Administration to market Finasteride Tablets, USP 5 mg. Distribution of the product will begin immediately. Finasteride 5mg tablets are the generic equivalent of Merck & Company’s Proscar® tablets which are indicated for the treatment of benign prostatic hypertrophy (BPH). Annual sales of Finasteride 5mg tablets in the U.S. were approximately US$364 million for the twelve months ending March 2007, according to IMS Health data. Doug Boothe, Executive VP of US Commercial & Administration: “The launch of Finasteride tablets in the United States exemplifies the synergy generated from Actavis’ global R&D, sourcing and manufacturing network, and represents an important addition to our rapidly expanding product portfolio in the US market.”ProductMon, 21 May 2007 14:27:00 GMT{1F11F0B1-6C48-4861-8388-DDC156A85BF1}http://www.actavis.com/en/media+center/newsroom/articles/bupropion_100_200_us.htm Actavis today announced that it has received approval from the FDA to market Bupropion HCl Extended-Release (SR) tablets 100mg and 200mg. Distribution of the product will commence immediately. Bupropion HCl SR is used in the treatment of major depressive disorder. Bupropion HCl SR Tablets, the generic equivalent of GlaxoSmithKline's Wellbutrin® SR, are now available from Actavis in the following strengths: 100mg, 150mg, and 200mg. Annual sales of Wellbutrin® SR 100mg and 200mg and the generic equivalent in that strength in the United States was USD115 million for the 12 months ending March 2010 according to IMS Health data. The addition of the 100mg and 200mg Bupropion HCl SR complements Actavis’ already approved and marketed Bupropion HCl SR 150mg. Actavis received approval of Bupropion HCl SR 150mg in March, 2008. Michael Perfetto, Vice President of Actavis' Sales & Marketing in the US: “The approval of Bupropion SR 100mg and 200mg allows Actavis to provide the full range of strengths available on both Bupropion SR and XL products and offers a significant value to our customers and patients. This approval also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace.”ProductWed, 21 Jul 2010 17:31:00 GMT{1F3CF68D-02E7-4980-88BD-D19A1B0256D8}http://www.actavis.com/en/media+center/newsroom/articles/youth_in_europe_actavis_iceland_continue_support.htm The Youth in Europe (YIE) drug prevention programme has released research tracking the incidence of smoking (daily), drinking and cannabis experimentation amongst 15 to 16-year-old students in Iceland from 1998 to 2011. And the results are astonishing. The number of young people who got drunk within the last 30 days has dropped from 42% in 1998 to just 9% in 2011. The level of youngsters smoking on a daily basis has decreased from 23% to 5%, and those experimenting with cannabis from 17% to 3%. Iceland and Actavis continue to support the fight against substance abuseYIE is considered by many to be the biggest health promotion project targeting youth substance abuse across Europe. This evidence-based, international programme was initiated by European Cities Against Drugs (ECAD) and is carried out in cooperation with major European cities. Taking a broadly holistic approach, its aim is to decrease the likelihood of substance use among young people. The city of Reykjavík, Iceland, serves as the chair and provides management for this programme, while research is conducted by the Icelandic Centre for Social Research and Analysis (ICSRA). Today at the Frankfurt Book Fair, the programme’s principal sponsor Actavis announced that it would be extending its backing of the programme until 2016. This international pharmaceutical company, which has its roots in Iceland, is also a sponsor of the Icelandic Pavilion at the Book Fair, and made its announcement alongside YIE’s patron, the President of Iceland, Olafur Ragnar Grimsson. Olafur Ragnar Grimsson, President of Iceland and Patron of Youth in Europe said:“It is a tragedy to see young people all over Europe fall prey to dangerous drugs. It is our duty to protect our youth from this scourge and the criminals who run this business. We all have to think constructively about how we can contribute to this important fi¬ght. The most productive way is to base our actions on scientifi¬c knowledge and social research demonstrating which preventive programmes produce the most successful results. The gathering of knowledge in Iceland is of this nature and it is a privilege to bring it now to the benefit of others and thus help families and young people to lead a healthy and happy life.” Claudio Albrecht, CEO of Actavis said:“The younger adolescents are when they start drinking alcohol, the more likely they are to become abusers of drugs later in life. This is one of the key findings of the studies to date. The research shows that spending time with parents is important in decreasing the likelihood of substance misuse, while having friends who misuse substances can increase the likelihood. Adolescents who participate in sports, organised youth work and extra-curricular activities in school, are less likely than other adolescents to use drugs. This means that we need to activate all at once, the family, the peer group, the school, those who organize youth activities and authorities in order to succeed in fighting substance use”, said the CEO. “Experts in Iceland have spent more than a decade researching the factors that contribute most to the prevention of drug abuse, and Icelandic society has been mobilised in this fight. Today we are a global company, yet we remain extremely proud of our Icelandic roots and we are determined to help disseminate this valuable approach throughout Europe. That’s why we have now extended our sponsorship until 2016.” Enquiries Actavis GroupFrank StaudEVP Corporate CommunicationTel: +41 79 230 95 78E-mail: fstaud@actavis.com Youth in Europe / ICSRAJon SigfussonTel.: +354 825 6431 E-mail: jon@rannsoknir.is Note to editors:Cities participating in the YIE drug prevention programme include: Reykjavik, Oslo, Helsinki, Riga, Vilnius, Sofia, Bucharest, Istanbul, St. Petersburg, Liepaja, Jurmala, Arilje, Kaunas and Klaipeda. Milan and Moscow have recently signed up to the programme. By the autumn of 2012, ECAD plans to have 25 cities participating and at least 50 cities by 2016. In addition to the research conducted in Reykjavik, two pilot studies have been carried out in the other cities. A minimum of 2,800 students participated in the research in each city. The research is used to evaluate the most effective prevention measures. Young people and their families, schools, youth clubs and authorities, are then mobilised in a cooperative effort to combat substance abuse. CommitmentTue, 11 Oct 2011 11:53:00 GMT{2032E209-CC55-4DAF-8970-A1F206FA3F34}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+extends+portfolio.htm Actavis today announces the launch of five new products in the United States, all of which will be marketed under the Group's own label. The five products include:Dantrolene: the generic equivalent of Dantrium, a product already manufactured by Procter & Gamble to treat chronic spasticity and malignant hyperthermia. It is produced in three different strengths - 25, 50 and 100mg capsules.Isradipine: the generic equivalent of DynaCirc, a product of Reliant Pharmaceutical. It is used for the treatment of hypertension and produced in two different strengths - 2.5 and 5mg capsules.Amantadine: is the generic equivalent of Symmetrel, a product of Endo Pharmaceutical. It is used to treat symptoms of influenza A virus. It is also prescribed for the treatment of Parkinson's and drug-induced extra-pyramidal reactions. It is only produced in 100mg capsules.Dipyridamole: is the generic equivalent of Persantine, a product of Boehringer Ingelheim. Dipyridamole is an anti-platelet, used to reduce the risk of blood clots after heart valve replacement. It is produced in three different strengths - tablets containing 25, 50 and 75mg.Spironolactone: is the generic equivalent of Aldactone, a product of Pfizer. Spironolactone is used for the management of primary hyperaldosteronism, edema, hypertension, and hypokalemia. It is now produced in three different strengths 25, 50 and 100mg tablets.Commenting on the new product launches, President of North America sales Sigurdur Oli Olafsson, said:"These product launches lend additional support to our growing portfolio in the US market and are a further demonstration of the strength of our broad pipeline. We have had a strong first half of the year and expect to launch a total of 15 generic products during 2006, which will drive our growth in this important market. We also remain on course to file at least 30 new ANDAs this year." ProductWed, 05 Jul 2006 11:19:00 GMT{253B50E4-DE56-492A-8E3A-A924E7F8FD2F}http://www.actavis.com/en/media+center/newsroom/articles/new+sales+office+mongolia.htm Actavis announced today that it is expanding its sales network with a new office in Mongolia. The company has begun selling direct to distributors in the country. The new Actavis office is located in the Mongolian capital, Ulaanbaddar. The office will officially open on 13 September 2004. Ms Dambiinyam Nyamsamba will head the sales office. She has been working as an agent for Actavis in Bulgaria for the past two years. A further two medical representatives will join her, both of whom have been specifically trained for their new roles. Actavis currently has 38 products registered for the Mongolian market. A large international exhibition of medical equipment and pharmaceuticals will be held in Ulaanbaddar in September. Actavis will be active participants and taking the opportunity to promote the Group's new name for the first time in Mongolia. Although relatively small, the pharmaceutical market in Mongolia offers good potential. The Group's strategy is to increase sales through new product registrations and new regions, active promotion through Medical Representations towards doctors and mass media channels. Office address:Zuun bileg 402Jigjidjav StreetI Khoroo, Chingeltei DistrictUlaanbaatarMongoliaTel/Fax: +976 11/ 315312OtherMon, 23 Aug 2004 10:42:00 GMT{2607CF16-DDFD-4839-93C2-42B85E9F7CBF}http://www.actavis.com/en/media+center/newsroom/articles/actavis+kéri+launches+ramipril.htm Actavis’ subsidiary Kéri Pharma Generics, in Hungary, acquired 30 September, has launched the cardiovascular product Ramipril tablets, to the Hungarian market. The product is the first one, supplied to Kéri by Actavis, but the company expects to launch another product supplied by Actavis later this year. Ramipril, primarily used in the treatment of hypertension in patients with cardiovascular problems was first launched by Actavis in January in 2004, in three countries, marking the largest product launch in the Group’s history. The product is supplied by Actavis’ Third-party division, Medis and is sold under the brand name of Meramyl, which is a registered brand name of Kéri Pharma, in three strengths (2.5 mg, 5 mg and 10 mg). According to Sigurdur Oli Olafsson, Chief Executive of Sales & marketing, International, this launch marks the first delivery of an Actavis product to the Hungarian market by Kéri. Actavis plans to register and launch products to the Hungarian market under its own brand name. Actavis already has 12 Marketing Authorisations in the Hungarian market, for products that can now be launched to the market. ProductMon, 10 Oct 2005 15:48:00 GMT{2676E91A-A159-4EC0-A615-3DC5E5B8AF3D}http://www.actavis.com/en/media+center/newsroom/articles/actavis+ceo+pharmaceutical+conference.htm Robert Wessman has been invited to present the Actavis story to institutional investors and CEOs at the 2005 ABN Amro Global Generic Pharmaceutical Conference on the theme of "The Emerging Role of the Indian Pharma" taking place in Mumbai, India, from the 9 to 11 March. Mr. Wessman will be speaking about the growth in generics, Actavis’ strategic focus, plans in India and how the company is going to implement these, amongst other subjects. The event will provide the perfect platform for understanding the new industry dynamics and for creating top-level contacts in this sector.OtherFri, 11 Mar 2005 16:02:00 GMT{271C037B-182A-4141-BD2C-EE3235F6E301}http://www.actavis.com/en/media+center/newsroom/articles/award+malta.htm Actavis Ltd in Malta has been presented with the 2006 Grant Thornton Award for Enterprise and Foreign Direct Investment by the Hon Dr Austin Gatt LLD MP, Minister for Investment, Industry and Information Technology on behalf of the partners and directors of Grant Thornton. Grant Thornton International is one of the world's leading organisations of independently owned and managed accounting and consulting firms. The Grant Thornton Award for Enterprise & Foreign Direct Investment was set up in 2001 by Grant Thornton in Malta. The Award aims to honour companies, organisations and individuals who have distinguished themselves in the fields of entrepreneurship, foreign direct investment as well as the promotion of investment and trade. On accepting the award, Mr. Sergio Vella, Managing Director of Actavis Ltd in Malta said, “This award represents an achievement rendered possible by the dedication of our employees as well as the trust of our parent company and all our stakeholders.” Actavis Ltd is a subsidiary of Actavis Group. The Maltese operation alone boasts a workforce of about 380 employees.OtherMon, 11 Dec 2006 17:40:48 GMT{27B48923-00AC-4A21-80CE-C8CE8D32DE5E}http://www.actavis.com/en/media+center/newsroom/articles/fentanyl+us.htm Actavis today announced that it has received approval from the US Food & Drug Administration to market Fentanyl Transdermal System. Distribution of the product will begin immediately. Fentanyl Transdermal System is the generic equivalent of Alza/Janssen’s Duragesic® and available in 25, 50, 75 and 100 mcg/hour strengths. Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products or immediate release opioids.Robert Wessman, President and CEO said: “The approval of fentanyl transdermal system signifies an important milestone for Actavis. The addition of transdermal fentanyl is representative of our continued effort to expand the depth and breadth of our product portfolio, and highlights our product development expertise in specialty generic products.” Annual brand and generic sales of fentanyl transdermal system in the US were approximately US$1.2 billion for the twelve months ending June 2007 according to IMS health data. More information about Actavis in the United States can be found at www.actavis.us ProductWed, 22 Aug 2007 12:01:00 GMT{2A6D87EB-3015-4ED4-AC4E-666066EDA0BE}http://www.actavis.com/en/media+center/newsroom/articles/actavis+at+cphi+conference.htm Actavis and Medis employees from the Group‘s diverse departments worldwide participated in this year‘s annual CphI conference held in Milan, Italy, in October 2007. CPhI, now in its 18th year, is the world’s leading pharmaceutical trade conference. The first CPhI Worldwide in 1990 attracted 250 visitors and 16 companies, while at the present time about 22,000 industry professionals visit some 1,500 exhibiting companies from more than 120 countries. Medis – Actavis‘ third party sales division — has had its own stand at the CPhI exhibition for the past 8 years, but shared the floor with Actavis Group this year for the first time. Both Actavis and Medis plan to be present at next year‘s CphI in Frankfurt, Germany.OtherTue, 30 Oct 2007 16:07:00 GMT{2B272C35-88DD-44E0-9061-5C55BDDD1F88}http://www.actavis.com/en/media+center/newsroom/articles/record+profits+for+actavis+in+2004.htm Actavis is well prepared for further growth, said CEO Robert Wessman at the company’s Annual General Meeting yesterday, 31 March. The company yielded record profits last year, of EUR63 million. Profit was 55% up on the previous year, and turnover was 43% higher than the year before (EUR452 million). Mr Wessman said that the company had high expectations of investments in companies in central Europe, India and the USA, and that Japan too was an interesting market area. He added that sales of pharmaceuticals to Europe and the USA entailed considerable synergistic effects. "Americans use half the pharmaceuticals produced in the world, so that is a very interesting market for the company." Mr Wessman said that the company intended to sell goods under its own label in the USA. "The company’s research and development work has never been more effective, and we have a good reputation in regulatory approval of pharmaceuticals ― and we have repeatedly succeeded in being first to market with new generic pharmaceuticals after expiry of patents,” said Mr Wessman. Great benefit from Stock Exchange listingBjorgolfur Thor Bjorgolfsson, chairman of the board of Actavis, said that the listing of Actavis on the Stock Exchange had yielded spectacular benefits. "In 2003 the share price rose nearly 200%; in retrospect one may say that this rise was somewhat premature, and hence demand for shares in our company has slowed accordingly." Mr Bjorgolfsson said that preparations were well in hand for listing the company on a foreign stock exchange, but that the board wanted to proceed cautiously and time the listing favourably. Mr Bjorgolfsson added: "But the key to Actavis’ growth lies not least in strong internal growth, which is based on strong R&D and widespread marketing activity. The crucial factor is to get new products to the market as soon as the patent expires." 50 new products to the market this yearNine products were launched in 2004; Actavis was first to market with five of these. Own-label sales were up 60% and third-party sales by 24%. Fifty new products are expected to be launched by Actavis this year. The Annual General Meeting resolved to pay shareholders a 10% dividend on the face value of shares, which represents 5.1% of the company’s profit in 2004. A resolution was also passed to authorise the company’s Board to increase share capital by ISK 450 million at face value. The company’s Board was re-elected: the Board members are Bjorgolfur Thor Bjorgolfsson, Andri Sveinsson, Karl Wernersson, Magnus Thorsteinsson and Sindri Sindrason. Annual General Meeting 31 March 2005OtherFri, 01 Apr 2005 10:38:00 GMT{2C9D11DC-890A-432B-91BB-2EB219293062}http://www.actavis.com/en/media+center/newsroom/articles/actavis+partnership+algeria.htm Actavis has signed an exclusive distribution and packaging agreement for a number of generic products with Laboratoire Pharmaceutique Algérien (LPA), an Algerian owned and operated pharmaceutical company, headquartered in Algiers. The agreement with LPA, one of the leading pharmaceutical companies in Algeria, is an important stepping stone for the entrance of Actavis in this fast-growing market. The Algerian pharmaceutical market is the third-largest in Africa after Egypt and South Africa. Commenting on this partnership, Hordur Thorhallson, Executive Vice President Emerging Markets, Actavis said: “The progress that the regional office in Malta has achieved so far is very promising and this enhances the role of this office as a regional hub for North, Central and West Africa” Mr Ait Adjedjou, President, LPA said that he was very pleased that LPA had signed on with a world leader such as Actavis and said that the investment that his company was laying out had to be taken into context, in the sense that the world was in a global slowdown, yet the investment was still going ahead. Also present at the contract signing ceremony were Mr Daniel Vella Friggieri – Regional Director North, Central and West Africa, Actavis and Mr Guillaume Tornadre – Operations Director, LPA. About Laboratoire Pharmaceutique AlgérienLPA is a leading company in Algeria with over 20% share of the pharmaceutical distribution market. Operational since 1996, the distribution company is designed to meet the needs of European pharmaceutical companies and standards and its growth has been the main support to the development of its production facilities.OtherThu, 04 Dec 2008 14:11:00 GMT{2D0778A9-4741-48BC-AACD-EC175AD8C82D}http://www.actavis.com/en/media+center/newsroom/articles/actavis+totowa+concent+decree+fda.htm Decree outlines path to move forward on manufacturing at Totowa facilities Actavis Inc. today announced that it has reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company’s Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe. The Consent Decree only affects operations at Actavis Totowa in New Jersey. Pursuant to the Consent Decree, Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice (cGMP) and has passed follow-up FDA inspections of the facilities. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly. “We have been working with the FDA to address compliance issues at the Totowa facilities,” said John LaRocca, Actavis Inc.’s chief legal officer. “We have an entirely new management team in place at Little Falls and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the Agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.” Prior to reaching this agreement, Actavis engaged PAREXEL, a well regarded outside firm, to assess Actavis Totowa facilities. PAREXEL has 25 years of experience in helping companies bring safe and effective treatments to the global marketplace. PAREXEL will continue to work with Actavis Totowa to facilitate ongoing compliance with the Consent Decree. Editor’s Note:The Totowa facilities affected by this Consent Decree are located in New Jersey. Two of these facilities (“Little Falls” and “Riverview”) are oral-dose manufacturing sites, and one (“Taft”) is a packaging facility. InquiriesActavis U.S. Media lineTel: (973)-889-6689E-mail: media@actavis.comOtherMon, 29 Dec 2008 15:10:52 GMT{2DB11ED3-9F32-4EAE-BA8B-2C204EB29F4B}http://www.actavis.com/en/media+center/newsroom/articles/avinza+patent+challenge.htm Actavis confirms that Actavis Elizabeth L.L.C. has initiated a challenge of the patent listed in connection with King Pharmaceuticals’ Avinza® (morphine sulfate extended-release capsules). Actavis believes that it is the first company to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avinza. Actavis filed its ANDA for Avinza containing the paragraph IV certification with the US Food and Drug Administration (FDA) in June 2007. Upon receiving filing acceptance from the FDA, Actavis Elizabeth L.L.C. notified King Pharmaceuticals and the patent owner. On 10 September, 2007, King issued a press release that confirmed that it received Actavis Elizabeth's paragraph IV certification notice and that it intends to enforce its patent. Avinza® capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. The product had annual sales of approximately US$169 million for a 12 month period, ending June 2007, according to IMS Health data. More information about Actavis in the United States can be found at www.actavis.usProductMon, 17 Sep 2007 08:00:00 GMT{2E008F2C-754E-469F-8D22-94CD9257F8F6}http://www.actavis.com/en/media+center/newsroom/articles/sildenafil+bulgaria.htm Actavis has launched Sildenafil tablets in Bulgaria. This is Actavis Group’s first launch of the product, which also was the first generic sildenafil to enter the Bulgarian market. Sildenafil Actavis is the generic equivalent of Pfizer's Viagra® and is prescribed to treat erectile dysfunction. Sildenafil Actavis is available in Bulgaria in 25mg, 50mg and 100mg tablets, in packs of one or four. Annual brand product sales amounted to EUR1.5 billion worldwide in 2008; EUR1.4 million in Bulgaria (IMS Health data). Sildenafil Actavis is manufactured by Actavis in Malta. Actavis offers one of the broadest product portfolios and strongest pipelines in the generics industry with around 830 products on the market and about 350 products under development and pending registration. Actavis products are registered in more than 60 countries. The group had more than 660 product and market launches in 2008, with well over 300 product and market launches in 2009 to date. Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. The company has operations in 40 countries, with more than 10,000 employees.ProductThu, 18 Jun 2009 14:09:00 GMT{33B369BC-29B2-4686-8BB0-DC0A029ACBE8}http://www.actavis.com/en/media+center/newsroom/articles/actavis+wins+top+marketing+award.htm Actavis’s international marketing campaigns were honoured yesterday as Iceland’s best. The fast-growing pharmaceutical company has operations in 25 countries and its headquarters are in Iceland, where it has been awarded “Marketing Company of the Year” by the Icelandic Marketing Association IMARK. Presenting the awards, the country’s President Olafur Ragnar Grimsson also paid tribute to Actavis Chairman Bjorgolfur Thor Bjorgolfsson, who was named “Marketeer of the Year”. Actavis and its forerunner have succeeded, through energetic marketing and an effective policy of expansion, in building up an international corporation in the pharmaceutical sector, over a period of a few years. The company now employs around 7,000 people.Robert Wessman, CEO of Actavis, said that an extraordinary and united effort by staff has made it possible to build up an international trademark, strengthening the company’s standing across world markets. “The publicity campaign for our new brand has laid the foundations for marketing a product portfolio that is backed up by a strong and progressive development programme,” commented Wessman. The Actavis Group, which came into existence on 17 May this year following the consolidation of a number of companies, had succeeded in promoting its name and trademark throughout its major markets in a short space of time according to Bjorn Viglundsson, Chair of IMARK. At the awards ceremony yesterday he said: “Through good organisation, participation by people in all market areas and effective management, the company succeeded in promoting its name splendidly. At the same time Actavis has united people in numerous companies in 25 countries, under a single trademark representing a strong company with great ambitions.” The Group’s new name Actavis was chosen after extensive research. The element acta means action, while vis signifies strength. The branding project was carried out in collaboration with a British consultancy firm, Financial Dynamics, and Hvita Husid (the White House), an Icelandic advertising agency.OtherTue, 26 Oct 2004 09:54:00 GMT{33C82310-92BD-4044-B00C-BC5933719E53}http://www.actavis.com/en/media+center/newsroom/articles/alprazolam+us.htm Actavis today announced that it has received approval from the U.S. Food & Drug Administration to market Alprazolam ER tablets. Distribution of the product will commence in coming weeks. Alprazolam ER tablets, the generic equivalent of Pfizer’s Xanax® XR tablets, will be available in 0.5 mg, 1 mg, 2 mg, and 3 mg strengths. Alprazolam ER tablets are indicated for the treatment of anxiety and panic disorder. Annual sales of Alprazolam ER tablets in the U.S. were approximately US$53.9 million for the twelve months ending December 2006 according to IMS Health data.ProductWed, 14 Feb 2007 14:00:00 GMT{355CBB45-1F01-4A33-BB61-33D9DB69FAEC}http://www.actavis.com/en/media+center/newsroom/articles/Sigurdur15thEGAConf.htm Sigurdur Oli Olafsson, Actavis’ CEO, was a speaker and panel member at the 15th annual EGA conference, of the European Generic Medicines Association, in Barcelona 3-5 June 2009. Sigurdur discussed the future of generics in a turbulent environment, including the impact of the current world economical situation and expressed his vision on how generic players must remain competitive in current and future challenges. The title of the conference was “Generic medicines enhancing pharmaceutical competition and ensuring healthcare sustainability”.OtherMon, 08 Jun 2009 14:50:00 GMT{358258F7-B5DA-474D-B1AB-492F21D77F2B}http://www.actavis.com/en/media+center/newsroom/articles/awards+bulgaria.htm Actavis EAD, part of the Actavis Group, has been recognised for its social contribution to Bulgaria with two responsible business awards from the Bulgarian Business Leaders Forum and a prize for corporate donations from the Bulgarian Finance Minister. The Bulgarian Business Leaders Forum presented Actavis with two awards for its involvement in the Green and Lighted Sofia project. The project included renovating the light in the garden near the former Royal Palace in Sofia and the entire renovation of the ‘Garden of Health’. The Forum presented Actavis with both its special ‘Engage’ award and another prize in the ‘investor in the environment’ category for encouraging its employees to get involved in the project. The prizes were presented to Actavis EAD Managing Director, Nikolay Hadjidonchev by special guest Lord Watson of Richmond, a member of the International Business leaders Forum of the Prince of Wales. Accepting the prizes Mr. Hadjidonchev said, “These awards are recognition mainly for Actavis’ employees, for their great commitment and involvement in the maintenance of our ‘Garden of Health’. I would like to thank them and to assure you that Actavis will continue to implement projects that are socially responsible and correspond to our company’s values.” In addition to these awards, Bulgarian Minister of Finance Plamen Oresharski presented Actavis with the ‘Biggest Corporate Donor of Goods and Materials in 2006’ prize. The ranking of largest corporate donors is based on the financial value of companies’ annual donations, with Actavis’ donations amounting to BGN 345 851. CommitmentTue, 28 Nov 2006 22:32:00 GMT{359131E1-82BA-4A2E-B23E-CCCE34F53C2D}http://www.actavis.com/en/media+center/newsroom/articles/finasteride+france.htm Actavis launched Finasteride in France on day one, when the originator’s patent expired on Monday 22 June. The distribution of the product has already commenced. Finasteride Actavis was launched by the company under its brand name, and at the same time by various Medis clients. Medis, Actavis‘ Third Party sales division, handles the sales of intellectual property and pharmaceutical products to other pharmaceutical companies in most EU nations and elsewhere and has marketing authorisations in over 50 countries. Finasteride, used for the treatment of prostate cancer, is the generic equivalent of Merck‘s Proscar®. Finasteride Actavis is available in tablets of 5mg in France. Finasteride Actavis was developed by Actavis in Iceland and has already been launched by Actavis and its third party clients in many other European countries and in the United States. Actavis has well over 300 product and market launches on the Group’s various markets to date in 2009. A number of the products were first to market or launched on patent expiry, including Finasteride, Gemcitabine and Pantoprazole in Western Europe; Fluvastatin SR, Levofloxacin, Nebivolol and Sildenafil in Eastern Europe; and Atorvastatin, Donepesil, Fludarabine, Fluvastatin SR, Gemcitabine, Irinotecan, Isosorbide Mononitrate, Levofloxacin, Pantoprazole and Salbutamol in other markets.ProductWed, 24 Jun 2009 10:56:00 GMT{35974F02-03AD-4943-BB45-8B48B11D2EFB}http://www.actavis.com/en/media+center/newsroom/articles/rep+office+vietnam.htm Actavis has opened a representative office in Ho Chi Minh City, Vietnam. The office was officially inaugurated by Jonas Tryggvason, Executive VP CEEA. The pharmaceutical market in Vietnam has an estimated value of US$700 million with a growth rate of more than 20% in 2006. Generic products are expected to grow by double digits at least until the end of the decade. Economic conditions in this vibrant country with 84 million inhabitants, have been continuously improving, after the opening of the country back in 1994, following years of isolation. The economic growth and increasing consumer purchasing power, holds opportunities for Actavis to become a major player in the pharmaceutical market.OtherMon, 16 Apr 2007 23:59:00 GMT{35B2EAC2-A53A-423C-A02A-56BE2D8ED57C}http://www.actavis.com/en/media+center/newsroom/articles/claudio_reuters_handelsblatt.htm Claudio Albrecht was interviewed by the global news agency Reuters and the leading German business paper Handelsblatt during his trip to Germany on 9 February. Reuters reports Claudio's confirmation that last year was Actavis' best ever year and talks about measures the company is taking to boost earnings. The news agency quotes him as saying that Actavis is not in an ideal position when it comes to enterprise value, but adds that after two to three years an initial public offering (IPO), a sale or a tie-up with another company could become an option. Handelsblatt focuses on possible acquisitions in markets where the company is underrepresented, including Poland, Russia, Turkey and Southern-Europe. The paper says Stada is not on Actavis’ radar, as its main strength is Germany, a market that’s not attractive at the moment due to pricing pressures. English:Actavis Is Looking for Acquisitions, Chief Tells Handelsblatt (Bloomberg)Actavis to boost its M&A appeal in 2-3 years (Reuters) German:Actavis Will Konsolidierung der Generikabranche vorantreiben (Reuters TV interview)OtherThu, 10 Feb 2011 13:30:00 GMT{3A2CA7B2-2A90-4C0E-9947-41B210570326}http://www.actavis.com/en/media+center/newsroom/articles/180_day_exclusivity_zplpidem.htm Actavis has received approval from the FDA to market Zolpidem Tartrate Extended-Release Tablets, USP 6,25mg CIV in the United States. Distribution of the product has commenced. As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6,25mg, Actavis has been awarded 180-day exclusivity to market this product. Zolpidem Tartrate extended-release tablets 6,25mg, the generic equivalent of Ambien® CR 6,25mg by Sanofi-Aventis, had US sales of approximately USD129 million for the 12 months ending 30 June, 2010 (IMS Health data). Doug Boothe, CEO of Actavis in the US: “The approval of Zolpidem ER Tablets 6,25mg offers a significant value to our customers and patients. This approval, along with the first-to-file exclusivity, also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace.” Prescribing information is available at www.actavis.us/Zolpidem.ProductTue, 19 Oct 2010 13:04:00 GMT{3DF0D1FC-3CB8-444B-95DA-244DF779F6FA}http://www.actavis.com/en/media+center/newsroom/articles/share+offering+to+finance+amide+acquistion.htm Actavis’ share offering will take place from 15 – 23 June 2005. The share offering is part of Actavis’ financing of the acquisition of the US based generic pharmaceutical company, Amide. Click here to view the Prospectus document in a new window (pdf, 2.5 mb) The share capital will be increased by 344,864,993 shares or 11.5% of the total share capital. The share capital is 2,993,780,301 shares prior to the share increase but will be 3,338,645,294 after the increase. The new shares will only be offered to shareholders. The Board of Directors also decided to sell 198,613,449 own shares in the offering. In total 543,478,442 shares will be sold to shareholders or 18.15% of the total share capital. Shares offered:18.15% of total share capital which equals 19.4% of outstanding share capital Subscription period:15 to 23 June 2005 Pre-emptive rights:Based on company's share registry at the end of trading, 3 June 2005 Price offered:ISK 38.5 To be paid before:June 30, 2005 The price of the new shares and the own shares in the offering will be ISK38.5 per share. The subscription period will be from 15 to 23 June 2005, both days included. The shareholders' pre-emptive rights will be based on the Company's share registry at end of trading, 3 June 2005. Shareholders can subscribe to their shares on the webpage of Islandsbanki hf. from 10:00 o’clock on 15 June 2005 till 15:00 o’clock on 23 June 2005. A loggin and password have been sent to all shareholders by mail. Shareholders may subscribe to a higher amount than their pre-emptive right. Shareholders may assign to other parties their right to subscription in part or in full. The right to increased subscription is non-assignable. Islandsbanki hf. acts as a manager in the share offering and underwrites the offering along with Landsbanki Islands hf. Payment coupons are to be paid no later than 30 June 2005.OtherMon, 13 Jun 2005 10:01:00 GMT{3E48866C-A6AF-4AC5-9430-22C80D8076CE}http://www.actavis.com/en/media+center/newsroom/articles/Actavisseniorappointments.htm - Actavis EVP Gudbjorg Edda Eggertsdottir appointed deputy CEO -- New Actavis chief complements his team with internal promotions - Actavis has appointed Gudbjorg Edda Eggertsdottir, Deputy CEO. At the same time, Valur Ragnarsson has been appointed Executive Vice President of Third-party sales; and Doug Boothe, CEO of Actavis United States. Valur will join the Group’s Executive board with immediate effect, while Gudbjorg Edda and Doug already are executive board members. Gudbjorg Edda Eggertsdottir joined Actavis following the Company’s merger with Delta, where she had been Deputy CEO and Managing Director of Exports and Development since 1999. She was appointed Actavis’ Chief Executive of Third-party sales in 2002.Gudbjorg Edda has an MSc degree in Pharmacy and has worked in the pharmaceuticals industry since 1976. Valur Ragnarsson joined Medis, Actavis’ Third-party sales division, in 2001 and was appointed Managing Director in October 2003. Earlier in his career he held the posts of Marketing Manager of Lundbeck in Iceland and later as Marketing Manager of Aventis.Valur is a pharmacist by education and has worked within the pharmaceutical industry since 1988. Doug Boothe joined Actavis through the acquisition of Alpharma in 2005. During the past four years he has held a variety of management positions within the company, the most recent of which was Executive Vice President U.S. Commercial and Administration. Prior to joining Actavis, Doug worked for General Electric, Mars & Co Consulting, Xerox Corporation, and Pharmacia. Doug holds a B.S. in Engineering from Princeton University and an MBA from Wharton School of Business. Actavis announced changes at the helm last week, when Robert Wessman stepped down. Commenting on the senior appointments today, succeeding CEO Sigurdur Oli Olafsson said:“We have a world-class management team with global expertise. We fully intend to continue the remarkable Actavis growth story but our main focus this year will remain on internal growth.” New Actavis deputy CEO Gudbjorg Edda Eggertsdottir, said:“The best business leaders build teams that remain flexible, teams that continue to perform even after their departure. Through the changes in ownership last year, it was business as usual at Actavis. Following the departure of Robert Wessman, it will continue to be business as usual at Actavis. We have an incredibly committed team that will continue to provide quick to market, low cost, high quality pharmaceuticals around the global marketplace.”OtherTue, 12 Aug 2008 12:41:43 GMT{42A6E877-0C31-435F-8A84-BD4D06B332D0}http://www.actavis.com/en/media+center/newsroom/articles/floxapen+acquisition.htm Actavis today announced that it has agreed to purchase Floxapen® from GlaxoSmithKline (GSK) for Europe. Actavis will take over the distribution of the product in coming weeks. Floxapen® capsules, syrup and injection contain the active ingredient flucloxacillin, which is used to treat infections affecting the skin and soft tissue, bone infections, urinary tract infections, respiratory tract infections, meningitis and blood poisoning. Flucloxacillin is also sometimes used to prevent infections during major operations such as bone or heart surgery. Floxapen® has been on the market since early 1970s and has experienced consistent sales growth since then. Sales are expected to be around EUR12.0 million for full year 2007. Floxapen® is currently available in Austria, Belgium, Ireland, Luxemburg, Malta, Netherlands, Portugal, Switzerland and the UK. The product is sold under the Staphylex trademark in Germany. GSK will act as the distributor in the markets where Actavis does not have presence until April 2008. Sigurdur Oli Olafsson, Deputy CEO said: “While Actavis has established one of the strongest pipelines in the generic industry, a core component of our growth strategy is to seek opportunistic acquisitions that add strong products with market leading positions to our portfolio. Floxapen® does exactly that and provides us with another high turnover product that we can sell across multiple markets.”ProductFri, 04 May 2007 13:22:00 GMT{432D69BF-BAD5-4B0C-BCC0-AB91F35B69B0}http://www.actavis.com/en/media+center/newsroom/articles/griseofulvin+US.htm Actavis has launched Griseofulvin Oral Suspension in the United States. Distribution of the product will commence immediately.Griseofulvin Oral Suspension USP, the generic equivalent of Ortho-McNeil’s Grifulvin® V, will be available in the 125mg/5mL strength. Griseofulvin is indicated for the treatment of fungal infections of the skin, fingernails and toenails. Annual sales of Griseofulvin Oral Suspension USP in the U.S. were approximately US$38 million for the twelve months ending March 2007 according to IMS Health data.ProductTue, 31 Jul 2007 13:00:00 GMT{447AD987-2557-43E4-A1D7-BF5E6533E6B2}http://www.actavis.com/en/media+center/newsroom/articles/mycofenolate_mofetil_europe_patent.htm Actavis today announced the launch of Mycofenolatmofetil Actavis, immediately after the patent expired in the UK, Netherlands, Germany, Sweden, and Finland. Mycofenolatmofetil Actavis (mycophenolate mofetil) is the generic equivalent of Roche’s Cellcept®. It is used with other medicines to lower the body’s immunity after heart, kidney or liver transplant. Mycofenolatmofetil Actavis is available in 500mg tablets or 250mg capsules. Annual brand product sales in Europe were about EUR400 million, for the 12 months ending June 2010 (IMS data). Actavis has already launched the product in Bulgaria, Iceland, Norway, Portugal, Romania and Slovakia, where no patent was in place. Further launches of the product are planned over the coming months in various other countries.ProductFri, 05 Nov 2010 10:43:00 GMT{44AC7E2F-A347-430F-A2D0-5FCB0900EE79}http://www.actavis.com/en/media+center/newsroom/articles/otc+brands+thornton+ross.htm Actavis has acquired all rights to ten OTC brands from Thornton & Ross Ltd. This acquisition strengthens Actavis’ rapidly growing OTC proposition. The acquisition of the ten brands will be with immediate effect. Actavis will become wholly responsible for the distribution from 1 October 2007. The new additions to the Actavis OTC portfolio include: Cymalon (cystitis treatment) Dermidex (dermatological cream) Electrolade (oral rehydration powder) Ellimans Embrocation (massage embrocation for rheumatic and muscular pain) Gastrocote (heartburn relief) Goddards Embrocation (massage embrocation for relief of muscular pain) Morhulin Ointment (nappy rash treatment) Orovite 7 (multivitamin with 7 essential vitamins) Sominex (night time sleep aid) Yeastvite (remedy for the speedy relief of tiredness) Richard Hollies, Actavis OTC Director in the UK, comments, “We are delighted to have acquired these brands which have such fantastic pharmacy heritage. We are currently developing marketing plans for all these products and once finalised, we will inform the trade of all our plans. In the meantime our first priority is to ensure full continuity of supply and we have already put arrangements in place to achieve this.”ProductMon, 17 Sep 2007 09:00:00 GMT{46D0914C-4518-41F8-A674-59047582713F}http://www.actavis.com/en/media+center/newsroom/articles/serbian+journalists+visit+actavis.htm A group of Serbian journalists visited Actavis headquarters on 7-8 July. The purpose of the visit was to promote the activities of Actavis Group and to provide information on Iceland and its inhabitants. The Serbian guests also visited the Chamber of Commerce for an in-depth presentation on the Icelandic business environment, followed by sightseeing tours of Iceland. The visit was organised by Actavis Balkan, the Group’s subsidiary in Belgrade, which handles sales & marketing of Actavis products in the Balkan region. Actavis’ activities in Serbia comprise of two separate companies, Actavis Balkan and the manufacturing plant, Zdravlje Actavis in Leskovac. Actavis has had operations in Serbia since 2002 when it acquired Zdravlje, one of Serbia’s largest producers of generic pharmaceuticals. Sandra Stejner, Communications Manager at Actavis Balkan, said the visit was an important step in informing the journalists about the activities of Actavis Group. “The visit was a great success, and the group found it both informative and enjoyable,” said Sandra.OtherFri, 15 Jul 2005 09:35:00 GMT{48D85600-3DA9-43D4-96B0-1CC2E7C1DB2B}http://www.actavis.com/en/media+center/newsroom/articles/eahp+congress.htm Actavis will be participating in the Congress of the European Association of Hospital Pharmacists (EAHP) in Maastrict, 27-29 February.The Annual Congress of the EAHP is the largest hospital pharmacy meeting in Europe, reportedly attended by some 2,000 colleagues from all over the world. Actavis has set its sights firmly on the hospital sector and currently has around 300 pending applications worldwide for injectable medicines. Furthermore, Actavis' ambitious pipeline comprises more than 60 new projects, developed both internally and through established relationships with other developers. Actavis already markets over 50 hospital products, with a focus on oncology products and a growing range of anti-infectives, local anaesthetics and analgesics. Recently Actavis signed an agreement with Pfizer to acquire a manufacturing site specialising in the production of oncology products. The site, which covers an area of 300,000 square metres, is located in Nerviano, Italy. At the same time Actavis entered into a multi-year exclusive agreement with Pfizer for the supply of oncology products. Actavis has further extended its portfolio through the acquisition of Floxapen from GSK, as well as Reteplase (Rapsylin) and Isotretenoin (Acitretin) from Roche. Actavis‘ exclusive rights agreement to distribute and sell the Deltaselect injectable range in Germany and other select countries came into effect in October 2007. This transaction has established Actavis as a major player in the German hospital market. Actavis currently markets over 30 molecules from the Deltaselect portfolio in the German market and plans are in place to introduce up to 8 complementary molecules over the coming year. Work is also already underway to register and sell these products in a number of other countries. More information about Actavis' hospital productsProductTue, 26 Feb 2008 17:22:00 GMT{4A80E613-6B34-4BE3-98B7-3AE7E743ABFA}http://www.actavis.com/en/media+center/newsroom/articles/losartan_actavis_switzerland_day-one.htm Actavis has launched the antihypertensive drug Losartan on day one, as the patent expired in Switzerland. The product was launched by Actavis under its own name, and by customers of Medis, Actavis’ Third-party sales division. Losartan, marketed by Merck under the brand name Cozaar®, is mainly used to treat high blood pressure. Generic Losartan by Actavis is available in Switzerland in 50mg and 100mg tablets. Losartan Actavis was developed and produced by Actavis in Iceland. The product was launched on 21 December, when the patent expired in Switzerland. A record year for Actavis product launches Actavis achieved more than 720 product- and market launches in 2009, compared to over 660 in 2008, which was also a record year for the Group. Actavis offers one of the broadest product portfolios and strongest pipelines in the generics industry with around 830 products on the market and about 350 products under development and pending registration. Actavis products are registered in more than 60 countries.ProductWed, 06 Jan 2010 11:45:00 GMT{4BF46FFC-A6CD-4A89-BE91-F84E2F28E0F3}http://www.actavis.com/en/media+center/newsroom/articles/pharmacy+business+awards.htm Actavis has been awarded the Generic Product of the Year award at this year’s Pharmacy Business Awards, held in London. Actavis received the award for the launch of its Lansoprazole drug, which is used to treat ulcers. The award comes less than a year after the company made its entry into the UK market, through the acquisition of the generics division of the pharmaceutical company Alpharma, which has now been rebranded under the Actavis name. Sara Vincent, Country manager in the UK said: “I am delighted that we have received this award which recognises the tremendous success of our UK operation. This is a great example of Actavis’ approach to integration, which has allowed the business to continue to prosper during a period of change. “Actavis is a dynamic organisation constantly seeking new opportunities to grow and these are exciting times for us with over 20 product launches planned this year alone.” ProductWed, 25 Oct 2006 09:20:00 GMT{4D049A66-3F43-478C-BE41-CE5687CE223A}http://www.actavis.com/en/media+center/newsroom/articles/alina_cm_romania.htm Alina Culcea has been appointed as Country Manager for Actavis in Romania, responsible for the Romanian Sales and Marketing Division. Alina joined Actavis Romania in May 2006 as Human Resources Director. Over the past five months, Alina has acted as an interim Country Manager for Romania. Alina has worked in the pharmaceutical industry for the past 14 years. She was HR manager at Pfizer Romania, before joining GlaxoSmithKline where she held various managerial positions, both in and outside of Romania. In addition to gratuating from a Medical University, Alina has trained in various programmes, including the Leadership Development Program at INSEAD.OtherMon, 03 May 2010 09:30:00 GMT{4DCF9DBE-1CD6-4C7C-B10F-42B5957E6173}http://www.actavis.com/en/media+center/newsroom/articles/Three+cities+join+Youth+in+Europe.htm The cities of Istanbul, Helsinki and Stockholm became members of the pan-European programme Youth in Europe – a drug prevention programme on February 24th. The cities’ vice mayors signed an agreement at the board meeting of ECAD, European Cities Against Drugs in Istanbul. Eight cities have already signed and more are expected to join in the coming weeks and months. Actavis Group is the main sponsor of the programme which includes a special contribution for research and social action in Istanbul as well as in the cities of St. Petersburg, Vilnius, Belgrade and Sofia. The programme builds on more than 20 years of experience in youth research carried out by social scientists in Iceland. The research has shown what factors are important for families in preventing adolescents from beginning to use drugs. The cities will carry out three surveys among 15-16 year olds on lifestyle, aspirations and drug use in the next five years and also work towards mobilizing society against drugs according to a programme outline.CommitmentMon, 27 Feb 2006 14:02:00 GMT{4DF3B3F1-269F-474A-82C5-B56BDEE26101}http://www.actavis.com/en/media+center/newsroom/articles/valacyclovir_chl_us.htm Actavis has received approval from the FDA to market Valacyclovir Hydrochloride Tablets. Valacyclovir Hydrochloride Tablets, 500mg and 1000mg, had US sales of approximately USD1.5 billion for the 12 months ending 31 December 2010 (IMS Health). Valacyclovir Hydrochloride (also spelt Valaciclovir) is the generic equivalent of Valtrex® by GlaxoSmithKline.ProductTue, 29 Mar 2011 15:48:00 GMT{4E4EBFFE-B998-4558-A03D-5FE9251A6BE1}http://www.actavis.com/en/media+center/newsroom/articles/actavis+sponsors+icert+bulgaria.htm Icelandic opera and art contributed to a special programme of cultural events at Sofia University in Bulgaria last week. Sponsored by Actavis and the National Bank of Iceland (Landsbankinn), the IceArt initiative aimed to reinforce cultural links between the two countries. Opening the festival, Iceland’s Minister of Industry and Commerce Valgerdur Sverrisdottir presented the University with copies of the legendary Icelandic sagas. She said that the countries’ relations had intensified in recent years, especially with regard to investments in Bulgaria, and that the time was right to strengthen them further with cultural exchanges. The Icelandic consul in Bulgaria Bjorgolfur Gudmundsson then presented the university with a copy of the Prose Edda of Snorri Sturluson, a renowned source of Norse mythology, before a performance by the Hafnafjordur Operatic Choir. Money raised at all the events will go towards the work of an international women’s organisation in Bulgaria, which promotes breast-cancer prevention, research, education and treatment. The IceArt culture days were held in conjunction with the visit of an Icelandic trade mission to Bulgaria, which is expected to promote trade between the two nations. The IceArt Programme:• The Hafnarfjordur Opera Choir at Sofia University, conducted by Elin Osk Oskarsdottir• Raddbandafelag Reykjavikur in the Alexander Nevsky Cathedral, conducted by Sigrun Grendal• An open-air photographic exhibition of Icelandic nature, by Hordur Danielsson and Mats Wibe Lund• An exhibition of paintings by artist Eirikur Smith, in the gallery of the Bulgarian Ministry of Culture• The Hafnarfjordur Opera Choir, at the Bulgaria Hall with the Sofia Philharmonic CommitmentSun, 24 Oct 2004 09:59:00 GMT{5070D28E-F729-4FF5-93AA-384494A8D3C9}http://www.actavis.com/en/media+center/newsroom/articles/actavis+eur24+million+nordic+bank.htm The Actavis pharmaceuticals group has concluded a credit agreement with the Nordic Investment Bank for nearly ISK2 billion (EUR24 million) for the creation of the company’s new development centre in Hafnarfjordur, Iceland. The state-of-the-art centre will comprise a development plant and laboratory of 4,000 sq m and will open at the end of 2005. The loan will also be used to finance Actavis’ principal development projects, such as pharmaceutical research by Colotech A/S, Actavis’ Danish subsidiary. Actavis’ development centre was previously located at two places in Reykjavik, on Borgartun and Skutuvogur. All these activities will transfer to Reykjavikurvegur in Hafnarfjordur, where Actavis also has its Icelandic offices. Actavis’ credit agreement with the Nordic Investment Bank is for a term of eight years with repayments commencing in 2008. "The credit granted by the Nordic Investment Bank is a sign of the bank’s strong support of Actavis and its expansion plans," said Robert Wessman, CEO of Actavis.OtherFri, 10 Dec 2004 09:40:00 GMT{50E6CE03-5AC3-4044-8C9A-AC0072C4FECA}http://www.actavis.com/en/media+center/newsroom/articles/gudbjorg_edda_ega_president.htm The European Generic medicines Association’s board announced the election of Actavis’ Gudbjorg Edda Eggertsdottir as its new president at a meeting in Warsaw on 12 October. Gudbjorg Edda has been active in the generics medicines industry for over 30 years, witnessing the many challenges it has already faced on its way to becoming an essential part of the global healthcare offering. She has impressive industry pedigree, which includes significant experience in the generic medicines sector. Gudbjorg Edda is Actavis’ President Iceland, Strategic Projects. She has been part of the EGA Executive Board for two years. Gudbjorg Edda fully understands the restrictive conditions in which the generics and biosimilars industries must now operate and the challenges they face in seeking to bring affordable and reliable medicines to the citizens of Europe. These include: more evidence of price cuts and tendering; increased regulation and global competition; and the need to promote an industrial policy to make Europe the centre of generic and biosimilar medicines manufacturing – a goal to which Actavis is committed. Gudbjorg Edda wants to increase patient access to these medicines by increasing demand-side measures and encouraging decision-makers to understand that relying solely on price cuts will have serious negative consequences in the longer term. “We need to work with the national governments to promote sustainable pricing systems for our products, and to convince them that the best way forward is to: promote demand for our products; and to increase generic penetration. An important part of achieving that is to ensure immediate access to the markets post patent expiry, e.g. to ban all forms of patent linkage,” Gudbjorg Edda said. She will also help to guide the industry through the challenges of globalisation faced by generic and biosimilar medicines. “If we want to promote the global impact of biosimilars, we must support global development. We cannot live with separate development programmes for Europe, US and Japan – not only is this unethical, it is also simply far too costly,” Gudbjorg Edda said.OtherWed, 12 Oct 2011 15:33:00 GMT{50F6522B-7FB5-4B1E-87E2-8E29EE6096BB}http://www.actavis.com/en/media+center/newsroom/articles/hctz+new+strength+us.htm Actavis has received approval from the U.S. Food & Drug Administration to market Hydrochlorothiazide Tablets USP, 12.5 mg. Distribution of the product will begin immediately. Hydrochlorothiazide 12.5 mg tablets are therapeutically equivalent to the reference listed drug (RLD), Hydrochlorothiazide Tablets USP 12.5 mg, of Mylan Pharmaceuticals, Inc. The newly approved 12.5mg strength joins Actavis’ current line of Hydrochlorothiazide 25mg and 50 mg tablets. Hydrochlorothiazide is used to treat high blood pressure and fluid retention caused by various conditions, including heart disease.ProductFri, 02 Mar 2007 14:00:00 GMT{51B54945-9BB4-4562-9A00-BD16FB39AE63}http://www.actavis.com/en/media+center/newsroom/articles/r+and+d+award+iceland.htmThe Actavis research and development facility in Iceland has won an annual award for the design and setup of wiring, plumbing and ventilation systems. Only one Icelandic company wins this local award each year. This is Actavis’ second such award; the Company’s manufacturing site in Hafnarfjordur, Iceland, took the prize in 1999. Iceland’s minister of health, Mr. Gudlaugur Thor Thordarson, presented the award. Jon Gunnar Jonsson, Managing Director of Actavis Iceland: “We never compromise on quality, not on this or any other aspect of our manufacturing of pharmaceutical products. Quality is paramount at Actavis and the contractors we work with are fully aware of that, too, as this award shows. Our commitment to quality has also been repeatedly confirmed in assessments, audits and inspections by our customers and the authorities.” Actavis’ R&D facility in Iceland, the Group’s principal research and development site, is about 3,200 square metres and was opened in late 2006. R&D plays a pivotal role in Actavis’ growth. The division’s work fuels the future portfolio of products for the market. With 650 products on the market and a further 377 projects in the pipeline, Actavis’ portfolio is one of the strongest in its field.OtherMon, 22 Oct 2007 18:42:00 GMT{5300A7E3-E795-40E2-947A-745C373EBE66}http://www.actavis.com/en/media+center/newsroom/articles/comments+financial+crisis.htmIn light of recent market events in the Icelandic financial sector, which are a consequence of the world financial crisis, Actavis Group would like to clarify its position.The financial crisis does not impact our normal course of business, and Actavis will remain focused on providing quality products to its customers.Actavis Group hf. is not exposed to the Icelandic banks in regards to funding or normal banking facilities. Our banking operations are with international banks not exposed to the current events in Iceland. We therefore, as before, have full banking operations without restrictions, both to make payments and receive payments.Actavis is a global generic pharmaceutical company with a turnover of about EUR1.7bn this year, with only 1% of our revenues generated in Iceland.Actavis provides high-quality, low-cost products to its customers in the US, Europe, and other major markets of the world. Notwithstanding the challenges facing the world economy, we continue to experience rising demand and to launch new products.The company is present in 40 countries around the globe, and its products are registered in more than 60 countries. The company‘s books are in euros.OtherTue, 14 Oct 2008 23:03:00 GMT{54197B66-9E58-40EF-8734-C0B0C733E8CB}http://www.actavis.com/en/media+center/newsroom/articles/actavis+to+acquire+us+amide.htm Actavis Group and Amide Pharmaceutical, Inc., a privately owned US generic pharmaceuticals company, announce today that Actavis has reached an agreement to acquire Amide for an initial gross consideration of US$500 million in cash with up to an additional US$100 million payable over two years subject to performance. Upon closing the acquired company is expected to have a cash balance of approximately US$40 million. The deal brings together two premier generics companies with complementary strengths in Europe and the US and represents a significant milestone in Actavis’ plans to become one of the leading global companies within the sector. The combination of Actavis’ brand and product development strength and geographic coverage in Europe with Amide’s strategically important foothold in the US market is expected to generate significant opportunities to drive revenue growth, margin enhancement and create further value for the enlarged Group. On completion, the operations of Actavis Inc. in the US will be combined with the activities of Amide in New Jersey. Agreement has been reached with key members of Amide’s senior management to remain with the Group, with Amide President Mr Divya C Patel becoming a member of the Actavis Executive Board. The acquisition provides Actavis with a platform from which to launch future products into the US, the world’s largest generic pharmaceuticals market. The enlarged group will benefit from products that have been identified in Amide’s portfolio that can be marketed in Actavis’ existing markets. Actavis will gain access to Amide’s best in-class product development and regulatory capabilities in the US as well as its broad experience in marketing and distribution. Actavis will acquire increased production capacity through Amide’s US Food and Drug Administration ("FDA") approved manufacturing facilities and new plant, expected to be completed in 2006. The enlarged Group will have one of the broadest portfolios in the generics sector with over 500 products on the market and minimal overlap between the respective products. The enlarged Group has 136 products in its in-house development and is expected to file at least 15 Abbreviated New Drug Applications ("ANDAs") in 2005. Actavis expects the acquisition to be 45%-50% accretive to profit before tax and 30%-35% earnings per share in the first full year following completion Actavis will partially finance the acquisition through a pre-emptive placing in Iceland of its own treasury shares (6.6%) and of newly issued shares to raise a total of EUR250 million in market value. The balance of the consideration for the acquisition will be financed with a new 5-year syndicated credit facility of EUR500 million which will partly be used to refinance Actavis’ existing short- and long-term debt. Commenting on the acquisition, Mr Robert Wessman, President and CEO of Actavis, said: "This transaction is a significant step in our strategy to build one of the world’s leading generic pharmaceutical companies. Amide is a highly profitable company with a broad range of marketed products, a strong product pipeline and an excellent management team and workforce. It is well positioned in the key US market and will provide the critical mass for Actavis to enter the US with its own products. The transaction brings considerable product and marketing synergies and positions us well to take advantage of further opportunities in the rapidly expanding generic pharmaceuticals market." Mr Divya C Patel, President of Amide, added: "We are extremely enthusiastic about the mutual benefits to be gained from this transaction. There is an excellent strategic fit between the two companies and it provides Amide with the ability to leverage its market position as well as expand its product portfolio in the coming years. Furthermore, Actavis gains a significant platform to extend its current product offerings into Amide’s US distribution channels. We look forward to joining the Actavis Group." OtherFri, 20 May 2005 10:19:00 GMT{542FFDB8-B2CA-4E4C-A783-35DCF3F65F70}http://www.actavis.com/en/media+center/newsroom/articles/actavis+clamelle+award.htm Actavis were triumphant last week in Birmingham, UK, at the annual SMaRT Awards winning Best POM to P Switch of the Year Award for Clamelle. The Clamelle training materials were also awarded Highly Commended in the Best Educational Initiative for Pharmacists category. The SmaRT (Sales, Marketing and Retail Training) Awards, sponsored by Numark, exist to acknowledge the excellence of training initiatives and sales and marketing support programmes provided by manufacturers to pharmacists and their staff. Best switchClamelle was awarded the title of Best POM to P switch in the pharmaceutical industry in 2008. Following the reclassification of azithromycin 500mg from prescription-only (POM) to pharmacy (P, OTC) medicine status, the Clamelle Chlamydia Test Kit and Clamelle Azithromycin 500mg tablets were launched in November 2008, under the banner of the Clamelle Chlamydia Service. Competition in this category was fierce with Feminax Ultra (naproxen), Bayer and Voltarol (diclofenac), Novartis Consumer Health. Excellent Educational InitiativeThe Clamelle training materials which were prepared to support the launch of Clamelle were highly commended in this category. All UK pharmacists and pharmacy assistants received the training materials which were accredited by both NPA and CPP. Clamelle websiteProductThu, 26 Feb 2009 10:27:00 GMT{54395A53-3A38-412B-B013-10FB1311CC22}http://www.actavis.com/en/media+center/newsroom/articles/bupropion+xl+us+150+mg.htm Actavis today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market Bupropion Hydrochloride extended-release tablets (XL) 150mg. Distribution of the product has commenced. Bupropion Hydrochloride extended-release tablets (XL), available in 150 & 300mg strength, are the generic equivalent of Wellbutrin XL® for the treatment of major depressive disorder. Annual U.S. sales of brand and generic Wellbutrin XL® were US$1,481 million for the 12 months ending September 2008 according to IMS Health data. Commenting on the new approval, Doug Boothe, CEO of Actavis in the United States said: “Bupropion XL 150mg, together with 300mg which was launched in August this year, offers significant value to our customers and patients. This approval also underscores Actavis’ emphasis and capability in bringing complex controlled-release products to the marketplace.”ProductMon, 01 Dec 2008 12:40:00 GMT{5459DE27-7932-429C-ABAB-B65EFBCCD2AC}http://www.actavis.com/en/media+center/newsroom/articles/three+new+chief+executives.htm The Actavis Group today announces that it has made three new executive appointments. The changes are designed to further strengthen the overall structure and efficiency of the business as it continues to grow and expand into new markets. The two new positions that have been created on the Chief Executive’s Board are that of Corporate Development and Strategy and Organisational Development. The new members of the Executive Board are: Sigurdur Oli Olafsson (36), Chief Executive of Corporate Development.Sigurdur Oli Olafsson will be responsible for Mergers and Acquisitions, Portfolio Management and Global Market Information, In-licensing and Business Development. Olafsson is currently Managing Director of Actavis Inc. in the USA, and he will continue in that position for the time being. Mr Olafsson, a Pharmacist from the University of Iceland, joined Actavis in 2003 after working for Pfizer UK from 1998 and then Pfizer in the US from 2001 where he held a post in Global Research and Development. Previously Olafsson served as Marketing Manager for an Actavis subsidiary, later becoming Drug Development Manager. Svafa Gronfeld (39), Chief Executive of Strategy and Organisational Development. Gronfeldt will become responsible for integrating Actavis’ corporate strategy within the Group, following up objectives and tactical plans, and supporting the development of the Group’s organisational structure. She will also coordinate HR practices across the Group, which will include managing the Actavis Group Academy. Gronfeld, who previously served as a Director of Consultancy at IMG Deloitte in Iceland, is a lecturer in Business Administration at the Business and Economics division of the University of Iceland. She has conducted leadership training in the US and the UK. She has a PhD in Industrial Relations from the London School of Economics and Political Science. Per Edelman (41), currently Head of International Commercial Affairs S&M, will take the role of Chief Executive of Sales and Marketing Own Brand as of 01.11.2004. Edelman joined Actavis this June from Alpharma, where held the position of Leader of Business Development. Prior to that, he was Alpharma’s European Director of Sales & Marketing. Edelman graduated with an MBA from the Copenhagen Business School and has also completed a number of management programmes with the London Business School and Harvard Business School. Kristjan Sverrisson, currently Chief Executive of Sales and Marketing Own Brand, will leave the company as of 1 November to take on other responsibilities. Kristjan Sverrisson will continue to work for Actavis for the next months as a consultant. The Executive Board would like to take this opportunity to thank Kristjan for his contribution and cooperation over the years and extend their best wishes for the future. Facing the future with confidence“It is important that we harmonise our operations after recent mergers and acquisitions. These new functions will ensure we streamline our efforts as much as possible while maintaining our careful focus on customer needs. The new structure also means that we are better placed for further growth and for easier integration of new businesses.” said CEO Robert Wessman.OtherWed, 13 Oct 2004 10:31:00 GMT{56E80932-4C57-4966-9FC9-68A7CB0265DB}http://www.actavis.com/en/media+center/newsroom/articles/actavis+enters+korea.htm Actavis has entered into an exclusive distribution agreement, for a number of generic products, with J&M Pharma, Co Ltd, a Korean owned and operated pharmaceutical company, headquartered in Seoul, Korea. The agreement is an important step in building Actavis’ presence in the Korean generics market. Actavis is one of the world's leading generic pharmaceutical companies specialising in the development, manufacture and sale of generic pharmaceuticals. Actavis has operations in 40 countries, with 11,000 employees. Actavis’ products are already marketed in the Asia Pacific region, in markets including Singapore, Hong Kong, China, Australia, Indonesia, Taiwan, Malaysia and Vietnam. Commenting on this partnership Thomas Runkel, Vice President of Actavis in the Asia Pacific region said: “The partnership with J&M is an important milestone for our entrance into the fast growing Korean market. We look forward to working with J&M to bring our extensive generic product portfolio of first class generics onto the Korean market fast.” Tae-Hwan Kim, President of J&M, said: “We are excited to enter into an exclusive distribution agreement with Actavis for selected generic products. We will strive to position Actavis as a trusted generic brand in the Korean market and make a success story with its esteemed products.” Andrew Suh, CEO of Cosmo USA IBRC, Inc., a life science industry consulting company, served an integral role in bringing Actavis and J&M together for this opportunity.OtherThu, 30 Oct 2008 12:30:00 GMT{57315477-A21E-423E-B6AF-04A784F91021}http://www.actavis.com/en/media+center/newsroom/articles/clamelle+wins+otc+marketing+award+2009.htm Clamelle was once again the talk of the town at the OTC Marketing Awards 2009 in London on the 5th March, winning two of the prestigious awards. Most Innovative New OTC ProductClamelle (azithromycin) was awarded the title ‘Most Innovative New OTC Product’ with one judge describing the Clamelle Chlamydia Service as a ‘revolutionary switch’ and another declaring it ‘a major public health advance’. Best OTC Pharmacy Training The extensive educational training materials produced to support the switch were awarded the ‘Best OTC Pharmacy Training’ Award. A ground breaking switch must be supported by top-class training for pharmacists and their staff – and this was, according to the judges, exactly what the Clamelle Chlamydia Service materials did. These two awards build on Clamelle’s success earlier in the year when the Clamelle Chlamydia Service was awarded ‘Best POM to P switch of the Year’ at the SMaRT Awards in Birmingham. Clamelle website Actavis UKProductTue, 10 Mar 2009 13:58:00 GMT{573C15C4-8B42-452A-8700-D992AFF10575}http://www.actavis.com/en/media+center/newsroom/articles/two_companies_shortlisted_polfa_warszawa.htm Two companies have now been shortlisted to buy Polfa Warszawa; Actavis and the Polish pharmaceutical company Polpharma. This was announced by Polfa Warszawa’s owner, the state-owned Polski Holding Farmaceutyczny (PHF), on 31 August. Commenting on this latest development, Actavis CEO Claudio Albrecht said he remains convinced that Actavis is the best option, not only for the Polish employees, but also for the state. "The Polish government needs to achieve the best sales return on the asset, but it must also secure ongoing employment and Polfa’s flourishing export business. Poland has much higher strategic importance for Actavis than for our Polish competitors.” Polfa Warszawa is one of Poland's largest pharmaceutical companies. If successful in its purchase, Poland would become Actavis’ third-largest market, after the US and the UK. The Company would also acquire a plant for producing ampoules, turning Polfa Warszawa into a global technology centre from which the Group could export products into other markets.OtherWed, 31 Aug 2011 18:39:00 GMT{5789138B-540B-4CFC-9B1A-917AC89B6082}http://www.actavis.com/en/media+center/newsroom/articles/medicines+to+centre+for+missionary+animation.htmDuring the month of October, Actavis Ltd donated around 25 million tablets, worth EUR200,000 to the Centre for Missionary Animation. Actavis has contributed by donating medicines used to treat infections, tuberculosis, cardiovascular and respiratory disorders. The Centre for Missionary Animation, founded 25 years ago, is an international entity within the Missionary Society of St. Paul. Medicines donated by Actavis have been shipped to clinics run by the Centre for Missionary Animation in two major cities in Peru, the capital city Lima and Arequipa. These medicines will be distributed free of charge to the poor people who attend these clinics and who would otherwise not afford to pay for their healthcare. Actavis Ltd is a subsidiary of Actavis Group. The Maltese operation alone boasts a workforce of no less than 380 highly skilled employees.CommitmentSat, 25 Nov 2006 17:42:00 GMT{585FA0B1-436D-4209-8824-451DE8EC1F88}http://www.actavis.com/en/media+center/newsroom/articles/actavis+amide+acquires+three+products.htm Actavis’ recently acquired subsidiary Amide Pharmaceuticals Inc., in the USA has acquired three generic pharmaceuticals from Novartis’ (Novartis) AG’s subsidiary Sandoz. The investment in the products comes as a result of a ruling by the US Federal Trade Commission, approving Novartis’ acquisition of Eon Labs, Inc (Eon) on the condition that they divest three overlapping products to Amide to prevent competition in the US market. According to Mr. Divya Patel, Amide’s CEO, the three products Desipramine (Anti-depressant), Orphenadrine (Muskulo-skeletal) and Rifampin (Antibiotic), are a valuable addition to Amide’s portfolio with expected annual revenues of about US$4-5 million, and will strengthen the companies position in the market. Actavis’ merger with Amide was a platform for Actavis’ expansion into the US market. The company’s vision is to become of one the world’s leading generic pharmaceuticals companies.ProductWed, 03 Aug 2005 09:18:00 GMT{5867D8FA-E195-4A27-82B3-48F97B61DBAF}http://www.actavis.com/en/media+center/newsroom/articles/balkanpharma+donates+pediatric+clinic.htm As a part of the initiative called “Bulgarian Christmas” Balkanpharma has donated medicine to the pediatric clinic in Plovdiv. The initiative is under the patronage of the President of the Republic and its main purpose is to help to socially disadvantaged families and ill children. The donation is aimed to the Multy Target Clinic for Active Treatment “St. George” – Plovdiv, pediatric and medical genetic Clinic. On February 19th, 2004 Nikola Karadimov – Secretary of the President of the Republic and Mr. Vladimir Afenliev, Executive Director in Balkanpharma handed the donation to the Director of the Pediatric Clinic - Associated Professor Mr. Evgeni Genev. Balkanpharma, the biggest pharmaceutical company in Bulgaria, has produced the medicine. The donation will cover the medicine need of the Hospital for six months. Donated pharmaceuticals are vitamins, pain relief medicine, antitemperature and antitusive medicine, antibiotics, medicine aimed for treatment of neuralgic and cardio vascular system diseases. Balkanpharma is a social responsible company. Charity activities are an important part of the program for company development. Balkanpharma has frequently responded accordingly to the most painful problems of the Bulgarian society.CommitmentMon, 23 Feb 2004 11:47:00 GMT{588EFB09-6B6C-4ED6-8589-010EF33182D5}http://www.actavis.com/en/media+center/newsroom/articles/keri+pharma+rebranded.htm New name completes successful integration process Keri Pharma Generics in Hungary will be rebranded as Actavis with immediate effect. This follows Actavis’ acquisition of Keri Pharma Generics in 2005 and the completed integration of the business. Since its acquisition by Actavis, sales revenues of the company have grown dynamically, and in 2008 they are expected to exceed HUF 8bn. The company has introduced a number of products successfully on the Hungarian market in recent years and plans to extend its portfolio with 16 additional products this year and a further 18 in 2009. Keri Pharma Generics will become formally known as Actavis Hungary and will continue to be led by Gabor Keri, Country Manager. Commenting, Robert Wessman, President and CEO of Actavis said:“Our acquisition of Keri Pharma Generics in 2005 marked Actavis’ first steps into the Hungarian market with own-label products. The formal introduction of the Actavis name into the market is the final step in the integration process but just the beginning of the next stage in our development in this market. We have a solid platform from which to achieve further growth in Hungary.” In addition to its professional mission, Actavis Hungary gives special importance to social involvement. The university training of pharmacists has a long tradition in Debrecen. Actavis Hungary has invited applications for a scholarship for successful and ambitious pharmacy students to support their university studies.OtherWed, 27 Feb 2008 10:06:00 GMT{5987210E-F73D-4CC0-83E3-90CA154B3341}http://www.actavis.com/en/media+center/newsroom/articles/Youth+in+Europe+Vilnius.htm Actavis and Vilnius, the capital of Lithuania, have signed a sponsorship agreement supporting Vilnius’ participation in a pan-European drug prevention programme. Svafa Gronfeldt, deputy to the CEO of Actavis and Arturas Zuokas, Mayor of Vilnius, signed the five-year contract this weekend in Actavis’ headquarters in Iceland, in the presence of the President of Iceland and the Mayor of Iceland’s capital city Reykjavik. The programme is based on Icelandic research oriented preventions, spanning the last two decades, documenting risk and preventive factors. “Youth in Europe – A drug Prevention Programme” is an international comparative research study about drug prevention methods, risk and protection factors in European cities. The participating cities will also work towards mobilizing society against drugs according to a programme outline. The President of Iceland, Olafur Ragnar Grimsson is the programme’s patron. The city of Reykjavík serves as the chair of the programme and Actavis is the programme’s main sponsor. Commenting, Svafa Gronfeldt, deputy to the CEO of Actavis Group, said the project is in line with Actavis’ strategy. “It is important that pharmaceutical companies take part in social programmes like Youth in Europe, which aims to prevent drug abuse among young people. It is a particular pleasure for us to support this programme in Vilnius. The Baltics are a very important and growing part of the Actavis family.“ Actavis will sponsor this ambitious drug prevention program in five European cities; Vilnius, Belgrade, Sofia, Istanbul and St. Petersburg, and also provides funding for the research in Iceland.CommitmentMon, 21 Aug 2006 18:36:00 GMT{59C58B4D-47F6-4B32-986E-D63A6D3235FC}http://www.actavis.com/en/media+center/newsroom/articles/ondansetron+US.htm Actavis today announced that it has launched Ondansetron Tablets in the US. Actavis will market the product under an agreement with Natco Pharma Limited. Distribution of the product will commence immediately. Ondansetron hydrochloride tablets, the generic equivalent of GlaxoSmithkline’s Zofran® tablets, will be available in 4 mg and 8 mg strengths. Ondansetron hydrochloride tablets are indicated for prevention of nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. Annual sales of Ondansetron hydrochloride tablets in the US were approximately US$746 million for the twelve months ending March 2007 according to IMS Health data.ProductWed, 27 Jun 2007 13:00:00 GMT{5AAF17A5-55E9-4E19-948C-404633F29367}http://www.actavis.com/en/media+center/newsroom/articles/actavis+at+cphi+2008.htm Employees from Actavis Group's diverse departments worldwide will be present at this year's annual CPhI conference, held in Frankfurt, Germany, 30 September to 2 October, 2008. Medis – Actavis‘ third party sales division — had its own stand at the CPhI exhibition for 8 years, but shared the floor with Actavis Group last year for the first time. Actavis and Medis employees will take part in the CPhI conference, the world’s leading pharmaceutical trade conference, now in its 19th year. CPhI Worldwide was launched in 1990 as an international convention on pharmaceutical ingredients and intermediates. The first CPhI Worldwide in 1990 attracted 250 visitors for the 16 exhibitors. This year about 24,000 industry professionals are expected, visiting about 1,500 exhibiting companies from more than 125 countries. CPhI websiteOtherMon, 29 Sep 2008 09:26:00 GMT{5AC1D325-B2B8-4601-982F-F62E7EB8A576}http://www.actavis.com/en/media+center/newsroom/articles/actavis+acquires+pharma+avalanche.htm Actavis Group (ACT), the international generic pharmaceutical company, today announces that it has acquired the Czech generic pharmaceutical company Pharma Avalanche. Financial details were not disclosed. Headquartered in Prague, Pharma Avalanche was established in 2000 and currently employs 30 people. Its primary focus is on the marketing and sale of generic pharmaceuticals on the Czech and Slovak Republic markets. The acquisition is not expected to have any material effect on Actavis’ financial results. Commenting on the acquisition, Sigurdur Oli Olafsson Chief Executive of Corporate Development said: "This acquisition is in line with our strategy to extend Actavis’ presence in central Europe. It provides us with a direct sales and marketing presence on the Czech and Slovak Republic markets. This also gives us a good platform from which to register and launch Actavis products in these markets."OtherTue, 22 Mar 2005 15:53:00 GMT{5BA4FA43-864B-44D0-80D1-820F17282706}http://www.actavis.com/en/media+center/newsroom/articles/atorvastatin+serbia.htm Clinical professionals from all over Serbia gathered recently in the heart of Belgrade for a high-level seminar on statins. The event, held at the capital’s beautiful Old Court building, was a fitting backdrop for the launch of Actavis’ newest statin Atacor (atorvastatin), used in the treatment of hypercholesterolemia (the presence of high levels of cholesterol in the blood, a contributor to cardiovascular disease). Atacor (atorvastatin), the generic equivalent of Pfizer's Lipitor®, efficiently regulates the blood cholesterol levels and is one of the most efficient drugs used in the therapy of primary hypercholesterolemia. A number of expert speakers from the Clinical Centre of Serbia were invited to discuss the significance and advantages of statins for a range of conditions at the Actavis-sponsored seminar. Opening the proceedings was Professor Zorana Vasiljevic from the Institute for Cardiovascular Diseases (ICD), who explored the successful use of statins in treating arteriosclerosis of coronary arteries. Also presenting were Professor Miloje Tomasevic from the ICD (discussing the pleotrophic effect of statins), Professor Nebojsa Lalic from the Institute for Endocrinology, Diabetes and Metabolic Disorders (the application of statins as part of Type II Diabetes treatment) and Professor Ljiljana Beslac-Bumbasirevic from Serbia’s Institute for Neurology (treatment outcomes on patients with aneurisms). ProductTue, 28 Oct 2008 16:39:00 GMT{5C1961D3-2406-47AF-90AE-98FC42D745C3}http://www.actavis.com/en/media+center/newsroom/articles/ramp+for+disabled+bulgaria.htm Actavis has built a ramp for the access of disabled people to a major cathedral in Bulgaria. The ramp was officially opened by Nikolay Hadjidonchev, Actavis’ Bulgaria Managing director, in the presence of admiral Hristo Kontrov, Governor of the Varna region. The ramp is at the main entrance to the Uspenie Bogorodichno Cathedral / Dormition of the Theotokos Cathedral, in the coastal town of Varna. Thus, the biggest Church in the region is now easily accessible for disabled people. Special guests of the event were the Mayor of Varna Kiril Yordanov, Steven Spectar, chairman of the organization “American friends of disabled people in Bulgria” and representatives of the Bulgarian Church. Actavis awarded for cultural and social merits During the ceremony Mrs Donna Steiger, Chairman of the International Tribunal of crimes against humanity in the area of disabled people awarded Actavis for “Contribution for global development and special merits for cultural and social priorities for 2008”. This award has been founded by the USA Senate and UN. Due to the architectural importance of the Cathedral, which is a cultural monument, a group of international specialists in restoration advised the building process and the match to the overall architectural look of the Church. Special marble in art-deco style in dark grey and pink colours was used for the ramp facing in unison with the ancient coral pavement of the overhead road. The cost of the ramp amounts to BGN 200 000. First ramp in SofiaWith the ramp opening in Varna, Actavis continues its national campaign called “Architecture Accessibility for Disabled People to Bulgaria’s Spiritual Symbols”. The campaign was launched last year with the opening of the first ramp to the Alexander Nevski Cathedral in Sofia. CommitmentFri, 30 May 2008 15:42:00 GMT{5C83B0FC-D7AE-40D5-9CEE-61AEC01258C2}http://www.actavis.com/en/media+center/newsroom/articles/digitek+recall+customer+support.htm On 25 April, Actavis Totowa LLC initiated a Class 1 nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label. Acting together with Actavis to enact the recall of the product, Mylan Pharmaceuticals, Inc. as the distributor of Digitek, retained Stericycle customer service centre (tel. 1-888-276-6166) to act as the recall coordinator immediately following Actavis’ decision to recall the product. Consumers are asked to direct all enquiries they may have regarding this recall to Stericycle for proper handling and distribution. Representatives at the service center are available to support all consumer queries and to provide direction on how to return the product. If you have any questions about your treatment, or any medical inquiries regarding the product or possible substitutes, you should contact your physician immediately. For further information, please visit Actavis' United States websiteProductFri, 09 May 2008 22:32:00 GMT{5D8348A3-0A97-4BBD-9DBA-403963052035}http://www.actavis.com/en/media+center/newsroom/articles/libya_donation_malta.htm “I personally thank Actavis on behalf of the Libyan people for this generous offer and the Maltese government for making this shipment possible. Malta has always been an exemplary neighbouring country to Libya. Malta never refused to offer support to the Libyan people and is continuing to show solidarity in this moment of crises and difficulty,” said Dr. Mohammed Sayeh, Senior Member of the National Transitional Council of Libya at a press conference in Malta today. “We know Libya is faced with shortages of essential supplies. Actavis is one of the world’s largest generic pharmaceutical companies and takes its social responsibility very seriously. That’s why Actavis donates EUR2M worth of medicines to Libya now. The goods will leave Malta on Sunday and arrive in Tripoli during next week”, said Actavis CEO Claudio Albrecht. He emphasized the role of the Maltese government in this donation. “Without the Malta’s help in coordinating this, the donation wouldn’t have been possible in this short period of time.” In total, 170 pallets of urgent medicines are on their way from Malta to Tripoli. The donation includes cardiology, anti-infective, pain management and gastrointestinal products amongst others. Actavis‘ donation will be sent to the Medical Supply Organisation within the Ministry of Health in Libya, for distribution to all affected areas within the country. The regional office in Malta is responsible for the Africa region, Libya being part of this region. Enquiries Actavis GroupFrank StaudEVP Corporate CommunicationTel: +41 79 230 95 78E-mail: fstaud@actavis.com Actavis MaltaDaniel Vella FriggieriRegional Director NCWATel: +356 2248 33 00E-mail: dvellafriggieri@actavis.com.mt CommitmentFri, 14 Oct 2011 14:25:28 GMT{5DEEB5D7-41A5-4AD0-BDD3-86E8C470B285}http://www.actavis.com/en/media+center/newsroom/articles/new+actavis+us+website.htm Actavis has launched a new local website in the United States: www.actavis.us. Like on other local Actavis sites, local activities and products are in the forefront, whereas on the Corporate website the main focus is on investor relations and the corporate directory. North America is Actavis’s single largest market with one-third of the company’s sales generated there. Following three major acquisitions in the US since 2005 - Abrika Pharmaceuticals, Amide Pharmaceuticals and the US generic arm of Alpharma Inc. - the company is now the eighth largest generic company in the market by value and the fifth largest by volume. Work on the site has been ongoing for a couple of months, in cooperation between Actavis’ Corporate communications and the local US team, BSH in Bulgaria and Eskill in Iceland. The same web-team developed Actavis’ Corporate website, launched in October 2006, as well as Actavis’ Iceland website, launched in December. A new Actavis website in the Netherlands will be launched shortly, and several other new local website launches are planned in the coming weeks. Actavis on the web: Bulgaria (Bulgarian/English) Denmark (Danish) Finland (Finnish) Iceland (Icelandic) Malta (English) Netherlands (Dutch) Norway (Norwegian) Poland (Polish) Portugal (Portugese) Romania - Sindan (English) Russia (Russian) Serbia - Zdravlje (Serbian) Sweden (Swedish) UK (English) Ukraine (Ukrainian) US (English) OtherSat, 03 Feb 2007 14:37:00 GMT{5FC5D447-4B3A-418C-8E07-699F3B7AD49E}http://www.actavis.com/en/media+center/newsroom/articles/pharmaco+main+sponsor+national+gallery.htm Pharmaco has extended its contract with the National Gallery of Iceland and will continue to be its main sponsor for the next two years. Pharmaco became the main sponsor for the National Gallery of Iceland in the year 2002. Robert Wessman, CEO of Pharmaco, says that the contract is in line with the company’s strategy to sponsor and strengthen Icelandic arts and to promote Icelandic art around the world. Pharmaco will continue its active participation in sponsoring special exhibitions and events at the art gallery. Additionally, the continuation of the sponsorship enables the National Gallery to present a major display of modern American art in Iceland this year, where among others, art by Jeff Koons, Andy Warhol, Sherri Levine and Richard Prince will be shown.CommitmentMon, 02 Feb 2004 12:01:00 GMT{60C25DA6-87C5-473D-A3FA-B9C5D782E5CF}http://www.actavis.com/en/media+center/newsroom/articles/figure+skating+2007.htm Actavis is a major sponsor of the European Figure Skating Championship taking place in Warsaw, Poland from 22 – 28 January 2007. All major skating champions of Europe participate in the event. The event enjoys vast popularity throughout Europe and is being broadcast on TV stations around the continent as well as on major Sports Channels, such as Eurosport and ESPN.Actavis has a sales and marketing office in Warsaw, Poland and employs in total around 100 people in Poland.CommitmentThu, 25 Jan 2007 23:03:00 GMT{6372ABD9-10AC-45BC-91DA-830417564C68}http://www.actavis.com/en/media+center/newsroom/articles/actavis+ireland+launched.htm Actavis has entered the Irish market this week, with plans to create up to 25 new local jobs over the next five years and to launch over 120 generic drugs in Ireland, with the potential to save millions of euro off the country’s annual health bill. The new roles Actavis will create are in addition to 11 corporate employees currently based in Ireland. Actavis Ireland Managing Director Tony Hynds:“Over the next five years, we plan to rapidly expand our offering in Ireland in all channels - hospital-specific, prescription and over the counter medicines, and offer a reduction of up to 60% on the cost of drugs.” Hynds said the arrival of Actavis into the Irish market came at a time when the country was struggling to meet the rapidly rising cost of healthcare. “The strength of our product pipeline means we can not only offer more choice to doctors, pharmacists and consultants, but a high quality alternative to big brand names with identical ingredients at a far cheaper price to the Health Service Executive and the Irish consumer” He continued, “On just six of the 20 new products we plan to launch this year, there is the potential to save over EUR22 million.” “In Ireland, Actavis has established a team with deep expertise in the local industry, people who understand the nature of the market here, and has given them the backing of a vast global product pipeline,” Hynds added. Actavis launched a generic cancer treatment drug, Gemcitabine, on the Irish market on Monday. It was made available for prescription from 9th March, on day one when the patent for Gemcitabine expired in Ireland. OtherWed, 11 Mar 2009 14:20:00 GMT{64482477-769F-4B59-8086-93AE0A663F1E}http://www.actavis.com/en/media+center/newsroom/articles/new+pharmaceutical+plants+india.htm Actavis has announced that three new construction projects are underway at Actavis in India. Actavis’ Deputy CEO, Guðbjörg Edda Eggertsdóttir recently broke the ground for a new pilot plant and a new API (active pharmaceutical ingredient) plant at Actavis’ existing API facility in Alathur, close to Chennai, India. These new facilities will enable Actavis API Alathur to scale up more products as well as to increase commercial volumes. On the same day, the Deputy CEO also broke the ground for a new SOD (solid oral dosage) plant at Actavis’ current SOD site in Alathur. This plant is to be built to international standards and will eventually have a capacity of 4 billion tablets. Construction is expected to be completed in 2009. Actavis’ Executive Vice President of R&D, Stefan J. Sveinsson, has also inaugurated new labs at Ticel Bio Park in Chennai: a stability lab which has been setup as an independent unit to cater to stability requirements within the group. It has a capacity to handle 9000 samples per year; and laboratories for analytical development in connection with Actavis’ API R&D activities in Bangalore, India. Commenting on the new wave of construction, Gudbjorg Edda Eggertsdottir, Actavis’ Deputy CEO, said: “The API facility will be the first major manufacturing site for Active Pharmaceutical Ingredients within the Group, and it is an important step for the company in controlling the full value chain of pharmaceutical products. This site will bring us an edge in the industry, will enable us to improve our service to our customers. Also with respect to the SOD facility many of our goals for growth in the future are tied to this manufacturing site, where we will produce first class pharmaceutical products for our markets in Europe and elsewhere. When complete this manufacturing site will be one of the largest within the group, and it will be designed and built to the most stringent standards to fulfil the requirements of the regulators.”Actavis currently operates 22 manufacturing sites in 14 different countries.OtherMon, 27 Oct 2008 17:00:00 GMT{6472CDC7-0929-4181-820D-21F1C37238F0}http://www.actavis.com/en/media+center/newsroom/articles/decubal+launch+romania.htm Decubal, Actavis‘ complete range dedicated exclusively to dry skin, has been officially launched in Romania. The range comprises 17 products. The products, based on long-term research and clinic testing, are dedicated to cleaning and caring for the face, body, scalp and hair. Decubal was developed following requests from dermatologists in the Nordic countries, and in collaboration with them, and does not contain perfumes or preservatives. The products are recommended for people of all ages, male and female. The launch event in Romania was opened with a short presentation of the brand’s history and development, delivered by Martin Reidar, International Business Manager OTC Actavis group, who came to Romania especially for the launch. His introduction was followed by an unconventional presentation of the products by Irina Nicolae, Product Manager Actavis in Romania. In perfect harmony with the personality of Decubal, the launch event was “painted” in red and white, the official colours of the brand. Highly recognized dermatologists, numerous pharmacists and representatives of the media attended the event where a unique fashion show revealed stylish accessories exclusively created for Decubal by the avant-garde designer Kristina Dragomir, who captured in an inimitable style the dynamism and vivacity of Decubal. Decubal has already been launched by Actavis in numerous other countries, including Bulgaria, the Baltics, Portugal and Iceland, as well as in the Scandinavian countries where it has been a well known product range for years. More information about Decubal can be found on the local websites: Romania: www.decubal.roBulgaria: www.actavis.bgDenmark: www.decubal.dkFinland: www.actavis.fiIceland: www.actavis.isNorway: www.decubal.noPortugal: www.decubal.pt Sweden: www.decubal.se ProductThu, 27 Mar 2008 17:01:00 GMT{659BB9CB-BF2A-4AFC-8C06-8CC1D98B813F}http://www.actavis.com/en/media+center/newsroom/articles/double+win+at+business+awards.htm Pharmaco began February on a winning note, overcoming stiff competition to scoop two of Iceland’s most prestigious business awards, both of them for the first time. In the 2003 Icelandic Knowledge Award, the company finished ahead of KB Bank, the Baugur retail group and biotech company Medcare Flaga. The award, now in its fourth year, is sponsored by the Icelandic Association of Business Consultants and Economists (FVH). This year’s theme was Change Management, and was judged by a panel comprising four of the country’s leading academic and business figures. Pharmaco CEO Robert Wessman was also voted Icelandic Businessman of the Year for 2003. In its second year, this award is based on the views of senior management of Iceland’s top 100 companies, FVH members and the judges. Both awards were presented to the company today by Iceland’s Minister of Industry and Commerce, Valgerdur Sverrisdottir, at a lunchtime ceremony held at Reykjavik’s Nordica Hotel. Accepting the award, Robert Wessman dedicated the achievement to the efforts of Pharmaco employees and said that the award was huge incentive to continue the ambitious work they have all undertaken.OtherSat, 07 Feb 2004 11:58:00 GMT{6734FED0-FD3E-4630-A9FA-55C7CE263D35}http://www.actavis.com/en/media+center/newsroom/articles/actavis+france+launched.htm Actavis in France was formally launched on 23 October at a one-day conference held at the Centre Étoile-Saint Honoré, close to the Champs Elysées in Paris. Actavis started preparing its greenfield operation in France in 2007, to market and sell Actavis products on the French market. The Group’s offices in the country are located in Le Plessis-Robinson just outside Paris. About 80 Gx products are already on the market. About 120 guests attended the conference whose theme was: “Economic changes, sustainable development: What impacts and what role for health professionals?” Sigurdur Oli Olafsson, Actavis Group’s CEO addressed the conference which was also attended by Svend Andersen, EVP of Sales and Marketing in Western Europe. Philippe Ranty, Managing Director for Actavis in France, presented Actavis, its growth story and strategy and introduced the products and services available to the French market. OtherFri, 31 Oct 2008 15:13:00 GMT{67FA1D23-15E9-47F3-B26A-511E303A225E}http://www.actavis.com/en/media+center/newsroom/articles/heinemann+managing+director+actavis+germany.htm Actavis has today announced the appointment of Thomas Heinemann to the position of managing director of Actavis in Germany. Heinemann joins Actavis from CT Arzneimittel in Berlin where he served as Managing Director of Sales and Marketing. Heinemann will play a key role in driving Actavis’ expansion in the German market, where Actavis aims to achieve strong growth in coming years. The appointment follows Actavis’ recent agreement with the largest supplier of health insurance in Germany, Allgemeine Ortskrankenkassen (AOK), for which it has been selected as a preferred partner. Prior to CT Arzneimittel, Heinemann held several positions at Azupharma, a German generics manufacturer, later taken over by Novartis and renamed to Sandoz, including Head of Pharmacy and Hospital business unit and Head of sales and marketing, where he was responsible for a division of 360 people and a member of the Executive committee. Prior to Sandoz, Heinemann worked in product management and marketing and sales for Thomson Brandt. His education is in business administration with focus on sales and marketing. Commenting on Heinemann’s appointment, Robert Wessman, President and CEO of Actavis, said: “I am delighted that Thomas has agreed to run our operations in Germany. His experience of the German market will be a great asset for us and support our strategy, to become a leading player in Germany, through our strong pipeline and ambitious sales force”. OtherFri, 06 Jul 2007 08:00:00 GMT{68E61C10-F0B6-4A6D-B61E-275A179C7672}http://www.actavis.com/en/media+center/newsroom/articles/iceland+minister+visits+actavis+in+bulgaria.htm Valgerdur Sverrisdottir, Minister of Industry and Commerce in Iceland, led a large Icelandic trade mission to Bulgaria 15-19 October. The delegation included representatives of 14 Icelandic companies, including Actavis. The company has pioneered foreign investment in Bulgaria and is one of the country’s largest employers, with around 3,700 employees. At a seminar designed to promote trade relations between the two countries, several Bulgarian companies gave presentations on their businesses. Delegates also visited a number of local companies, including Actavis and the Bulgarian telephone company BTC. On her visit to the Actavis HQ in Sofia, Minister Valgerdur Sverrisdottir commended the company’s business achievements and its investment efforts in the country. Kristjan Sverrisson, representing Actavis on the trade mission, said the visit had been very successful and that the foundations were in place for future trade links. The trade mission comprised software, hi-tech, pharmaceutical and financial companies and attracted local media coverage. It went on to visit Romania and met with other companies in that region. The trip was organised by the Trade Council of Iceland in close colOtherWed, 20 Oct 2004 10:27:00 GMT{68F79F23-83EF-48F7-8427-1595D608F57E}http://www.actavis.com/en/media+center/newsroom/articles/actavis+comments+filing+doj+complaint.htm Actavis, Inc. today said that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed a complaint seeking a permanent injunction against the business of its Actavis Totowa LLC subsidiary in the United States. The filing comes as the company continues to work to address compliance issues stemming from an inspection of the Actavis Totowa facilities by the FDA earlier this year. Since May 2008, the company has focused entirely on ensuring the quality and integrity of its manufacturing and quality systems. Actavis remains confident that the actions it has taken to remedy the compliance and manufacturing issues at Actavis Totowa will exceed FDA’s expectations and will more accurately represent Actavis standards for good manufacturing practices than what FDA previously observed. The company views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA in a timely manner. “We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we’ve communicated regularly and candidly with the FDA, the public, our employees and our customers,” said John LaRocca, Actavis Inc.’s Chief Legal Officer. “Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency and ourselves.” Editor’s Note: On April 25, 2008, Actavis Totowa LLC initiated a Class 1 nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label. The recall followed an inspection conducted by the Food and Drug Administration that revealed operations at the Little Falls, N.J., facility which did not meet the FDA’s or Actavis’ standards for good manufacturing practices. On August 1, the company initiated a precautionary, voluntary recall — to the retail level — of all drug products manufactured at its Little Falls facility. InquiriesActavis U.S. Media lineTel: +1 (973)-889-6689E-mail: media@actavis.com Actavis GroupHjördís ÁrnadóttirDirector – External CommunicationsTel: +354 535 2300 / 840 7476E-mail: harnadottir@actavis.comOtherFri, 14 Nov 2008 09:57:00 GMT{68FF6575-EB9A-4BE1-A24C-9AACA03AC592}http://www.actavis.com/en/media+center/newsroom/articles/actavis+pure+iceland+exhibition.htm Actavis is one of the principal collaborators of the exhibition Pure Iceland, which was opened at the Science Museum in London on 20 January, and will continue until 21 April. The exhibition, which is held on the initiative of the Icelandic Embassy in London, has been in preparation for two and a half years. The exhibition, which occupies about 1,000 m², focuses on Iceland’s unique nature and climate, and how the Icelanders use their natural resources to generate clean electricity. A visit to the exhibition will be an all-round audiovisual experience, exploring Iceland’s energy resources, volcanic eruptions, earthquakes, climatic fluctuations, avalanches and other aspects of the country’s nature and weather. Experiments with the utilisation of hydrogen for fuel, and Iceland’s potential in that field, will also be examined. Gudbjorg Edda Eggertsdottir, Chief Executive, Sales & Marketing, Third-party sales at Actavis, says that collaboration on the exhibition is consistent with the company’s policy of sponsoring various artistic and cultural projects, as well as sports and humanitarian causes. Many events are scheduled in connection with the exhibition, for both young and old. Striking features include an erupting volcano, and the contribution of the Vesturport theatre company, whose actors will tell traditional Icelandic tales and answer visitors’ questions. Heather Mayfield, Deputy Head of the Science Museum, comments that it is very exciting to undertake such an unconventional form of exhibition, in which a wide variety of stimuli, not least the theatre company’s participation, will lead the visitor to think about Iceland and its people. Iceland’s Minister of Foreign Affairs, Geir H. Haarde, formally opened the exhibition on the evening of Thursday 19 January. TV personality Magnus Magnusson was guest of honour at the opening. OtherFri, 20 Jan 2006 14:30:00 GMT{6950215E-3127-4440-B41C-967DC83110D3}http://www.actavis.com/en/media+center/newsroom/articles/actavis+europes+500+2005.htm Actavis has qualified as one of Europe’s 500 champions of growth for 2005. In their nomination Europe’s 500 states, “your outstanding employment growth over the last three years places your company amongst these top 500 companies selected from across 25 European countries. Your performance ranks your company within the top 50”. Actavis Group's subsidiary Delta (now Actavis hf. in Iceland) was nominated for Europe’s 500 list in 2001 and 2002.OtherWed, 28 Sep 2005 16:04:00 GMT{6B0048DE-46AD-4EA2-A456-12319C0D73A5}http://www.actavis.com/en/media+center/newsroom/articles/actavis+introduces+lisinoton+moscow.htm Actavis presented its new product Lisinoton (Lisinopril) at the Russian national congress "People and Medicine" which was held in Moscow 18-22 April. It was the twelfth congress under this name and Actavis, which takes part in the congress regularly, sponsored it this year. The congress was accompanied this year by an exhibition of pharmaceutical companies which showed their products, development companies that presented new medical equipment, and medical press with their magazines. "People and Medicine" was arranged by the Russian Ministry of Health, the Russian Ministry of Education and Science, the Russian Science Academy, the Russian Academy of Medical Science and the all-Russian Fund "Human Health". "People and Medicine" is the largest event of the Russian pharmaceutical market. Actavis takes part in it regularly and sponsored it this year. Many participants were drawn to Actavis’ bright-orange stand, where its new product Lisinoton (Lisinopril) was presented – the first Actavis product in the Russian market. The launch was successful; the product was transported from Iceland to Russia on 3 April and has been very well received by the market. Product sales have been fast and very successful. The Actavis brand was heavily promoted on a big video screen, by a quiz among congress participants and information on the company spread by reps. Events of this kind contribute to Actavis brand promotion, and maintain a good basis for the company’s successful business activity.ProductMon, 02 May 2005 10:24:00 GMT{6B0FCC4E-33A8-4D04-B042-A2AD31138005}http://www.actavis.com/en/media+center/newsroom/articles/actavis+amide+fda+approval+loxapine.htm Actavis Group hf. (“ACT”) today announces that Amide Pharmaceutical, a subsidiary of Actavis Group in New Jersey USA has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for the product Loxapine Capsules USP. Loxapine is an antidepressant drug, the generic equivalent of Capsules marketed by Watson Laboratories Inc.. The product is used in the treatment of Schizophrenia. Loxapine Capsules are marketed in four strengths 5mg, 10mg, 25mg and 50mg. The product will not have material effect on Actavis’ financials for 2005. ProductThu, 11 Aug 2005 09:12:00 GMT{6B37959D-A16F-45E0-AB75-357DB2998027}http://www.actavis.com/en/media+center/newsroom/articles/actavis_shortlisted_to_buy_polfa_warszawa.htm Actavis is one of three companies shortlisted to buy Polfa Warszawa, the Polish company’s owner has announced. In addition to Actavis, Polish Polpharma and Adamed were on the list of three potential buyers. The state-owned Polski Holding Farmaceutyczny (PHF), which owns Polfa Warszawa, announced that the three companies would be admitted to negotiations on selling the Polish company. Polfa Warszawa is one of Poland's largest pharmaceutical companies. If successful in its purchase, Poland would become Actavis’ third-largest market, after the US and the UK. The Company would also acquire a plant for producing ampoules, turning Polfa Warszawa into a global technology centre from which the Group could export products into other markets. Actavis CEO Claudio Albrecht said when the Company’s decision to bid for Polfa Warszawa was announced, that the Polish company would not only strengthen Actavis’ position in the strategically important Polish market, but it would also offer synergies with the Group’s existing operation in Russia.OtherMon, 25 Jul 2011 09:52:00 GMT{700F7878-4EDB-4F34-8A82-E359E67E4344}http://www.actavis.com/en/media+center/newsroom/articles/actavis+new+name+for+pharmaco+group.htm Actavis is from 17 May 2004 the new name for the Pharmaco Group of companies. The name change is a step towards building a major international brand in generic pharmaceuticals. The move forms part of a broader strategy to consolidate the various businesses within the Icelandic-headquartered group in order to build a leading global pharmaceuticals company offering customers faster, better access to the latest generic products. The introduction of the Actavis name on 17th May will unite the group companies under one brand after a four year period of significant expansion through organic growth and international acquisitions. Today, the group employs around 7,000 people in 25 countries in Europe, North America, the Middle East and Australia. The name change will initially affect six brands within the group: Balkanpharma, a leading pharmaceutical brand in Eastern Europe, the Baltic republics, Russia and the CIS countries; Delta and Omega Farma in Iceland; Pharmamed in Malta; United Nordic Pharma in Scandinavia; and the Iceland-based holding company Pharmaco. The group’s two other businesses - Fako in Turkey and Zdravlje in Serbia - will continue to trade under their existing names for the time being, but will carry the sub-branding ‘An Actavis company’. Medis, the group’s division dealing with third party sales, will retain its current identity. A new logo and corporate identity will be gradually introduced across the business and its products over the coming months. The company believes that its strategy of uniting its businesses under the Actavis brand will help it to respond to the significant market opportunity for generic pharmaceuticals as patents expire on blockbuster products in the coming years. Group president and chief executive officer Robert Wessman said; “Our group has come a long way in a very short time, and the market for generic pharmaceuticals is changing very fast. Uniting our group under the Actavis brand will be a key asset in helping us fulfil our vision to become a leading global generic pharmaceuticals company. “While our relationship with our customers will not change, being part of a bigger brand will help us to offer an even better standard of service in the future. By consolidating our development expertise, production capabilities and customer service network, we aim to offer faster access to the latest generic products and a wide portfolio of affordable, high quality pharmaceuticals.”OtherThu, 13 May 2004 11:41:00 GMT{70974910-8993-4B78-8CAE-1D1216D68474}http://www.actavis.com/en/media+center/newsroom/articles/olanzapine_europe_11.htm Actavis Group, the international generic pharmaceuticals company, this week marketed Olanzapine tablets in Austria, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Romania, Sweden and the UK, immediately after the patents expired on 26 and 27 September, respectively. Olanzapine is launched in two forms by Actavis, as conventional film coated tablets and as orodispersible tablets. Developed by Actavis’ R&D in Iceland, the tablets are produced at the Company‘s manufacturing site in Malta. Olanzapine is used in the treatment of schizophrenia and bi-polar disorder and is the generic equivalent of the Zyprexa® brand product from Eli Lilly. Actavis was able to market Olanzapine in Germany in 2007-2008, following a ruling by a German Patent Court that made the launch of a generic version possible. Olanzapine has already been launched by Actavis in a number of European countries, including Bulgaria, Czech, Hungary, Iceland, Malta, Slovakia and Spain. Annual branded product sales were about EUR4.5 billion globally for the year ending June 2011 according to IMS data. EnquiriesActavis GroupHjordis ArnadottirDirector – External CommunicationsTel: (+41) (0)41 462 7300E-mail: harnadottir@actavis.comProductFri, 30 Sep 2011 08:45:00 GMT{7220CCD0-BD6A-4706-B764-C0A9DCD17B6B}http://www.actavis.com/en/media+center/newsroom/articles/uk_pharmacy_business_award_2010.htm Actavis was awarded the “Innovations in Generics” award at this year’s Pharmacy Business Awards in the United Kingdom, winning the award for the second year in a row.Actavis, the second largest supplier of generic medicine in the UK, has launched up to 165 new products in the past three years; 60 of which were launched in 2009 alone. Actavis’ commitment to day one patent expiries has resulted in numerous day one launches including Lercanidipine and Losartan, with further major patent expiry launches in the pipeline this year.Other outstanding achievements by Actavis in the UK include the introduction of vialshield® hospital packaging, which provides unique safety and protection for vials against breakages and spills. Actavis also focused on providing robust clarity for product labelling and layout with the redesign of Actavis’ hospital packaging and the subsequent launch of “Safety Packaging”. Jonathan Wilson, Director at Actavis UK: “Winning the award demonstrates how Actavis is on the cutting edge of innovation when it comes to patient safety and also the ease of use for our products. Again we are extremely pleased to receive recognition for our groundbreaking innovations”.The award took into account Actavis’ contributions to the service and training within the industry, as well as the continued development of the award-winning Actavis Online Academy and the introduction of the HR service, Ask BoB. Michael Cann, Director Generics at Actavis UK:“With almost 3,000 users in the industry, the Actavis Academy consistently provides innovative ways to train and develop pharmacy staff in an environment that is developing rapidly. We are very proud of the contributions to the service and the role it plays in serving our customers and the industry as a whole.” For more information on the Actavis Academy, please visit our UK websiteCommitmentTue, 26 Oct 2010 12:54:00 GMT{72475930-DD84-4BA8-AD6B-9E8798221863}http://www.actavis.com/en/media+center/newsroom/articles/Repaglinide_launch.htm Actavis Group has launched Repaglinide tablets in the UK, Sweden and Hungary immediately after patent expiry. The product was launched simultaneously in Germany and will be launched in Italy and France in July. Repaglinide tablets have also been launched by an Italian customer of Medis, the Actavis subsidiary responsible for third-party sales. Developed and produced by Actavis Malta, Repaglinide is used in the treatment of Type 2 diabetes and is the generic equivalent of the NovoNorm®/Prandin® brand by Novo Nordisk.Sales of the originator product achieved EUR366.7m in 2010 (IMS Health, MIDAS MAT December 2010). “Repaglinide is one of the most important oral anti-diabetics. We continue to intensify our focus on this therapeutic area and this product launch represents an important milestone in the development of our diabetes franchise,” said Lars Ramneborn, Executive Vice President of Europe Sales at Actavis.ProductThu, 07 Jul 2011 16:57:00 GMT{74F5ED73-DF2A-47A1-89CB-ABBEA8D33980}http://www.actavis.com/en/media+center/newsroom/articles/oxymorphone_hcl_extended_release_us.htm Actavis has begun shipping Oxymorphone Hydrochloride Extended-Release Tablets, CII 7.5mg and 15mg, a generic equivalent of Opana ER® in the United States. Michael Perfetto, Vice President, Sales & Marketing of Actavis, Inc. in the US: “Oxymorphone Extended-Release Tablets offer significant value to our customers and patients. This launch exemplifies Actavis’ focus, commitment and capability in bringing complex controlled-release products to our customers.” The 7.5mg and 15mg strength of Opana ER had US total sales of approximately USD21.9 million for the 12 months ending 31 March 2011, according to IMS Health. Please see prescribing information at Actavis' US website InquiriesDavid Myers, Jr.Senior Manager, Products & CommunicationsActavis Inc., Morristown, NJTel: (973)993-4503Email: dmyers@actavis.com About Actavis Inc.:Actavis Inc. is the US distributor of the product and the United States subsidiary of Actavis Group hf. Approximately one third of Actavis Group hf’s sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis Inc. has U.S. manufacturing facilities in Elizabeth, NJ and Lincolnton, NC. Actavis also has research and development facilities in Elizabeth, NJ, Owings Mills, MD and Sunrise, FL. Actavis Group hf is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. The company has operations in 40 countries, with more than 10,500 employees. Opana ER ® is a trademark owned by a party other than Actavis. Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.ProductThu, 21 Jul 2011 08:37:00 GMT{759BDFB7-40E8-49B4-BFF2-27A73AD33611}http://www.actavis.com/en/media+center/newsroom/articles/fluvastatin+sr+uk+nl.htm Actavis has launched Fluvastatin SR in the UK and the Netherlands. Actavis was first to market in both countries. Fluvastatin SR extended release tablets from Actavis are the generic equivalent of Novartis‘ Luvinsta® SR / Lescol® XL and are available in 80mg tablets in both markets. Fluvastatin SR is used to treat high cholesterol levels in the blood. Fluvastatin SR tablets are manufactured by Actavis Malta and developed by Actavis‘ R&D in Iceland. This launch was possible after Actavis won a court case in January 2009 in the UK, whereby Novartis’ formulation patent for Fluvastatin SR, which prevented launch of the product until 2017, was revoked. The formulation patent has also been revoked in the Netherlands.ProductThu, 09 Apr 2009 10:00:00 GMT{7604D350-90BB-4EFA-ADEC-F40C481280BE}http://www.actavis.com/en/media+center/newsroom/articles/NIFEdipine+XR.htm Actavis today announced that it has launched NIFEdipine extended-release tablets. Distribution of the product will commence immediately. Actavis’ NIFEdipine extended-release (XR) tablets are the generic equivalent of Bayer’s Adalat® CC tablets and available in 30mg and 60mg strengths. NIFEdipine XR tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.Doug Boothe, Executive VP of US Commercial & Administration said: “NIFEdipine XR is the first product launch from Actavis South Atlantic LLC (formerly Abrika Pharmaceuticals) since the acqisition of Abrika in April 2007. It is going to be a valuable addition to our rapidly expanding product portfolio and solidifies our strategy to further grow our business in the controlled release segment along with other technically difficult markets.” Annual sales of Nifedipine XR tablets (Adalat®CC and its generic equivalent) in the U.S. were approximately US$143 million for the twelve months ending March 2007 according to IMS health data.ProductTue, 26 Jun 2007 13:00:00 GMT{77087126-7C8B-414C-9AB0-1E3E5D53EB77}http://www.actavis.com/en/media+center/newsroom/articles/actavis+sponsor+youth+in+Europe.htm Actavis Group, the international generics pharmaceutical company, is sponsoring an ambitious pan-European programme that has been developed to find effective ways of preventing teenagers from becoming addicted to drugs. ECAD, European Cities Against Drugs, is a non-profit organization that has developed Youth in Europe – A Drug Prevention Programme, which Actavis will support. Youth in Europe – A Drug Prevention Programme builds on the success of prevention work in Reykjavík, the capital of Iceland, that showed through extensive research on youth behaviour, that the most effective ways to fight drugs is based on facts. The Icelandic programme has shown that a coordinated approach between city authorities, youth- and sports clubs, schools and families, leads to the best results. The lessons drawn from two decades of research shows: The younger adolescents are when they start drinking alcohol, the more likely they are to abuse drugs later in life. That support from parents and their monitoring and time spent with parents is important in decreasing the likelihood of substance use. The research highlights the importance of guardianship, school and community attachment, as well as informal social control. Having friends that drink, smoke hashish, or use other drugs, increases the likelihood of similar behaviour among the adolescents themselves. Adolescents that participate in sports and other organized youth work such as participating in extra curriculum in school are less likely than other adolescents to use drugs. The more time adolescents spend together in unstructured activities, away from guides and role models who encourage youth to invest in conventional culture, the more likely it is that they fall prey to substance use or delinquent behaviour. The research shows that we need to activate all at once, the family, the peer group, the school, those who organize youth activities and authorities in order to succeed in fighting substance use. Now these lessons are being brought to ten European cities by ECAD. The steering committee is headed by City Councillor Dagur Eggertsson in Reykjavík and Tomas Hallberg, the director of ECAD. The city of St. Petersburg became the first city to sign an agreement with ECAD at a meeting on 17 December between the Governor of St. Petersburg, Ms Valentina Matvienko and The President of Iceland, Olafur Ragnar Grimsson, who is the Patron of the Programme. The Governor signed a memorandum for the participation in the ambitious drug prevention programme over the next five years. CommitmentFri, 16 Dec 2005 15:03:00 GMT{77D39025-5CAC-4ED5-90B1-82FDFCD259DF}http://www.actavis.com/en/media+center/newsroom/articles/irinotecan+hydrochloride+injection+us.htm Actavis has received approval for Irinotecan Hydrochloride Injection from the US Food & Drug Administration. Distribution of the product will commence immediately. Irinotecan Hydrochloride Injection, the generic equivalent to Pfizer’s Camptosar®, will be available in 40 mg/2 mL and 100 mg/ 5 mL vials and is used in the treatment of patients with metastatic carcinoma of the colon or rectum. Annual sales of Irinotecan Hydrochloride Injection in the United States were approximately US$556 million for the 12 months ending December 2007 according to IMS Health data. Doug Boothe, Executive Vice President of US Commercial & Administration, said: “The launch of Irinotecan marks the expansion of Actavis’ US portfolio into the injectable pharmaceuticals arena. Actavis has set its sights firmly on the hospital sector and currently has around 300 pending applications worldwide for injectable medicines. Furthermore, Actavis’ ambitious pipeline comprises more than 60 new projects, developed both internally and through established relationships with other developers.” Actavis already markets over 50 hospital products worldwide, with a focus on oncology products and a growing range of anti-infectives, local anaesthetics and analgesics.ProductFri, 29 Feb 2008 08:00:00 GMT{7867E275-3968-4321-B385-B97BAB3B144B}http://www.actavis.com/en/media+center/newsroom/articles/actavis+sweden+lorabid.htm Actavis’ subsidiary in Sweden has acquired the pharmaceutical product Lorabid from the pharmaceutical company Eli Lilly & Company. Lorabid contains the active substance Loracarbef and is an antibiotic medicine, used to treat mild-to-moderate bacterial infections of the lungs, ears, throat, sinuses, skin, urinary tract, and kidneys. It is marketed as capsules in 200 mg., 400 mg. and oral suspension 40 mg/ml. The product will be marketed in Sweden. According to Roger Tapper the acquisition of this product is part of the Group’s strategy to grow its business in Northern Europe. Actavis has 18 products on the Swedish market and a number of Marketing Authorisations for products that will be launched in the near future.ProductThu, 24 Nov 2005 15:25:00 GMT{78A79E97-176A-4BA0-B53A-8AAC89361B82}http://www.actavis.com/en/media+center/newsroom/articles/fentanyl+recall+us.htm Actavis Inc., the United States manufacturing and marketing division of Actavis Group, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis’ subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution. The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis. The recall is being conducted in cooperation with the US Food and Drug Administration. Fentanyl patches sold by Actavis in Europe are not affected by this recall. The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which has the potential to cause the patch to leak fentanyl gel, therefore, as a precaution, Actavis is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief. Anyone who has Actavis Fentanyl patches should check the box for the following lot number and expiration date to see if they have patches that are being recalled. The affected lots are: Lot no Strength Exp Date NDC 27261 25 mcg/hr 5/09 67767-120-18 27391 25 mcg/hr 6/09 67767-120-18 27488 25 mcg/hr 6/09 67767-120-18 27317 50 mcg/hr 5/09 67767-121-18 27475 50 mcg/hr 6/09 67767-121-18 27514 50 mcg/hr 7/09 67767-121-18 27536 50 mcg/hr 7/09 67767-121-18 27538 50 mcg/hr 8/09 67767-121-18 27318 75 mcg/hr 5/09 67767-122-18 27409 75 mcg/hr 6/09 67767-122-18 27476 75 mcg/hr 6/09 67767-122-18 27537 75 mcg/hr 8/09 67767-122-18 27319 100 mcg/hr 5/09 67767-123-18 27545 100 mcg/hr 7/09 67767-123-18 Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The patches are double-branded, with Abrika on the pouch and Actavis on the box. Affected patches should not be handled directly. Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877 422 7452. Patients using fentanyl patches who have medical questions should contact their health-care providers. Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.ProductSun, 17 Feb 2008 21:46:00 GMT{78B41E74-0222-4679-8FA2-38130890551C}http://www.actavis.com/en/media+center/newsroom/articles/levetiracetam_xr_us.htm Actavis has received FDA approval of Levetiracetam Extended-Release tablets, a generic equivalent of Keppra XR®. Shipping in the United States commenced immediately following approval. According to IMS Health, Keppra XR® had US total sales of approximately USD161 million for the 12 months ending 30 June 2011. EnquiriesDavid Myers, Jr.Senior Manager, Products & CommunicationsTel: +1 (973) 993 4503E-mail: dmyers@actavis.com Keppra XR ® is a trademark owned by a party other than Actavis.ProductThu, 15 Sep 2011 16:18:00 GMT{79E288DD-A059-45F9-997C-900EF3C9C585}http://www.actavis.com/en/media+center/newsroom/articles/pantoprazole+patent+launch+germany+ireland+netherlands.htm Actavis launched Pantoprazole tablets in Germany, Ireland, and the Netherlands as the patent expired on 6 May. This is Actavis Group’s first own brand launch of this molecule. In Germany and the Netherlands, the product was also launched by Actavis’ third party sales division’s (Medis’) customers at the same time. Earlier this year, Medis’ customers launched the product in Hungary and Poland. Pantoprazole, a proton pump inhibitor (PPI), is used to treat acid-related stomach and throat problems, including acid reflux (GERD), erosive esophagitis, and Zollinger-Ellison syndrome. Pantoprazole Actavis is the generic equivalent of Wyeth‘s Protonix®. Pantoprazole Actavis is available in 20mg and 40mg tablets. The product was developed by Actavis R&D in Iceland, and manufactured by Actavis Malta. IMS Health reported EU Brand sales of EUR1.1 bln in 2008. ProductMon, 11 May 2009 10:30:00 GMT{7A6248A2-E661-4851-A7CB-06E36CDEDE80}http://www.actavis.com/en/media+center/newsroom/articles/actavis_expands_iceland_site.htm Actavis has announced plans to expand its manufacturing site in Iceland, increasing capacity at the site by 50%. Fifty new jobs will be created as a result. The Hafnarfjordur, Iceland manufacturing site exports 95% of its products. After expansion the SOD-site‘s capacity will be about 1.5 billion tablets pr. year, depending on the mix of products. Production is expected to start at the new facility by year end 2010, with no disruption to current manufacturing capabilities. The site produces many of Actavis‘ latest generics and specialises in new product launches. Actavis hf in Iceland currently employs about 300 people, mostly in production and quality. By the end of this year, 50 new jobs will be created following the expansion. Actavis Group employs over 10,000 people in 40 countries, including about 570 in Iceland. The Hafnarfjordur site is ISO 14001 and OHSAS 18001 certified and runs on sustainable energy; electricity from hydropower and geothermal heating. Actavis remains committed to its environmental, health and safety performance, with 11 of its manufacturing sites ISO 14001 certified, seven with an OHSAS 18001 certification.OtherMon, 08 Feb 2010 09:07:00 GMT{7D6320E8-3A64-42C8-AB46-81EF1EE0DC90}http://www.actavis.com/en/media+center/newsroom/articles/actavis+first+own+product+czech.htm Actavis Group has launched its first own-label product in the Czech Republic. The product is the anti-epileptic pharmaceutical drug Lamotrigin. The initial delivery of the product will be marketed in three strengths (25 mg, 50 mg and 100 mg). Headquartered in Prague, Actavis’ operation in the Czech Republic was established in 2000 and currently employs 30 people in its office in Prague. Its primary focus is on the marketing and sale of generic pharmaceuticals on the Czech and Slovak Republic markets.ProductFri, 16 Dec 2005 14:54:00 GMT{807B1D3E-5DC2-4418-8DAA-D00AFA299E62}http://www.actavis.com/en/media+center/newsroom/articles/sindan+awards+olimpians.htm Actavis’ Romanian subsidiary Sindan has for the 14th time awarded the Romanian group of pupils who have received medals at the International Chemistry Olympics. This year the Romanian Olympics returned from Korea with four Olympic medals, silver and three bronzes. Razvan Costin Cioc from the National College “Dr. Ioan Meşotă” in Braşov won a silver medal while Ştefan Andrei from National College „Mihai Viteazul” in Slobozia, Maria Alexandra Pătraş from Theoretic Highschool „Ovidius” in Constanţa and Ioan Teodor Trotuş from National College „Vasile Alecsandri” in Galaţi each brought home a bronze medal. Sindan, the only Romanian pharmaceutical company specialized in producing and distributing oncological products, awards the four Olympic heroes with 1000 Euro for each bronze medal and 1500 euro for the silver medal. „I believe that supporting these students is a duty of honour for Sindan – Actavis, a duty which we assumed 14 years ago and we will take it in the future. Some of these young people will probably be our colleagues in five years, and this would be the greatest honour for us! I wish to thank our Olympic competitors for their perseverance and their love for science and I assure them that Sindan – Actavis will always be close to them” stated Dr. Laurenţiu Scheusan, General Manager Sindan – Actavis Romania.CommitmentMon, 31 Jul 2006 17:52:00 GMT{83B0ED85-1136-428C-B016-FC15CE76D510}http://www.actavis.com/en/media+center/newsroom/articles/actavis+launch+glimepiride.htm Actavis announces that it has been among the first to launch the generic drug Glimepiride, into a number of important markets in Europe. Glimepiride is the generic equivalent of Amaryl/Amarel a product of Aventis. The drug will be marketed under Actavis’ own-label in five countries - Denmark, Finland, Estonia, Latvia and Lithuania, and through its Third Party division, Medis, in eight other European countries. Glimepiride is an oral blood-glucose lowering drug used for diabetes. It is produced in four different strengths – tablets containing 1mg, 2mg, 3mg and 4mg – in seven package sizes. The drug is used for non-insulin-dependent diabetes, the most common form of the disease, and it works by increasing insulin sensitivity in the body. The development plant at Actavis in Malta has worked on the development of the product in recent years and production started there last autumn. The launch has been timed to coincide with the expiry of the originator’s patent during the first week of December. Gudbjorg Edda Eggertsdottir, Chief Executive, Sales & Marketing, Third-party sales at Actavis said; “This marks a milestone for the company because Glimepiride is the first product that has been both developed and produced in our production facility in Malta. Furthermore, Actavis is entering a new therapeutic category, but Glimepiride is a drug against diabetes. Our team in Malta has done an excellent job.” Actavis is also launching Benazepril tablets in Germany through its subsidiary Medis. Benezepril is a drug prescribed for blood pressure, which belongs to the ACE-inhibitor group, a category of drugs on which Actavis has placed great emphasis on. It includes drugs such as Ramipril, Lisinopril and Enalapril. Benazepril Hydrochlorothiazide was launched when the originator’s patent expired in the end of last June. ProductMon, 12 Dec 2005 15:07:00 GMT{845EFB3D-38AE-454F-AB03-963A65302410}http://www.actavis.com/en/media+center/newsroom/articles/beijing_office_opens.htm Actavis has established a regional office for China at Beijing's Youth Plaza Office Building. Actavis' Beijing office will primarily handle registrations for imported products and related regulatory issues, as well as sales activities. The Beijing office will be responsible for further developing Actavis' business in China. The Company is already established in Guangzhou in Guangdong province, where it operates a manufacturing site. About 80% of Actavis' sales in China have been in Guangdong, but the company‘s ambitious plans for growth in the Chinese market over the coming years include an expansion into other provinces, with the addition of the Beijing office as a first step. The Beijing office is located on the Third Ring Road which is the busiest section of the Central Business District in the Chinese capital. The Actavis (Foshan) Pharmaceutical Co., Ltd. is a joint venture between the Actavis Group and Foshan Chanbende Development Co., Ltd. The Guangdong manufacturing site employs 300 people producing antibiotics and other products, particularly for use in the treatment of the digestive and cardiovascular system. Contact details for Actavis in ChinaOtherTue, 04 May 2010 09:44:00 GMT{858F40DE-D7C2-48F1-8228-988B950D9DF5}http://www.actavis.com/en/media+center/newsroom/articles/annual+general+meeting+2005.htm Annual general meeting of Actavis Group hf. 31 March 2005. Subject Agenda of the annual general meeting. The Board of Actavis Group hf. proposals. Results of Annual General Meeting. Presentations (PDF) Presentations Chairman of the Board and President & CEO.Annual Report (PDF)Annual Report 2004. News Record profits for Actavis in 2004 Stock information Stock exchange news Investors Investors calendar OtherFri, 01 Apr 2005 11:55:00 GMT{85FAAE93-7968-41BE-AF49-EB134321B28C}http://www.actavis.com/en/media+center/newsroom/articles/sindan+rebranded.htm Sindan, the leading European generic pharmaceutical company specializing in the manufacturing and distribution of oncology products, will be rebranded as Actavis with immediate effect. This follows Actavis’ acquisition of Sindan in March 2006 and the completed integration of the business. Since its acquisition by Actavis, Sindan has continued to experience strong growth. The business generated revenues of EUR95 million in 2006 and expectations for 2007 are for sales of EUR115 million. Additional investment expected to build platform for future growthActavis is committed to extending its business in Romania and its capabilities in the field of oncology to take further advantage of the fast growing domestic and international market. To achieve that the Group will continue to invest in the oncology business and initial plans are in place to expand Actavis’ oncology facilities either through acquisition or new development and build a platform for future growth and create further opportunities for employees. Actavis has one of the strongest pipelines in the generic industry, with over 355 projects under development, covering all key therapeutic classes. The Company has successfully introduced a number of products from its international portfolio into the Romanian market and had seven product launches in 2006. During 2006, 376 product and market launches were made (163 molecules), out of which 54 were first to market for the Group as a whole. This year, 17 new Actavis products will enter the Romanian market in the retail segment, covering central nervous system, cardiovascular and anti-infective therapeutic classes and OTC products. The Romanian division is expecting a 30% growth in exports by the end of 2007, which represents the Group’s strong oncology portfolio. Sindan will become formally known as Actavis Romania and the existing management team, led by Laurentiu Scheusan, will continue to be actively involved in the business. At a formal launch ceremony held in Bucharest, Romania, Robert Wessman, President and CEO of Actavis, Jonas Tryggvason, Executive Vice President of Central-Eastern Europe and Asia (CEEA), Sales & Marketing Division and Laurentiu Scheusan, Country Manager, Romania were present. Robert Wessman, President and CEO of Actavis:“Our acquisition of Sindan has been a huge success. The formal introduction of the Actavis name into the Romanian market is the final step in the integration process but just the beginning of the next stage in our development and investment in this exciting environment. We have a solid platform from which to achieve further growth and take our Romanian business to the next stage.” About Sindan Founded in 1991, Sindan is headquartered in Bucharest, Romania, and currently employs almost 280 people across the country. The Company is one of Europe’s leading manufacturers of generic oncology pharmaceuticals and the largest hospital distributor in the country. In 2005, Sindan had a distribution network within 7 countries, Japan, UK, Poland, Hungary, Slovakia, Bulgaria and Moldavia with 7 products distributed in 2006. Moreover, Sindan is the only Romanian producer who distributes medicines on the Japanese market. At present, the oncology portfolio comprises 29 products. Another 61 approvals for product distribution were obtained for UK, Japan, Poland, Hungary, Bulgaria, Serbia, Srpska, Macedonia, Slovakia, Belarus, Moldova and Russia. More than 200 approvals are pending for USA, Japan, EU countries, Russia, Turkey, Croatia, South Africa and the Balkans. OtherThu, 26 Apr 2007 08:00:00 GMT{86057455-C399-403F-9BB4-3BA5B2C1BCE7}http://www.actavis.com/en/media+center/newsroom/articles/actavis+ramipril+france.htm Actavis Group, the international generic pharmaceuticals company, has launched the cardiovascular product Ramipril in France upon patent expiry., The product is sold via Actavis’ subsidiary, Medis to third party customers, who market the product under their own label. The first deliveries account for close to 20 million capsules in four strengths. In recent years, Ramipril sales have risen immensely; firstly due to the increase of cardiac events in the developed countries and secondly due to a recent research finding which demonstrates the benefits of Ramipril for people at high risk for cardiovascular events. In most of the European countries, the Ramipril patent expired in January 2004. Actavis has already launched Ramipril in these markets and today, Ramipril is among Actavis’ top-selling products. Gudbjorg Edda Eggertsdottir, Executive Vice President, Third-party Sales Global, says in recent years, the French generic market has been the fastest growing market in Europe. Medis has made an effort to expand its sales into France and Ramipril is expected to increase our market share in this market, which has already become one of Medis’ most important markets. ProductMon, 30 Jan 2006 14:26:00 GMT{882F6B1A-FE70-4E5D-A9A4-DF84304167E4}http://www.actavis.com/en/media+center/newsroom/articles/bupropion+us.htm Actavis has received two separate approvals from the US Food & drug administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately. Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR® and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR® were US$ 498 million for the 12 months ending December 2007 according to IMS Health data. Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban® and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban® were US$ 12 million for the 12 months ending December 2007 according to IMS Health data. Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said: “These approvals further enhance our strength in the area of modified release products and provide valuable options to our customers and patients.” More information about Actavis in the United States can be found at www.actavis.usProductFri, 28 Mar 2008 14:40:00 GMT{8888A857-CFEF-4C4D-A23E-BF3ED1E4FC71}http://www.actavis.com/en/media+center/newsroom/articles/anastrozole_Europe.htm Actavis Group, the international generic pharmaceuticals company, today announced the launch Anastrozole Actavis in the UK, Germany, Netherlands, Ireland, Italy, Sweden and Finland immediately after the patent expired on 11 and 12 February, respectively. Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women. Anastrozole Actavis is the generic equivalent of AstraZeneca‘s brand product Arimidex® The brand sold for EUR492 million in Europe for the twelve month period ended September 2010. (IMS Health).ProductTue, 15 Feb 2011 12:42:00 GMT{8B5631D7-E1CF-47BB-AF2B-8675133CDEE5}http://www.actavis.com/en/media+center/newsroom/articles/knowledge+prize+2007.htmActavis has been awarded the Knowledge Prize of the Association of Economists in Iceland for the third time. The selection board was unanimous in its decision. The theme of the prize this year was “mergers and acquisitions”. The companies Marel and Össur were nominated along with Actavis. In delivering its verdict, the selection board stated:“Actavis has been highly successful when it comes to acquisitions and mergers of companies worldwide. It has grown rapidly, yet in spite of this the management has retained a clear vision for the future of the company. Actavis has acquired more than 20 companies in the past few years, both private concerns and listed companies. Its revenues have increased by an average of 58% per year over the past seven years, and its shares have gone up by an average of 50% per year during the same period. Its market value is some ISK 233 billion, a 88-fold increase since year-end 1999. The company has increased its size 68-fold in terms of employee numbers. “This success may, among other things, be attributed to the fact that the company set off with an effective strategic plan regarding mergers and acquisitions, in which the integration of all main processes are kept in sync. Actavis has strongly emphasised integration and bringing its policies, goals and values to its new companies. Emphasis has also been placed on keeping on board the key employees of the companies that have been acquired. The dissemination of information and internal and external communication has been focused and exemplary. The company has placed great emphasis on ensuring the effectiveness of internal processes and the implementation of a company culture in which the goal is for employees to do even better, facilitate more growth and enjoy their work. All of this has led to vast benefits for stakeholders. In terms of the best processes for mergers and acquisitions, it is safe to say that this company is on a global scale.” Róbert Wessman, CEO of Actavis, says that it is a great honour for the company to be the recipient of the Knowledge Prize for the third time. “What has been most demanding in these past few years is not just the acquisition of the companies, but their successful operations. It is even more important to ensure that everywhere there is the same vision, same thought process, same culture and same momentum. We have spent considerable time on these internal workings and in my view this has delivered excellent results. We have managed to increase the company’s returns year-on-year, despite vast growth. This recognition and success of course results from the work of many people, so in my view it is recognition for those 11,000 employees that work for us today.”OtherSun, 25 Feb 2007 16:06:52 GMT{8C6AC222-3731-47B7-87BB-0E24C927B1B0}http://www.actavis.com/en/media+center/newsroom/articles/Actavis_enter_Biosimilars.htmActavis Group today announced that it plans to enter into the field of biosimilars. Dr. Claudio Albrecht CEO of Actavis commented on the upcoming due diligence on Biopartners in Switzerland: “By entering into Biosimilars the generic companies gain access to a portfolio that requires a new approach to development and marketing. We will have generic companies investing significantly more in research and we will see originator companies developing generics. Only the large generic players such as Teva, Sandoz, Mylan and Actavis have the capability to do this, either by themselves or in partnerships with originators. We want to be selective with our biologic target portfolio. Endocrinology (a branch of biology and medicine dealing with the endocrine system) is one of the most interesting growth areas in the pharmaceutical industry. Actavis now offers a broad selection of oral diabetic medicines, so the addition of insulin and later insulin analogue is thus rational for Actavis and one of the areas we are looking towards. Actavis is also one of the leading suppliers of generic oncology products, with a wide selection of products used in chemotherapy. Biosimilars could therefore also be an ideal addition to our oncology franchise.” Attached is a press release from Bioton on the agreement.Press release from Bioton (.DOC , 49kb) OtherTue, 07 Sep 2010 14:13:00 GMT{8E2C0400-281A-47A1-B238-777E93EFC0E0}http://www.actavis.com/en/media+center/newsroom/articles/digitek+digoxin+recall+us.htm Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all-lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate. For further information please visit Actavis' United States website: www.actavis.us ProductFri, 25 Apr 2008 19:47:00 GMT{8EC17DF5-CAF6-4706-A6D0-009B2A46B6D0}http://www.actavis.com/en/media+center/newsroom/articles/letrozole_cancer_europe.htm Actavis Group has launched Letrozole tablets on day one after the patents expired in Austria, Germany, Finland, Ireland, Italy, the Netherlands, Romania, Sweden and the UK. At the same time, Letrozole was marketed by Actavis in Poland, a patent free market for this product, and will be launched in a number of European markets over the coming months.Letrozole tablets are indicated for treatment of postmenopausal women with breast cancer. Available in 2.5mg strength in packs of 14 and 28, Letrozole tablets are developed and manufactured by Actavis in Romania. Letrozole Actavis is the generic equivalent of Novartis‘ Femara® brand. Brand product sales in Europe in 2010 were about EUR403 million (IMS Health data). ProductFri, 26 Aug 2011 13:40:00 GMT{8F7AAAC6-2BF8-4A60-BC2F-1BBBA3BD1059}http://www.actavis.com/en/media+center/newsroom/articles/zolpidem+tablets+us.htm Actavis today announced that Carlsbad Technology, Inc. (CTI) has received approval of its ANDA for Zolpidem Tartrate tablets from the U.S. Food & Drug Administration. Actavis will market the product under an agreement with CTI in the United States. Distribution of the product will commence immediately. Zolpidem Tartrate tablets, the generic equivalent of Sanofi Aventis’ Ambien® tablets, will be available in 5 mg and 10 mg strengths. Zolpidem Tartrate tablets are indicated for the short-term treatment of insomnia. Annual sales of Zolpidem Tartrate tablets in the U.S. were approximately US$2.2 billion for the twelve months ending December 2006 according to IMS Health data. Actavis expects 2007 sales to total EUR1.6bn, with approximately one-third of these sales coming from the United States, the company’s single largest market. In the U.S. alone, the company made 38 ANDA filings in 2006 and expects to file 40-45 in the year 2007 along with 18-20 new product launches. The company’s U.S. operations are located in New Jersey, Maryland, North Carolina, and Florida. More information about Actavis in the United States can be found at www.actavis.usProductFri, 27 Apr 2007 12:00:00 GMT{903106D4-854E-4ED1-BFAB-E24EB22C9E15}http://www.actavis.com/en/media+center/newsroom/articles/topiramate+uk+de+fr+ch.htm Actavis today announced the launch of the antiepileptic drug Topiramate in the UK, Germany, France and Switzerland. The product was launched on day one as the originator’s patent expired on 25 September. Actavis was first to market in all four countries. Topiramate is used to treat epilepsy and will be sold in tablets of 25mg, 50mg, 100mg and 200mg. Topiramate is the generic equivalent of Janssen-Cilaq’s Topamax® / Epitomax®.According to IMS Health, Janssen-Cilag’s product had sales of approximately €98 mln for the 12 months ended June 2009 in the four countries of UK, Germany, France and Switzerland. Topiramate Actavis was developed by Actavis’ R&D in Iceland and in produced by Actavis in Hafnarfjordur, Iceland. Actavis has already launched Topiramate in other countries where no patent protection was in place, including Portugal in 2007.ProductTue, 29 Sep 2009 06:00:00 GMT{90FEF9E8-7A33-4F8A-B072-175BA0D5FDBF}http://www.actavis.com/en/media+center/newsroom/articles/risperidone+europe.htm Actavis launched Risperidone tablets on day one in a number of European countries, including Germany, the UK, Netherlands and Denmark. Medis, Actavis’ third party sales division, has also launched Risperidone in various markets, including France and Germany. Earlier in 2007 Actavis marketed Risperidone in Turkey and Romania. Medis had previously launched Risperidone in Portugal, Poland and other countries in 2006. Risperidone, the generic version of Janssen Pharmaceutica’s Risperdal®, is produced in 0,25mg, 0,5mg, 1mg, 2mg, 3mg, 4 mg and 6mg strengths by Actavis. The product was developed by Actavis R&D and manufactured in Iceland. Risperidone is used to treat the symptoms of psychotic disorders, such as schizophrenia, mania or bipolar disorder, or irritability associated with autistic disorder. Annual sales of Risperidone amounted to about 1bn EUR in the European Economic Area (APR 2006 – MAR 2007), according to IMS Health data. ProductWed, 19 Dec 2007 10:43:00 GMT{943EC5ED-C118-4515-9DCB-E2D9BB7608F7}http://www.actavis.com/en/media+center/newsroom/articles/sofia+joins+youth+in+europe.htm The city of Sofia became member of the the pan-European programme Youth in Europe – a drug prevention programme, on 5 July. The Mayor of Sofia, Mr. Boyko Borissov, Mr Jonas Tryggvason, Actavis’ Executive VP Sales and Marketing CEEA and Mr. Dagur Eggertsson, Board Member of ECAD, European Cities against Drugs, signed the tripartite agreement at a special ceremony. Actvais Group is the main sponsor of the ambitious drug prevention program for implementation of effective measures to prevent distribution, selling and use of illegal substances in five European cities – Sofia, St. Petersburg, Vilnus, Belgrade and Istanbul. The Group donates EUR40,000 to the city of Sofia over the next five years to support the project in partnership with ECAD. “I would like to thank Actavis for the support regarding this programme as well as for its contribution for helping the Municipality like in other projects like the garden restoration project” the Mayor of Sofia said during the event.The signing ceremony held at the prestigious Sheraton hotel, caused a surge of publicity. The event was attended by the Deputy Minister of education, over 30 journalists and representatives of non-governmental organizations and local communities. The ceremony was followed by a reception.CommitmentTue, 11 Jul 2006 00:14:00 GMT{9509F8CD-55A8-4566-B077-4FC113F7E081}http://www.actavis.com/en/media+center/newsroom/articles/welsh_chemist_awards.htm Actavis was recognised for customer service and innovation at the Welsh Chemist Awards in Cardiff on 5 May. The Barnstaple based Actavis in the UK won 2 of the 3 company awards available, and was presented with awards for ‘Best Customer and Professional Support’ and ‘Best Training Support’. Best Customer and Professional SupportIn 2009 Actavis invested heavily in its 40 strong customer facing service team to ensure that they were able to offer the best advice to pharmacies on business issues and the Actavis broad medicine portfolio. With more than 350 medicines available throughout the UK and a further 300 in development, Actavis has one of the broadest product portfolios and pipelines in the industry. Committed to providing first class generics and support to pharmacists, Actavis consistently aims to be first to market with generic medicines. Best Training SupportActavis was awarded this title for its commitment to supporting customer training, with particular reference made to their online pharmacy training tool - The Actavis Academy Online. Launched in 2009, the Actavis Academy is a free online training resource for pharmacists. More information on the Actavis Academy: www.actavis.co.uk The Awards were hosted by trade publication Welsh Chemist Review and attended by all leading pharmaceutical companies in the UK.CommitmentWed, 19 May 2010 14:21:00 GMT{96586406-CF29-4207-A1CE-4AF2DC0B8736}http://www.actavis.com/en/media+center/newsroom/articles/risedronate_eu.htm Actavis today announced the launch of Risedronate in four countries in Europe, immediately after the patent expired. Actavis launched the generic equivalent of Warner Chilcott‘s Actonel® under its own brand on day one in Germany, France, the United Kingdom and Ireland. The product was also launched by Medis, the Company‘s sales division to third party clients, in France. Risedronate is used to prevent and treat postmenopausal osteoporosis. Risedronate from Actavis is available in 35mg tablets. The product is developed and produced by Actavis in Iceland. The brand product had sales in the four European countries of approximately EUR130 million for the 12 months ending 30 September 2010, according to IMS Health.ProductWed, 22 Dec 2010 16:32:00 GMT{965F3E45-2818-4F2B-BB0B-3450022D28BD}http://www.actavis.com/en/media+center/newsroom/articles/actavis_withdraws_from_polfa_warszawa.htm Actavis has decided to withdraw from the process of buying state owned Polfa Warszawa. CEO and Chairman Claudio Albrecht says he regrets this very much and explains this was due to various unacceptable conditions. “For a company like Actavis, which strives to maintain excellent governance practices, it was impossible to stay in a process where the seller insisted on buyers not being able to perform confirmatory due diligence on a number of key items”. Albrecht also stated that the price level which has been reached in the process makes it impossible to free up more funds for corrective actions in these areas of diligence without being very dilutive for the overall business. Going forward, Albrecht said: “Poland is and will remain an important market for Actavis. The strategy going forward is to launch products which are similar to those of Polfa Warszawa, especially in the OTC field, but at much lower prices for the Polish customers. Today Actavis is one of the fastest growing pharmaceutical companies in Poland”. EnquiriesActavis GroupFrank StaudEVP Corporate CommunicationTel: +41 79 230 95 78E-mail: fstaud@actavis.comOtherWed, 28 Sep 2011 05:35:00 GMT{966C595A-2B66-4B99-8A8D-F258678507EE}http://www.actavis.com/en/media+center/newsroom/articles/presidents+india+iceland+lay+cornerstone.htm Dr. Abdul Kalam, President of India, and President Olafur Ragnar Grimsson of Iceland laid the cornerstone of a new Actavis building in Hafnarfjordur 30 May, which will house the company’s development centre. The new building, on the site of Actavis headquarters, is nearly 3,000 m² in area; a 350 m² development factory will also be constructed on the site. The buildings will house most of Actavis’ research and development activities in Iceland and are expected to be in full use by the summer of 2006. At a reception held in connection with the Indian President’s visit to Actavis headquarters, the company’s CEO Robert Wessman introduced Actavis’ research and development work and the collaborative agreement between Actavis and Emcure in India to develop inexpensive generic pharmaceuticals for use against HIV, the virus which causes AIDS.From left to right: Olafur Ragnar Grimsson, President of Iceland, Dr. Abdul Kalam, President of India, Madame Moussaieff, Robert Wessman, CEO of Actavis Group, and Satis Metha, Chairman of Emcure. "We all have a duty to play a part in the battle with this terrible disease," said Wessman in his address. The Presidents of India and Iceland have taken a keen interest in the battle against AIDS and they wholeheartedly support this collaborative venture, as both stated in their addresses on this occasion. Before the distinguished guests departed, Robert Wessman presented President Kalam with a gift from Actavis, a sculpture by an Icelandic artist.OtherTue, 31 May 2005 10:12:00 GMT{967D254B-B8DB-42D4-B16F-9E3FA6DD016F}http://www.actavis.com/en/media+center/newsroom/articles/epirubicin+hydrochloride+injection+us.htm Actavis has received approval from the US Food & Drug Administration to market Epirubicin Hydrochloride Injection. Epirubicin Hydrochloride Injection, the generic to Pfizer’s Ellence®, has been approved in 10 mg / 5 mL, 50 mg / 25 mL, and 200 mg / 100 mL configurations and is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumour involvement following resection of primary breast cancer. Annual US sales of brand and generic Epirubicin HCl Injection were US$17.5 million for the 12 months ending June 2008 according to IMS Health data. Actavis currently markets over 50 hospital products worldwide, with a focus on oncology products and a growing range of anti-infectives, local anesthetics and analgesics. Epirubicin HCl Injection, is developed by Actavis scientists in Romania. It's Actavis' second injectable oncology product in the United States; Actavis received FDA approval for Irinotecan Hydrochloride Injection in February.ProductMon, 06 Oct 2008 05:00:00 GMT{9893F2CD-CFD2-447E-9AFD-3A1FABF3B66F}http://www.actavis.com/en/media+center/newsroom/articles/new+actavis+ceo.htm Robert Wessman has stepped down as the Chief Executive Officer of Actavis Group to put greater focus on his investment company Salt Investments. Wessman will continue to serve on the Actavis Board of Directors. The new Chief Executive Officer is Sigurdur Oli Olafsson, former Deputy CEO. Sigurdur Oli Olafsson joined Actavis in 2003, after working for Pfizer UK from 1998 and moving to Pfizer US in 2001 to take a post in Global Research and Development. Prior to that, he served as Marketing Manager of Omega Farma (now part of Actavis), later becoming its Drug Development Manager. Olafsson became the Managing Director of Actavis Inc. in the US in 2003. He became Chief Executive of Corporate Development in 2004 and Chief Executive of Sales & Marketing International in 2005. He has been Deputy CEO since 2006. Olafsson holds a Pharmacy degree from the University of Iceland. Bjorgolfur Thor Bjorgolfsson, Chairman of Actavis Group, commented: “The Board of Directors of Actavis Group would like to thank Robert Wessman for his near ten year contribution to the group. He has been CEO of Actavis since 2002 when Delta and Pharmaco merged and Actavis was created. Previously he had led Delta for three years. Mr. Wessman has played an important role in shaping and realising Actavis’ vision and executing its successful strategy for growth. Under his management the company has become one of the five leading generic pharmaceutical companies in the world. The Board welcomes Sigurdur Oli Olafsson as the new CEO of the company. We know that under his leadership the company will continue to provide excellent service to its customers and maintain its role as one of the world’s leading companies in the development, manufacturing and sales of high quality generic drugs.” Robert Wessman, leaving the CEO position at Actavis Group:“The past years at Actavis have been a true adventure. I‘m proud to look back at the tremendous growth of the company. Actavis is now in a solid position as a major global generic pharmaceutical player. I would like to thank the whole Actavis team for the partnership. This incredible group of people has in my mind pulled off an amasing achievement. I now look forward to moving on to new challenges where I will focus on my investment company, Salt Investments, that has been growing very fast during the past year.“ Sigurdur Oli Olafsson new CEO of Actavis Group:“Actavis is currently in a strong position among the top five generic pharmaceutical companies in the world. It is important to continue the remarkable Actavis growth story, so the position at the helm is an enormous responsibility to assume. I‘m ready for the challenge and look forward to continuing work with our 11-thousand employees on the continued success of the Group. Demand for generic pharmaceuticals is on the rise globally, independent of economic cycles. The development of new generic pharmaceuticals is among Actavis‘ major strengths and I consider it one of our top priorities to use it to further strengthen our position in our key markets in Europe, North-America and Asia.”OtherTue, 05 Aug 2008 18:52:00 GMT{9A3A980E-D6C0-4672-8B0E-C2BE3D9BFD58}http://www.actavis.com/en/media+center/newsroom/articles/site_expansion_hafnarfjordur_opened.htm Zero carbon footprint for tablet manufacturing and packaging Actavis Group, the world’s fourth largest generic pharmaceutical company, today formally opened a new expansion to its pharmaceutical manufacturing site in Iceland. Powered solely by geothermal energy, giving it a zero carbon footprint for tablet manufacturing and packaging, the site uses no fossil fuels. The facility is fully accredited to supply the EU market. The opening ceremony was attended by the President of Iceland, Olafur Ragnar Grimsson and members of parliament. Claudio Albrecht, CEO Actavis:“The site is 100% powered by geothermal energy, and is therefore the most eco-friendly pharmaceutical facility in the world. It meets both the ISO14001 environmental standard and the OHSAS18001 health- and safety standard, reflecting the strong Environment, health and safety commitment of our company. This latest investment increases the production capacity in Iceland by 50%, giving us a significantly increased launch capability for the EU market. This is our principal development and launch site for Europe. We’re proud to be able create jobs in Iceland by expanding this site.“ Following the expansion the production capacity of the Hafnarfjordur, Iceland site is about 1.5 billion tablets, around 96% of which are exported to the European markets. The Group’s investment on the expansion is about EUR8M. Actavis operates 14 manufacturing sites in 12 different countries: US, Bulgaria, Iceland, China, Italy, India, Indonesia, Malta, Romania, Russia, Serbia, and the UK. The Group’s total production capacity is the equivalent of about 24bn tablets.CommitmentFri, 14 Jan 2011 10:29:00 GMT{9DBA4DA4-58B3-4947-8B08-5AA62531ED92}http://www.actavis.com/en/media+center/newsroom/articles/actavis_divests_norgesplaster.htm Actavis has sold Norgesplaster, its manufacturing facility for plasters and athletic tape and adhesive coating, in Vennesla, Norway, to a newly formed entity Norgesplaster AS. Norgesplaster AS is a legal entity owned by private Norwegian investors. The transaction covers all assets and contracts related to Norgesplaster. Actavis became the owner of Norgesplaster in December 2005, following the acquisition of the generics division of Alpharma. Actavis’ focus remains on its core business, generic pharmaceuticals. Actavis will continue to operate a sales and marketing office in Oslo for pharmaceutical products. Norgesplaster is Norway’s leading supplier of plasters and medical grade anchored products. Actavis and Norgesplaster AS will work closely together to ensure that there will be no disruption in supply or services. Current employees will continue to be employed by Norgesplaster. The transaction was closed on 29 January 2010 but will have financial effect from 1 January 2010. The financial details of the transaction are not disclosed.OtherMon, 01 Feb 2010 11:58:00 GMT{9DCA4702-0DC1-44DF-B983-B63DC1DF668F}http://www.actavis.com/en/media+center/newsroom/articles/refinancing.htm - Albrecht to chair the Board Actavis today announced it has successfully agreed a debt refinancing in collaboration with its lenders. The refinancing gives Actavis a capital structure that positions the Company strongly for the future and provides it with the flexibility to continue to grow, especially in southern Europe, Japan, the Middle East & northern Africa, and increase market penetration in current geographies. Another key priority will be the entry into the segment of biological products (biosimilars), a product group which requires a strong financial position due to the high development cost. Combined with the potential for strong operational performance and the recent appointment of Dr. Claudio Albrecht as CEO, the refinancing transaction puts Actavis in a strong position to achieve its growth targets. The refinancing has the full backing of Actavis’ management team and its key stakeholders. Dr. Claudio Albrecht will also chair the Board, which will be further strengthened by the appointment of non-executive directors, some of whom have extensive industry experience. Dr. Claudio Albrecht, Chief Executive of Actavis said: “With the refinancing successfully agreed on, the Group is now well placed for the future and can continue to execute its growth strategy on a robust platform, providing additional stability and opportunity for Actavis’ employees both in Iceland and around the world.” The refinancing is expected to complete after satisfaction of customary conditions in the coming months.OtherWed, 21 Jul 2010 21:27:00 GMT{9E098F38-386C-43B1-8FBF-21C04BC28D88}http://www.actavis.com/en/media+center/newsroom/articles/bulgarian+media+visit+iceland.htm From 29 September to 1 October editors-in-chief and deputies of editors-in-chief of national Bulgarian media visited Actavis headquarters. The visitors met with the President of Iceland H. E. Olafur Ragnar Grimsson at the president’s mansion, Bessastadir and several top executives at Actavis. The President underlined that the business cooperation with Bulgaria was of high importance for Iceland. According to him the relationship between the two countries has been strengthened considerably for the last couple of years. He claimed that this positive development was largely due to the efforts of the Bulgarian President, George Parvanov, who paid his first official visit to Reykjavik at the beginning of September 2002.After a short tour of the manufacturing plant in Hafnarfjordur, the Bulgarian media had the opportunity to talk with Mr Thor Bjorgolfsson, Chairman of the board of Actavis. Mr Bjorgolfsson commented on Actavis’ investments in Bulgaria as being the key to further expansion in the Balkan region.Actavis’ President and CEO, Robert Wessman presented Actavis’ history and underlined the importance of the Higia acquisition as a sign of Actavis’ development in Bulgaria.OtherTue, 11 Oct 2005 15:41:00 GMT{9E56EF4D-04A1-4749-8319-C8534E5D6D71}http://www.actavis.com/en/media+center/newsroom/articles/actavis+launches+terbinafine.htm Actavis has launched a new antifungal-medicine, Terbinafine, to 15 European countries, with more countries being added before the end of the year. The product, whose patent recently expired, was shipped to clients at patent expiry. The first orders were around 10 million tablets and the company estimates that Terbinafine will become the Group’s highest selling antifungal-medicine. The product is still not expected to reach the Group’s ten highest selling products. Terbinafine is a well known medicine, mainly used in the treatment of fungal infection in skin and nails. Terbinafine from Actavis is distributed in tablets in two strengths, but the company is also developing a Terbinafine cream. The product was originally launched in the UK in 1990, but its patent expired recently. The product is manufactured and packaged by Actavis in Malta, and Actavis’ subsidiary Medis will handle the sale of the product in Europe under customer label, but Actavis Nordic will distribute the product in own-label in the Nordic countries. The product has been available in Iceland for a few years. According to Gudbjorg Edda Eggertsdottir, Chief Executive of Sales & marketing, Third-party, Global, it is always a major event when a new product is launched in the Group. “I am particularly happy to see the product being launched in so many countries at this initial stage. With the launch of this product we will expand our product portfolio at the same time as we enter a segment of the market which we have not had a strong position, that is in antifungal-medicine. This is the second time Actavis in Malta launches a new product and the staff there has shown exceptional determination in its preparation.”ProductMon, 12 Sep 2005 16:17:00 GMT{9EEA6324-2FE2-4394-A7A1-4D59FF065DB6}http://www.actavis.com/en/media+center/newsroom/articles/actavis+bioluz+contract.htm Actavis’ hospitals division has signed a co-development contract with Bioluz, experts in the development and manufacture of injectable drugs (IV drugs) in ready to administer bags. Demand for ready to use products is increasing primarily as they offer greater security that products are correctly prepared whilst minimising occupational exposure to dangerous products and saving time. Actavis is one of the leading generic pharmaceutical manufacturers in the world. Actavis has been rapidly expanding its presence in the hospitals market and has a range of injectable products in addition to a comprehensive oncology range comprising over 30 molecules. Bioluz is a fully integrated drug manufacturer focused on premixed drugs in flexible bags and is part of the Technoflex group - European leader in design and production of infusion bags and connectors. Bioluz is the only European independent CMO to offer aseptic filling of IV drugs in sterile flexible bags. James Burt, Global Director of Actavis’ Hospital Unit commented: “The contract with Bioluz signifies an important development for our hospitals business, as it enables us to provide further diversity in our product offering and a strong foothold in the fast growing market for IV drugs in ready to use format.“ Jean-Jacques Chappaz, Bioluz CEO commented: “The deal signed with Actavis is in line with our will to partner with the major pharmaceutical companies. There is no doubt about increasing demand in premixed IV drugs, mainly for safety issues.” ProductMon, 26 Oct 2009 13:34:00 GMT{9F62885D-4259-47A2-AE0E-CE1C7A04B195}http://www.actavis.com/en/media+center/newsroom/articles/new+development+centre+iceland.htm A brand new development centre is now open for business in Hafnarfjordur, Iceland. The “pilot-scale” production building is part of a wider EUR13 million-investment in facilities for R&D, Quality and Operations that will ensure Actavis is able to develop a broader range of products in a very efficient manner. The goal is to condense the division’s operations into one location. Within the next 12 months the remainder of R&D functions including the laboratories, analytical development units and patent department will also be on site. The modern facility will enable Actavis in Iceland to produce a wider range of products than ever before. It also allows the manufacturing of more products simultaneously and has been designed to accommodate development of creams and ointments in the future. It now shares the same warehouses as the main production facility, which will help to produce cost-efficiencies in the longer term. In the R&D division in Iceland there are around 100 staff working on about 30 products and delivering between nine and eleven dossiers each year, as well as supporting other Actavis R&D divisions. Serving mainly the full-scale production plant in Iceland, the team here are developing a wide range of products with the exception of anti-biotics, hormones and compounds requiring high containment.OtherFri, 07 Oct 2005 15:54:00 GMT{9FE0C395-41A9-4987-8539-1125896F88D4}http://www.actavis.com/en/media+center/newsroom/articles/rep+office+albania.htm Actavis recently opened a representative office in Albania. It was officially inaugurated in Tirana by Jonas Tryggvason, Executive Vice President CEEA. More than 200 healthcare professionals attended the opening Ceremony and the launch of Actavis name and brand. A conference was held, starting with product presentations performed by local KOL’s about the therapeutic use of the newly launched Actavis products.The pharmaceutical market in Albania has an estimated size of EUR120 million with a growth rate of more than 10% in 2006. Generic product sales are expected to grow by double digits at least until the end of the decade. Contact informationOtherThu, 02 Aug 2007 10:45:00 GMT{A0A411AE-83F6-46A1-8883-B6B272B3A2D4}http://www.actavis.com/en/media+center/newsroom/articles/ceo+visits+croatia.htm Robert Wessman, President and CEO of Actavis, visited Zagreb, Croatia today to advance the Group’s preliminary proposal to acquire PLIVA, one of Europe’s leading pharmaceutical companies. Mr Wessman visited the Zagreb Stock Exchange to discuss the possibility of listing Actavis in Croatia on completion of the acquisition. Actavis wants to encourage ongoing support from the investment community in Croatia, and a listing would enable existing PLIVA investors to participate in the combined entity and benefit from its future growth. Mr Wessman also attended a press conference in Zagreb to explain Actavis’ proposal and the substantial benefits that it offers to investors, employees, customers and the local community in Croatia. Mr Wessman told the gathering of 40 journalists that there was minimal overlap between the two businesses and the merger would create the world’s third-largest generics company, securing the long term future of PLIVA’s manufacturing and R&D capabilities and its strong brand recognition in Europe. He explained that the combined entity would have the scale necessary to compete with larger industry rivals and benefit from significantly enhanced growth prospects. Commenting on his visit, Mr Wessman said: “I am delighted to be in Zagreb and I hope that my visit demonstrates just how serious we are about bringing Actavis and PLIVA together. Our industry continues to consolidate at a rapid rate and I believe that the combination of these two companies will create a business with a dominant position in the market and excellent long term growth prospects. PLIVA and Actavis compliment each other in almost every respect. They have complimentary geographic coverage, therapeutic focus and a product pipeline with minimal overlap. This will make the integration process very straight forward and the benefits of the combination immediate. PLIVA will be a crucial part of the enlarged Group and its ongoing strategy. We want to encourage the ongoing support of local investors, which is why I have met with the Zagreb Stock Exchange today to ensure that a listing in Croatia is something that Actavis can achieve quickly. I am delighted that the response to our enquiry has been so positive and I look forward to sitting down with PLIVA’s management in the coming weeks to discuss our proposal in even greater detail and work towards bringing these two great companies together.” OtherMon, 27 Mar 2006 10:29:00 GMT{A344FBBF-37DC-464C-9712-76CA14B70FBA}http://www.actavis.com/en/media+center/newsroom/articles/generic_medicines_ims_report.htm IMS has launched the report “Generic Medicines: essential contributors to the long-term health of society - sector sustainability challenges in Europe”. In the report, IMS's Alan Sheppard looks at the sustainability of the generics sector and assesses its benefits to the provision of healthcare across Europe. According to the report, over half of the volume of medicines are supplied as generics medicines but this represents just 18% in value terms. The European Generic Medicines Association have estimated that, to date, generics medicines in the European Union have generated savings in the order of EUR30 billion. Key takeaways from the report: Generic medicines provide an affordable, gold standard medication for many major illnesses Generic medicines allow access to medicines for a greater proportion of the population Generic medicines stimulate healthy competition with the branded sector Generic medicines deliver savings to national health bills Generic medicines are high quality products The full report can be downloaded from IMS' website:Generic Medicines: essential contributors to the long-term health of society - sector sustainability challenges in Europe (PDF, 1MB) About IMS Health OtherMon, 29 Mar 2010 16:08:00 GMT{A582D9D6-D7EF-4586-9AD4-6574812BA8E0}http://www.actavis.com/en/media+center/newsroom/articles/actavis+kadian+specialty+drug+portfolio.htm Actavis has acquired the brand name drug Kadian® from King Pharmaceuticals for not more than USD127.5M, based on quarterly sales related milestones, ending 30 June 2010. Kadian® which is an extended release morphine sulfate product, is the first originator brand product to be marketed by Actavis US. The company anticipates marketing Kadian® only in the United States. “The acquisition of Kadian is the latest step in Actavis’ strategy to expand our specialty drug portfolio and is well aligned with our emphasis on bringing complex controlled-release products to the marketplace,” said Actavis US CEO Doug Boothe. “Kadian has enjoyed significant market share and we are excited about its continued prospects as a drug that benefits many patients.” Kadian®, used to treat moderate to severe chronic pain, is a currently marketed in 20mg, 30mg, 50mg, 60mg, 80mg, 100mg and 200mg dosage strength capsules. Kadian’s wide range of dosage strengths allows physicians to give patients more treatment options in managing their pain. Actavis and its Elizabeth NJ facility have a long history with Kadian®. The product was originally developed and commercially launched at the facility. Actavis has been the contract manufacturer for Kadian® since 2005, when Actavis acquired Alpharma's human generics business.OtherTue, 30 Dec 2008 14:07:00 GMT{A5ADF688-5338-4784-8970-7703523210C2}http://www.actavis.com/en/media+center/newsroom/articles/actavis+market+two+new+generics.htm Actavis Group has introduced two new generics to the markets of nine European countries through its subsidiary Medis. The generics in question are two dosage forms of Lamotrigine, a medicine belonging to the central nervous system therapeutic group. With a launch quantity of approximately 40 million tablets, the two new generics are expected to be a strong contributor to the Actavis portfolio, even though they may not reach Actavis’ top 10 product list. Lamotrigine is primarily used for the treatment of epilepsy and to prevent mood episodes in patients with bipolar disorders. The medicine first came to the market in Europe in 1990, and its patent expired on 30 May 2005. The challenging development of Actavis’ generic formulations took place mainly in Iceland over a period of approximately five years, and involved such factors as bio studies, registration procedures, production validation and quality assurance. Both dosage forms, which are produced in Actavis’ production plant in Iceland, will be both marketed by Actavis Own Brand Division and sold by Medis to third-party customers, who will market the products under their own labels. According to Gudbjorg Edda Eggertsdottir, Chief Executive, Sales and Marketing, Third Party Division, the launch preparation was an extensive process. "The production and development of the new generics have been challenging, but successful, and we have managed to supply all our customers with registered products as soon as the patent expired."ProductThu, 02 Jun 2005 10:07:00 GMT{A6D65397-0C2D-47B7-BF67-D41762D4209F}http://www.actavis.com/en/media+center/newsroom/articles/president+iceland+new+plant+india.htm According to a press release from the presidential office, on Monday President Olafur Ragnar Grimsson of Iceland opened a new pharmaceutical plant in Pune, India. The plant is operated by Indian pharmaceutical company Emcure, which has concluded a collaboration agreement with Actavis. Emcure is one of India’s leading pharmaceuticals companies. At the opening of the new plant, Satish Mehta, CEO and principal owner of Emcure, expressed great satisfaction with the planned collaboration with Actavis; he said that the companies could together achieve great results on the pharmaceuticals market in the USA and elsewhere in the world. On Sunday the president was also present in Bangalore when a declaration was signed on the purchase of Lotus, a leading pharmaceutical research company, by Actavis. The president, who was accompanied on his visit to India by Robert Wessman, CEO of Actavis, and Actavis executives Ashok Narasimhan and G. R. S. Raghavan, based in London and in India, also visited other pharmaceutical and genomics companies in Bangalore and Hyderabad. The president stated that, at his meeting in Delhi last week with Indian President Dr. A.P.J Abdul Kalam, it was determined that Indian-Icelandic collaboration in the field of pharmaceutical development and production would be given prominence during the President of India's forthcoming visit to Iceland this May. OtherTue, 08 Feb 2005 16:10:00 GMT{A7073BCC-1F82-4225-91F7-3F28324AD430}http://www.actavis.com/en/media+center/newsroom/articles/chiral+api.htm Actavis has acquired a 90% share in Zhejiang Chiral Medicine Chemicals Company for an undisclosed amount. Strategic RationaleChiral is specialized in research, development and production of active pharmaceutical ingredients (APIs). The acquisition is part of Actavis’ strategy to get direct access to low cost API manufacturing. Actavis has already established an API R&D centre in India with a pipeline of 70 products. This new acquisition together with Actavis’ API manufacturing site in India will increase the Group’s cost competitiveness as well as being of strategic importance for Actavis Group in selling APIs to other pharmaceutical companies. There are substantial synergies between Chiral’s and Actavis’ portfolios which will result in significant cost reduction of major product lines. About Zhejiang Chiral Medicine Chemicals CompanyFounded in 2001, Chiral currently employs close to 200 employees in its API manufacturing plant, located in Hangzhou, China. Its products are currently sold to various pharmaceutical companies outside China. About Actavis GroupActavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in 40 countries, with 11,000 employees. In addition to building up a strategic position in APIs, Actavis produces generic pharmaceuticals at 21 production sites in 13 countries, with an annual capacity of 24 bn tablets and capsules. In China, Actavis operates a manufacturing site in Guangdong, which produces tablets, capsules, suspensions, solutions, creams and ointments. After this acquisition Actavis employs close to 500 people in China. Commenting, Robert Wessman, CEO and President of Actavis said:“This new facility will enable Actavis to further reduce its manufacturing costs and is an important extension of our activities in China. In addition, this further strengthens our backward integration, increasing our API manufacturing capacity.”OtherWed, 09 Apr 2008 10:12:00 GMT{AA40A3D6-C368-4F8B-84B9-EE6CA7B18732}http://www.actavis.com/en/media+center/newsroom/articles/bicalutamide+norway.htm Actavis today announces the launch of Bicalutamide tablets in Norway. Bicalutamide is the first generic version of the oncology drug to be made available in the country. Bicalutamide, the generic version of AstraZeneca’s Casodex®, is used as a treatment for prostate cancer and will be available in tablet form in either 50mg or 150mg doses. Commenting on the launch of Bicalutamide, Per Ivar Rivenæs, Marketing manager of Actavis in Norway, said: “Bicalutamide is among the top 15 pharmaceuticals in Norway and we are delighted to be the first company to make a generic version available in the Norwegian market.” More information about Actavis in Norway can be found in the Corporate directory (English and Norwegian) and on the Actavis.no website (Norwegian).ProductThu, 13 Sep 2007 08:54:00 GMT{AB314F3C-7DCA-41C4-BD7A-100E3A395F8E}http://www.actavis.com/en/media+center/newsroom/articles/ir+nordic+award.htmActavis has been nominated as having the best investor relations practice for an Icelandic large cap company by IR Magazine at the Nordic Awards ceremony held in Oslo, Norway.Actavis also won this same award in 2004. The awards are based on a survey conducted among 200 investors, analysts and other professionals throughout the Nordic region. Commenting, Halldor Kristmannsson, VP of Corporate Communications and IR, said:“Transparent, regular and open communication with the investment community and our shareholders has been a significant priority of ours at Actavis for many years. We are delighted that our efforts have won such ringing endorsement and recognition from investors and analysts.”OtherMon, 18 Jun 2007 10:54:42 GMT{AC6623BC-FECA-4D3A-A9CB-CB5DEC4BAE1B}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+expands+in+India.htm Actavis announces today that it has opened new premises for its subsidiary Lotus Labs in Bangalore, India. The new premises will house offices, laboratories and facilities for clinical bioequivalence studies. About 200-300 people will work within the premisis, which has a total area of about 3,000 m2; representing a very important step in the development of Actavis’ operations in India. Iceland’s Minister of Education, Culture and Science, Þorgerdur Katrin Gunnarsdóttir, which opened the premises, and Iceland’s newly-appointed Ambassador to India, Sturla Sigurjonsson, accompanied by a trade delegation from Iceland. Stefan Jokull Sveinsson, Chief Executive of Actavis’ R&D, commented:“Actavis' success has been built on strong local roots and this expansion of the company’s activity in India is in line with our ongoing strategy of drawing on the large skill base and expertise in the region, and extending our reach to drive future growth. Actavis has plans for further expansion by opening a centre for stability studies which will provide additional support for the Group’s operations in Europe and the USA. The company also plans to use Lotus Labs’ old premises for other activities as development of active pharmaceuticals (API).” During the past year Actavis has greatly expanded its operations in India, investing approximately EUR20 million in Lotus Labs, a pharmaceutical research company, in February 2005. Lotus, which was founded in 2001, has its headquarters in Bangalore and employs about 260 people. It specialises in clinical studies and bioavailability studies of pharmaceuticals. Actavis entered into partnership agreements with four Indian pharmaceutical companies last year: Emcure, Shasun and Orchid. The agreements with Emcure involve contract manufacturing for the US market; those with Shasun and Orchid concern both manufacture and development of pharmaceuticals. The agreements secure lower supply cost and also substantiallly expand the group’s capacity in the field of development. Actavis has four employees in India working on commercial development, implementing agreements and seeking out new opportunities for the Group.OtherThu, 02 Mar 2006 13:48:00 GMT{ACA08EF0-6E81-4860-8C56-78EA1B8A238B}http://www.actavis.com/en/media+center/newsroom/articles/actavis_relief_haiti_earthquake.htm Actavis has pledged over EUR1.5M worth of pharmaceuticals and cash to the relief efforts following the recent devastating earthquake in Haiti. The support is sent from various countries where Actavis operates, including Iceland, Bulgaria, Turkey, the UK and the US. A part of the donation has already been delivered, including USD10.000 in cash to the American Red Cross and products from Actavis in the US to two non-profit organisations, Americares and Operation Smile. Over 600-thousand tablets of generic drugs from Iceland were received by the SOS children‘s villages in the Dominican republic and transported by land from there to Haiti, which shares the same island. Other relief efforts by Actavis are still under way. The products donated include some of the most needed medicines, including analgesics and antibiotics. Gudbjorg Edda Eggertsdottir, Actavis‘ Deputy CEO:“A natural disaster on this scale touches all of us. Actavis decided immediately following the earthquake to pledge its support. There is a shortage of drugs in Haiti that we have responded to, with our initial support being in the form of cash donations. The logistics surrounding transport of drugs between continents can take time, especially considering the destruction caused to the Haitian infrastructure, but we are currently working on the transportation of the next wave of donated products.”CommitmentTue, 09 Feb 2010 15:00:00 GMT{ADE09772-8451-4F65-BA9F-6292C14F41A9}http://www.actavis.com/en/media+center/newsroom/articles/n-ireland+award.htmActavis has been awarded the Best Professional/Customer Care of the Year award at this year’s Northern Ireland Pharmacy Awards, held in Belfast. Michael Cann, Head of Sales in the UK said: “We were thrilled to have been recognised for supporting Northern Ireland pharmacy and this is a testament, not only to our customer-facing staff, but also to our people who work so hard within our commercial propositions, product portfolio and service areas. It is also recognition to our Accumulator partners in Northern Ireland, Sangers and AAH, who have helped us develop our service to support the Northern Ireland pharmacy market."OtherSun, 11 Feb 2007 23:59:45 GMT{AF7F56FF-6334-4082-827C-47470218F178}http://www.actavis.com/en/media+center/newsroom/articles/Signing+ceremony+in+London.htm On 8 February 2006, Actavis held a signing ceremony for its US$1.3 billion Syndicated Credit Facility in support of its acquisition of Alpharma's US and International human generics business. The financing was a landmark transaction, representing not only the largest capital raising exercise ever held by the company but also the largest acquisition financing raised by any European pharmaceutical company in 2005. The transaction was well received in the European loan market, raising a significant oversubscription. The signing celebration, held at the Tate Modern Gallery in London, was attended by in excess of 50 bankers representing the 26 banks that took part in the financing. UBS acted as Mandated Lead Arranger and Sole Bookrunner and was represented amongst others by Jonathan Macdonald, head of Global Syndicated Finance for Europe, Middle East, Africa and Asia.OtherMon, 20 Feb 2006 14:13:00 GMT{B0098594-A018-4850-B3C9-16B319281480}http://www.actavis.com/en/media+center/newsroom/articles/valaciclovir_actavis_france_europe.htm Actavis has launched Valaciclovir in France and a number of other European Economic Area countries. Valaciclovir, used to treat herpes virus infections, is one of the top selling drugs coming off patent in France in 2009. Valaciclovir was launched on day one in France, both under the Actavis brand and by customers of Medis - Actavis’ Third-party sales division. Actavis’ own brand product also entered the market on patent expiry in the UK and Norway, while Medis’ customers launched in Italy. The patents expired on 20-21 December. Valaciclovir Actavis will soon be entering other European markets. Valaciclovir Actavis is the generic equivalent of GlaxoSmithKline’s Valtrex® / Zelitrex®. The generic drug from Actavis is available in 500mg tablets, and 1000mg in some markets. Valaciclovir (also spelt valacyclovir) is used to treat herpes virus infections, including cold sores, shingles and genital herpes in adults as well as chickenpox and cold sores in children. Annual brand product sales were EUR169m in the EEA (IMS Health data, 12 months ended September 2009).Valaciclovir Actavis was developed by Actavis R&D and is manufactured by Actavis in Iceland.ProductTue, 22 Dec 2009 06:45:00 GMT{B147888A-CF6C-4159-805D-8A62C0AD100C}http://www.actavis.com/en/media+center/newsroom/articles/amlodipine+us.htm Actavis has received final approval of Amlodipine besylate tablets from the US Food & Drug Administration. Distribution of the product will commence immediately. Amlodipine besylate tablets, the generic equivalent of Pfizer’s Norvasc® tablets, will be available in 2.5 mg, 5 mg and 10 mg strengths and are indicated for the treatment of hypertension, chronic stable angina and vasospastic angina. Annual sales of Amlodipine besylate tablets in the US were approximately US$2.5 billion for the twelve months ending June 2007 according to IMS Health data. More information about Actavis in the United States can be found at www.actavis.us ProductMon, 10 Sep 2007 05:00:00 GMT{B2C7F6BE-26D6-4C1B-9649-2B64F83FF3D6}http://www.actavis.com/en/media+center/newsroom/articles/actavis+ceo+speaker+in+Malta.htm Robert Wessman Actavis’ CEO was a speaker at the Commonwealth Business Forum 2005, in Malta in November. The event is a major international business event which brings together over 500 government and business leaders from throughout the Commonwealth and beyond. This event is being held in connection with the Commonwealth Heads of Government Meeting of 53 nations. In his speech Mr. Wessman discussed the topic; Making Globalisation Work – Access to Global Investment. He outlined the factors shaping the generic pharmaceutical industry in recent years on global level and his vision on the future development of the industry. With continued pressure on healthcare costs, governments continue to support the growth of the generics industry. Continued consolidation, the patent expiry of a large number of multi-billion dollar patented products and increased efforts to reach economies of scale will continue to shape the industry in the next decade. Mr. Wessman described the growth strategy of Actavis Group, the challenges it has faced and the key factors in becoming a truly successful global operation. Seizing the opportunities in the industry has enabled Actavis to grow from being a small domestic company, in Iceland to becoming a global corporation with operations in around 30 countries. As an example, a favourable business environment in Malta has made Actavis’ operation in the country one of the key contributors to the growth of the Group.OtherWed, 14 Dec 2005 15:11:00 GMT{B3C02B90-87B7-430E-A131-AC15C7189E4F}http://www.actavis.com/en/media+center/newsroom/articles/fda+warning+letter.htm Actavis announced today that it has received a warning letter from the U.S. Food and Drug Administration (FDA), related to its inspection of the Group's solid oral dose manufacturing facility in Little Falls, New Jersey. The Warning Letter identifies deficiencies in the way that Actavis has handled its adverse medical event reporting obligations. The Warning Letter also questions the marketing status of certain of Actavis's older products that are currently being marketed by the Group relying on pre-ANDA drug approval mechanisms ("Older Drugs"). Since the inspection, Actavis has materially revised its adverse drug event and pharmacovigilence procedures to address certain deficiencies and to establish a system that ensures continuous compliance with regulatory expectations. The Group has also complied with all previous adverse medical event-reporting obligations that were over due or deficient. Management is confident that each of the identified Older Drugs are currently being marketed in accordance with applicable regulations, but is undertaking a full review of these products to address the FDA's concerns. Actavis has already submitted to the FDA a comprehensive response to the Warning Letter. The Group is confident that based on the actions it has taken to date and its willingness to undertake any additional actions that may be required, it will fully address the concerns of the FDA. Furthermore, the Group does not anticipate launching new products from the plant until it has resolved all outstanding compliance issues to the satisfaction of the FDA. This is not expected to result in a material impact on 2006 financial results or the Group's guidance on growth and margins in 2007.OtherThu, 14 Sep 2006 10:35:00 GMT{B61133A6-BDED-4974-9671-FCD3B18A3B33}http://www.actavis.com/en/media+center/newsroom/articles/Annual+General+Meeting+2006.htm The Annual General Meeting of Actavis Group, will be held on Tuesday 28 March 2006 at Hotel Nordica in Reykjavik, Iceland, at 17:00 GMT. Agenda: 1. Topics according to article 4.04 in the Company’s Articles of Association. 2. Other issues The Company’s annual accounts for the year 2005 are available for shareholders at the Company’s headquarters at Reykjarvikurvegur 76-78, Hafnarfjordur, Iceland.OtherMon, 27 Mar 2006 13:38:00 GMT{B755C9D8-5830-4E53-B4EE-817C8CB8ADE1}http://www.actavis.com/en/media+center/newsroom/articles/results+annual+meeting+2005.htm The proposals submitted at Annual General Meeting of Actavis Group hf. on Friday 31 March 2005 were approved unanimously. 1. The following proposal stock option plan was approved: The AGM of Actavis Group hf. agrees to authorise the Board to implement a stock option plan for it’s employees for up to nominal value ISK50,000,000 (fifty million). The Board shall decide on the details of the plan. 2. The following proposal of authorisation for issuance of new shares was approved: The Board is authorised to issue new shares for up to nominal value ISK450,000,000 (four hundred and fifty million). This authorisation expires 31 March 2010. These shares shall be in the same class as other shares in the company. The rights attached to the shares can be exercised on the day of the share issue. The Board shall decide whether the contribution for the shares can be other than cash. If the authorisation is used to satisfy duties according to a stock option plan for its employees or payment for acquisition of shares or assets in companies and license agreements, the Board can decide not to give the shareholders of the company their right of first refusal to subscribe to the new issue. 3. The following proposal for an authorisation to purchase own shares was approved: The general meeting of Actavis Group hf., convened on 31 March 2005, passes a motion to the effect that the company’s board of directors is authorised, on behalf of the company, to purchase shares in the company, up to the maximum of 10% of share capital, at a purchasing price which is restricted to +/-5% of the registered sales exchange value of shares on the day of purchase. This authorisation remains valid for 18 months from the day it is passed. 4. The following proposal of payment of dividend was approved: The company’s Board of Directors proposes a payment of 10% dividend on the nominal value of capital stock to stockholders in the year 2004 which corresponds to 5.1% of net profit. 5. The meeting elected the following Members of the Board: Björgólfur Thor Björgólfsson – Chairman Andri Sveinsson Karl Wernersson Magnús Þorsteinsson Sindri SindrasonOtherFri, 01 Apr 2005 11:49:00 GMT{B9295F42-CF3D-4465-B80F-D2712D808FFE}http://www.actavis.com/en/media+center/newsroom/articles/actavis+sells+manufacturing+bulgaria.htm Actavis Group hf., the international generic pharmaceuticals company, today announces that its Bulgarian subsidiary, Balkanpharma Razgrad AD, has partly been divested to Biovet AD Peshtera. The business focuses on the manufacture of active pharmaceutical ingredients ("API´s"), veterinary products and finished pharmaceutical forms. Actavis will now divest a part of the site, which manufactures API´s and veterinary products. Actavis will continue operating part of the plant related to the manufacture of finished forms. Financial details were not disclosed. The sale is not expected to have a material affect on Actavis financial results or its operations in 2005. The sale of the plant reflects Actavis’ strategy to focus on the growth of its core business.OtherFri, 22 Jul 2005 09:22:00 GMT{BAB1A695-A7EA-4361-A160-A3FAD6DAE4AD}http://www.actavis.com/en/media+center/newsroom/articles/carvedilol+us.htm Actavis today announced that it has received approval from the US Food & Drug Administration to market Carvedilol tablets in the US. Distribution of the product will commence immediately. Carvedilol tablets, the generic equivalent of GlaxoSmithKline’s Coreg® tablets, will be available in 3.125, 6.25, 12.5 and 25 mg strength. Carvedilol tablets are indicated for the treatment of left ventricular dysfunction following myocardial infarction and for the management of essential hypertension. Annual sales of Carvedilol tablets in the US were approximately US$1.7 billion for the twelve months ending June 2007 according to IMS Health data. More information about Actavis in the US can be found at www.actavis.us ProductWed, 05 Sep 2007 18:00:00 GMT{BD65BC67-5D25-4F62-AD39-227E7B6D4DB2}http://www.actavis.com/en/media+center/newsroom/articles/actavis_in_zug_contact.htm The new Actavis headquarters in Zug, Switzerland is progressing. Around 100 of the Company's employees have already moved into their new offices in Tower 4. In May the “Orange Power Tower” will be officially opened. Of course, Actavis remains an Icelandic company, with a key site for manufacturing, research & development as well as Medis, the third-party sales division, located there. Contact Actavis in Zug: Tel.: +41 (0)41 462 7300 Post address:ActavisTurmstrasse 24CH 6300 ZugSwitzerland Visiting address:Street: Turmstrasse 24 (via Sumpfstrasse), 4 TowersTown: SteinhausenOtherMon, 04 Apr 2011 07:32:00 GMT{BFD01875-0D11-4A38-B716-1E0640E1A0C4}http://www.actavis.com/en/media+center/newsroom/articles/fentanyl+patch+europe.htm - Actavis product already on market in 6 other countries including Germany and the US Actavis has launched Fentanyl patch for severe chronic pain in Finland, Sweden and Poland. The Actavis Fentanyl patch was launched earlier this year into Actavis’ markets in six other countries, including Germany and the United States, with more market launches to follow. Fentanyl transdermal patch is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids. Fentanyl transdermal patch is the generic equivalent of Alza Janssen's Duragesic®. The patches deliver consistent and reliable pain relief for 72 hours. They are discreet, easy to use, and are available in up to five strengths to suit the needs of the individual;12, 25, 50, 75, and 100 micrograms per hour. Annual global sales of Fentanyl transdermal patches in the European Economic Area were approximately EUR657 million for the twelve months ending March 2007, according to IMS Health data.ProductTue, 23 Oct 2007 08:00:00 GMT{BFE48F90-E849-4748-BCBD-7A8AEC8672F8}http://www.actavis.com/en/media+center/newsroom/articles/fosinopril+hct+france.htm Actavis today announced that its third-party sales division, Medis, has launched Fosinopril HCT on patent expiry in France, 26 November. The product will be marketed in France by Medis’ customers. Fosinopril HCT (Fosinopril and hydrochlorothiazide combination) is used to treat high blood pressure and is available in France in 20/12,5mg tablets. Fosinopril HCT is the generic equivalent of the brand Foziretic, marketed in France by Merck Lipha Santé. The generic tablets were developed by Actavis R&D and are made in Actavis‘ manufacturing site in Hafnarfjordur, Iceland. The product has already been marketed by Actavis in a number of European countries. Annual brand product sales in France were EUR5.9 mln, for the 12 months ending September 2008 (IMS Health data).ProductThu, 27 Nov 2008 15:38:00 GMT{C03ABAF4-B7B9-40A0-AB5E-411C91827FF9}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+market+sertraline+europe.htm Actavis, the international generic pharmaceuticals company, has launched the antidepressive medicine Sertraline in two pharmaceutical forms, tablets and capsules. The launch marks the largest product launch of the Group this year. The product is being marketed both under the company’s own label and under customer labels through Medis, Actavis’ third-party sales division. First deliveries of the product consist of about 70 million tablets and capsules. Sertraline is produced in three strengths, 25 mg, 50 mg and 100 mg. It is mainly used in the treatment of depression and mental disorders. The product has been available for a while in Spain and Central and Eastern Europe, where market authorisations were granted in 2003 and 2004. It is now being launched in 14 countries upon patent expiry. The product is produced in Actavis’ manufacturing facilities in Iceland and Malta. According to Gudbjorg Edda Eggertsdottir, Actavis’ Chief Executive for Sales and marketing, Third-party Global, this is the most important and geographically extensive product launch made by the Third-party division this year, and Sertraline is now being sold in a total of 19 countries. “The year has been extremely busy for our staff,” she says, “but with the resilience and collaboration of our people we were able once again to launch a new product on the market on the date of patent expiry.”ProductTue, 01 Nov 2005 15:31:00 GMT{C2F98E97-656D-4704-A5D0-CE15CBF95AFD}http://www.actavis.com/en/media+center/newsroom/articles/actavis+generic+health+australia+distribution+agreement.htm Actavis in Australia has entered into an exclusive distribution agreement for a number of retail products, with Generic Health Pty Ltd, an Australian owned and operated generic pharmaceutical company headquartered in Melbourne, Australia. The agreement is an important step in building Actavis’ presence in the Australian retail market. Generic Health Pty Ltd is a privately held, fast growing Australian owned and operated pharmaceutical company, marketing, selling and distributing a range of generic pharmaceutical prescription and OTC medications. The Company‘s strategic focus has been on delivering low cost, high quality products linked to simplified and transparent transactions. Generic Health was founded in 2004, by Mr Gavin Upiter, who has had extensive international experience in the pharmaceutical industry.Commenting on this partnership Thomas Runkel, Vice President Asia Pacific of Actavis said: “The partnership with Generic Health is an important milestone for our entrance into the Australian market. We are convinced that Generic Health is the right partner for us to bring our extensive retail product portfolio of first class generics to the Australian market fast.” Actavis in Australia Generic Health‘s websiteOtherFri, 16 May 2008 11:24:00 GMT{C401221A-A2C8-4A38-BF6B-BA9415271567}http://www.actavis.com/en/media+center/newsroom/articles/for+new+products+us.htm Actavis recently received approval on four new products from the United States Food & Drug Administration. The four products include: Phendimetrazine tartrate tablets, 35mg: the generic equivalent of Bontril® tablets by Valeant Pharmaceuticals, are indicated in the adjunct management of weight loss. Annual sales of Phendimetrazine tartrate tablets had annual sales of US$3.1 million for the 12 months ending December 2007 according to IMS Health data. Buspirone tablets, 30mg: the generic equivalent of Bristol Myers Squibb’s Buspar®. Buspirone tablets, used in the treatment of anxiety disorders, had annual sales of US$15.4 million for the 12 months ending December 2007 according to IMS Health data. Baclofen tablets: the generic equivalent of Lioresal® tablets by Novartis, will be available in 10mg and 20mg strengths. Baclofen tablets are used to relax muscles and relieve pain and discomfort associated with certain nerve disorders. Benztropine Mesylate Tablets, 0.5mg, 1mg, 2mg: are the generic equivalent to Cogentin®. Benztropine mesylate is an antidrykinetic, which reduces the symptoms of Parkinson’s disease by improving muscle control and reducing stiffness. Annual sales of Benztropine mesylate were US$ 12,8 million for the 12 months ending December 2007 according to IMS Health data. Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said: “These approvals signify our commitment to provide our customers with a broad and expanding pipeline. We launched 19 products in the United States in 2007 and plan to increase that number in 2008. Actavis currently has over 70 pending applications at the FDA, including a growing list of first-to-file generic products. This momentum in our development pipeline will ensure that we continue to be on the forefront of bringing new generic products to market.” ProductThu, 28 Feb 2008 18:24:00 GMT{C40CF589-86D4-44A4-92CE-FBB04837F064}http://www.actavis.com/en/media+center/newsroom/articles/third+party+sales+div+first+to+market+with+quinapril+germany.htm Actavis Group hf., the international generic pharmaceuticals company, today announces that its third-party sales division, Medis, was the first company in Germany to get marketing authorisation for generic Quinapril now that the patent has expired. Quinapril will be sold by the division's customers, who will then sell the product under their own brand.Quinapril, is primarily used for the treatment of hypertension in patients with cardiovascular problems, and is manufactured by Actavis in Iceland. Germany is the first market where the product is being launched, although a marketing authorisation was granted last year in the UK. The launch there has been postponed until June. Medis is the third-party sales division that handles sales of Actavis pharmaceutical products and intellectual property to other pharmaceutical companies, which then sell the products under their own brand names. Medis clients include some of the largest pharmaceutical companies in Germany. Commenting on the launch, Gudbjorg Edda Eggertsdottir, Chief Executive, Sales and Marketing Third-party Sales at Actavis, said: “Whilst we do not expect Quinapril to become one of the highest selling products in our third-party sales division, this launch represents a further step forward in our objective of being first to market when patents expire. Germany is an important market for Actavis and we are confident of making further progress in this region.”ProductTue, 01 Jun 2004 11:02:00 GMT{C77916EC-B6AE-43DF-B7B8-F7F5D211BE05}http://www.actavis.com/en/media+center/newsroom/articles/vdak+aev+contract.htm Actavis today announced that its subsidiary in Germany has signed a partnership contract with the German VdAK / AEV association. The association represents seven health insurance funds in Germany that provide coverage for around 8.7 million people across the country. 42 Actavis products recommendedUnder the terms of the contract, Actavis will supply a wide range of products used for the treatment of chronic and acute illnesses. The agreement follows the signing with the largest health insurance provider in Germany, Allgemeine Ortskrankenkassen (“AOK”) in March, where Actavis was also selected in a preferred partnership agreement. The association has only selected Actavis for all of the 42 products, whose products will be listed and recommended for the patients of the participants. The new agreement is valid for one year. Participants will include the following: DAK - German employee health insurance company, Hamburg HEK - Hanseatic health insurance company, Hamburg HMK - Hamburg Munich health insurance company, Hamburg Hkk - Commercial health insurance company, Bremen GEK -Gmünder private health insurance fund, Swabian Gmünd HZK - Health insurance company for professionals in building industry and wood processing, Hamburg KEH - Private health insurance fund - Heusenstamm Svend Andersen, Executive VP for Western Europe, the Middle-East and Africa, said: “Our agreement with the VdAK/AEV association is recognition for our business in Germany. Our growing presence, combined with a dynamic pipeline of products will benefit around 9 million German health insurance policy holders going forward and we are excited to start this new business relationship. This means that German doctors and pharmacists will be encouraged to recommend products from Actavis, supporting our sales growth in the market”ProductMon, 30 Apr 2007 07:30:00 GMT{C8B74BC6-6074-4043-BC54-9CF37D2A3D86}http://www.actavis.com/en/media+center/newsroom/articles/thru+ny+samheitalyf+fra+Actavis+a+markad+i+Evropu.htmActavis hefur sett á markað þrjú ný samheitalyf í Evrópu. Lyfin eru þróuð á Íslandi og eru meðal fjölmargra lyfja sem Actavis mun markaðssetja í Evrópu á næstu mánuðum. Á árinu 2006 voru um 300 markaðssetningar á nýjum lyfjum á hina ýmsu markaði samstæðunnar og búist er við að sá fjöldi aukist talsvert á árinu 2007. Lyfin eru hormónalyfið Fínasteríð, þunglyndislyfið Mirtazapín og flogaveikilyfið Topiramate. Fínasteríð, sem er samheitalyf frumlyfsins Proscar frá lyfjafyrirtækinu Merck, er notað við góðkynja stækkun blöðruhálskirtils og hefur verið selt á Íslandi í nokkur ár undir heitinu Fínól. Til að byrja með er lyfið selt á Spáni, í Portúgal og Slóveníu í töfluformi og nemur sala frumlyfsins um 60 milljörðum króna á ári í heiminum. Mírtazapín munnlausnartöflur eru samheitalyf frumlyfsins Remeron frá lyfjafyrirtækinu Organon og nemur sala frumlyfsins um 20 milljörðum króna á ári í heiminum. Topiramate verður selt í Portúgal en þar var ekkert einkaleyfi fyrir lyfinu, en einkaleyfið rennur út 2009 á helstu mörkuðum í Evrópu. Heiti frumlyfsins er Topimax frá frumlyfjafyrirtækinu Janssen-Cilaq. Lyfin verða markaðssett bæði undir eigin vörumerkjum Actavis og seld til þriðja aðila í gegnum dótturfélag samstæðunnar, Medis. Lyfin eru góð viðbót við öflugt lyfjasafn samstæðunnar og búist er við að Mirtasapín verði í hóp söluhærri lyfja sem seld verða til þriðja aðila. ProductMon, 22 Jan 2007 10:55:53 GMT{C9F98A1E-9563-43C9-B9E2-3055E89B66C1}http://www.actavis.com/en/media+center/newsroom/articles/gemcitabine+actavis+launched+on+day+one+eu.htm Actavis has launched the oncology product Gemcitabine in EU markets, at patent expiry. The launch represents a significant milestone in Actavis’ developing hospital business. Gemcitabine is the first major oncology product to be made available by Actavis on the date of patent expiry in Western Europe. Actavis will be manufacturing the product at two of its manufacturing sites. Coupled with three registered sources for APIs (Active Pharmaceutical Ingredients), this will ensure one of the most robust and competitive supply chains in the industry. Gemcitabine will be launched in eight EU markets in March, including Germany, France and the UK. The product will be launched in the remaining EU markets as tender cycles permit later in the year. The product has also previously been launched in several less regulated markets around the world. Speaking about the event, Scott Richards, EVP of Actavis’ Hospital Business, said: “The day one launch of Gemcitabine is a great achievement for Actavis’ hospital business, which was formed just over two years ago. This launch demonstrates our ability to compete in the demanding generic oncology arena. We will be selling this product alongside our growing range of other injectable generic products via our own hospital sales teams around the world and via select partners and distributors in various countries”. The originator product, Lilly’s Gemzar, is estimated to have generated around US$ 1.5 billion in annual revenue. Gemcitabine is used in the treatment of cancer including lung cancer, pancreatic cancer, bladder cancer and breast cancer.ProductMon, 09 Mar 2009 13:59:00 GMT{CA56FA14-49F4-4380-963E-CD0EF0DE8BD9}http://www.actavis.com/en/media+center/newsroom/articles/lercanidipine_actavis_europe.htm Actavis today announced the launch of Lercanidipine in five European countries. Lercanidipine is mainly used to treat high blood pressure. Actavis launched the product under its own brand name on day one in the UK and France, where the patents expired on 20 and 21 January, respectively. The product was also launched on day one in France, the UK, the Netherlands, Belgium and Italy by clients of Medis, Actavis’ Third-party sales division. Lercanidipine Actavis will be launched in various other European countries as patents expire in the near future. Lercanidipine tablets, indicated for hypertension, are the generic equivalent of Zanidip® and Lercadip®. Lercanidipine from Actavis is available in 10mg and 20mg tablets. Brand sales in the EU were EUR290m in the 12 month period ended September 2009, with France and the UK accounting for EUR130m of the sales over the same period (IMS Health data). Generic Lercanidipine was developed by Actavis in Iceland and is manufactured by Actavis in Malta.ProductMon, 25 Jan 2010 08:55:00 GMT{CABA845D-0526-400E-B521-84FF64998FD3}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+subsidiary+Amide+receives.htm Actavis Group, the international generic pharmaceuticals company, today announces that its wholly owned subsidiary, Amide Pharmaceutical Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cyclobenzaprine HCl Tablets, USP. Cyclobenzaprine HCl Tablets, USP is the generic version of McNeil Consumer & Specialty Pharmaceuticals’ Flexeril® Tablets, 5 mg and is used to ease pain arising from musculoskeletal conditions. Amide Pharmaceutical, Inc., located in Little Falls, New Jersey, develops, manufactures and markets a select line of high quality pharmaceuticals. The company was acquired by Actavis Group in May 2005.ProductWed, 22 Feb 2006 14:06:00 GMT{CB54D823-FBFE-49AD-905D-28BAB3F7F7FF}http://www.actavis.com/en/media+center/newsroom/articles/bupropion+hcl+300mg+us.htm Actavis has received approval from the US Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (XL) 300mg. Distribution of the product will commence immediately. Bupropion Hydrochloride extended-release tablets (XL), available in 300mg strength, are the generic equivalent of Wellbutrin XL® for the treatment of major depressive disorder. Annual US sales of brand and generic Wellbutrin XL® 300mg were US$581 million for the 12 months ending June 2008 according to IMS Health data. Commenting on the new approval, Douglas Boothe, Chief Executive Officer of Actavis, Inc. in the United States, said: “Bupropion XL compliments our existing Bupropion SR offerings and expands the dosage options for our customers and patients. This approval also highlights Actavis Group’s focus and expertise in bringing complex controlled-release technologies to the marketplace.”ProductMon, 18 Aug 2008 21:07:00 GMT{CC164FF1-D723-43F2-B35A-A5848BDBB55C}http://www.actavis.com/en/media+center/newsroom/articles/atomoxetine_fda_approval.htm Actavis has received approval from the United States Food & Drug Administration (FDA) to market Atomoxetine HCl capsules for the treatment of ADHD (attention deficit / hyperactivity disorder). No release date has been set for Atomoxetine, Actavis’ generic equivalent to Eli Lilly and Company’s Strattera®. The US Court of Appeals for the Federal Circuit is reviewing a ruling from 12 August that invalidated Lilly’s patent, which is due to expire in 2017. Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths. According to IMS Health data, US sales of Strattera® were USD532 million for the 12-month period ended June 2010. ProductWed, 01 Sep 2010 20:57:00 GMT{CC23E8C7-261E-4E1E-A782-F99B68D1940A}http://www.actavis.com/en/media+center/newsroom/articles/sumatriptan+actavis+sweden.htm Actavis today announces the launch of Sumatriptan tablets in Sweden. Sumatriptan Actavis is the first generic version of the migraine drug to be made available in the country, and is being marketed immediately after patent expiry. Sumatriptan, the generic equivalent of Glaxo SmithKline’s Imigran® and Imigran Novum®, is used for the relief of signs and symptoms of acute migraine. Sumatriptan Actavis is available in 50mg and 100mg coated tablets. Sales of Imigran® and Imigran Novum® tablets in Sweden amount to EUR11.1 million, making Sumatriptan the mostly used 5-HT1-receptor agonist in this market. Actavis has launched 23 new generic products in 2006 in the Nordic region, including Amlodipine and Glimepirid in Sweden and Finland, Zolpidem in Sweden, Tamsulosin in Denmark and Norway, and Lansoprazol in Finland. About ActavisCelebrating its 50th anniversary this year, Actavis is one of the world’s leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. Based in Iceland, the company has operations in over 30 countries, with over 10,000 employees. The company’s market cap is approximately EUR2.9bn (US$3.6 billion) and it’s listed in the Iceland Stock Exchange. Actavis expects 2006 sales to total EUR1.4bn, with approximately 6% of these sales coming from the Nordic region. ProductWed, 01 Nov 2006 13:40:00 GMT{D0675BFE-6189-413D-B940-A63F498A4B42}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+reaffirms+proposal+PLIVA.htm The Board of Actavis Group notes PLIVA’s announcement on 27 March 2006 and subsequent comments from its press conference this morning. The Group continues to believe that its preliminary proposal to combine Actavis and PLIVA offers terrific value for investors, employees, customers and the local community in Croatia. Friendly offerActavis’ primary objective is to discuss a combination of the two businesses in a friendly manner. The Group has sought to engage in serious discussions with Mr. Covic, PLIVA’s CEO, since the middle of 2005. Despite numerous conversions with Mr. Covic since then, no reasonable progress was made. So a letter was sent by Robert Wessman, President and CEO of Actavis, to the PLIVA board on 13 March outlining Actavis’ proposal. Well informed media reports concerning Actavis’ approach that appear to have been leaked to the Croatian media prompted the Group’s decision to issue a press release on 17 March in accordance with Icelandic Stock Exchange regulations. Preliminary offer creates immediate shareholder valueActavis has made a preliminary proposal that remains subject to standard due diligence and discussions with management. The preliminary proposal represents a 35% per cent premium over the average PLIVA share price during the last three months. Furthermore, it represents a 48% premium to PLIVA’s average 12 month share price and values PLIVA at approximately US$1.6 billion. The all cash preliminary proposal provides investors with an immediate and tangible return on their investment and in Actavis’ evaluation the price recognises expected future growth in sales and revenues. The preliminary proposal equates to 10x 2006 EBITDA and 23.4x 2006 Net Income based on analyst forecasts. This proposal is in line with or above recent multiples paid in precedent transactions and reflects PLIVA’s historical performance and current outlook. Positive implications for employeesActavis is absolutely committed to creating jobs in Croatia by transferring production to the country, increasing R&D activities there and by making Croatia a hub for Central and Eastern Europe. Actavis is surprised that Mr. Covic constantly tries to undermine this commitment, especially given its strong track record in transferring products to countries such as Malta and Bulgaria. Transferring production and increasing capacity in CroatiaActavis fails to understand how PLIVA’s plans to move production from the US and Dresden would avoid the issues PLIVA raises if Actavis were to move its own production into Croatia. Actavis has a strong track record of being able to drive down manufacturing costs across the Group, without impacting the employee base. The Group is therefore extremely confident that it can move production from a number of its existing facilities elsewhere in the world to PLIVA’s Croatian facilities, in a successful manner and work with the regulatory bodies in Croatia to overcome any concerns that they might have. PLIVA will maintain its strong Croatian heritagePLIVA will become the headquarters for a substantial part of the enlarged business, and at the same time benefit from Actavis’ global footprint and infrastructure. Furthermore, Actavis will seek a listing in Croatia to encourage ongoing support from the investment community in Croatia. Actavis highly values PLIVA’s Croatian roots and has expressly stated that it is committed to revitalizing the PLIVA brand and expanding its recognition in key markets. Actavis also has a high opinion of PLIVA’s management team and envisages them playing a central role in the new company and sharing decisions regarding future strategy. Actavis CEO, Robert Wessman comments:“Our preliminary offer is friendly in every respect and the fact that the details of our preliminary proposal are in the public is a consequence of market rumours and our obligations as a listed company. We have been quite clear from the outset that our proposal is preliminary and subject to standard due diligence and fully reflects PLIVA’s historical performance and limited guidance. We are encouraged by Mr Covic’s comments today that consolidation is a logical step for PLIVA and we have made repeated requests to meet and discuss our proposal in detail. We are confident that as soon as that can be achieved they will be supportive. We can then start working towards bringing these great companies together and building a business capable of safeguarding the future prospects of our employees, offering a stronger value proposition for our shareholders and even greater choice and faster delivery for our customers.” OtherThu, 30 Mar 2006 13:29:00 GMT{D20D179C-6ECA-4C6F-9F7B-918C9DF1E1BC}http://www.actavis.com/en/media+center/newsroom/articles/actavis+convention+pharmaceutical+ingredients+brussels.htm Last week Actavis participated in CPhI (the Convention for Pharmaceutical Ingredients), which is the largest sales exhibition of its kind within the generic pharmaceutical industry. This year’s show, held in Brussels, was attended by around 20,000 people from around the world. As well as exhibiting at its own stands, Actavis uses these important events to meet existing suppliers and customers, as well as meeting potential new ones. "Actavis has been sending delegates to the show for more than 10 years now, and it seems that each year we have to increase the number of people we send because of growth in the industry and interest in our business" said Gudbjorg Edda Eggertsdottir, Chief Executive of Actavis’ Third Party Sales division. Actavis had two stands at the show, one for Third Party Sales division and another for the API (Active Pharmaceutical Ingredients) business under the Actavis name. CPhI was launched in 1990 as an international convention for pharmaceutical ingredients. Sixteen companies exhibited at the first CPhI, which attracted 250 visitors, while nowadays 20,000 industry professionals visit some 1,200 exhibiting companies from over 110 countries in the world. CPhI is the leading exhibition in the field of pharmaceutical ingredients and related industries. OtherMon, 20 Dec 2004 16:31:00 GMT{D3AFE66C-07C0-4307-B09C-FF37C27F93C1}http://www.actavis.com/en/media+center/newsroom/articles/razgrad+mbo.htm Actavis has today signed a Letter of Intent to sell its manufacturing subsidiary in Bulgaria “Balkanpharma-Razgrad AD” to a newly formed company “Antibiotic-Razgrad AD”. The new company has been set up by representatives of current management at the plant in Razgrad with the aim of managing and developing its manufacturing assets. Actavis will simultaneously, on closing, enter into a contract manufacturing agreement with the new company so that Actavis can continue to have security of supply for its current portfolio of products manufactured in the plant. Thus, Actavis will continue to market all products without interruption. The Razgrad site, which produces antibiotics in different forms: tablets and capsules, powder injections and sterile liquid forms, creams and unguents, is the smallest of three Actavis manufacturing sites in Bulgaria. Actavis has no plans to divest its Bulgarian manufacturing sites at Dupnitza (tablets, capsules) and Troyan (suspensions, gels, ointments, syrups), which are of strategic importance for the Actavis operation. Dimitar Papazov, Managing Director, Antibiotic-Razgrad AD:“This local-management buy-out provides the new owners with an excellent opportunity to leverage idle capacity at the Razgrad plant. Antibiotic-Razgrad will be contract manufacturers for Actavis and fully intend to add more such contracts in the near future in order to improve cost and competitiveness. Our activities will remain closely linked to Actavis and we will continue to follow Actavis’ best practices and high quality standards.” Ivan Urumov, Managing Director, Actavis Operations, Bulgaria:“Actavis has built a solid platform in the past and our main focus in 2008 has been on integration and organic growth. While consolidating our manufacturing into core facilities, we have increasingly been bringing in contract manufacturing. At the same time, we are investing in future growth and expanding our pipeline, with portfolio acquisitions, in-licensing, and of course our own research and development. We are delighted to sign a manufacturing contract with the new owners of the Razgrad facility, a group we of course know and trust. We presume ours will be only one of their manufacturing contracts at the factory in the future.” Subject to necessary regulatory consents, Actavis and Antibiotic-Razgrad expect to close this deal within the next two months.OtherMon, 08 Dec 2008 13:59:00 GMT{D6610B6C-0AA6-4409-9118-D2462DE4D952}http://www.actavis.com/en/media+center/newsroom/articles/finasteride+14+countries.htm Actavis today announced the launch of Finasteride tablets in 14 European countries. The distribution of the product has already commenced. Actavis has already had well over 100 product and market launches this year, and before year end more than 500 launches will be completed. Finasteride was launched as the patent protection expired in the UK, the Netherlands, Germany and Denmark. Actavis currently sells the product under its own label in 12 countries, both in Europe and in the US. Actavis’ Third Party division sells the product to a number of its customers in eight countries. Finasteride is a new molecule in Actavis‘ portfolio this year and is available in tablets of 5mg. It is the generic equivalent of MSD‘s Proscar® tablets and is used as a treatment in benign prostatic hyperplasia (BPH) and in prostate cancer. Actavis’ formulation was developed in Iceland and the bioequivalence study was conducted in South Africa. The production takes place in India. ProductMon, 11 Jun 2007 15:23:00 GMT{D74348F0-A917-4D4F-BC40-4733EADE9731}http://www.actavis.com/en/media+center/newsroom/articles/italy+first+launch.htm Actavis has marketed its first own brand products in the Italian market. Italy, population 58 million, is the fourth largest European pharmaceutical market which Actavis enters. The Italian generics market has expanded at double-digit rates in recent years with company branded generic products especially showing significant growth recently. The Company recently opened offices in Saronno, just north of Milan, close to the Malpensa airport. With close to 200 registration processes running, Actavis Italy has already launched about 20 products. The initial launch was Amoxicillin (antibiotic) in October, followed by Calcio carbonato (osteoporosis), Citalopram (antidepressant), Diazepam (central nervous system), Gentamicine (antibiotic), Gentamicine/ Betamethasone (dermatologic), Bromazepam (central nervous system), Lormetazepam (central nervous system), Pupybel (eye care) and Triazolam (insomnia) in November. Scheduled December launches include Ceftriaxone (antibiotic), AmoxiClav (antibiotic), Carvedilol (cardiovascular), Aciclovir (antiviral) Nimesulide (FANS) and Ranitidine (gastrointestinal). Actavis’ Third party sales division, Medis, entered the Italian market in 2004, marketing its products through other pharmaceutical companies. Medis is currently selling 13 products into Italy, and a few major patent expiry launches are coming up at the end of the year, including Ramipril and Ramipril HCT (cardiovascular). Svend Andersen, Executive Vice President, WEMEA, said:“Actavis has the scale to support a price conscious Italian market and more importantly the high quality products that Italians require. We expect to launch 74 products next year and will support it by full infrastructure and sales force.”OtherWed, 12 Dec 2007 09:00:00 GMT{D8017A91-FD42-4229-BE59-EAB43E585CCF}http://www.actavis.com/en/media+center/newsroom/articles/germany+actavis+nr+2.htm – Record sales of EUR66 million achieved in Europe’s largest generic market Actavis today announced that the German market has become the Group’s second largest market as of the first half of the year, with EU35 million in sales of its own label products. When sales from Actavis’ third party division are taken into account, total sales in the market amounted were EUR66 million in the first half of the year. North America is currently Actavis’ largest market with over EUR500 million in annual sales. According to IMS data, the sales increase means that Actavis Deutschland GmbH is now the seventh largest generic pharmaceuticals company in Germany, Europe’s largest generic pharmaceuticals market (according to IMS Q2 2007, ranked by groups of companies). Despite challenging market reforms and significant price erosion in Germany, Actavis has managed to deliver 21% revenue growth over 2006. This has been achieved as a result of Actavis’ dynamic product pipeline and fast growing sales force, which is currently over 130 people. Recent contract wins such as the preferred partnership agreement with Allgemeine Ortskrankenkassen (“AOK”), Germany’s largest General local health insurance provider, and German VdAK / AEV insurance association, which Actavis now provides over 40 products for, have helped the company in Germany to deliver these impressive results. Sigurdur Oli Olafsson, deputy CEO, said: “Our strong performance in Germany is testament to our fast growing product portfolio and pipeline combined with our commitment to customer service. Whilst Germany continues to be a very competitive market, we managed to secure a number of high-profile contracts in 2006, which have now helped us to increase our market share. Going forward, we expect to see good growth in our German business, through a growing number of new product launches, continued alliances with leading German insurance funds as well as our important partnership arrangements with German generic companies for product supply.”OtherWed, 22 Aug 2007 06:00:00 GMT{D98BDA20-7B97-4F19-85AC-557A5AADD1BC}http://www.actavis.com/en/media+center/newsroom/articles/tablets_for_japan_in_record_time.htm Actavis managed to deliver 10 million Levothyroxine tablets within only 20 days. These tablets are used in the treatment of thyroid problems. The tremendous earthquake on the 11th March damaged the production plant of a company called Aska, which is a joint venture partner of Actavis. This left Japan with a potential supply shortage of Levothyroxine. Aska requested assistance from Actavis on 14th March and it was suggested that Actavis UK may be able to help, as both Levothyroxine strengths (50mcg and 100mcg) that were needed are made on the Barnstaple site. By the 16th March we had started sending documents to Japan to allow the product to get an emergency registration, with product samples and dozens more documents following over the next few days. By the 18th we were able to offer 10 million tablets in the form of UK packs. The Japanese government had to grant an exceptional application for a new generic product. By March 31st the teams combined efforts had resulted in both the accreditation of Barnstaple and also approval of the emergency application. The Levothyroxine was dispatched and arrived in Tokyo on the 4th April, only 20 days after the initial request was received. Sara Vincent, UK-Actavis Managing Director, promised to “continue our support as required, until the Aska site is back up and running”.OtherWed, 20 Apr 2011 07:16:00 GMT{DA76D2E9-2392-4147-B9F3-CECD03477EE8}http://www.actavis.com/en/media+center/newsroom/articles/sigurdur+oli+olafsson+keynote+speaker+financial+times+pharmaceutical+conference.htm Actavis' CEO, Sigurdur Oli Olafsson, was keynote speaker at the FT Global Pharmaceutical & Biotechnology Conference 2009, in London on 18 November. In his presentation, "Transformation through collaboration - Increasing collaboration of originators & generics," he discussed his view of the future of an industry on the move, with generics and emerging markets in the midst of the growth strategy. With its business model designed for constant improvement of cost efficiencies, he said, the generics industry is more recession proof than most. Stefan Jokull Sveinsson, Actavis' EVP Research and development, was keynote speaker at the World Generic Medicines Congress Americas 2009, in Washington DC on 18 November. He presented his views on the role of generic medicines in the provision of affordable and effective healthcare with topics including government initiatives to lower health cost and the role of generics in providing affordable medicine in a fiercly competitive environment with constant price erosion.OtherThu, 19 Nov 2009 16:34:00 GMT{DC59F2E5-2D4C-4D2B-AAE5-00FB964E491F}http://www.actavis.com/en/media+center/newsroom/articles/default.htmNot real newsOtherWed, 25 Oct 2006 17:03:00 GMT{DFDE6556-E03C-4735-AF9F-A505F64B624D}http://www.actavis.com/en/media+center/newsroom/articles/Pilocarpine+Tablets+US.htm Actavis has begun shipping Pilocarpine Hydrochloride 7.5mg tablets in the U.S., to complement Pilocarpine 5mg tablets that the company currently offers in the U.S. Pilocarpine Tablets are used to treat dryness of the mouth and throat caused by a decrease in the amount of saliva that may occur after radiation treatment for cancer of the head and neck or in patients with Sjogren's syndrome. Pilocarpine Tablets 7.5mg is the authorized generic of MGI Pharma’s Salagen® 7.5mg tablets, which are produced by brand company and marketed under the Actavis label. ProductThu, 07 Sep 2006 17:35:00 GMT{E079AB78-DC57-40B9-AFB5-C22CA14A4D1A}http://www.actavis.com/en/media+center/newsroom/articles/iso+standard+actavis+zdravlje+serbia.htm Zdravlje Actavis in Serbia has been formally presented with certificates for the international standards ISO 9001:2000 (quality) and ISO 14001 (environment), as well as OHSAS 18001 (occupational health and safety) by the authorised certification house, SGS. The certification ceremony was held in Belgrade. Goran Stojilković, Managing director Zdravlje Actavis:“Great teamwork and the efforts of all our employees have brought our company to the highest European quality, environmental and health- and safety standards. We are proud of our company’s commitment to developing environmental awareness in the local community.” Other Actavis manufacturing sites holding an ISO 14001 certificate include Hafnarfjordur, Iceland; Dupnitza, Bulgaria; Barnstaple, UK and Norgesplaster, Norway, while Actavis’ Russian manufacturing site Zio Zdorovje also holds an ISO 9001 certificate. CommitmentFri, 30 May 2008 16:30:00 GMT{E0E9168D-3DF0-4189-A65C-CE0E2EA26D7D}http://www.actavis.com/en/media+center/newsroom/articles/olanzapine_four_europe_day_one_patent.htm Actavis launched Olanzapine tablets in Spain, Bulgaria, Slovakia and Hungary immediately after the patents expired on 24 April. Olanzapine is the generic equivalent of the brand product Zyprexa® from Eli Lilly. It is used in the treatment of schizophrenia and bi-polar disorder. The product is launched in two forms by Actavis at this time; as film coated tablets in Bulgaria, orodispersible tablets in Slovakia and Hungary, and in both forms in Spain. Olanzapine Actavis was developed at Actavis’ R&D site in Hafnarfjordur, Iceland and produced at the Company‘s manufacturing site in Malta. Actavis launched Olanzapine in Germany in September 2007, after a German Patent Court ruled that Lilly’s patent was invalid, making the launch of a generic version possible. In other European countries, the patents for Olanzapine will in most cases expire in September 2011.ProductThu, 05 May 2011 08:58:00 GMT{E113EB05-C389-45A3-BBE9-8176381DAA3D}http://www.actavis.com/en/media+center/newsroom/articles/actavis+clamelle+azithromycin+UK.htm Actavis welcomes the announcement that a pharmacy licence for azithromycin has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The successful application relates to the pharmacy licence for Clamelle Azithromycin 500mg Tablets. Actavis UK Ltd applied to switch azithromycin tablets from prescription-only to pharmacy status. Clamelle will be the first oral antibiotic available from a pharmacist without a doctor’s prescription. Clamelle is indicated for the treatment of individuals with confirmed asymptomatic Chlamydia trachomatis genital infection and for the treatment of their sexual partners. The dosage is two tablets taken together as a single dose. Clamelle will be available for people 16 years and over if they have tested positive for the infection and have no symptoms, and for their sexual partners. Individuals will be able to obtain over the counter (OTC) Clamelle from participating pharmacies following confirmation of diagnosis and a thorough consultation with the pharmacist, and without a prescription from their GP or GUM clinic. Sara Vincent, Country Manager, Actavis UK:“We are delighted to have been granted a pharmacy licence for Clamelle. This successful application is in line with Actavis UK’s programme of POM to P switches*, which is running in parallel with the expansion of the OTC brand portfolio through organic growth and strategic acquisitions.” Actavis UK Ltd is now developing pharmacy training materials and launch plans for Clamelle, as well as a Clamelle-branded chlamydia test kit. *POM to P: Prescription Only Medicine to Pharmacy (OTC).ProductWed, 06 Aug 2008 10:55:00 GMT{E128724E-2DFC-4E35-90D7-E8F9FE68935D}http://www.actavis.com/en/media+center/newsroom/articles/atorvastatin+spain.htm Actavis today announced that its third-party sales division, Medis, has delivered 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market. The product, Atorvastatin Magnesium, is launched by four of Spain’s largest generic pharmaceutical companies. Distribution of the product to Spanish pharmacies has already commenced. Atorvastatin efficiently regulates the blood cholesterol levels and is one of the most effective drugs used in the therapy of primary hypercholesterolemia. Atorvastatin Magnesium is produced by Actavis in 10mg, 20mg and 40mg tablets. Pfizer, the originator, markets its product in Spain under the brand names of Cardyl® and Zarator®. Atorvastatin’s US brand name is Lipitor®. Atorvastatin tablets are subject to widely varying patent situations around the world, which is why Medis has invested significantly in different forms of the molecule. In Spain, the patent landscape is different to other Western European markets, and the originator product, containing Atorvastatin Calcium, is patented until 2010. Medis is currently promoting three different dossiers for Atorvastatin and has been supplying a product suitable for Central Eastern Europe for close to two years. Medis’ alternative generic, Atorvastatin Magnesium, can be launched in Spain now, as it has been approved by the Spanish authorities. Medis has worked closely with its clients on the preparations for the launch. The world's top selling drug Actavis has already launched Atorvastatin Calcium under its own brand name in 15 countries in Europe and Asia where there was no patent. Atorvastatin Magnesium will be launched in Spain under Actavis’ own brand name shortly. Annual sales of Cardyl® and Zarator® in Spain are approximately EUR396 million (2008, IMS Health). Atorvastatin is currently the top selling drug in Spain, and indeed the world.ProductThu, 01 Oct 2009 12:44:00 GMT{E2232884-595F-41FA-8A22-B7595C8554F4}http://www.actavis.com/en/media+center/newsroom/articles/three+products+europe.htm Actavis is one of the first to launch three new generic products into a number of key European markets including Germany, the UK, Hungary and Poland. The drugs include Sumatriptan, used to treat migraine headaches, the atypical antipsychotic Risperidone and Granisetron, the anti-nausea drug. The new drugs have been developed in Actavis’ in-house R&D facilities in Iceland and Malta and by Actavis’ partners in India. Sumatriptan is one of the most widely sold migraine drugs in the world and has been used to treat millions of patients for years with good results. Risperidone is used to treat delusional psychosis, including schizophrenia, and some forms of bipolar disorder and psychotic depression. Granisetron reduces nausea and vomiting, common adverse effects associated with chemotherapy. Each of these products will be marketed by Actavis’ European sales force and through Medis, Actavis’ third party sales division, who will distribute the drugs to their customers on the Continent. Commenting, Gudbjorg Edda Eggertsdottir, Executive Vice President of Third Party Sales said: “Actavis has one of the largest product pipelines in the industry with close to three hundred drugs under development and registration today. We have already introduced over one hundred new products into different markets this year underlining our ability to bring new drugs to the market on patent expiry. The products we are launching will support our strong portfolio in these markets, but are not expected to be among the Group’s highest selling products in 2006.”ProductMon, 29 May 2006 20:20:00 GMT{E3199645-5346-450E-ADDE-90D5A3F004E8}http://www.actavis.com/en/media+center/newsroom/articles/Levofloxacin_launch.htm Actavis Group has successfully launched Levofloxacin tablets on day one after patent expiry in eight European countries (UK, Germany, France, the Netherlands, Austria, Finland, Italy and Slovenia). The product was simultaneously launched by Actavis in Poland and via customers of Medis, the Actavis subsidiary which is responsible for third-party sales, in France. Levofloxacin tablets, used in the treatment of a variety of infections, have already been launched by Actavis in countries such as Bulgaria, Hungary, Malta, Portugal and Romania, where no patent was in place. Developed and manufactured by Actavis in Iceland and Malta respectively, Levofloxacin Actavis is the brand equivalent of Levaquin/Tavanic*. Sales of the originator product achieved EUR1.7bn in 2010 according to IMS Health data. Levofloxacin is also available from Actavis in a solution for infusion in most of the markets listed above.* Levaquin/Tavanic was developed and launched by Daiichi Sankyo, and comarketed with licensee Johnson & Johnson in the US and Sanofi-Aventis in Europe.ProductThu, 07 Jul 2011 16:54:00 GMT{E34CBC13-3BEF-4AF8-95FA-2053569C46EC}http://www.actavis.com/en/media+center/newsroom/articles/isotretinoin+glimepiride+turkey.htm Actavis has launched its Isotretinoin product under the brand name Zoretanin in Turkey. Zoretanin is currently the only generic Isotretinoin available in this market. Zoretanin is a prescription drug and is indicated for the treatment of severe acne, which does not respond to other treatments. It contains the active substance Isotretinoin, which belongs to the group of drugs called retinoids, which are structurally related to vitamin A. It reduces the activity of sebaceous glands, which produce fat in the skin. Zoretanin was launched to Dermatologists in Turkey on 19 September in 10mg and 20 mg capsules. At the same time Actavis has also launched a generic version of Glimepiride, originally released by Aventis Pharma under the brand name Amaryl. The Actavis brand name in Turkey is Diaglin. Used to treat type 2 diabetes, the drug is available in 1mg, 2mg, 3mg and 4mg tablets. The launch of Zoretanin and Diaglin demonstrates Actavis’ ongoing commitment to the growing Turkish market. Products launched by Actavis in Turkey in the past 12 months include generic versions of Paroxetine, Ramipril, Fexofenadine and Alendronic Acid. Worldwide, Actavis has over 650 products on the Group’s markets, and over 350 products under development and pending registration. 40-45 ANDAs are expected in the US market in 2007. Actavis products are registered in more than 60 countries and over 500 product and market launches are expected in Group markets in 2007.ProductMon, 01 Oct 2007 11:34:00 GMT{E35EB5BD-721D-4DA5-B575-F13C34865CF4}http://www.actavis.com/en/media+center/newsroom/articles/actavis+first+to+market+new+generic++in+3+countries.htm Actavis Group has introduced a new cardiovascular generic product to the Dutch, British and Swedish markets upon patent expiry; Fosinopril tablets, in two strengths. The launch quantity is approximately 13 million tablets and the product is an important contributor to Actavis’ strong cardiovascular product line. The product is not expected to have any material effect on the company’s finances. Fosinopril is primarily used for the treatment of hypertension and congestive heart failure. The medicine first went on the market in Europe in 1990, and its patent protection expired on 2 July 2005. Actavis’ development took place in Iceland, and bioequivalence studies were performed in Canada. Produced in Actavis’ production plant in Iceland, the product will be sold in Western Europe by Medis to third-party customers. The product will be sold by Actavis Nordic Own-label in Sweden, and will be introduced by Actavis Own-label in selected Eastern European markets later this year. “This is the fourth new product launch for Actavis in only five weeks, so the staff of our production facility here in Iceland have been under considerable pressure to get all the new products out to the customers in time for patent expiry,” says Gudbjorg Edda Eggertsdottir, Chief Executive, Sales & Marketing, Third-party Global division. “They really deserve a lot of credit for making this launch possible. Fosinopril is an important addition to our product portfolio, although it is not expected to be among our top-selling products.”ProductWed, 06 Jul 2005 09:39:00 GMT{E38A334F-A124-49AB-BA89-96F5C596EA39}http://www.actavis.com/en/media+center/newsroom/articles/bumper+beginning+actavis+uk+2009.htm Actavis are pleased to announce the launch of 6 new generic products in the first 6 weeks of 2009 to start what promises to be an exciting year for the company in the United Kingdom.All new products have been launched in Actavis packaging that has been carefully designed to maximise safety and compliance. The new products include: Fenofibrate Capsules, Perindopril Tablets, Domperidone Tablets, Penicillin VK Tablets, Mirtazapine Tablets and Sertraline Tablets.Jonathan Wilson, Marketing Director at Actavis says: “These products are another excellent addition to our portfolio of products, a portfolio that has grown by more than 25 products in the last year alone and currently has a further 300 in development.”ProductFri, 06 Mar 2009 01:00:00 GMT{E3F419B3-9E51-4745-965D-FB66F0E7560D}http://www.actavis.com/en/media+center/newsroom/articles/tamsulosin_us.htm Actavis has begun shipping Tamsulosin capsules to its customers in the United States. Tamsulosin, the generic equivalent to Flomax®, is used to treat benign prostatic hyperplasia (BPH). Actavis is partnering with Synthon Pharmaceuticals to launch and market Tamsulosin capsules in the United States. Actavis offers Tamsulosin in a 0.4 mg strength capsule. Annual sales of Flomax® capsules in the United States were approximately USD2.17 billion for the 12 months ending December 2009, according to IMS Health data. ProductWed, 28 Apr 2010 09:28:00 GMT{E63E4E11-60DB-4024-B377-4881C42CAB46}http://www.actavis.com/en/media+center/newsroom/articles/terbinafine+us.htmActavis today announced that it has launched Terbinafine hydrochloride tablets in the US. Distribution of the product will commence immediately.Terbinafine hydrochloride tablets, the generic equivalent of Novartis' Lamisil® tablets, will be available in 250 mg strength. Terbinafine hydrochloride tablets are indicated for the treatment of fungal infections of the fingernail and toenail.Annual sales of terbinafine hydrochloride tablets in the US were approximately US$687 million for the twelve months ending March 2007 according to IMS Health data.ProductMon, 09 Jul 2007 13:50:00 GMT{E6CA27FA-EA1B-4B75-A42F-2A5E459B49EF}http://www.actavis.com/en/media+center/newsroom/articles/actavis+lanzoprazole+glimepiride.htm Actavis Group (ICEX: ACT), the international generic pharmaceuticals company, announces that it has launched two medicines, Lanzoprazole and Glimepiride, into the Danish and Finish markets. The products will be sold through the Groups subsidiary companies in Denmark in Finland. Lanzoprazole is prescribed for the treatment of gastric ulcers and is available in capsules containing 15 and 30 mg dosage strengths. Glimepiride is an oral blood-glucose lowering drug used for diabetes. It is produced in four different strengths – tablets containing 1mg, 2mg, 3mg and 4mg dosage strengths. The medicine is used for non-insulin-dependent diabetes, the most common form of the disease. Actavis has launched both products following patent expiries in Finland and Denmark. The Group expects to leverage its strong distribution and marketing abilities to generate significant market share in these countries.ProductTue, 17 Jan 2006 14:34:00 GMT{E6E7A63E-CF80-47FF-A762-7BAB0EDA63D4}http://www.actavis.com/en/media+center/newsroom/articles/new+country+manager+bulgaria.htm Mr Tahsin Yuksel joins Actavis in Bulgaria as the new Country Manager. The previous CEO Kristjan Sverrisson is moving to Denmark, where he will lead the Actavis group's global marketing and sales operation. Actavis in Bulgaria (formerly known as the Balkanpharma Group of companies) will be split into two separate functions with immediate effect - Operations and Commercial. Ivan Urumov will continue to head the Operations part of the business and Tahsin Yuksel has been appointed head of the Commercial entity in the country. Mr Yuksel's appointment is effective 1 September 2004 and he will report to Kristjan Sverrison.Yuksel joins Actavis from Organon in Poland, where he has worked as Country Manager for the last few years. Prior to that he was the Country Manager for Organon in Turkey, his home country.Yuksel graduated as a medical doctor in 1984 from the Aegean University School of Medicine in Turkey. He has worked in the industry for most of his working life in a variety of marketing, medical, sales and general management roles. OtherMon, 30 Aug 2004 10:40:00 GMT{E719B02E-3C00-433C-BAFD-532E61FD643A}http://www.actavis.com/en/media+center/newsroom/articles/actavis+first+to+market+new+cardiovascular+product.htm Actavis Group has introduced a new generic product to the German market, through its subsidiary Medis: the cardiovascular generic Benazepril Hydrochlorothiazide tablets. With a launch quantity of approximately 10 million tablets, the product is expected to be a good contributor to the Actavis portfolio, even though it is not regarded as likely to reach Actavis’ top 10 product list. Benazepril HCT is primarily used for the treatment of hypertension. The medicine first went on the market in Europe in 1992, and its patent in Germany expired on 29 June 2005. Germany is by far the most important market for this product. The development of Actavis’ generic formulation, which started five years ago, took place in Iceland, and the bioequivalence study was performed in Canada. Produced by Actavis’ production plant in Iceland, the product will be sold by Medis to third-party customers, who market the product under their own labels. According to Gudbjorg Edda Eggertsdottir, Chief Executive, Sales & Marketing, Third-party Global division, the launch preparation was an extensive process. “This time we are launching yet another cardiovascular product from the group of ACE inhibitors, a group of products Actavis has specialized in which includes products such as Ramipril, Lisinopril and Enalapril. Benazepril HCT is a smaller product than the aforementioned ones, but it is still an important product, in which competition is less fierce than in the larger products.”ProductFri, 01 Jul 2005 09:43:00 GMT{E7498EDC-C3A3-4083-BE16-4E4956FB5783}http://www.actavis.com/en/media+center/newsroom/articles/ftc+approval+for+abrika.htmActavis Group announces the successful completion of its acquisition of Abrika Pharmaceuticals Inc., a US based specialty generic pharmaceuticals company engaged in the formulation and commercialization of both controlled release ("CR") and other technically difficult pharmaceutical products. The Company will be consolidated into Group accounts from mid April 2007. The acquisition increases Actavis' critical mass and ability to leverage its position in the key US market. Actavis now becomes one of the leading companies in the US market in the development of CR products, with over 50 CR products in the pipeline and 100 employees dedicated in the development of CR products. In addition, over EUR50 million is expected to be invested in CR development in 2007. The enlarged Group has 12 pending ANDAs for CR products with the FDA. Abrika's development expertise and infrastructure will enable Actavis to utilize its existing CR technology and accelerate growth in the niche CR market. Actavis will also seek opportunities to register Abrika's products in Actavis European markets.The formal completion follows approval from The Federal Trade Commission to let the deal proceed on the basis that Actavis and Abrika divest all rights and assets needed to market generic Isradipine capsules. The divestment has no financial impact on Actavis financials in the US. Sigurdur Oli Olafsson, Deputy CEO:“Our acquisition of Abrika represents another significant step forwards for our business in the US, a key market where we already generate a third of our total revenues. Abrika enables Actavis to become a leading player in the controlled release market and additional investment will enable us build on our strong position to achieve further growth.” Related material: Actavis Launches Glipizide ER Tablets M&A overview OtherMon, 23 Apr 2007 13:26:00 GMT{E7987320-A89E-49A6-A028-AC2C9F872A06}http://www.actavis.com/en/media+center/newsroom/articles/actavis+russia+two+products.htm Actavis in Russia, a subsidiary of Actavis Group (ICEX: ACT), the international generic pharmaceuticals company, has recently launched the antihistamine Cetrizine 10 mg in Russia. The product has been available in Iceland for a few years where a market authorisation was granted in 1997. Actavis’ subsidiary Medis, which handles sales to third-party customers, launched the product in February 2002. The product is being registered in other Group’s markets, such as in Ukraine, Moldavia and Belarus and the Group expects to launch the product in these markets early next year. Furthermore, Actavis plans to launch the cardiovascular generic product Fosinopril in Russia at the end of October. Fosinopril is primarily used for the treatment of hypertension and congestive heart failure. Fosinopril, which is produced in Actavis’ manufacturing facility in Iceland, was first launched in July of this year in three countries, as its patent expired. The pharmaceutical comes in two dosages, 10 mg and 20 mg and its first delivery is roughly two million tablets. According to Jonas Tryggvason, Actavis’ regional manager for Russian and the Commonwealth of Independent States (CIS), these new products are an important addition to the Group’s portfolio. “We are gradually building a strong product portfolio of pharmaceuticals that had their patents expire recently. This will strengthen our position further as an international supplier of pharmaceuticals of the highest quality”, commented Jonas Tryggvason. Actavis in Russia employs around 200 people in Russia, Ukraine and the CIS. The operation is managed from Moscow. This subsidiary of Actavis Group, has five offices in addition it its office in Moscow located in Belarus, Ukraine, Kazakhstan, Mongolia and Georgia.ProductMon, 26 Sep 2005 16:11:00 GMT{E7D413B0-45ED-491A-94CB-FA824A07F60B}http://www.actavis.com/en/media+center/newsroom/articles/irinotecan+eu.htm Actavis today announced the launch of Irinotecan, a cancer drug, in the UK, France, Netherlands, Germany, Austria and Sweden on 13 and 14 July. The patents expired on 12 and 13 July, respectively. Actavis was first to market in all 6 countries. Irinotecan Hydrochloride concentrate for solution for infusion is the generic equivalent to Pfizer’s Camptosar® and is available in 40mg/2ml and 100mg/5ml vials. Irinotecan is used in the treatment of patients with metastatic carcinoma of the colon or rectum. Annual sales of Irinotecan Hydrochloride Injection in the EU were approximately EUR350 million for 2008, according to IMS Health data.Actavis and its third party sales division, Medis, have now launched Irinotecan in more than 20 countries. Irinotecan Actavis is produced by Actavis Romania. Actavis entered the market for hospital products with the acquisition of Sindan in Romania in 2006. The company’s focus in this field is on oncology products, with a growing range of anti-infectives, local anaesthetics and analgesics. The company’s Romanian facility, which has now accomplished over 85 product and market launches in 2009, is approved by FDA, EMEA and the Japanese regulatory authorities. ProductTue, 14 Jul 2009 14:29:00 GMT{E8EFDBB3-28F2-4FFD-99ED-FE55316F40BF}http://www.actavis.com/en/media+center/newsroom/articles/halldor+resigns.htmActavis announces that Halldor Kristmannsson, Vice President of Corporate Communications and IR, will be leaving the company, to become the Managing Director of Corporate Communications at the international investment company FL Group. Halldor will complete certain projects for Actavis in the next few months. Sigurdur Oli Olafsson, deputy CEO will take over management of the Corporate communication team and lead the media relations. Mark Keatley, Actavis CFO will handle investor communications. Robert Wessman, President and CEO, said: "Halldor has done a tremendous job during his time at Actavis and on behalf of the Executive Board, I would like to thank him for his dedication and contribution."OtherWed, 26 Sep 2007 16:58:16 GMT{E9FB6A93-47F4-465A-84D7-BB4C7B16E79F}http://www.actavis.com/en/media+center/newsroom/articles/actavis+sponsors+unicef+iceland.htm Pharmaco is proud to become a founding sponsor of the Icelandic United Nations Children’s Fund (UNICEF), providing financial support to enable the charity to establish itself in the country. Robert Wessmann, Chief Executive Officer of Pharmaco and Stefan Stefansson, Executive Director of UNICEF Iceland, announced an agreement today that will allow UNICEF to have a presence in Iceland for the first time. The development of UNICEF’s headquarters in Iceland is now in its final phase. Once complete, Pharmaco's' sponsorship will also enable UNICEF Iceland to run its fundraising operations and provide support to the thousands of children in need across the world. This agreement is part of a continuing relationship between Pharmaco and UNICEF. Actavis' Maltese subsidiary, Pharmamed has been one of UNICEF main pharmaceuticals suppliers for many years. Commenting , Robert Wessman said: “Pharmaco is proud to be associated with UNICEF. It is an organisation that has helped to better the lives of thousands of children throughout the world, and we hope that our support will help to further the good work that they do.” About UNICEF UNICEF was founded in 1946 and it is one of the best known United Nations organisations. UNICEF is mandated by the United Nations General Assembly to advocate for the protection of children's rights, to help meet their basic needs and to expand their opportunities to reach their full potential. UNICEF works in 158 countries around the world. Some 84 per cent of the organisation's 7,000 posts are located in the field. There are eight regional offices and 125 country offices worldwide, as well as a research centre in Florence, a supply operation in Copenhagen and offices in Tokyo and Brussels. UNICEF’s headquarters.CommitmentMon, 15 Mar 2004 11:45:00 GMT{EA24B842-54DA-49D1-9C63-D61F9C312963}http://www.actavis.com/en/media+center/newsroom/articles/research+and+development+labs+actavis+south+atlantic+florida.htm Actavis South Atlantic (ASA), a United States division of Actavis, has opened new analytical and R&D laboratories to expand the Company’s research and development efforts for controlled release (CR) and other technically difficult generic pharmaceutical products. The new analytical labs have been expanded by about 300 sq m and the new R&D labs have been expanded by about 140 sq m. As part of the Sunrise, FL expansion, appropriate office space was also added to support both of the lab expansions. The CEO of Actavis Group, Sigurdur Oli Olafsson, participated in the celebration and ribbon cutting ceremony. Recently launched Actavis South Atlantic products in the United States include Bupropion XL and SR, the generic equivalents of GSK’s Wellbutrin XL® and SR® as well as Nifedipine ER, the generic equivalent of Bayer’s Adalat® CC. Actavis U.S. CEO Doug Boothe said, “Actavis in the United States is focused on our vision and commitment to be on the cutting edge of new technology. The expansion of our South Atlantic R&D facility ensures that we remain well-positioned to develop and manufacture ER (extended release) and CR (continuous release) drugs.” Actavis is one of the leading companies in the U.S. market in the development of CR products, with more than EUR50 million (USD 74 million) expected to be invested in CR development in 2008 and 200 employees dedicated in the development of CR products. Actavis has 13 pending ANDAs for CR products with the FDA. About CR drugsCR versions of drugs expand the therapeutic application of products and are highly sought after by branded pharmaceutical companies because of their ability to extend product life cycles. Actavis South Atlantic applies its proprietary technologies to selected high value branded pharmaceuticals and duplicates the release characteristics of the originator drugs in order to bring to market generic versions that can be substituted for these branded products. OtherMon, 03 Nov 2008 07:00:00 GMT{EC183ADE-A516-462D-AB34-21994DD0D3DF}http://www.actavis.com/en/media+center/newsroom/articles/olafsson+deputy+ceo.htmSigurdur Oli Olafsson, Executive Vice President of the North America sales division, will become the Deputy CEO of the Group, as of 1 December 2006, in addition to his current responsibilities. Olafsson, a Pharmacist from the University of Iceland, joined Actavis in 2003 after working for Pfizer UK from 1998 and then Pfizer in the US from 2001 where he worked in Global Research and Development. Previously Olafsson served as Marketing Manager for an Actavis subsidiary, later becoming Drug Development Manager. OtherWed, 29 Nov 2006 08:35:00 GMT{EE8D3389-BFF9-401C-A598-6E4AC77A7F8A}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+support+for+Indonesian.htm Supporting local children left homeless and helping to tackle the threat of Dengue fever are among the community initiatives recently undertaken by Actavis in Indonesia. On April 13 the local Actavis management team presented a cheque for USD 7,500 to the Director of SOS Children’s Villages Indonesia, part of the international child welfare charity. Five facilities are already operated by the charity in Indonesia and more are currently being built on the island of Sumatra, the area badly hit by tsunami disaster in December 2004. A further USD 2,500 was also donated in the form of books and educational posters to five schools close to the Actavis offices in Jakarta. The schools serve around 1,600 pupils in total and the books will enhance the much-needed library resources. More recently, Actavis sponsored a ‘fogging’ treatment for the densely populated district known as Kelurahan Pekayon in Jakarta. Performed by professional pest controllers, the treatment is designed to eradicate mosquito nests and prevent the spread of Dengue fever. The area spanning 20 hectares is home to more than 950 families. The initiatives are an important part of Actavis Indonesia’s charitable programme according to Actavis Regional Director Thomas Runkel. “Many of us were moved by our visit to the SOS Children’s home in Cibubur. We are delighted to add our support to this valuable initiative and demonstrate our commitment to the health and well-being of the communities we live and work in.” For more information on SOS Children’s Villages please visit www.sos-childrensvillages.orgCommitmentMon, 08 May 2006 11:46:00 GMT{EF16C072-923E-4D79-957A-CFCC726443E2}http://www.actavis.com/en/media+center/newsroom/articles/analysts+fund+managers+visit+headquarters.htm Fresh from reporting its second quarter results on Monday 9 August, Actavis opened up its corporate headquarters and manufacturing facilities to analysts and fund mangers the very next day. The visit, which was very well attended, started with a presentation from Hordur Thorhallsson, Managing Director of Actavis Group hf in Iceland. He spoke about the Company's progress to date, its ongoing strategy and vision for the future. Senior representatives of the Company then conducted a tour around the main production plant, showing visitors how some of Actavis' leading products are made before being distributed all over the world. The tour finished with a reception outside where guests were able to mix and talk freely with managers and other Group employees, marking the end to a very successful day.OtherWed, 11 Aug 2004 10:50:00 GMT{EF1A53C3-48AA-4FD7-A725-57567D397D6A}http://www.actavis.com/en/media+center/newsroom/articles/clamelle+launch+uk.htm Actavis UK Ltd has launched Clamelle Azithromycin 500mg Tablets and Clamelle Chlamydia Test Kits are now available for pharmacy distribution, following the POM to P reclassification of azithromycin. Clamelle Chlamydia ServiceThe Clamelle Chlamydia Service is a private service that is paid for by the consumer. It consists of the Clamelle Chlamydia Test Kit and Clamelle Azithromycin 500mg Tablets. The Clamelle test kit is purchased in a pharmacy, a urine sample posted off by the consumer to the laboratory and the result can be sent to the consumer by post or obtained from the pharmacy. If a confirmed positive test is received and if the treatment is deemed appropriate, following a sexual health consultation with the pharmacist, Clamelle Azithromycin 500mg Tablets can be supplied. The Clamelle Chlamydia service is run jointly by Actavis, the NPA and Gordon Laboratory Group (GLG), a private laboratory which carries out the gold standard Nucleic Acid Amplification Technique (NAAT) testing, manages the test results and the Clamelle customer database. Clamelle Chlamydia Test Kit and Tablets can only be sold by pharmacies that have registered with the NPA for the Clamelle Chlamydia service, obtained the NPA chlamydia resource pack and registered with GLG. Since the NPA launched the service three months ago, over 7,500 pharmacies have registered with the NPA and received the chlamydia resource pack. Clamelle TrainingThe Actavis Clamelle training packs have now been distributed to all UK pharmacies. This comprehensive training has been developed with genitourinary medicine expert input, is accredited by the College of Pharmacy Practice and British Association of Sexual Health and HIV (BASHH) and has been awarded the NPA Training seal. Clamelle Packaging Extensive consumer research was conducted into the packaging for both the Clamelle Azithromycin 500mg Tablets and Test Kit. The resulting pack’s clean white background gives a medical, professional feel enhanced with the contemporary silver Clamelle logo. In response to consumer feedback the packs have been designed to appeal to both females and males, with striking pink and blue graphics. SupportThe Clamelle Chlamydia Service will be promoted to the consumer with a £2 million pound spend. Single page advertisements will be appearing in early 2009 in women’s magazines and will be complemented with an extensive on-line awareness campaign. An educational consumer PR campaign will be initiated targeting national and regional media, magazines, radio and lifestyle websites. WebsiteA website www.clamelle.co.uk has been created to offer consumers information on chlamydia, about getting tested and treated, and a comprehensive FAQ section. The website also contains a Pharmacist section, which contains copies of all the Clamelle training materials for pharmacies to download. Note to editors: POM to P reclassificationThe MHRA granted a pharmacy licence for azithromycin in August 2008. The reclassification of azithromycin differs from previous POM to P switches: Azithromycin is the first oral antibiotic switch The medicine treats a sexually transmitted infection – chlamydia is a significant communicable disease and is associated with significant complication, including fertility The switch is linked directly to a pharmacy professional service. This involves: An accredited laboratory test to confirm diagnosis Effective treatment One to one sexual health consultation Clamelle Azithromycin 500mg Tablets and Clamelle Chlamydia KitClamelle Azithromycin 500mg Tablets is a new Pharmacy-only antibiotic indicated for confirmed asymptomatic genital Chlamydia trachomatis infection and epidemiological treatment of their sexual partners. It may be given to men and women aged 16 years and over who have tested positive for chlamydia and can also be given to their sexual partners, without them needing to take a test. The Clamelle Chlamydia Test diagnoses chlamydia using a laboratory Nucleic Acid Amplification Technique (NAAT) test, which detects the nucleic acid of the C. trachomatis bacterium. The NAAT test is the required gold standard test for detecting chlamydia infection in men and women.ProductFri, 14 Nov 2008 09:42:00 GMT{EF360ECA-DE82-4C15-B4CA-126F7697157B}http://www.actavis.com/en/media+center/newsroom/articles/bicalutamide+first+to+market.htm Actavis today announced the launch of Bicalutamide tablets in the United Kingdom, Germany and France. Bicalutamide Actavis is the first generic version of the oncology drug to be made available in the three markets. Bicalutamide, the generic version of AstraZeneca’s Casodex®, is used as a treatment for prostate cancer and will be available in tablet form in 50mg doses in all three markets, as well as in 150mg doses in the UK. Bicalutamide Actavis was launched on day one, when the brand product‘s patent expired; on 8 July in the UK and 9 July in Germany and France. Distribution of the product will commence immediately. Commenting on the launch of Bicalutamide, Svend Andersen, Executive Vice President of Western Europe Sales, said: “We are pleased to be the first generic pharmaceutical company to bring this product to the market — creating value for patients at a lower price. Bicalutamide is an important product in Actavis’ portfolio. It is used in treating prostate cancer and also in combination with other treatments of malign diseases, prescribed by both hospitals and general practitioners.” Actavis was able to launch generic Bicalutamide in some of its countries of operation as early as 2007, including the Czech Republic, Slovakia, Poland and Iceland. ProductThu, 10 Jul 2008 11:17:00 GMT{F08F469B-A9DD-48B2-81AE-01580B5FBCAE}http://www.actavis.com/en/media+center/newsroom/articles/actavis+donates+medical+supplies+afghanistan.htm Actavis delivered over a ton of medical supplies to Afghanistan today. The delivery contains a wide spectrum of antibiotics for children and adults and will be a significant aid to those people suffering in Afghanistan. The pharmaceuticals can be used in both home and hospital conditions for numerous infections. Kristjan Sverrisson, Chief Executive of Actavis’ Own Brand Division , together with the Deputy Minister of Foreign Affairs in Bulgaria, Gergana Grancharova, handed the medical supplies to Jonas Thorir Thorisson, Chief Executive Officer of Icelandic Church Aid, at the airport in Sofia yesterday. All the products were produced in Actavis plants in Bulgaria.The Icelandic Ministry of Foreign Affairs, Halldor Asgrimsson, initiated the donation in Afghanistan this morning. Iceland is involved in a NATO peace force in Afghanistan for the first time, and is currently responsible for the air traffic at the international airport of Kabul. Icelandic Church Aid and The Icelandic Red Cross will handle the medical supplies from Actavis and other donations from Icelandic companies and hospitals to distribute to people in need throughout Afghanistan. Kristjan Sverrisson commented: “The fact that the Icelandic Government has chosen us to help in this initiative is strong recognition for Actavis and the quality of our products. Our plants in Dupnitza, Troyan and Razgrad in Bulgaria have all been instrumental in this effort and demonstrate Actavis’ commitment to helping people in countries where good medication is desperately needed.“CommitmentWed, 02 Jun 2004 10:57:00 GMT{F0A02C90-32EE-4582-8479-6FFB22B29F31}http://www.actavis.com/en/media+center/newsroom/articles/Actavis_appoints_Albrecht_CEO.htm Actavis Group, the international generic pharmaceuticals company, today announced the appointment of former Ratiopharm leader Dr. Claudio Albrecht as its new CEO. Dr. Claudio Albrecht has been appointed as CEO of Actavis, with immediate effect. He has over 20 years of experience in the generics industry, having started his career with Sandoz in 1987 where he went on to serve as a Managing Director in the Netherlands, Germany and the US. In 2000 he joined Ratiopharm as global CEO during which time the company doubled sales and became the world’s third largest generic company (by revenues). In 2008 Dr. Albrecht established Cometh, a consultancy that has advised pharmaceutical companies on their growth strategies, including Actavis. Dr. Albrecht is 51 years old, an Austrian citizen and holds a PhD in law. Having led the successful restoration of Actavis’ US business and a turnaround in critical markets, Sigurdur Oli Olafsson is standing down as CEO. His departure follows seven years in senior management roles during which time Actavis has grown exponentially to become one of the world’s leading generics companies. Following a number of acquisitions over the last decade, Actavis’ senior management is currently spread across five different countries. A search is underway to find a central location where the senior team can be based in one place. Iceland will remain a key site for manufacturing, research & development and Medis, the third-party sales division. Thor Bjorgolfsson, founder and chairman Actavis Group, said:“I am delighted that we have attracted someone of Dr. Claudio Albrecht’s calibre to Actavis. I am certain that the Group will benefit considerably from his extensive leadership qualities. His experience and determination will help drive future growth in our great company. I would like to thank Sigurdur Oli Olafsson for his pivotal role in keeping Actavis a strong and robust company through difficult years.” Sigurdur Oli Olafsson said:“Despite the economic turbulence of the last few years, Actavis has continued to grow and significantly strengthen its performance in key markets, including the US. I want to thank all the Actavis employees I’ve worked with over the last seven years and I wish Claudio the best of success in his role.” Dr. Claudio Albrecht said: “I am very pleased to be joining a Group that is so well positioned for the future. Actavis has one of the best R&D pipelines in the industry, but we still need to grow our market presence in many of the big markets. Strong geographic expansion and better market penetration, especially in southern Europe and the emerging markets, will be our goal for the future. I am looking forward to the challenges ahead and working with my new colleagues and building our future together.” OtherWed, 23 Jun 2010 09:47:00 GMT{F2C749C8-314F-4493-8CDF-D05378733CF5}http://www.actavis.com/en/media+center/newsroom/articles/actavis+launches+decubal+for+men.htm Actavis has launched Decubal for men – a range of skincare products specially developed for men and their skin structure. The product line extension was launched in Denmark this month, and will be marketed in other countries, where other Decubal products are already present, during the coming months. Decubal, Actavis’ complete range dedicated exclusively to dry skin, has softened and repaired dry skin in the Nordic region for 30 years, and has recently been introduced by Actavis in multiple European countries. All products are created according to the highest pharmaceutical standards in close cooperation with independent dermatologists. Decubal does not contain perfumes or preservatives. Decubal products are only sold in pharmacies. Why a skincare range for men?In general, men have skin that’s thicker and rougher than women’s. Furthermore, men often experience discomfort while shaving, inconveniences such as redness, dryness, irritation and barber’s itch. The new Decubal for men range has been developed to help make the daily shaving more comfortable. Decubal for men – 3 steps in 10 minutes:1. Decubal for men face wash gel2. Decubal for men shaving gel3. Decubal for men 2 in 1 face cream (both aftershave and moisturizer) More information about Decubal (in Danish) ProductTue, 25 Nov 2008 15:45:00 GMT{F37A4787-2D8C-4779-8667-A38D8C3B89FE}http://www.actavis.com/en/media+center/newsroom/articles/meloxicam+us.htm Actavis has received approval from the U.S. Food & Drug Administration to market Meloxicam Tablets. Distribution of the product has already started. Meloxicam Tablets, the generic equivalent of Boehringer Ingelheim’s Mobic® Tablets, are available in both 7.5 mg and 15 mg strengths. Meloxicam is used to treat signs and symptoms of osteoarthritis and rheumatoid arthritis. Annual brand sales of Meloxicam Tablets in the U.S. were approximately US$1.1 billion for the full year 2005. In the US alone, Actavis expects to launch 15 new products in 2006, in addition to filing 30 ANDAs. The company’s US operations are located in New Jersey, Maryland and North Carolina.ProductThu, 03 Aug 2006 20:06:00 GMT{F53B1740-CF3C-4DDE-AB0D-E3A94BFC3A48}http://www.actavis.com/en/media+center/newsroom/articles/aok+contract.htm 16 Actavis products recommended Actavis has been selected by Allgemeine Ortskrankenkassen (“AOK”), Germany’s largest General local health insurance provider, in a preferred partnership agreement, a first of its kind of this size. Svend Anderson, Actavis Executive VP in West Europe, Middle East and Africa, said:“AOK choosing Actavis shows that we are regarded as trustworthy and capable pharmaceuticals manufacturer in Germany. Through our dynamic product pipeline, more than 25 million health insurance policy holders in Germany will benefit from our cooperation with AOK. This means that German doctors and pharmacists will be encouraged by AOK to recommend 16 products from Actavis, enabling us to increase our sales in the market” AOK has selected one to three companies for each molecule, whose products will be listed and recommended for AOK patients. Chosen for 16 molecules (out of 43), Actavis is the leading partner of AOK. The new agreement is valid through 2007. Germany is the Group’s third largest market, with approximately 8% of total sales. Around 10 new product launches are expected from Actavis in Germany in 2007. The company’s German operations are located in Langenfeld. ProductThu, 01 Mar 2007 14:38:00 GMT{F5553149-9238-4C08-B64E-E70936069783}http://www.actavis.com/en/media+center/newsroom/articles/Actavis+launches+new+website.htm The new Actavis Group website goes online today as part of the launch of the Company’s new name and corporate identity. Previously known as Pharmaco, the Actavis Group continues to consolidate the strengths and services of its companies, creating new value for healthcare professionals worldwide. Presenting the new Actavis name to staff and customers, CEO Robert Wessman said, “Changing our name does not alter the relationship with our customers - we continue to offer the personal care and attention to detail that people have come to expect from us. What is changing, however, is the range of services and products we now offer. “Through the consolidation of our development expertise, production capabilities and customer service network, we are well placed to offer better and faster access to the latest generic products, as well as a wide portfolio of affordable pharmaceuticals.” The new website offers access to product news and regional sites, in addition to up-to-date stock information and performance reports for investors.OtherTue, 18 May 2004 11:24:00 GMT{F5895E61-A843-4E7A-B7C0-D594B0795662}http://www.actavis.com/en/media+center/newsroom/articles/abrika+acquisition.htm Number of shares Offer price 100% EUR85 million net Additional EUR96 million subject to three year earn outNet cash EUR4 million Conditions Anti-trust clearance Completion Expected January 2007 Financing Loan facility of EUR85 million Information on the Abrika acquisition>> Download presentation (pdf)>> Press release>> Listen to conference call (mp3) Earn out Earn out payments of up to EUR96 million Net consideration (without earn out) represents a multiple of 9.5 x 2007 expected EBITDA Total consideration will represent 8.3 x 2007 expected EBITDA if all targets are met for both 2007 and 2008 Abrika overview Established May 2002 by Alan Cohen, formerly founder of Andrx Wholly-owned facility in Florida; 40 employees Strong track record in developing and marketing CR products Filed 9 ANDAs 2 products expected to be granted first-to-file exclusivity Ability to file 5-7 ANDAs a year Focused on CR generics now, with a longer term platform for proprietary products High operating leverage with attractive and lasting incremental margins Transaction rationale Puts Actavis in a leading position in the US CR market: 50 products in the pipeline 100 employees dedicated in CR development EUR50 million expected to be invested in CR development in 07 13 pending ANDA´s for CR products for enlarged Group Builds Actavis’ position in the US, strong platform for growth Actavis gains access to high margin product portfolio Significant demand for CR & IR drug versions from branded drug companies seeking to extend product life cycles Combination will have infrastructure to create a centre of excellence for CR products Creates parallel development opportunities for US and Europe OtherFri, 10 Nov 2006 10:17:00 GMT{F684905E-4126-4DF4-BE78-6190DBCA1411}http://www.actavis.com/en/media+center/newsroom/articles/ActavisdivestsinPoland.htm Actavis has sold a product portfolio of 7 established brands to Glenmark Pharmaceuticals Ltd. for an undisclosed sum. The agreement with Glenmark is effective from 1 July 2008. The divestment of the Actavis and Biovena products is part of Actavis‘ ongoing integration process, following the group‘s acquisition of more than 20 companies in recent years. The largest products in the portfolio sold to Glenmark are Cital, the leading brand of the anti-depressant citalopram in Poland, and Lamotrix (lamotrigine), a leading treatment for the management of epilepsy. ProductWed, 02 Jul 2008 14:23:13 GMT{F6B734CC-93E0-45DB-8F30-F027B9C66E7D}http://www.actavis.com/en/media+center/newsroom/articles/propranolol+us.htm Actavis today announced that it has received approval from the US Food & Drug Administration to market Propranolol Hydrochloride extended-release capsules. Distribution of the product will commence immediately. Propranolol Hydrochloride extended-release (ER) capsules are the generic equivalent of Wyeth Pharmaceuticals’ Inderal® LA capsules and available in 60mg, 80mg, 120mg and 160 mg dosage strengths. Propranolol ER capsules are indicated for the treatment of high blood pressure, long-term management of angina pectoris and prophylaxis of common migraine headaches.Doug Boothe, Executive VP of US Commercial & Administration said: “The launch of Propranolol is an important milestone for Actavis. With one of the strongest product pipelines in the industry, we continue to grow our business by increasing our product offering with affordable high quality generic drugs. This launch is also in line with our strategy to further grow our business in the controlled release product market and exemplifies our capability in controlled release oral solid products.” Annual brand sales of Propranolol ER capsules in the US were approximately US$192 million for the twelve months ending June 2007 according to IMS health data.More information about Actavis in the United States can be found at www.actavis.usProductMon, 13 Aug 2007 14:51:00 GMT{FAA5FDA1-E408-41E5-80B6-785A5B056B38}http://www.actavis.com/en/media+center/newsroom/articles/fentanyl+recall+expansion+us.htm Actavis Inc., the United States manufacturing and marketing division of Actavis Group, today announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States. This recall is an expansion of the Company’s initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects. All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States. Fentanyl patches sold by Actavis in Europe are not affected by this recall. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief. Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names: Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18. The lots covered by this recall have expiration dates between May 2009 and December 2009. Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these expiration dates. Anyone with Actavis Fentanyl transdermal system patches with the lot numbers listed on the attached schedule (below), should call 1 877 422 7452. Patients using fentanyl patches who have medical questions should contact their health-care providers. This recall is being conducted with the knowledge of the Food and Drug Administration. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids. Lots Being Recalled Lot Exp. Date NDC Strength 27540 Aug 09 67767-120-18 25mcg/hr 27584 Aug 09 67767-120-18 25mcg/hr 27666 Sep 09 67767-120-18 25mcg/hr 27759 Oct 09 67767-120-18 25mcg/hr 27611 Oct 09 67767-120-18 25mcg/hr 27762 Oct 09 67767-120-18 25mcg/hr 27761 Oct 09 67767-120-18 25mcg/hr 27832 Nov 09 67767-120-18 25mcg/hr 27747 Nov 09 67767-120-18 25mcg/hr 27758 Nov 09 67767-120-18 25mcg/hr 27903 Dec 09 67767-120-18 25mcg/hr 27573 Sep 09 67767-121-18 50mcg/hr 27576 Sep 09 67767-121-18 50mcg/hr 27667 Oct 09 67767-121-18 50mcg/hr 27668 Oct 09 67767-121-18 50mcg/hr 27581 Oct 09 67767-121-18 50mcg/hr 27763 Oct 09 67767-121-18 50mcg/hr 27751 Nov 09 67767-121-18 50mcg/hr 27586 Aug 09 67767-122-18 75mcg/hr 27572 Sep 09 67767-122-18 75mcg/hr 27582 Oct 09 67767-122-18 75mcg/hr 27583 Oct 09 67767-122-18 75mcg/hr 27745 Oct 09 67767-122-18 75mcg/hr 27746 Oct 09 67767-122-18 75mcg/hr 27539 Aug 09 67767-123-18 100mcg/hr 27574 Sep 09 67767-123-18 100mcg/hr 27575 Sep 09 67767-123-18 100mcg/hr 27577 Sep 09 67767-123-18 100mcg/hr 27578 Oct 09 67767-123-18 100mcg/hr 27579 Oct 09 67767-123-18 100mcg/hr 27580 Oct 09 67767-123-18 100mcg/hr 27610 Oct 09 67767-123-18 100mcg/hr 27612 Oct 09 67767-123-18 100mcg/hr 27743 Oct 09 67767-123-18 100mcg/hr ProductMon, 03 Mar 2008 16:38:00 GMT{FB0D6C9F-9CD8-469C-AE1A-98476041E84F}http://www.actavis.com/en/media+center/newsroom/articles/actavis+at+world+generic+medicines+congress+europe.htm Actavis' EVP CEE and MD for Spain were both speakers at the World Generic Medicines Congress Europe 2009, held in London 24-27 Feb. Milan Todorovic, Actavis' Executive Vice President Central Eastern Europe, was keynote speaker on globalisation and integration. His speech addressed the impact of culture in large scale acquisitions and mergers, with examples from the Company's integration process both at the local and global level. Actavis has made more than 20 acquisitions in recent years, while maintaining strong organic growth. Dr Angel Calvo, Managing Director, Actavis Spain discussed market conditions for Generics in Spain in 2009 and assumptions for 2013. The World Generic Medicines Congress Europe 2009 addressed the health economics, pricing and competition pressures facing the generics sector and building scale and value through globalisation.OtherSat, 28 Feb 2009 23:59:00 GMT{FC101A86-FB5B-459F-93C4-A076B60A7DBA}http://www.actavis.com/en/media+center/newsroom/articles/actavis_divests_higia.htm Actavis has announced the divestment of its Bulgarian distribution company, Higia EAD, to a local private investor, Rossitsa Veselinova Velikova. This decision is a result of the detailed business review conducted on global and local level in 2009. Actavis continues to focus its efforts on its core business, the development, production and sale of high-quality generic pharmaceuticals. Iliya Pashov, Executive director of Actavis Bulgaria: “Actavis is the biggest pharmaceutical company in Bulgaria in terms of sales and production. Our future plans are to focus on Actavis’ core business and that does not include distribution. Among a number of offers received we chose the best one, not only for Actavis but for the employees of Higia and its future growth on the local distribution market. Actavis will continue working with Higia and the other pharmaceutical distributors in Bulgaria.” OtherTue, 09 Mar 2010 10:44:00 GMT{FD23F0DC-E2C0-4B26-BCC4-7D53C3AD8675}http://www.actavis.com/en/media+center/newsroom/articles/changes+actavis+marketing+sales.htm Actavis has recruited Per Edelmann to be the Head of International Commercial Affairs for Sales and Marketing, Own Brand, a newly-created position. Per Edelmann will focus on Actavis’s market and portfolio development at a strategic level, as well as the Group’s in-licensing activities and other corporate projects. Edelmann joins Actavis from Alpharma where he was leader of Business Development and, prior to that, Director of Sales & Marketing Europe. Per Edelmann graduated with MBA from the Copenhagen Business School and has also concluded Management programs from London Business School and Harvard Business School. He will be based in the Nordic office in Hörsholm in Denmark and he will start working for Actavis first of July. Changes in Nordic Operations Actavis announces that Bjorn Adalsteinsson has undertaken a new position as International Market Coordinator. Björn previously served as the Area Manager of Northern Europe for Actavis. In his new role, Bjorn will coordinate development projects in the Own Brand business across all regions and oversee the planning, coordination and management of selected projects and activities. Bjorn joined Delta in 2000 as Marketing Manager for the Icelandic domestic market and became Area manager for the North Europe area for Actavis in 2003. The Area Manager position will be temporarily filled by Hans Henrik Raith, Chairman of the Danish subsidiary, Actavis AS, while recruitment for a new area manager takes place.OtherTue, 22 Jun 2004 10:53:00 GMT{FDC99587-AAED-4736-ABE2-E8F0242C2D9C}http://www.actavis.com/en/media+center/newsroom/articles/actavis+amide+fda+approval.htm Actavis Group, the international generic pharmaceuticals company, today announces that it’s subsidiary Amide Pharmaceuticals Inc. in New Jersey USA has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for the products Hydromorphone Hydrochloride Tablets USP and Dantrolene Sodium Capsules. Hydromorphone Hydrochloride Tablets is a narcotic analgesic drug, used in the treatment of pain. It is the generic equivalent of Dilaudid tablets of Abbott Laboratories. It is marketed in 8 mg strength. Dantrolene Sodium Capsules is the generic equivalent of Dantrium a product of Procter & Gamble and is used in the management in controlling the manifestations of clinical spasticity. The product is marketed in three strengths, 25 mg, 50 mg and 100 mg. According to Divya Patel, Chief Executive of the North America’s Division of Actavis Group, the two products are an important contribution to the Company’s growing portfolio. The products are not expected to have material effect on Actavis’ financials for 2005.ProductTue, 29 Nov 2005 15:16:00 GMT{FF91E685-1F85-4C65-A6F4-6245707BF79D}