http://www.actavis.comRSS feed of www.actavis.com60http://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+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 PARAXEL, a well regarded outside firm, to assess Actavis Totowa facilities. PARAXEL 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/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/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/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/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/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/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/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:o An accredited laboratory test to confirm diagnosiso Effective treatmento One to one sexual health consultation Clamelle Azithromycin 500mg Tablets and Clamelle Chlamydia Kit Clamelle 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/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+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/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, http://www.aska-pharma.co.jp/english. 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/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 EUR 50 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/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/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/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/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/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/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/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/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/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/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/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/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/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/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/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 15:42:35 GMT{5C83B0FC-D7AE-40D5-9CEE-61AEC01258C2}http://www.actavis.com/en/media+center/newsroom/articles/robert+wessman+ubs+conference+2008.htm Actavis today announced that Robert Wessman, Actavis’ President & CEO, will discuss “The strategy and competitiveness of Actavis in a fiercely competitive environment” at the annual UBS Global Specialty and Generic Pharmaceuticals Conference on Wednesday, 28 May 2008. This year's event will be held in London. The conference, held in England for the first time in its twelve year history, features presentations from over 80 top executives of leading specialty and generic pharmaceutical companies from North America, Europe, Africa, Latin America and Asia-Pacific, as well as panel discussions focused on key sector trends and issues.OtherMon, 26 May 2008 18:06:00 GMT{60F50C58-EDCA-4DE3-BA1E-43912EC43F12}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/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 website: Frequently asked questions Press release from 25 April ProductFri, 09 May 2008 22:32:16 GMT{5D8348A3-0A97-4BBD-9DBA-403963052035}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/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/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/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.us. ProductFri, 28 Mar 2008 14:40:09 GMT{8888A857-CFEF-4C4D-A23E-BF3ED1E4FC71}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.actavis.com.ro Bulgaria www.actavis.bgDenmark www.actavis.dkFinland www.actavis.fiIceland www.actavis.isNorway www.actavis.noPortugal www.actavis.pt Sweden www.actavis.se ProductThu, 27 Mar 2008 17:01:00 GMT{659BB9CB-BF2A-4AFC-8C06-8CC1D98B813F}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/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/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/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/robert+wessman+economist+pharma+2020.htm Actavis’ President and CEO Robert Wessman participated in the Economist’s “Pharma 2020 - Shaping the future of the pharmaceuticals industry” conference in London February 27th 2008. Robert participated in an executive discussion on the topic of Pharma 2020—is the industry ready? The executives discussed the opportunities the rapidly diversifying business environment is creating for the different players, the possible changes in the business model for big pharma, new models for collaboration and biotech. Other participants in the discussion were John Patterson, Executive Director, Development, and Board Member, AstraZeneca and Nigel Brooksby, UK Managing Director, Sanofi-Aventis. Conference websiteOtherWed, 27 Feb 2008 11:16:00 GMT{A43E90B6-D6A5-4D83-984F-A9051E3EE884}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/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/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 27261 25 mcg/hr 5/09 27391 25 mcg/hr 6/09 27488 25 mcg/hr 6/09 27317 50 mcg/hr 5/09 27475 50 mcg/hr 6/09 27514 50 mcg/hr 7/09 27536 50 mcg/hr 7/09 27538 50 mcg/hr 8/09 27318 75 mcg/hr 5/09 27409 75 mcg/hr 6/09 27476 75 mcg/hr 6/09 27537 75 mcg/hr 8/09 27319 100 mcg/hr 5/09 27545 100 mcg/hr 7/09Actavis 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 21:46:06 GMT{78B41E74-0222-4679-8FA2-38130890551C}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/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/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/rw+ft+conference+dec+2007.htm Actavis’ President and CEO Robert Wessman was the opening speaker at Financial Times’ Global Pharmaceutical and biotechnology conference 2007 in London on 3 December. His presentation, titled “New avenues for innovation in the global pharma and biotechnology,” included discussions on the future development of the pharmaceutical industry and the drivers of change for the health care industry; medical progress; demographic trends; social trends; technical progress; and market dynamics. Innovation was the main topic of the two-day conference, held at the Cumberland Hotel. Conference websiteOtherMon, 03 Dec 2007 10:04:57 GMT{BB1E6B64-DBD9-44EF-A8E9-EDB0A20136B8}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/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/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 EUR 657 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/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/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/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/doug+drysdale+ubs+conference.htm Actavis announced today that Doug Drysdale, Vice President of Mergers and Acquisitions for Actavis, will be presenting at the UBS Global Life Sciences Conference in at the Grand Hyatt Hotel in New York City on September 24-27, 2007. Doug Drysdale, VP of Mergers and Acquisitions for Actavis said: “I am grateful for the opportunity to represent Actavis at this renowned, annual conference. It is an honor to be invited to speak at this event and provide the company’s perspective on consolidation within the generic pharmaceuticals industry today.” The UBS Global Life Sciences Conference is one of the largest health care investor conferences in the world. Others attending and speaking include senior executives from the leading pharmaceutical, biotechnology and medical technology companies. OtherWed, 19 Sep 2007 20:35:00 GMT{46895CDC-F04C-4A8A-952F-672752F0AE0C}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/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/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.us.ProductMon, 17 Sep 2007 08:00:00 GMT{2E008F2C-754E-469F-8D22-94CD9257F8F6}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/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/gpha+conference+2007.htm Robert Wessman, President and CEO of Actavis, presentied at GPhA’s 2007 Annual Policy Conference on 6-7 September 2007 in Washington, D.C. at the Mandarin Oriental Hotel. During his presentation, Robert focused on the industry dynamics going forward. Robert Wessman, President and CEO of Actavis about the event:“This event serves as one of the industry’s most influential forums. I am honoured to be given the opportunity to participate in this event and join other industry leaders in the discussion of the most pressing issues occurring in the generic pharmaceuticals industry today.” The Generic Pharmaceutical Association’s 2007 Annual Policy Conference is one of the leading conferences on the generic industry’s latest developments. Topics at the event included top CEOs' personal views on the industry’s trends and challenges, regulatory highlights, business outlook, legislative occurrences, and current legal issues. Presentation slidesOtherThu, 30 Aug 2007 13:13:00 GMT{B37FF175-E3E8-4B5E-9A8F-E707647CBB18}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/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/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/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.* 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.” * According to IMS Q2 2007, ranked by groups of companiesOtherWed, 22 Aug 2007 06:00:00 GMT{D98BDA20-7B97-4F19-85AC-557A5AADD1BC}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.us. ProductMon, 13 Aug 2007 14:51:00 GMT{FAA5FDA1-E408-41E5-80B6-785A5B056B38}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/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/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/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/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/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)