Medivir and Reliant form strategic alliance for MIV-606

Report this content

MEDIVIR AND RELIANT PHARMACEUTICALS FORM STRATEGIC ALLIANCE FOR ANTIVIRAL MIV-606 - Reliant Acquires North American Rights - Huddinge, Sweden, and Liberty Corner, NJ, - Medivir today announced it has out-licensed the North American rights to the antiviral MIV-606 to Reliant Pharmaceuticals, LLC. Reliant will be responsible for conducting clinical studies, obtaining regulatory approval, and marketing the product in the U.S. and Canada. The companies will jointly seek marketing partners for MIV-606 in Europe, Japan and Asia. Based upon the Phase II results in patients with herpes zoster (shingles) obtained by Medivir, Reliant will continue clinical development of MIV-606 and conduct Phase III studies. "Everyone at Medivir is dedicated to seeing MIV-606 reach the U.S. and international markets as a novel herpes virus treatment," commented Jonas Frick, President and Chief Executive Officer of Medivir. "We are extremely confident Reliant will be able to achieve this goal by applying its expertise in clinical study design, navigating the regulatory process, and if successful, launching MIV-606 in the North American markets via Reliant's sales force of more than 750 sales reps. "I also believe that Reliant and its Phase III development efforts, which also includes synthesis and formulation activities, will be an asset to us when we together begin negotiations with other companies to market MIV-606 outside the U.S." "Today marks the first step in implementing the third phase of Reliant's business strategy, which is to commercialize New Chemical Entities (NCEs), the lifeblood of branded pharmaceutical companies. I am very proud of the Reliant team," stated Joseph J. Krivulka, President of Reliant Pharmaceuticals. "In less than two years, we have successfully implemented the first phase of our business plan, with the acquisition of marketed products, like Axid® and DynaCirc®, and the agreement to promote the Lescol® brand, as well as the second phase, with the filing of two New Drug Applications with the FDA for internally developed formulations of proven molecules". "The acquisition of rights to Medivir's NCE MIV-606 marks the third phase of Reliant's strategy. MIV-606 will be the first of many products we plan to add to our pipeline over the next several years. We will continue to seek out products in Phase II and Phase III development that match our focus in the primary care marketplace and our expertise in creating and implementing targeted marketing strategies." Terms of the Agreement Under the Agreement, Reliant is responsible for conducting and financing Phase III clinical studies, seeking regulatory approval in the U.S. and other countries, and, upon approval, marketing MIV-606 in the U.S. and Canada. Medivir will receive double-digit royalties from sales in North America and has retained the rights to market MIV-606 in the Nordic countries. The companies will work together to secure marketing partners in all countries in which the two companies will not actively market MIV-606. Future revenues from any non-North American partnering activities will be shared, except in Europe where the revenue split is biased in Medivir's favour to reflect Medivir's presence in its home bases of the UK and Sweden. The value of the strategic alliance amounts up to US$17 million. Reliant will pay US$5 million as a down payment to Medivir. Additional funds will be payable upon the successful completion of certain milestones. About MIV-606 MIV-606, along with its active metabolite, H2G, belongs to a proven class of herpes antiviral agents, which stop viral DNA synthesis. MIV- 606 is being examined as a treatment for a number of DNA viral diseases. Early studies suggest MIV-606 has broad-spectrum activity against herpes zoster (shingles), herpes simplex (cold sores and genital herpes), EBV (mononucleosis), and similarly functioning viruses. MIV-606 has been studied in several hundreds of patients in phase I and II clinical studies, and the results to date have been very promising. Prevalence of Herpes Viruses WebMD estimates that 850,000 people in the U.S. experience shingles each year. Approximately 20 percent of people who have ever contracted chickenpox will also experience shingles, since the same varicella- zoster virus causes both. While shingles can affect children and younger adults, the vast majority of people affected are over the age of 60. According to the National Herpes Resource Center, 50 to 80 percent of the U.S. adult population suffers from herpes simplex virus 1, or oral herpes virus, which causes cold sores. An estimated 25 percent of the adult population carries the herpes simplex virus 2, which causes genital herpes. Treatment options for these diseases are limited. Telephone conference Medivir will host a teleconference at 15.00 SE time. Jonas Frick CEO and Rein Piir, CFO/IR will present and comment on the partnership with Reliant. To participate please dial +44 (0) 20 8781 0579, code Medivir. The teleconference will be recorded and saved for 7 days. To reach the recorded version please dial +44 (0) 20 8288 4459 and use code 671362 from 17.00 SE time. For further information, please contact: Jonas Frick, President and CEO of Medivir +46 8 608 3100 Rein Piir, CFO and VP/IR of Medivir +46 8 608 3123 or +46 708 537292 Juliane Snowden, Director, Corporate Communications of Reliant +1 908 542 4452 or +1 917 208 5072 About the Medivir group Medivir is an innovative and specialized research company active in the pharmaceuticals sphere, located in Cambridge, UK, and Huddinge, Sweden. Medivir's research focuses on the development of new pharmaceutical compounds as inhibitors of target enzymes with protease or polymerase activity. The group comprises Medivir AB, the subsidiaries Medivir UK Ltd. and CCS AB, plus second-tier subsidiaries CCS (UK) Ltd. and Nordic Care Sweden AB (formerly Jill AB). Medivir has been listed on the Stockholm Stock Exchange since 1996. The research portfolio includes projects against HIV, jaundice, shingles, cold sores, osteoporosis, rheumatoid arthritis, asthma, multiple sclerosis and organ/graft rejection. Medivir has five projects in clinical development. Of these, two are moving towards Phase III trials after having completed Phase II trials. Two are in Phase I and one is in Phase II. Medivir's pre-clinical research encompasses a number of projects, of which one is on its way towards and two are in the lead optimization phase and one is in the late pre-clinical research stage. For more information about Medivir, visit the company's web site at www.medivir.com About Reliant Reliant Pharmaceuticals, LLC, located in Liberty Corner, New Jersey, is a rapidly growing, pharmaceutical company developing and marketing branded, patent-protected pharmaceutical products to primary care and targeted specialty physicians in the U.S.. Reliant Pharmaceuticals, LLC, is a privately-held company owned primarily by the Pritzker family business interests, Bay City Capital, Alkermes, management and members of its Board. Other investors in Reliant include Versant Ventures and Invemed/Gladwyne Partners. Reliant employs over 100 marketing, clinical, regulatory, and support staff at its headquarters as well as a sales management team which oversees a national sales force of 750 full-time professionals. Reliant, founded late in 1999, markets three branded, patent-protected pharmaceutical products to primary care and targeted specialty physicians in the U.S.: Lescol (fluvastatin sodium) and Lescol® XL extended-release tablets, developed by Novartis for cholesterol management; DynaCirc (isradipine) and DynaCirc CR, an extended-release formulation, also developed by Novartis for the treatment of hypertension, and Axid® (nizatidine) developed by Eli Lilly & Company for the treatment of ulcers and GERD. Sales of these products may approach one-half billion dollars in 2002. The company develops and implements sophisticated life cycle management strategies to extend marketing exclusivity or provide additional patent protection for its products. The company currently has two new drug applications pending with the U.S. Food and Drug Administration and several ongoing development projects. Certain statements set forth above may constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although we believe that such statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, there can be no assurance that we will be able to successfully develop or commercialize MIV-606. Reliant's business is subject to significant risks and there can be no assurance that actual results of its development activities and its results of operations will not differ materially from its expectations. Lescol® is a registered trademark of Novartis Pharmaceuticals Corporation Axid® is a registered trademark of Eli Lilly and Company DynaCirc® and DynaCirc CR® are registered trademarks of Novartis Pharmaceuticals Corporation More information can be found at www.reliantrx.com. ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/02/26/20020226BIT00700/wkr0001.doc http://www.waymaker.net/bitonline/2002/02/26/20020226BIT00700/wkr0002.pdf

Subscribe