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| | | ![]() Major Step Toward European Approval of Interferon Beta-1a CAMBRIDGE, Mass., Nov. 21, 1996 -- Biogen, Inc. (Nasdaq: BGEN) today announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion for Biogen's interferon beta-1a for the treatment of relapsing multiple sclerosis. Upon final approval, the product will be marketed in Europe under the brand name AVONEX(TM). It is also marketed in the U.S. under the brand name AVONEX. The CPMP's opinion represents the Agency's scientific evaluation of the product. According to the European procedure, the positive opinion will now be forwarded to the European Commission for final review and approval. Final Commission action grants a Marketing Authorization that is effective in all 15 member states of the European Union. Jim Vincent, Biogen's Chairman and Chief Executive Officer, said, "This is a major step toward European market approval, and another strong sign of the potential for this drug. AVONEX continues to grow at a significant rate in the U.S., where we expect to be the market leader in the foreseeable future. The CPMP recommendation, combined with U.S. sales growth and the additional approvals anticipated in other markets, underscores the major potential market for AVONEX throughout the world." AVONEX was licensed for the U.S. market in May 1996. Biogen has also applied for market approval in a number of other countries, including Australia, Canada, New Zealand, Switzerland and Norway. Biogen, Inc., headquartered in Cambridge, MA, is a biopharmaceutical company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. The Company's revenues are generated from U.S. sales of AVONEX (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen is focused primarily on developing and testing novel products for multiple sclerosis, inflammatory and respiratory diseases and certain viruses and cancers.
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