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| |  COPAXONE Cleared by FDA for Multiple Sclerosis KANSAS CITY, Mo., Dec. 23, 1996 -- Teva Marion Partners announced today that the U.S. Food and Drug Administration (FDA) has granted Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVIY) clearance to market COPAXONE(R) for the treatment of relapsing-remitting multiple sclerosis. Two pivotal clinical studies of COPAXONE(R) have demonstrated that the drug reduces the frequency of attacks. The marketing clearance follows a unanimous recommendation September 19 from the FDA's advisory committee on Peripheral and Central Nervous System Drugs. COPAXONE(R), formerly known as copolymer-1, is a new class of multiple sclerosis therapy. "For the first time, we have a non-interferon, nonsteroidal medication that reduces the frequency of relapses, delivering significant benefit to people with relapsing-remitting MS," said Kenneth Johnson, M.D., professor and chairman, Department of Neurology, University of Maryland Medical Center, Baltimore, and principal investigator of the COPAXONE(R) (glatiramer acetate for injection) multicenter clinical trial. "COPAXONE(R) is well tolerated without the flu-like symptoms, fatigue and depression side effects associated with other treatments for relapsing-remitting multiple sclerosis." The most common side effects associated with the use of COPAXONE(R) included injection site reactions, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety and muscle stiffness. Approximately 10 percent of patients with multiple sclerosis exposed to glatiramer acetate in premarketing studies experienced a constellation of symptoms immediately after injection that could include flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat and urticaria. The symptoms were invariably transient and self-limited and did not require specific treatment. "The FDA moved swiftly to make COPAXONE(R) available to people with MS who need it," said Eli Hurvitz, chief executive officer of Teva Pharmaceutical Industries, Ltd.. "The marketing clearance of COPAXONE(R) signifies entry into the branded marketplace for Teva and our marketing partner in the United States, Teva Marion Partners." The drug will become available in early 1997. Studies Show Reduced Frequency of Relapses In a two-year multicenter, randomized, double-blind, placebo-controlled trial of 251 patients, COPAXONE(R) (glatiramer acetate for injection) was shown to reduce relapses by an average of 29 percent when compared with placebo. What is Multiple Sclerosis? Multiple sclerosis is a chronic, often progressive disease of the central nervous system (brain, spinal cord and optic nerves), which affects 300,000 people in the United States (Approximately 10,000 people are diagnosed each year). The disease most often appears in people between the ages of 20 and 40 -- approximately 73 percent of people with multiple sclerosis are female. From Discovery to Marketplace COPAXONE(R) was discovered by scientists at the Weizmann Institute of Science in Israel -- Professor Ruth Arnon and Professor Michael Sela. The drug was developed and is manufactured by Teva Pharmaceutical Industries, Ltd. COPAXONE(R) will be marketed in the United States by Teva Marion Partners. Teva Marion Partners, based in Kansas City, Mo., is a partnership established between Teva Pharmaceutical Industries, Ltd. and Hoechst Marion Roussel, Inc. Teva Pharmaceutical Industries, Ltd., Israel's largest pharmaceutical company, develops, manufactures and markets branded and generic human pharmaceuticals, bulk pharmaceutical chemicals, medical disposables and veterinary products. The largest supplier of such products to Israel's public and private health-care markets, the company has manufacturing facilities in Israel, Western Europe and the United States, and more than 60 percent of its sales are generated outside Israel. A world leader in pharmaceutical-based health care, Hoechst Marion Roussel, Inc. is dedicated to extending and enhancing human life through the discovery, development, manufacture and sale of pharmaceutical products. Hoechst Marion Roussel, with global headquarters in Frankfurt, Germany, is a member of the Hoechst Group. Hoechst Marion Roussel's North America business is headquartered in Kansas City, Mo.
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