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| | | ![]() New Drug for Multiple Sclerosis Now Available JERUSALEM, Israel -- April 2, 1997 – Teva Pharmaceutical Industries Ltd. today announced that Copaxone(R), its innovative treatment for multiple sclerosis which was shipped into distribution late March, is officially launched. Copaxone is being marketed in the United States by Teva Marion Partners, Kansas City, MO, a partnership established for this purpose between Teva and Hoechst Marion Roussel (HMR). HMR, which is responsible for the distribution of Copaxone, is making Copaxone available to patients through both traditional retail pharmacy distribution and direct to patients through an arrangement with Caremark International, a leading provider of health care services. Teva Marion Partners is engaged in enhancing the management of multiple sclerosis. Teva Marion Partners has launched a patient support program called Shared Solutions(TM), an innovative new program specially designed to help patients, their families and their caregivers meet the many challenges posed by multiple sclerosis. For more information on Shared Solutions(TM) or Teva Marion Partners call 1-800-867-2444. Copaxone is the first nonsteroidal, non-interferon agent to alter the course of relapsing-remitting MS. Its mechanism of action is unknown. However, it is thought to modify immune processes associated with MS. "Copaxone (glatiramer acetate for injection) is well tolerated with no clinically significant difference in flu-like symptoms, depression or fatigue when compared to placebo, unlike other MS therapies," said Kenneth Johnson, M.D., professor and chairman, Department of Neurology, University of Maryland Medical Center, Baltimore, and principal investigator of a Copaxone multicenter clinical trial. In a two-year, multicenter, randomized, double-blind, placebo-controlled trial of 251 patients, Copaxone was shown to reduce relapses by an average of 29 percent when compared with placebo. In another randomized, double-blind, placebo-controlled trial involving 50 patients, patients receiving Copaxone also experienced a 75 percent reduction in relapse rate compared with placebo. Copaxone must be diluted with sterile water provided with the drug. A self-injection administration materials package accompanies the product at no extra charge. Copaxone is administered daily by subcutaneous injection (under the skin), similar to daily injections for people with diabetes. The most commonly observed adverse reactions associated with the use of Copaxone in clinical trials were injection site reactions (redness, pain, inflammation, itching or a lump at the site of injection), flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety and muscle stiffness. Injection site reactions were usually mild and most often did not require professional treatment. Some patients have reported a transient, self-limited reaction immediately after injecting Copaxone. This reaction is characterized by flushing or chest tightness with heart palpitations, anxiety, and difficulty in breathing. In clinical trials, these symptoms occurred rarely, generally appeared within minutes of an injection, lasted approximately 15 minutes, and resolved without further problems. Teva Pharmaceutical Industries Ltd., is Israel's largest pharmaceutical company, with three quarters of its sales outside Israel, mainly in the United States. The Company develops, manufactures and markets branded and generic human pharmaceuticals, bulk pharmaceutical chemicals, medical disposable and veterinary products.
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