FDA Advisory Committee concludes that COPAXONE is safe and effective for treatment of patients with relapsing multiple sclerosis

Business Wire, Sept 19, 1996

NEW YORK and JERUSALEM, Israel--(BUSINESS WIRE)--Sept. 19, 1996--Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVIY) today announced that a Peripheral and Central Nervous System Advisory Committee convened by the U.S. Food and Drug Administration (FDA) has unanimously concluded that COPAXONE (copolymer-1 for injection) is a safe and effective treatment for patients with relapsing multiple sclerosis.

"We are excited with the Advisory Committee conclusion," said Eli Hurvitz, Teva's Chief Executive Officer. "Teva is working closely with the FDA to fulfill the requirements for final marketing clearance. Both our chemical and sterile manufacturing plants have sufficient capacity to supply anticipated demand once marketing clearance is granted by the FDA."

"The multiple sclerosis community is in need of a well tolerated therapy which is effective over time," said Kenneth P. Johnson M.D., principal investigator of the COPAXONE multicenter clinical trial and professor and chairman, Department of Neurology, at the University of Maryland Medical Center, Baltimore. "It is our hope that medication such as COPAXONE , a well-tolerated, non-steroidal, non-interferon treatment that does not appear to produce neutralizing antibodies may help fulfill treatment needs."

The Advisory Committee's recommendation was based on data presented by the Company which summarized the safety and efficacy of COPAXONE . This data was collected from participation in double blind clinical trials as well as open label safety studies, totaling 1,100 patient years. COPAXONE was studied in patients across a broad range of disability.

COPAXONE was originally synthesized by Professor Sela and Arnon, and Dr. Teitelbaum at the Weizmann Institute of Science in Israel. Teva, which was granted a world-wide exclusive license for COPAXONE , is the developer and the manufacturer.

Once cleared for marketing by the FDA, COPAXONE will be marketed in the United States by Teva Marion Partners, Kansas City, MO., a partnership established between Teva Pharmaceutical Industries Ltd. and Hoechst Marion Roussel Inc. The latter will be responsible for the distribution of COPAXONE in the United States. Teva Marion Partners is dedicated to enhancing the management of multiple sclerosis. Teva Marion Partners has launched a patient support program called Shared Solutions , 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 or Teva Marion Partners call 1-800-867-2444.

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 product.

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