Teva receives FDA approvable letter for Copaxone.

JERUSALEM--(BUSINESS WIRE)--Oct. 7, 1996--Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVIY) announced that at the close of business on Friday, October 4, 1996 it was informed by the U.S. Food and Drug Administration ("FDA") that Copaxone is approvable as a therapy for the treatment of patients with relapsing remitting multiple sclerosis.

The FDA's letter is a critical step toward final marketing approval of Copaxone and follows by two weeks the unanimous recommendation of the FDA's advisory committee on Peripheral and Central Nervous System Drugs that Copaxone is a safe and effective treatment for patients with relapsing remitting multiple sclerosis.

"We are pleased that our application has reached this stage of regulatory review and are working with the FDA to expedite the remaining aspects of the approval process," said Mr. Eli Hurvitz, Teva's Chief Executive Officer.

The approvable letter indicates that the FDA is prepared to approve Copaxone for marketing upon the satisfaction of certain conditions, including action by the Company to address FDA comments regarding labeling and certain post approval requirements.

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 Pharmaceuticals USA, Inc. and Hoechst Marion Roussel Inc.

Teva Pharmaceutical Industries Ltd. is Israel's largest pharmaceutical company, with three quarters of its sales outside of Israel, mainly in the United States. The Company develops, manufactures and markets branded and generic human pharmaceuticals, bulk pharmaceutical chemicals, medical disposables and veterinary products.

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