Teva Pharmaceutical Industries Ltd. says Copaxone to be presented to September FDA advisory panel.

JERUSALEM, Israel--(BUSINESS WIRE)--July 19, 1996--Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVIY) announced that it was informed after the close of business yesterday by the U.S. Food and Drug Administration ("FDA") that the FDA has decided to schedule an advisory panel presentation by Teva regarding its New Drug Application ("NDA") for Copaxone(R), the Company's innovative treatment for relapsing multiple sclerosis.

Mr. William Fletcher, President of Teva Pharmaceuticals USA, Inc., stated, "The FDA had previously advised us that they did not consider an advisory panel presentation as a necessary step in the review process for Copaxone(R). However, as the Agency was finalizing its review of the NDA, it decided to revert to the same NDA review process as was utilized with other treatments for multiple sclerosis. The FDA has advised us that in order to meet its user fee timing guidelines for the review of the NDA -- which call for the issuance of an action letter by October, 1996, one year from the date of filing of the NDA-- it will schedule the presentation for the earliest available date -- the meeting of the Peripheral and Central Nervous System Drugs Advisory Panel on September 16-17, 1996. Accordingly, in the coming weeks, we will be working closely with the FDA to prepare the scope and content of the presentation to the panel."

Mr. Eli Hurvitz, Teva's Chief Executive Officer, stated, "While we are obviously disappointed by this unexpected decision, we are encouraged by the FDA's desire to act within its timing guidelines, its willingness to schedule the presentation in September and the extent to which the Staff has indicated that it will work with us in preparing for the presentation. We continue to believe that Copaxone(R) will receive the FDA's approval and preparations are in the final stage of completion for the manufacturing, marketing and distribution steps necessary to support a prompt nationwide product launch once final FDA approval is granted."

The statement made in this press release constitute "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks and uncertainties, including the fact that the administrative discretion of the FDA may result in either the timing or the nature of any approval for Copaxone(R) differing from that anticipated by the Company.

Teva Pharmaceutical Industries Ltd. manufactures and markets human pharmaceuticals, bulk pharmaceutical chemicals, bulk pharmaceuticals and medical disposables. Teva is the leading supplier of such products in Israel and has manufacturing facilities in Israel, Europe and the United States. Over 60 percent of its sales are generated outside of Israel.

CONTACT: Teva Pharmaceutical Industries Ltd., Jerusalem

Dan Suesskind

Chief Financial Officer

011/972-2-892-811

or

Morgen-Walke Associates, Inc., New York 

Investor Relations: Donna N. Stein

Press: Brian Maddox

212/850-5600