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August 07, 2001 11:35 a.m.
15 European Countries Agree to Approve Copaxone®


Jerusalem, Israel, August 7, 2001 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Aventis Pharma AG, the pharmaceutical company of Aventis (NYSE: AVE) announced today that 15 European countries agreed to approve Copaxone® (glatiramer acetate) for the reduction in frequency of relapses in patients with relapsing-remitting multiple sclerosis. Copaxone® will be marketed in Europe by Teva Pharmaceuticals and Aventis Pharma.

Following the successful completion of the Mutual Recognition Procedure(MRP) in Europe, Copaxone® will be launched in the various countries in Europe, starting in the last quarter of 2001 after granting of national marketing authorizations. Among the first launch countries will be Germany with the largest population of MS patients in Europe.

As first-line therapy, Copaxone® will offer patients with Multiple Sclerosis a new treatment option. Copaxone® is a new class of disease modifying therapy that has been shown in controlled clinical trials to be effective and generally well-tolerated ( Johnson et al, V 50, March 1998). Copaxone® has also clearly shown important reductions in relapse rates and significant effect on magnetic resonance imaging (MRI) monitored activity and burden of disease. Copaxone® has demonstrated continued efficacy over six years. In clinical trials, treatment with Copaxone® has not been associated with evidence of the development of neutralizing antibodies. Furthermore, Copaxone® is the only drug available for patients who do not benefit from or cannot tolerate beta-interferon.

Copaxone® was approved in the U.S.A. in 1996 followed by 22 other countries including Canada, Israel, Australia, UK and Switzerland. In Europe, the U.K. was the reference member state in the MRP, based on its marketing authorization granted to Copaxone® in August 2000.

Copaxone® is the fastest growing MS therapy in the United States with a market share of 26% of total prescriptions (IMS June 2001). Copaxone® is growing at more than twice the rate of the MS market.

Over 4000 Patients in Europe have already been receiving Copaxone® treatment for several years, through different programs, including compassionate use programs. It is estimated that there are at least 150,000 relapsing-remitting MS patients in Europe. Although the number of MS patients is similar to that of the U.S., the untreated MS population in Europe is about twice as large.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 40 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.

Aventis (NYSE: AVE), a world leader in pharmaceuticals and agriculture, is dedicated to improving life through the discovery and development of innovative products. In 2000, Aventis generated group sales of 22.3 billion euros and employed approximately 92,500 people in its Pharma and Agriculture businesses. Aventis announced in November 2000 that it intends to focus on pharmaceuticals and plans to divest its activities in agriculture. Aventis was launched in December 1999 through the merger of Hoechst AG of Germany and Rhone-Poulenc SA of France. Corporate headquarters are in Strasbourg, France. For more information, please visit:
Aventis Pharma AG is the pharmaceutical company of Aventis. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and the central nervous system disorders. Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis Pharma encompasses Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins headquartered in King of Prussia, Pennsylvania, USA.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration ("FDA") and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.