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More MS news articles for September 2003

Studies Show Copaxone(R) Is Effective in RRMS Regardless of Disease Severity

Meta-analysis of three studies confirms COPAXONE(R) (glatiramer acetate injection) reduces disability accumulation and relapse rate in mild, moderate, or severe relapsing-remitting multiple sclerosis

Aug. 21, 2003
Source: Teva Pharmaceutical Industries Ltd.
Kansas City, Mo.

The first published meta-analysis on COPAXONE(R) confirms the effectiveness of the drug on reducing disability accumulation and the relapse rate in patients with relapsing-remitting multiple sclerosis (RRMS). In addition, researchers validated that this effect remained regardless of whether the patients had mild, moderate, or severe RRMS when they entered the studies.

"We wanted to see if the severity of a person's MS had any effect on how well COPAXONE(R) worked," said Filippo Martinelli Boneschi, M.D., Department of Neuroscience, Scientific Institute and University H. San Raffaele, Milan, Italy. "What we found was that COPAXONE(R) was effective on patients who entered clinical trials with higher Expanded Disability Status Scale (EDSS) scores, as well as those who began with lower scores. In fact, COPAXONE(R) tended to have greater efficacy in patients with more severe disability and fewer relapses in the two years preceding clinical trial entry."

The study was published in the August issue of Multiple Sclerosis. It evaluated data from three randomized, double-blind, placebo-controlled trials (Bornstein et al., Johnson et al., and Comi et al.) that had shown COPAXONE(R) was effective in reducing relapses. A meta-analysis is an important study in determining whether the pooled data from several studies can still support the findings of single studies.

There were 540 patients total in all three clinical trials included in the study. Researchers looked at two main clinical outcomes -- reduction of the relapse rate and slowing of accumulated disability.

Approximately a one-third reduction of the total number of on-trial relapses was observed in patients receiving COPAXONE(R) (glatiramer acetate injection) who had a median time to the first relapse of 322 days vs. a median time to the first relapse of 219 days seen in those receiving placebo. This reflects a treatment effect of 32 percent (p = 0.01).

"Individually, studies for the immunomodulating drugs showed a relapse rate reduction of about a third. This study confirms that finding in COPAXONE(R)," said Dr. Martinelli Boneschi.

COPAXONE(R) is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE(R) is now approved in 42 countries worldwide, including the U.S., Canada, Australia, Israel, and all the European countries. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, COPAXONE(R) is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA), headquartered in Israel, is among the top 30 pharmaceutical companies in the world. Close to 90 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE(R).

COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.

Safe harbor statement

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.

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