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More MS news articles for September 2003

Copaxone® Significantly Reduces Disability in RRMS During First Year Of Treatment

Meta-analysis Results From Three Controlled Studies Also Demonstrated Sustained Effect

September 22, 2003
Source: Teva Neuroscience
Kansas City, Mo.

Copaxone® (glatiramer acetate injection) significantly reduced the sustained accumulated disability for people with relapsing-remitting multiple sclerosis (RRMS) during the first year of treatment with the drug.  Data presented recently at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Milan, Italy, demonstrated the reduction of sustained accumulated disability in patients continued throughout the entire study follow-up period, which ranged from nine to 35 months.

Dr. Jerry S. Wolinsky, M.D., director of MS research, University of Texas Health Science Center, Houston, presented the data from this study.  "The meta-analysis technique used in this study demonstrates consistency of efficacy results across three well-controlled clinical trials."

The meta-analysis study used data from three randomized, double-blind, placebo-controlled trials with Copaxone® and involved 540 patients. Compared to placebo, Copaxone® significantly reduced the number of patients accumulating a sustained increase in disability of at least one EDSS step for 90 days within the first year of treatment.  The clinical effect seen on disability at one year persisted throughout the entire follow-up period.

Copaxone® (glatiramer acetate injection) significantly reduced the number of patients who accumulated disability of one or more Expanded Disability Status Scale (EDSS) steps for 90 days during the first year of treatment (relative risk was 0.56 or a 44 percent reduction; p=0.02), and through the entire study period of up to 35 months of follow-up (relative risk was 0.65 or a 35 percent reduction; p=0.03).

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

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

Teva Pharmaceutical Industries Ltd., 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®.

See additional important information at http://www.copaxone .com/pi/index.html or call 1-800-887-8100 for electronic releases.  For hardcopy releases, please see enclosed full prescribing information.

Copaxone® (glatiramer acetate injection) is a registered trademark of Teva Pharmaceutical Industries Ltd.

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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