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More MS news articles for April 2003

Early Onset of Clinical Effects Seen With COPAXONE(R) Therapy

Research Evaluates Early and Sustained Clinical Effects Of COPAXONE(R) When Compared With Other Immunomodulating Therapies

Thursday April 3, 2003, 8:00 pm ET
Source: Teva Neuroscience, Inc.

As early as six months after starting therapy, COPAXONE® (glatiramer acetate injection) showed the ability to reduce relapses in relapsing-remitting multiple sclerosis (MS). In addition, benefits were sustained at 12 and 24 months, according to a poster presented this week at the American Academy of Neurology (AAN).

The study evaluated the time of onset of relapse rate reduction for people treated with COPAXONE® compared to those treated with other disease modifying therapies. This controlled, open-label study assessed how quickly COPAXONE® would begin showing clinical effects, such as relapse rate reduction.

"COPAXONE® demonstrated its ability to reduce relapses as early as six months in this study. This is comparable to the interferon data at six months. More significantly, the clinical benefit of COPAXONE® continued when reviewed after one year and two years on therapy," said Judith Haas, M.D., Jewish Hospital, Department of Neurology, Berlin, Germany.

The study is an ongoing prospective, controlled, open label trial that is looking at 255 people living with relapsing-remitting MS. At the start of the study, the annualized relapse rates for patients on all of the disease modifying agents were similar, ranging from 1.06 to 1.20. At six months, those taking COPAXONE® had a relapse rate reduction of 0.70 compared to baseline (p<0.001). Similarly the changes in relapse rate for all beta interferons at six months were statistically significant at the (p<0.02) level compared to 'prior to the study' relapse rate.

The COPAXONE® (glatiramer acetate injection) relapse rate reduction from baseline continued to improve with reductions of -0.73 at one year and -0.81 at two years, and that lowering was statistically significant than what was measured at the study outset (p<0.05).

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 35 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 or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

COPAXONE® 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.

Source: Teva Neuroscience, Inc.

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