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Study Shows Benefit Of Switch To Copaxone (Glatiramer Acetate Injection) For Multiple Sclerosis Patients: Presented at ENS

KANSAS CITY, MO -- June 23, 2003 -- Relapsing-remitting multiple sclerosis patients who failed to respond to treatment with Avonex® (interferon beta-1a) experienced a significant reduction in relapses after switching to non-interferon Copaxone® (glatiramer acetate injection), according to a platform presentation at the European Neurological Society (ENS) meeting this week.

The prospective study involved 85 patients who had been taking Avonex for 18 to 24 months. Eighty-five patients who failed to respond to Avonex or who experienced intolerable side effects were switched to Copaxone and followed for 36 to 42 months. Of the 85, follow-up data was available on 79 patients. The clinical study evaluated the annual mean number of relapses and Expanded Disability Status Scale (EDSS). The findings indicated that patients experienced a 58-percent reduction of relapses after switching from Avonex to treatment with Copaxone.

Researchers analyzed those patients who switched to Copaxone because of inability to tolerate side effects as well as those who showed persistent clinically active MS despite Avonex therapy. After switching to Copaxone, the group experienced a mean annualized reduction of relapses from 1.13 annually to 0.47 annually (p=0.0001). Neurologic disability recorded by measuring EDSS did not show worsening while on treatment with Copaxone.

"We saw the greatest improvement in patients who switched to Copaxone (glatiramer acetate injection) because of lack of efficacy with Avonex," said Omar Khan, M.D., Associate Professor of Neurology and Director of Experimental Therapeutics/Clinical Research, Multiple Sclerosis Center, Wayne State University, Detroit, Mich. "Follow-up beyond three years on patients taking Copaxone indicates a sustained reduction in the relapse rate without an increase in neurologic disability. Even though it is a prospective study of more than three years duration, because of the open-label design, one has to be careful in drawing conclusions. Overall, the study does provide meaningful information. Neurologists should consider switching therapies in MS patients who are deemed treatment failures while still in the relapsing-remitting stage of the disease. Treatment with Copaxone is an effective first-line therapy in relapsing-remitting MS and is an appropriate alternative to low dose weekly intra-muscular interferon beta-1a."

For the subgroup who switched drug because of lack of efficacy, the difference in the reduction in the relapse rate between Avonex (1.29) and Copaxone (0.48) was highly significant (p=0.0001). "Patients with relapsing-remitting MS who are on an immunomodulating therapy and have active clinical disease may benefit from switching therapies," said Christina Caon, MSN, RN, Program Coordinator, Multiple Sclerosis Center, Wayne State University, who presented the data at the ENS meeting. "Our observations may assist clinicians in recommending alternative options based on clinical information. However, consensus guidelines or criteria on when to switch patients need to be developed."

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 (glatiramer acetate injection) 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.

Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.


SOURCE: Teva Pharmaceutical Industries Ltd

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