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| |  REVISED: Glatiramer Acetate Reduced Relapses and Stabilized Disability as Measured by Expanded Disability Status Scale, When interferon beta-1a Failed NOTE: The above title has been corrected. KANSAS CITY, M.O. -- May 31, 2006 -- Relapsing-remitting multiple sclerosis (RRMS) patients who do not respond to treatment with Avonex(R) (interferon beta-1a), achieved significant reductions in relapse rates and disability when they switch to Copaxone(R) (glatiramer acetate injection). In a study published in the June issue of the European Journal of Neurology, Copaxone was shown to reduce annual relapse rate by an additional 57% over Avonex, and that neurologic disability, as measured by the Expanded Disability Status Scale (EDSS), did not worsen in 86% of patients. "Our data demonstrated the benefits of Copaxone(R) in reducing relapse rate in patients who were not effectively treated or could not tolerate other immune modulating therapies," reported Omar Khan, MD, associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University, and senior author of the study. A series of 85 consecutive RRMS patients treated with Avonex(R) for at least 18 months who experienced suboptimal clinical efficacy (at least one relapse in the previous year, n=62) or persistent intolerable toxicity (elevated liver function tests, low white blood cell counts, or post-injection fever, weakness, or fatigue for more than 24 hours after every injection, n=23), were switched to Copaxone(R) in this open-label study and followed prospectively for an additional 36 to 42 months (average 37.5 months). While on Copaxone(R) therapy, patients were seen every six months for neurological examinations, including EDSS scores. Annualized relapse rate for the entire patient group after switching to Copaxone(R) (glatiramer acetate injection) was reduced by 57% from 1.23 on Avonex(R) to 0.53 (P =.0001). In the subset of patients who switched to Copaxone(R) because of insufficient efficacy on Avonex(R) (n=62), the reduction was even more significant (61%), from 1.32 to 0.52 (P =.0001). Patients who switched to Copaxone(R) because of persistent toxicity on Avonex(R) (n=23), experienced an additional 23% reduction which did not reach statistical significance. In all patients, the average EDSS scores, as a measure of neurological disability, significantly improved during the more than three years of Copaxone(R) therapy, decreasing from 3.50 to 3.08 (P =.0001). Improved or stable EDSS scores occurred in 86% of patients. "We recognize the limitations of our study, such as the open-label design and lack of prospective follow-up in patients while receiving IFN beta-1a," stated Dr. Khan. "However, our results corroborated another larger prospective open-label study by Howard Zwibel, MD, Medical Director of Health South Doctors' Hospital Multiple Sclerosis Center, which demonstrated reductions in relapse rates in patients switched from Betaseron(R) to Copaxone(R), and suggested that clinical observations including relapse rates, patient tolerability, and toxicities assessed by serum laboratory parameters are valuable criteria for determining when a switch in therapy is warranted." About Copaxone(R) Copaxone(R) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, Copaxone(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, Copaxone(R) is marketed by Teva Neuroscience. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90% 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 and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets Copaxone(R) (glatiramer acetate injection). Copaxone(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.
SOURCE: Teva Neuroscience
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