Study Represents Extensive, Continuous Clinical Experience With Immune Modulating Therapy

Clinical experience and study data with COPAXONE® (glatiramer acetate injection) in relapsing-remitting multiple sclerosis (RRMS) patients with active disease (mean annual relapse rate of 2.9) now span more than a quarter of a century. In a long-term, open-label, compassionate use study of up to 26 years (prior to any immune modulating therapies approved by the Food and Drug Administration (FDA)), presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), clinical efficacy and safety data demonstrated reductions in relapse rates, slowed disease progression, and continued tolerability of COPAXONE.

"To see the long-term positive impact on disease progression in these patients on COPAXONE® is very helpful for clinicians and patients making treatment decisions, especially since long-term data with other therapies are scarce," said Dr. Aaron Miller, professor of neurology, Department of Neurology, Mount Sinai School of Medicine, New York, and lead investigator on the study. "Long-term data reinforcing the clinical utility, such as this experience with COPAXONE®, can be reassuring for patients and physicians when making treatment choices."

The author reported the long-term clinical experience in 46 RRMS patients treated with COPAXONE® for 1-26 years (average 10.5 years). Assessment of clinical effectiveness included annual relapse rates and Extended Disability Status Scale (EDSS) scores.

Safety was determined by reports of adverse effects. Patients were seen every six months. Of the original 46 patients, 18 remain active in the study, and of the 28 who withdrew, patient decision to withdraw was the most common reason (54 percent).

At entry, based on a patient's entire history, mean annual relapse rate was 2.9+/-1.4 (range: 1-7). At last clinical observation, mean annual relapse rate for 24 of 42 patients on COPAXONE® (glatiramer acetate injection) was reduced (0.1+/-0.2, p < 0.0001). In terms of EDSS, 24 of 42 (57%) patients had improved or unchanged EDSS scores at last observation compared to pretreatment entry of 3.0+/-1.8 (range: 0-6.5). Over the long course of the study, a non-significant change in average EDSS score was observed (3.0+/-1.8 at entry vs. 3.8+/-2.5 at last observation). Only 8 of 34 (23.5 %) patients with entry EDSS scores less than six, progressed to an EDSS score of six or more with average disease duration of greater than 17 years. For those patients remaining in the study (at the time of data cut-off for this abstract, n=18) with average disease duration greater than 24 years, only 26.7 percent progressed to EDSS greater than or equal to six. This compares favorably to a natural history cohort, which shows 50 percent progressing to six or greater at 15 years after disease onset. Long-term COPAXONE® therapy was well tolerated, and patients reported adverse events similar to those experienced in short-term trials.

About COPAXONE®

Current data suggest COPAXONE® is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. 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® (glatiramer acetate injection) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd. (NasdaqNM:TEVA - News), headquartered in Israel, is among the top 20 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 and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE®. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

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