SOURCE: Teva Neuroscience

April 14, 2005 15:00 ET

Novel Approach With COPAXONE® Showed Dramatic Improvements in Aggressive, Active, Relapsing-Remitting Multiple Sclerosis

Unique Mechanism of Action of COPAXONE® May Explain Synergistic Effects Seen When Using Combination Therapy in Treating Aggressive Forms of RRMS

KANSAS CITY, MO -- (MARKET WIRE) -- April 14, 2005 -- Results from an independent retrospective evaluation of a novel treatment protocol with COPAXONE® (glatiramer acetate injection) demonstrated long-term suppression of clinical and MRI activity in patients with very aggressive relapsing-remitting multiple sclerosis (RRMS). COPAXONE® was given in an open-label manner as sequential combination therapy with mitoxantrone (MX), then continued as monotherapy for up to five years (average 33 months, range 10-60 months). This combination stabilized or improved disability, significantly suppressed relapses, and exhibited no MRI evidence of new brain lesions. Data were presented in Miami Beach at the 57th Annual Meeting of the American Academy of Neurology. Recognizing the potential impact of this unique therapeutic approach in more aggressive forms of RRMS, Teva Neuroscience completed enrollment of 40 patients in December 2004 for a multicenter North American study designed to evaluate the safety of this combination and confirm these dramatic results.

Twenty-seven patients with early active RRMS were included in the independent study. Following induction therapy with MX alone, COPAXONE® was given in sequential combination with MX for three to seven months. The sequential combination dosing was standardized to five months for the final 17 patients entered, representing one or two pulses of MX. Patients then continued on long-term COPAXONE® monotherapy. While on MX alone, six relapses occurred. Only two relapses occurred, four and 12 months, after initiation of COPAXONE®. After an average of 33 months (range 10-60) of COPAXONE® monotherapy, patients remained progression free, and, at the most recent follow-up, Expanded Disability Status Scale (EDSS) scores were stable or improved in all patients.

MRI scans conducted in nine of the first 10 patients enrolled, at a mean of 42 months from initiation of the treatment protocol, showed a substantial reduction in T2 lesion load compared with pretreatment scans and no enhancing lesions. No unanticipated adverse effects were experienced with this novel combination.

These results extend and confirm data from the first 10 patients of the study cohort, previously presented at the 20th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2004. For these 10 patients, no relapses were seen at an average of 30 months (range 19-36) after starting COPAXONE® (glatiramer acetate injection) monotherapy. Average Extended Disability Status Scale (EDSS) score at the beginning of the study was 5.4, a level at which a patient could walk without aid or rest for about 100 meters, but had disability severe enough to preclude full daily activities. The average EDSS score for the first 10 patients at an average of 30 months on COPAXONE® monotherapy was 2.3, representing only a mild degree of disability, enabling patients to have more independence to return to full daily activities. The data on all 27 patients were analyzed and presented today.

Study investigator, Dr. Michael Boggild, The Walton Centre, Liverpool, U.K., commented on the significance of these results. "Our significant findings are very encouraging for patients who have severe, active forms of RRMS. The results may reflect a synergistic effect of this combination," said Dr. Boggild. "Mitoxantrone may be acting as a short-term immunosuppressant, further enhancing the effects of COPAXONE® in preventing inflammatory and neurodegenerative responses long-term. The unique mechanism of action of COPAXONE® and its ability to reprogram the T-cell response may make it a logical choice when combination therapy is needed for patients with particularly aggressive forms of disease. I'm encouraged that further ongoing studies may validate our results."

About COPAXONE®

Current data suggest COPAXONE® (glatiramer acetate injection) 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® is now approved in 43 countries worldwide, including the United States, Canada, Mexico, 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. (NASDAQ: TEVA), headquartered in Israel, is among the top 25 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. markets COPAXONE®. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd.

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