SOURCE: Teva Neuroscience

June 21, 2005 08:00 ET

Copaxone® Showed Greatest Reduction in Long-Term Relapse Rate Among MS Treatments

Four-Year Follow-Up Data Showed COPAXONE® Superiority; Extends Recently Published Two-Year Results

KANSAS CITY, MO -- (MARKET WIRE) -- June 21, 2005 -- A four-year study using a prospectively structured clinical database to assess comparative efficacy and safety of multiple sclerosis therapies, demonstrated that patients with relapsing-remitting multiple sclerosis (RRMS) treated with COPAXONE® (glatiramer acetate injection) showed superior relapse rate reduction than those treated with beta interferon therapies. According to data presented today at the European Neurological Society Meeting, Vienna, COPAXONE® produced the largest reduction, relative to pre-treatment in annual relapse rates at two, three, and four years after the initiation of treatment, when compared to three beta interferon therapies beta 1a (Avonex®), 22 microgram interferon 1a (Rebif® 22), and interferon beta 1b (Betaferon®) therapies. Additionally, the best treatment adherence and lowest drop-out rate sustained over four years after the initiation of treatment was seen with COPAXONE® compared to the beta interferons.

The study represents a follow-up analysis to a two-year open-label, non-randomized study recently published in the European Journal of Neurology. In the four-year study presented today, 247 RRMS patients were distributed across treatment groups as follows: 69 for Avonex®, 65 for Betaferon®, 40 for Rebif® 22, and 73 for COPAXONE®.

Group characteristics and baseline demographics were similar among the treatment arms and reflective of a RRMS population. The primary clinical endpoint was reduction of relapse rates relative to the annualized relapse rates for the two years prior to initiating therapy. Data were reported for 24, 36, and 48 months after initiating therapy.

Reduction in annual relapse rate at 48 months after initiation of treatment, relative to the annualized relapse rates for the two years prior to entry, for COPAXONE® (glatiramer acetate injection) was more pronounced than for the beta interferons; and this was statistically significant (p= 0.0053). The actual annual relapse rates for each of the treatments relative to pre-treatment rate were as follows: COPAXONE® 0.32 vs. 1.18 (a 73-percent reduction); Avonex® 0.61 vs. 1.07 (a 43-percent reduction); Betaferon® 0.72 vs. 1.16 (a 38-percent reduction); and Rebif® 22 0.56 vs. 1.14 (a 51-percent reduction). Additionally, when compared to the beta interferon therapies, COPAXONE® patients experienced significant reduction in annual relapse rate at each study time point. No significant differences in reductions from pre-treatment rate were noted among the beta interferons. The best results in terms of adherence to treatment and lowest drop-out rate sustained over four years after initiation of treatment were also achieved with COPAXONE®. A significantly higher percentage of patients continued COPAXONE® compared to the beta interferons due to perceived efficacy or lack of side effects at year four, a difference also reported at year two. Again, no differences were noted among the three beta interferon products.

"These data reinforce and extend the two-year results we recently published in the European Journal of Neurology," said principal investigator, Judith Haas, M.D., Jewish Hospital, Berlin. "Importantly, the results at four years remain robust and show significant advantage in terms of reductions in relapse rates with COPAXONE® compared to the beta interferon treatments. The quick clinical onset of action of COPAXONE®, as reported in our two-year data, and the ability of the patients to adhere to this therapy for the long-term, offer an important treatment option. This kind of data may assist people living with MS in making an informed decision with their physician about their immunomodulatory therapy. "

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 44 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 sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), 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 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.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and 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 or license their own generic products (so called "authorized generics") or successfully extend the exclusivity period of their branded products, the effects of competition on Copaxone® sales, Teva's ability to rapidly integrate the operations of acquired businesses, including its acquisition of Sicor Inc., regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to completion of appellate litigation, including that relating to Neurontin, 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, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, 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. 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.

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