Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals Neurology

 News Release - May 31, 2006

COPAXONE(R) Reduced Relapses and Stabilized Disability as Measured by Expanded Disability Status Scale, When Avonex(R) Failed

Significantly improved clinical course was observed after switching from Avonex(R)

KANSAS CITY, Mo., May 31 (HSMN NewsFeed) -- Relapsing-remitting multiple sclerosis (RRMS) patients failing Avonex® (interferon beta-1a) therapy as defined in the study, achieved significant reductions in relapse rates and in Expanded Disability Status Scale (EDSS) scores, a measure of disability, upon switching to COPAXONE® (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 percent over Avonex®, and that neurologic disability, as measured by the EDSS, did not worsen in 86 percent of patients.

"Our data demonstrated the benefits of COPAXONE® in reducing relapse rate in patients who were not effectively treated or could not tolerate other immune modulating therapies," reported Dr. Omar Khan, M.D., 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® 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® in this open-label study and followed prospectively for an additional 36 to 42 months (average 37.5 months). While on COPAXONE® 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® (glatiramer acetate injection) was reduced by 57 percent from 1.23 on Avonex® to 0.53 (p=0.0001). In the subset of patients who switched to COPAXONE® because of insufficient efficacy on Avonex® (n=62), the reduction was even more significant (61 percent), from 1.32 to 0.52 (p=0.0001). Patients who switched to COPAXONE® because of persistent toxicity on Avonex® (n=23), experienced an additional 23 percent 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® therapy, decreasing from 3.50 to 3.08 (p=0.0001). Improved or stable EDSS scores occurred in 86 percent 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, M.D., Medical Director of Health South Doctors' Hospital Multiple Sclerosis Center, which demonstrated reductions in relapse rates in patients switched from Betaseron® to COPAXONE®, 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."


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® 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. (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 and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE® (glatiramer acetate injection). COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

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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 risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, 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 under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on COPAXONE® sales, 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.

Source: Teva Pharmaceutical

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