SOURCE: Teva Neuroscience

June 09, 2005 08:00 ET

COPAXONE® Produced Significantly Greater Reduction in Relapse Rate Compared to Beta Interferon Therapies

Robust Treatment Effects Similar to Pivotal Trials Demonstrate Value of Retrospective Database Comparison Studies in Mirroring Clinical Practice

KANSAS CITY, MO -- (MARKET WIRE) -- June 9, 2005 -- Results from a still on-going independent study published in the European Journal of Neurology demonstrate COPAXONE® (glatiramer acetate injection) is associated with lower relapse rates than interferon therapies in patients with relapsing-remitting multiple sclerosis (RRMS). Compared to interferon beta 1b (Betaferon®), interferon beta 1a (Avonex®), and 22 microgram interferon beta 1a (Rebif® 22), COPAXONE® produced a statistically significant greater reduction in annual relapse rates at 24 months after initiation of treatment versus pre-study rates. Additionally, a significantly higher percentage of patients remained on COPAXONE® for the duration of the study compared to the beta interferons.

The open-label, non-randomized study, conducted at the Jewish Hospital, Berlin, Germany, evaluated 283 RRMS patients treated for at least six months. Patient numbers per treatment group were as follows: 79 for Avonex®, 77 for Betaferon®, 48 for Rebif® 22, and 79 for COPAXONE®. No statistical significance existed between treatment groups at baseline for gender, age, pre-study duration of disease, EDSS scores, and pre-study two-year relapse rates. Primary efficacy endpoints for the study included annualized relapse rates compared to pre-treatment baseline and across the four treatment arms, number of relapse-free patients, mean EDSS score changes, and progression rate (number of patients with a change of one step or more on EDSS). Tolerability to study medications was assessed based on dropouts due to absence of perceived efficacy or adverse reactions.

By the sixth month of the study, all treatments produced statistically significant reductions in annualized relapse rates relative to baseline. No differences were seen in the clinical onset of action among the therapies. By 12 months, COPAXONE® (glatiramer acetate injection) achieved a statistically greater relapse-rate reduction than Betaferon®, and at 24 months after initiation of treatment, relapse-rate reductions were greater with COPAXONE® (-0.81, p < 0.001) compared to all beta interferons. Although not reaching statistical significance, the percentage of relapse-free patients, 24 months after treatment initiation, was 58.2 percent for COPAXONE®, compared to 35.4, 45.5, and 45.8 percent for Avonex®, Betaferon®, and Rebif® 22, respectively. Additionally, there was a trend toward more patients remaining progression-free with COPAXONE® (based on a less than one point increase in EDSS); 87.5 percent of COPAXONE® patients compared to 74.5, 71.7, and 73.3 percent for Avonex®, Betaferon®, and Rebif® 22, respectively.

A significantly higher percentage of patients continued COPAXONE®, due to efficacy perception or lack of side effects or both, compared to the beta interferons. Highest discontinuation rates between six and 24 months were observed with Avonex®; 32.9 percent (26 patients), and the lowest with COPAXONE®; 8.9 percent (seven patients; p < 0.001).

Relapse-rate reductions in this comparative study were comparable to those previously reported in phase III placebo-controlled clinical trials with these agents at 24 months relative to baseline, supporting the validity of the observations and conclusions. Specifically, in the placebo-controlled studies, Avonex® and Betaferon® were associated with 50-percent reductions, Rebif® 22 demonstrated a 40-percent reduction, and COPAXONE® demonstrated a 60-percent reduction compared to baseline relapse rates. In the current study, relapse-rate reductions compared to pre-treatment baselines were 37 percent for Avonex®, 34 percent for Betaferon®, 43 percent for Rebif® 22, and 70 percent for COPAXONE® at 24 months. These similarities between the phase III trials and this open-label trial were noted, in spite of differing pre-study patient characteristics and different clinical courses of placebo groups. This underlines the clinical usefulness of database comparison studies in which the proven efficacy from pivotal studies is mirrored in routine practice.

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 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.

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.

Contact Information

  • Contacts:
    Melissa Nash
    Teva Neuroscience
    (816) 508-5149
    Email: Email Contact

    Mandy Levings
    Fleishman-Hillard
    (816) 512-2379
    Email: Email Contact