Healthcare Industry News: sanofi-aventis
News Release - May 8, 2006
Long-Term Copaxone(R) Study Showed 92% of Multiple Sclerosis Patients Were Still Walking Unaided After a Mean of 10 Years on Treatment10-Year Data from the Longest Continuous Prospective Study of Any MS Drug
KANSAS CITY, Mo., May 8 (HSMN NewsFeed) -- Data from a 10-year long-term study showed that 92 percent of relapsing-remitting multiple sclerosis (RRMS) patients in the study who remained on COPAXONEŽ (glatiramer acetate injection) were still walking without assistance despite an average disease duration of more than 15 years. These results were published in the June 2006 issue of the journal Multiple Sclerosis, which was mailed today.
This study represents the only prospective, open-label follow-up of more than 10 years' duration designed to evaluate continuous immunomodulatory therapy in RRMS patients. The study has been extended to 15 years.
"COPAXONEŽ provides RRMS patients with a treatment option that has demonstrated long-term efficacy and safety," said Corey Ford, M.D., PhD, Associate Professor of Neurology, Director of the Multiple Sclerosis Specialty Clinic and Medical Director of Pharmacy at the University of New Mexico Health Sciences Center and an investigator in the study. "Results of the study are consistent with the presumed mechanism of action of COPAXONEŽ, which appear to treat inflammation and neurodegeneration, the underlying pathologies of multiple sclerosis."
Patients who remained in the study and were on COPAXONEŽ had a relapse rate reduction of more than 80 percent over a mean of 10 years in the trial. On average, patients experienced only one relapse every five years compared to an average of 1.18 attacks a year before entering the study.
A favorable safety profile was maintained over the course of the study. The most common adverse events associated with COPAXONEŽ were local injection-site reactions and immediate post- injection reactions. No other immune- mediated disorders, infections, or malignancies were reported.
This study of COPAXONEŽ (glatiramer acetate injection) in 251 RRMS patients began in 1991 as a double-blind, placebo-controlled trial in which patients were randomized to receive either COPAXONEŽ 20 mg or placebo by subcutaneous injection daily for a mean of 30 months. A total of 232 patients (125 COPAXONEŽ and 107 placebo, the modified intent-to-treat cohort, or mITT) were evaluated in this analysis.
After double-blind treatment, all patients were offered COPAXONEŽ as part of an ongoing, prospective, open- label study. All of the original 11 U.S. study sites participated, and these patients were evaluated every six months. Patients were also examined, usually within seven days, if they experienced symptoms suggestive of a relapse. After 10 years, 108 patients of the 232 remained in the study on COPAXONEŽ.
Investigators looked at the percentage of patients who progressed to Kurtzke Expanded Disability Status Scale (EDSS) 4 -- a stage at which they were still ambulatory despite moderately severe disability; EDSS 6 -- a level at which a cane, crutch or brace is required for mobility; and EDSS 8 -- a state in which the patient is wheelchair-bound.
At the start of COPAXONEŽ treatment, patients had an average EDSS score of 2.79. At 10 years, the ongoing patient group on COPAXONEŽ showed significantly decreased accumulation of disability, with 24 percent of patients reaching EDSS 4, eight percent reaching EDSS 6 and only one percent reaching EDSS 8 compared with 68 percent, 50 percent and 10 percent respectively in the withdrawn with long-term follow-up visit (LTFU) cohort.
The 50 patients who withdrew from the trial and returned for the 10-year LTFU showed significantly increased disability compared with ongoing patients treated with COPAXONEŽ. The mean increase in EDSS score was 2.24 points in those patients who withdrew compared with a 0.50 point increase in patients remaining on COPAXONEŽ (p<0.0001). Similarly, 62 percent of the ongoing COPAXONEŽ patients had stable or improved EDSS scores.
"The results from this trial and the fact that patient safety was maintained over time make these data clinically useful for the MS community," said Ford. "No other immunomodulatory agents used to treat multiple sclerosis have been followed continuously for as long as COPAXONEŽ."
After a mean of 10 years, patients who continued COPAXONEŽ treatment showed significantly less disability than those who withdrew from the study and returned for the long-term follow-up visit. This was evaluated using the EDSS.
"COPAXONEŽ was shown to maintain efficacy over the long term. As a group, the patients who remained in the study had no significant changes in EDSS -- even after 10 years of treatment," said Ford.
Current data suggest COPAXONEŽ (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONEŽ is indicated for the reduction of the frequency of relapses in RRMS.
The most common side effects of COPAXONEŽ are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONEŽ is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONEŽ is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONEŽ is marketed by Teva Neuroscience, Inc.
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 COPAXONEŽ. COPAXONEŽ is a registered trademark 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 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 AllegraŽ, NeurontinŽ, OxycontinŽ and ZithromaxŽ, the effects of competition on CopaxoneŽ (glatiramer acetate injection) 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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