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|September 18, 2008 3:19 p.m.|
|Longest Prospective Study in MS Confirmed Robust Clinical Benefits and Safety of Copaxone®|
More than 80 percent of patients were able to walk unassisted following 15 years of treatment and average disease duration of 22 yearsJerusalem, Israel, September 18, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced new data from the longest prospective study of treatment to relapsing-remitting multiple sclerosis (RRMS), which proves robust efficacy and safety of COPAXONE® (glatiramer acetate injection). Findings demonstrated that more than 80 percent of patients were able to walk unassisted following 15 years of treatment and average disease duration of 22 years. The majority of the 100 patients in the study experienced either stable or improved disability rates over the duration of the study, as measured by the Expanded Disability Status Scale (EDSS), as well as a 78 percent reduction in annualized relapse rate (ARR) from baseline. These data further confirm the benefits of long-term, daily use of COPAXONE® in treating the RRMS, while reinforcing the already established excellent safety profile of the therapy.
Based on the positive results of these data, patients will continue to be followed to 20 years of treatment.
"These data are of value to the MS community, as they reassure the ability of COPAXONE to effectively slow the natural progression of this disease using daily treatment" said Corey Ford, M.D., Ph.D., University of New Mexico and primary investigator of the study. "Until we find a cure for multiple sclerosis, patients and physicians need a treatment that can safely provide a clinical benefit over the long-term" he added.
These data were presented today at the World Congress on Treatment and Research in Multiple Sclerosis, the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS, in Montreal, Canada.
About the Study
The study "Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15-Year Analysis of the U.S. Prospective Open-label Study of Glatiramer Acetate," a follow up to the pivotal, Phase III trial, followed 100 ongoing COPAXONE® patients through February, 2008. Patients' EDSS scores were evaluated every 6 months. Confirmed disability progression was defined as 1.0 EDSS point increase sustained for 6 months. Patients were classified as "stable/improved" if EDSS score changes were less or equal to 0.5 points. Proportions of patients who reached confirmed thresholds of EDSS 4, 6, or 8 while on COPAXONE®, and Kaplan-Meier (KM) estimates of median times to these thresholds were obtained.
The study looked at both patients who received COPAXONE® treatment ongoing for an average of 13.6+1.3 years, as well as patients in a modified intention-to-treat (mITT) cohort (n=232), who received at least one dose of COPAXONE®, with an average treatment duration of 8.6+5.2 years.
The ARR for the ongoing patient cohort declined from 1.12+/-0.82 to 0.250.34/year, and 57 percent of patients experienced either stabilized or improved EDSS scores. While being treated with COPAXONE®, the mITT patients' ARR declined from 1.18+/-0.82 to 0.43+/-0.58/year; 54 percent of patients experienced stable/improved EDSS with COPAXONE® treatment.
The estimated time for one quartile of patients in the mITT group to reach an EDSS of 4 was, on average, 3.98 years, versus 6.8 years for those patients who remained on COPAXONE® throughout the study. In both cohorts, less than 25 percent of patients reached EDSS of 6 and 8.
COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® 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.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.
Teva's 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 our 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: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra® , Neurontin®, Lotrel® and Protonix®, the effects of competition on our innovative products, especially 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 Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").