Phase III Data Published in Annals of Neurology Show That a Higher Concentration Dose of Glatiramer Acetate Given Three Times a Week Reduced Annualized Relapse Rates in the Treatment of Relapsing-Remitting Multiple Sclerosis

Teva Pharmaceutical Industries Ltd. TEVA announced today that data from the Glatiramer Acetate Low-frequency Administration (GALA) study, published in the Annals of Neurology, show that a 40mg/ 1mL dose of COPAXONE® (glatiramer acetate injection) administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for COPAXONE® is 20mg/ 1mL, which is a once a day subcutaneous injection. The GALA study, a multinational, phase III, double blind, placebo controlled study, was designed to evaluate the efficacy, safety and tolerability of an investigational 40mg/ 1mL dose of GA given three times a week over a period of 12 months for the treatment of RRMS. The published data show that glatiramer acetate (GA) 40mg/ 1 mL injections administered three times a week reduced annualized relapse rates by 34.0% (p<0.0001), reduced the cumulative number of new and enlarging T2 lesions by 34.7% (p<0.0001) when measured at six and 12 months, and the cumulative number of gadolinium enhancing lesions by 44.8% (p<0.0001) when measured at six and 12 months, as compared to placebo in patients with RRMS. “We are pleased with the positive data of the GALA study which may lead to meaningful benefits for RRMS patients,” said lead study author Omar Khan, M.D., Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI. “COPAXONE® 40mg/ 1 mL given three times a week demonstrated a favorable safety and tolerability profile, with the overall frequency of adverse events comparable to those seen in the placebo group.” The most common adverse event in the GA group was injection site reactions (35.5% with GA vs. 5.0% with placebo). About the Study The objective of the GALA study was to assess the efficacy and safety of glatiramer acetate (GA) 40mg/ 1mL administered three times weekly (tiw) compared with placebo in patients with relapsing–remitting multiple sclerosis (RRMS). This randomized, double-blind study was conducted in 142 sites in 17 countries. Patients with RRMS with at least one documented relapse in the 12 months before screening, or at least two documented relapses in the 24 months before screening, and an Expanded Disability Status Scale score ≤ 5.5, were randomized 2:1 to receive either subcutaneous (sc) GA 40mg/ 1mL tiw or placebo for 12 months. Of 1,524 patients screened, 1,404 were randomized to receive GA 40mg/ 1mL sc tiw (n = 943) or placebo (n = 461). Ninety-three percent and 91% of patients in the placebo and GA groups, respectively, completed the 12-month study. GA 40mg/ 1mL tiw was associated with a 34.0% reduction in risk of confirmed relapses compared with placebo (mean annualized relapse rate = 0.331 vs 0.505; p < 0.0001). Patients who received GA 40mg/ 1mL tiw experienced highly significant reduction (p < 0.0001) in the cumulative number of gadolinium-enhancing T1 (44.8%) and new or newly enlarging T2 lesions (34.7%) at months 6 and 12. GA 40mg/ 1mL tiw was safe and well tolerated. The most common adverse events in the GA group were injection site reactions (35.5% with GA vs 5.0% with placebo). About COPAXONE® COPAXONE® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at http://copaxone.com/pdfs/PrescribingInformation.aspx. For hardcopy releases, please see enclosed full prescribing information. COPAXONE® is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.