JERUSALEM--(BUSINESS WIRE)--Oct. 10, 2012-- Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. The GALA study was designed to evaluate the efficacy, safety and tolerability of an investigational dosing regimen of glatiramer acetate (GA), the therapeutic agent in COPAXONE® (glatiramer acetate injection), which is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS). Detailed study results will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France during the late-breaking news parallel session on October 13, 2012.
“We are excited about the potential to offer RRMS patients another safe and effective treatment option for this chronic and debilitating disease,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. “The GALA study demonstrates Teva’s ongoing commitment to the research and development of products aimed at meeting the specific needs of the RRMS community.”
In the GALA study, a one-year randomized, double-blind, placebo controlled study, GA 40 mg/1 ml significantly reduced annualized relapse rates (ARR) by 34.4 percent (p<0.0001) versus placebo. Additionally, a significant 34.4 percent reduction in the cumulative number of new and enlarging T2 lesions (p<0.0001) and a significant 44.8 percent reduction in the cumulative number of gadolinium-enhancing (GdE) legions (p<0.0001) was observed in patients treated with GA 40 mg/1 ml versus placebo. At 12 months, there was no significant difference in percent change of brain volume between GA and placebo. Discontinuation rates among the GA and placebo patient cohorts were comparable.
GA 40 mg/1 ml demonstrated a favorable safety and tolerability profile. The overall frequency of adverse events was comparable to those observed in the placebo group. The most commonly reported adverse events were injection site reactions, headaches and nasopharyngitis.
“The GALA study was aimed at evaluating an alternative dosing regimen of COPAXONE® (20 mg/1 ml glatiramer acetate daily subcutaneous injection), an RRMS therapy that physicians and patients have relied on for almost two decades,” said lead study author, Dr. Omar Khan, Professor and Interim Chair, Department of Neurology and Director, Multiple Sclerosis Clinical Research Center & Image Analysis Laboratory, Wayne State University School of Medicine, Detroit, MI. “The results demonstrate that GA 40 mg/1 ml injected three times weekly has the potential to provide an alternative therapeutic option for patients with RRMS, offering a higher dose of GA at a reduced injection frequency to improve patient experience, without compromising efficacy or safety.”
Further analyses are ongoing in an open-label extension of the trial through pre-planned follow-up beyond the initial 12-month placebo-controlled phase. Teva plans to work with health authorities to determine next steps.
About the GALA Study
The multinational Phase III Glatiramer Acetate Low-frequency Administration (GALA) trial was designed to examine the efficacy, safety and tolerability of glatiramer acetate (GA) 40 mg/1 ml injection administered three times a week compared to placebo in a randomized double-blind placebo-controlled design in over 1,400 patients with relapsing-remitting multiple sclerosis. Currently, COPAXONE® (glatiramer acetate injection) is marketed in a 20 mg/1 ml daily dose. The primary endpoint of the study is the total number of confirmed relapses during a 12-month, placebo-controlled phase.
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://www.sharedsolutions.com/redirect/PrescribingInformation.pdf. 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.
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Last updated on: 10/10/2012