Teva Pharmaceutical Industries Ltd. announced completion of patient enrolment for the GALA (Glatiramer Acetate Low-frequency Administration) trial. This international phase III trial in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to examine the efficacy, safety and tolerability of 40mg Copaxone (glatiramer acetate injection) administered three times a week compared to placebo. The primary endpoint of the trial is the total number of confirmed relapses during a 12-month placebo-controlled phase, which will be followed by an open-label extension phase.
Patient enrollment was completed in May 2011, recruiting over 1,400 patients at 180 sites in the United States, Europe, Central Eastern Europe and Israel. Results from the trial are expected in the second quarter of 2012.
"The GALA trial demonstrates Teva's commitment to the continued research and development of Copaxone, the global-leading RRMS therapy with 20 years of robust efficacy and safety data," said Professor Yitzhak Peterburg, Teva's group vice president, global branded products. "With glatiramer acetate 40mg three times a week, we hope to further enhance the patient experience over the long-term."
The GALA study investigates glatiramer acetate 40mg administered three times a week in comparison to placebo. This dose (glatiramer acetate 40mg) is a higher strength than the currently marketed 20mg of Copaxone injected daily.
Copaxone is currently approved in over 50 countries worldwide and is indicated for the treatment of RRMS and for patients presenting with clinically isolated syndrome (CIS). It is the worldwide market-leading RRMS treatment with a global market share of 31 per cent.
MS is a chronic, often disabling disease that attacks the central nervous system. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. In the US today, there are approximately 400,000 people with MS, with 200 more people diagnosed every week. Worldwide, MS is thought to affect more than 2.1 million people.
Copaxone 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. Copaxone (glatiramer acetate injection) is now approved in more than 50 countries worldwide, including the United States, Russia, 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. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.