ECTRIMS Congress 2013
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced further results from a long-term, open-label extension study of glatiramer acetate (GA). The extension study was designed to evaluate the long-term neurologic disease course, and the safety and efficacy of glatiramer acetate 20 mg daily, the therapeutic agent in COPAXONE® (glatiramer acetate injection), which is indicated for reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS). Detailed study results will be presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark during poster session P577 on October 3, 2013.

“To our knowledge, glatiramer acetate is the only treatment for multiple sclerosis that has been prospectively studied for nearly two decades in a continuously monitored, long-term study”

“To our knowledge, glatiramer acetate is the only treatment for multiple sclerosis that has been prospectively studied for nearly two decades in a continuously monitored, long-term study,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd.

In this analysis of 74 patients, the cumulative annualized relapse rate (ARR) over the study period was 0.2, with 24.3 percent of patients remaining relapse-free through the entire observation period. Additionally, 63.3 percent of enrolled patients stayed below EDSS 4, while 79.5 percent stayed below EDSS 6 throughout the course of the study. Advancement to secondary progressive MS (SPMS), defined by a greater than 1.0-point EDSS progression (or greater than 0.5 for patients with baseline scores greater than 6) sustained for greater than or equal to 12 months without relapse, was seen in 35 patients (47 percent). Adverse events (AEs) leading to study discontinuation with incidence greater than one percent over the 20-year observation period were largely related to site reactions, while incidence of serious AEs were notably low, with no unexpected findings.