Published on June 15, 2012 at 2:51 AM
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
positive top-line results from the GALA (Glatiramer Acetate
Low-Frequency Administration) Phase III clinical trial assessing the
efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate
injection (GA) administered subcutaneously three times a week compared
to placebo in relapsing-remitting multiple sclerosis (RRMS) patients.
Study results showed that GA 40 mg/1 ml significantly reduced disease
activity, while maintaining a favorable safety and tolerability profile.
The one-year randomized, double-blind placebo-controlled study recruited
more than 1,400 patients at 155 multinational sites. Results showed that
GA 40 mg/1 ml met the study's primary endpoint by significantly reducing
the annualized relapse rate (ARR) by 34.4 percent compared to placebo
(p<0.0001). Initial analysis of the data indicates that secondary
clinical endpoints were achieved, with the exception of reduction in
brain atrophy. Following the initial 12-month, placebo-controlled phase,
there will be an ongoing open-label extension of the trial.
"We are pleased with the results of this study that show the potential
of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe
treatment option with COPAXONE® using a more convenient dosing regimen"
said Serge Stankovic, Senior Vice President of Clinical Research, Global
Branded R&D, Teva Pharmaceutical Industries Ltd. "We remain focused on
the continued research and development of products aimed at improving
the treatment experience for patients with MS."
Further analyses of the GALA study data are ongoing, and detailed
results will be presented to the scientific community in the near
future. Teva plans to work with health authorities to determine next
Source: Teva Pharmaceutical Industries Ltd.