Biotech Values

[DewDiligence]

Teva’s own PR on thrice-weekly Copaxone. Note that the comparator
in the GALA study was placebo, not the regular formulation of Copaxone.

http://finance.yahoo.com/news/teva-announces-top-line-results-120000176.html

›Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage for Glatiramer Acetate Given Three Times Weekly for Relapsing-Remitting Multiple Sclerosis

14-Jun-2012 8:41 am ETCompanies:

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (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 steps. [Notably, there is no indication of the timing of an NDA submission.]

The most commonly reported adverse events in the study were injection site reactions, headaches and nasopharyngitis. The overall frequencies of adverse events were comparable to those observed in the placebo group.

ABOUT THE STUDY

The multinational Phase III Glatiramer Acetate Low-frequency Administration (GALA) trial was designed to examine the safety, efficacy 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 patients with relapsing-remitting multiple sclerosis. The 40 mg/1 ml dose is higher than the currently marketed 20 mg/1 ml daily COPAXONE® (glatiramer acetate injection). The primary endpoint of the study is the total number of confirmed relapses during a 12-month, placebo-controlled phase.‹