Teva Pharma (TEVA) Reports Top-Line Results from GALA Phase III Trial for Glatiramer Acetate, Says Data Met Primary Endpoint
Tweet Send to a FriendGet Alerts TEVA Hot Sheet
Price: $39.21 -0.36%
Overall Analyst Rating:
NEUTRAL (
Up)
Dividend Yield: 3.2%
EPS Growth %: -23.8%
Overall Analyst Rating:
NEUTRAL (
Up)Dividend Yield: 3.2%
EPS Growth %: -23.8%
Trade TEVA Now!
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.
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.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
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.
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.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Janssen Pharma (JNJ) Plans Slew of Filing, Extension Submissions by FY17
- DISH Network (DISH) Remains Concerned Over National Security Interests in SoftBank/Sprint Deal
- Amazon (AMZN) Expands Kindle Fire HD into 170 Additional Markets
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
