This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

Teva To Present Positive Data For Glatiramer Acetate 40 Mg/1 Ml Given Three Times Weekly For Relapsing-Remitting Multiple Sclerosis

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. The GALA study was designed to evaluate the efficacy, safety and tolerability of an investigational dosing regimen of glatiramer acetate (GA), the therapeutic agent in COPAXONE ® (glatiramer acetate injection), which is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS). Detailed study results will be presented at the 28 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France during the late-breaking news parallel session on October 13, 2012.

“We are excited about the potential to offer RRMS patients another safe and effective treatment option for this chronic and debilitating disease,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. “The GALA study demonstrates Teva’s ongoing commitment to the research and development of products aimed at meeting the specific needs of the RRMS community.”

In the GALA study, a one-year randomized, double-blind, placebo controlled study, GA 40 mg/1 ml significantly reduced annualized relapse rates (ARR) by 34.4 percent (p<0.0001) versus placebo. Additionally, a significant 34.4 percent reduction in the cumulative number of new and enlarging T2 lesions (p<0.0001) and a significant 44.8 percent reduction in the cumulative number of gadolinium-enhancing (GdE) legions (p<0.0001) was observed in patients treated with GA 40 mg/1 ml versus placebo. At 12 months, there was no significant difference in percent change of brain volume between GA and placebo. Discontinuation rates among the GA and placebo patient cohorts were comparable.

GA 40 mg/1 ml demonstrated a favorable safety and tolerability profile. The overall frequency of adverse events was comparable to those observed in the placebo group. The most commonly reported adverse events were injection site reactions, headaches and nasopharyngitis.

“The GALA study was aimed at evaluating an alternative dosing regimen of COPAXONE ® (20 mg/1 ml glatiramer acetate daily subcutaneous injection), an RRMS therapy that physicians and patients have relied on for almost two decades,” said lead study author, Dr. Omar Khan, Professor and Interim Chair, Department of Neurology and Director, Multiple Sclerosis Clinical Research Center & Image Analysis Laboratory, Wayne State University School of Medicine, Detroit, MI. “The results demonstrate that GA 40 mg/1 ml injected three times weekly has the potential to provide an alternative therapeutic option for patients with RRMS, offering a higher dose of GA at a reduced injection frequency to improve patient experience, without compromising efficacy or safety.”

Further analyses are ongoing in an open-label extension of the trial through pre-planned follow-up beyond the initial 12-month placebo-controlled phase. Teva plans to work with health authorities to determine next steps.

Stock quotes in this article: TEVA 

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
DOW 16,262.56 +89.32 0.55%
S&P 500 1,842.98 +12.37 0.68%
NASDAQ 4,034.1610 +11.4670 0.29%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs