This Day On The Street
Continue to site
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

Emergent BioSolutions Advances Program Supporting Licensure Of A Post-Exposure Prophylaxis Indication For BioThrax

Emergent BioSolutions Inc. (NYSE: EBS) today announced that its pivotal Phase 3 clinical study evaluating the immunogenicity and safety of a three-dose BioThrax ® (Anthrax Vaccine Adsorbed) regimen for post-exposure prophylaxis (PEP) has been completed and has met its primary and key secondary endpoints. The company has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA) and these results will be used to support an eventual supplemental Biologics License Application (sBLA) seeking licensure of a PEP indication for BioThrax. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. BioThrax is not licensed for use in a post-exposure setting.

“Emergent’s on-time completion of this study and submission of our clinical study report represents a key milestone in our BioThrax PEP development program,” said Adam Havey, executive vice president and president of Emergent’s biodefense division. “These data represent the culmination of a multi-year effort aimed at evaluating the use of BioThrax for PEP. This work is an excellent example of the partnership between industry and the U.S. Government agencies including BARDA, FDA, the National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention.”

The Phase 3 open-label clinical study enrolled 200 healthy adult volunteers and was conducted at four sites within the U.S. Data from this study will be presented at the International Conference on Bacillus anthracis, B. cereus, and B. thuringiensis (Bacillus ACT) in September 2013. This study is fully funded under contract number HHSO100200700037C provided by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

Additionally, data from non-clinical and clinical PEP studies that preceded the Phase 3 study have been published in the July issue of Clinical and Vaccine Immunology. The publication describes pre-exposure and post-exposure vaccine efficacy study data in animal models of anthrax disease, as well as exploratory clinical vaccine immunogenicity study data. This is the first comprehensive report of animal and clinical studies evaluating efficacy and immunogenicity of a vaccine that will utilize the FDA “Animal Rule” as a pathway to licensure by demonstrating efficacy in adequate and well-controlled animal models.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is not licensed for use in a post-exposure setting. The safety and efficacy of BioThrax have not been established in pediatric or geriatric populations. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 16,790.19 +13.76 0.08%
S&P 500 1,979.92 -7.13 -0.36%
NASDAQ 4,748.3610 -32.9030 -0.69%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs