Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, to conduct a non-interference study to be used to support a Post-Exposure Prophylaxis (PEP) indication for BioThrax ® (Anthrax Vaccine Adsorbed). This agreement provides the company with up to $8.43 million in additional funding. The non-interference trial, targeted to commence in the fourth quarter of 2012, is expected to involve 120 healthy volunteers and is designed to demonstrate non-interference of BioThrax when administered in conjunction with antibiotics. Approval of a PEP indication would enable BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax only has a pre-exposure prophylaxis indication.
Separately, under its development contract with BARDA, Emergent has completed dosing and the last subject visit in a pivotal PEP immunogenicity and safety study evaluating a three-dose vaccination schedule for BioThrax. Data from this study, which involves 200 healthy volunteers, will also be used by the company in support of a PEP indication for BioThrax. The company anticipates preliminary data from this study will be available in the fourth quarter of 2012.
These studies are fully funded under contract number HHSO100200700037C, provided by the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services.
About Emergent BioSolutions Inc.Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com. 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. The safety and efficacy of BioThrax in a post-exposure setting have not been established. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV