Emergent BioSolutions has met the primary and secondary endpoints of a Phase III study evaluating a three-dose BioThrax (Anthrax Vaccine Adsorbed) regimen for post-exposure prophylaxis (PEP). The company has submitted the final study report to the Biomedical Advanced Research and Development Authority (BARDA) and the FDA and the data will be used to support a sBLA. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease, but it is not currently 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 study enrolled 200 healthy adult volunteers and was conducted at four sites in the U.S. This study is 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.