Emergent BioSolutions secures BARDA funding for BioThrax PEP indication

Emergent BioSolutions, Inc., announced on Monday that it has secured funding from the Biomedical Advanced Research and Development Authority to conduct a study for supporting a Post-Exposure Prophylaxis indication for BioThrax.

The agreement with BARDA, which exists within the office of the assistant secretary for preparedness and response in the U.S. Department of Health and Human Services, provides Emergent BioSolutions with as much as $8.43 million in added funding. BioThrax is the only vaccine that has been licensed by the U.S. Food and Drug Administration for preventing anthrax.

The non-interference study is anticipated to involve 120 healthy volunteers and is designed to show non-interference of BioThrax when given in conjunction with antibiotics. If a PEP indication of the vaccine is approved, BioThrax would then be able to be used in combination with antibiotics in people who may have been exposed to spores of anthrax. BioThrax currently only has an indication for pre-exposure prophylaxis.

Emergent has finished dosing and the final subject visit in an important PEP safety and immunogenicity study evaluating a three dose BioThrax vaccination schedule as part of its BARDA development contract. The separate study involves 200 healthy volunteers and will be used to support a PEP indication for the vaccine. Preliminary data from the study is anticipated to be available by Q4 2012.