Emergent BioSolutions will conduct a noninterference study, which will be used to support a postexposure prophylaxis (PEP) indication for anthrax vaccine BioThrax® under an agreement with the Biomedical Advanced Research and Development Authority (BARDA). This agreement provides the company with up to $8.43 million in additional funding.
The noninterference trial, targeted to commence in the fourth quarter of 2012, is expected to involve 120 healthy volunteers. It is designed to demonstrate noninterference 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 that preliminary data from this study will be available in the fourth quarter of 2012.
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. Individuals are not considered protected until they have completed the three-dose primary immunization series.
BioThrax is manufactured from a culture filtrate, made from a nonvirulent strain of Bacillus anthracis. To date, Emergent has reportedly delivered over 55 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 11 million doses have been administered to more than 2.7 million military personnel, according to the company.