Emergent BioSolutions initiates Phase 2 study to evaluate BioThrax Emergent BioSolutions announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax when administered in conjunction with antibiotics. This non-interference study will be used to support a supplemental Biologics License Application seeking licensure of a Post-Exposure Prophylaxis indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. The primary objective of this Phase 2 study is to evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic prior to and following the administration of a 3-dose series of BioThrax. Preliminary data from this study are expected in the fourth quarter of 2013.
Emergent BioSolutions receives FDA approval of Anthrasil Emergent BioSolutions announced that the FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous, also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Achievement of this milestone triggers a $7M payment to the company under a development contract with the Biomedical Advanced Research and Development Authority. Anthrasil has received Orphan Drug designation and as a result of this approval, the product qualifies for seven years of market exclusivity.