Biopharmaceutical company Emergent BioSolutions [EBS] received a potential five-year, $186.6 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to resume development of a next-generation recombinant protective antigen (rPA) anthrax vaccine product candidate. The initial award is for $51 million for a two-year base period that will fund activities related to process characterization and assay validation, as well as formulation and stability studies. The award comes more than two years after Emergent acquired the assets and rights to an rPA anthrax vaccine product candidate and related technology from VaxGen [VXGN] for $2 million, plus $8 million in potential milestone payments. BARDA also has separate advanced research and development contracts with PharmAthene [PIP] and Pfenex for rPA-based anthrax vaccines. VaxGen, largely on its own dime, had been developing the rPA-based vaccine under a potential $877 million contract awarded in 2004 from the Department of Health and Human Services (HHS) has as part of Project BioShield. BARDA is part of HHS. That contract was terminated for default by HHS in Dec. 2006 because VaxGen was unable to begin clinical trials of the drug that month as required, which in turn were being held up because the Food and Drug Administration had concerns about the vaccine candidate’s stability in storage. For VaxGen, that was basically the end of its efforts to develop the anthrax vaccine because under the contract terms the company was only going to be paid when it delivered the vaccine. Emergent’s new contract is cost-plus, meaning that the government will share in the development risk. The goal of the advanced R&D contracts is to advance products to the stage of development where they would potentially qualify for a procurement contract under BioShield.
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