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Emergent BioSolutions secures funding from BARDA for anthrax vaccine

Monday, June 4, 2012

Emergent BioSolutions of Rockville, Md., has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to conduct a non-interference study to be used to support a post-exposure prophylaxis (PEP) indication for BioThrax, an adsorbed anthrax vaccine.

The agreement provides Emergent with up to $8.43 million in additional funding. The non-interference trial, targeted to commence in the fourth quarter of 2012, is expected to involve 120 healthy volunteers and is designed to demonstrate non-interference 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 preliminary data from this study will be available in the fourth quarter of 2012.

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