Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md., has signed a contract with BARDA/NIAID, valued at up to $29.7 million, to fund the further development of AV7909, a next generation anthrax vaccine candidate within Emergent's portfolio of anthrax countermeasures. The three-year contract provides up to $24.9 million of funding for manufacturing of clinical lots, for non-clinical safety and efficacy studies, and for stability studies to further demonstrate that the vaccine candidate does not need refrigeration during storage, a key requirement of this vaccine development initiative. In addition, the contract provides up to $4.8 million for a Phase I clinical trial, to be funded as an option that, if exercised, would increase the value of the contract to $29.7 million.
This development contract will be jointly administered through the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).
"We are very encouraged to have signed this development contract with BARDA/NIAID in support of AV7909, one of our next generation anthrax vaccine candidates," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "We look forward to continuing to work with the U.S. Government to advance all aspects of AV7909, as it pursues a multi-prong approach in responding to the ongoing threat of bioterrorism."
This contract is in addition to and separate from:
The recently announced $24 million contract with HHS to fund continued development of an anthrax monoclonal antibody; The recently announced notification received from HHS that states the company's proposal to provide 25 million doses of a recombinant anthrax vaccine is technically acceptable and within the competitive range; and Ongoing discussions with HHS for the continued supply of BioThrax, the only vaccine licensed by the FDA for the prevention of anthrax, for the Strategic National Stockpile (SNS).
In addition to the further development of AV7909, Emergent's franchise of anthrax countermeasures includes: BioThrax - the only vaccine licensed by the FDA to prevent anthrax. More than
two million men and women of the U.S. military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS; rPA - a recombinant anthrax vaccine candidate, which...