ROCKVILLE, Md. — Emergent BioSolutions Inc. announced Sept. 26, 2008, that it has signed a government contract valued at up to $29.7 million to further development of AV7909, a next generation anthrax vaccine candidate.
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 of the Department of Health and Human Services and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health.
“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 CEO 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.
AV7909 is composed of BioThrax (Anthrax Vaccine Adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909 (VaxImmune) licensed from Pfizer Inc. AV7909 was successfully tested in multiple pre-clinical studies and in a clinical trial.