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 R&D Authority (BARDA) 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.
Daniel Abdun-Nabi, president and COO of Emergent BioSolutions, said: “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. We look forward to continuing to work with the US government to advance all aspects of AV7909, as it pursues a multi-prong approach in responding to the ongoing threat of bioterrorism.”