Emergent BioSolutions Awarded $29M 5-Year Contract To Develop A Dry Formulation Of NuThrax, A Next Generation Anthrax Vaccine

Emergent BioSolutions Inc.

announced today that it has signed a contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop a dry formulation of NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, the company's next generation anthrax vaccine candidate. This five-year contract, valued at up to $29 million, provides funding for manufacturing and non-clinical activities through the preparation of an Investigational New Drug application to the U.S. Food and Drug Administration. The dry formulation of NuThrax is intended to increase stability of the vaccine candidate at ambient and higher temperatures, with the objective of eliminating the need for cold chain during shipping and storage. “Emergent is pleased with NIAID's continued support of the development of NuThrax, which we anticipate will demonstrate an enhanced product profile that includes requiring fewer doses, eliciting a higher immune response, and dispensing the need for cold chain due to a dry formulation,” said Adam Havey, executive vice president and president biodefense division of Emergent BioSolutions. “We are committed to responding to the U.S. government's needs to combat the ongoing threat of bioterrorism.” NuThrax is comprised of BioThrax® (Anthrax Vaccine Adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. The company is currently conducting a randomized, parallel-group, active-controlled, double-blind Phase 2 study designed to evaluate the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two- and three-dose immunization schedules and two dose levels. This development contract HHSN272201400038C will be administered through NIAID, part of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS).