Emergent BioSolutions Inc. has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company's next generation anthrax vaccine candidate. The contract, valued at $31 million, consists of a 30-month base period of performance to develop NuThrax for post-exposure prophylaxis of anthrax disease. Activities to be completed under the contract include process validation, consistency lot manufacture, assay validation, non-clinical studies, and start-up activities in preparation for the phase 3 clinical trial.

"Emergent looks forward to working with BARDA to advance the development of NuThrax towards a phase 3 study. We are committed to addressing the US government's desire for a next generation anthrax vaccine with an enhanced product profile that includes requiring fewer doses, eliciting a higher immune response, and dispensing the need for cold chain with a dry formulation," said Adam Havey, executive vice president and president biodefense division of Emergent BioSolutions. "Moving to these final stages of development is also made possible by earlier support from the National Institute of Allergy and Infectious Diseases (NIAID) for the early stage development of NuThrax, which led to the successful completion of our phase 2 clinical study. NIAID is also supporting current efforts to develop a dry formulation for this vaccine candidate."

NuThrax is comprised of BioThrax (Anthrax Vaccine Adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. In 2014, Emergent successfully concluded a randomized, parallel-group, active-controlled, double-blind phase 2 study, which was 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. The study results, which were presented at the ASM Biodefense and Emerging Diseases Research Meeting last month, suggest further study of a two-dose schedule of NuThrax in light of the favorable tolerability profile and immunogenicity response relative to three doses of BioThrax.

This contract HHSO100201500004C for the advanced development of NuThrax is funded by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (HHS). The Phase 2 clinical trial was conducted with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS under development contract number HHSN272201000035C. Contract HHSN272201400038C to develop a dry formulation of NuThrax is also administered through NIAID.

Emergent BioSolutions is a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats.