Emergent BioSolutions, Inc., announced on Friday that it has signed a multi-year contract for the advanced development and delivery of NuThrax (vaccine adsorbed with CPG 7909 adjuvant), the company’s next-generation anthrax vaccine candidate.
The contract, signed with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to develop NuThrax for post-exposure prophylaxis of anthrax disease is valued at approximately $200 million.
NuThrax consists of BioThrax (anthrax vaccine adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. Safety, efficacy and stability for NuThrax were established through several Phase 1 and Phase 2 clinical studies.
The contract also requires Emergent to deliver an initial two million doses of NuThrax to the Strategic National Stockpile (SNS) following emergency use authorization (EUA) pre-approval by the U.S. Food and Drug Administration (FDA). Emergent anticipates that NuThrax could be authorized for emergency use by the FDA as early as 2018, triggering deliveries of NuThrax to the SNS in 2019.
“Emergent is pleased that BARDA has selected NuThrax to address the U.S. government’s desire for a next generation anthrax vaccine with an enhanced product profile that includes requiring fewer doses and eliciting a faster immune response,” Daniel J. Abdun-Nabi, president and CEO of Emergent BioSolutions, said. “We look forward to collaborating with BARDA to further develop NuThrax towards an EUA-eligible product for the SNS and subsequently towards FDA licensure.”
The contract includes procurement options for the delivery of an additional 7.5 million to 50 million doses of NuThrax to the SNS that is valued from approximately $255 million up to $1.4 billion, respectively, as well as options for an additional clinical study and post-marketing commitments valued at $48 million. If both options are exercised in full, the total contract value would increase to up to $1.6 billion.
Activities to be completed under the based period of performance according to the contract include licensure-enabling non-clinical and clinical studies, the manufacture and delivery of initial doses to the SNS, and the submission of a Biologics License Application to the FDA with an expected FDA-licensure under the Animal Rule.
Emergent has received five grants and contracts funded by BARDA and the National Institute of Allergy and Infectious Diseases since 2008, totaling approximately $127 million for the early stage and advanced development of NuThrax, including the development of a dry formulation for the vaccine candidate.