Date: 2014-09-08
Type of information: Development agreement
Compound: AV7909 - dry formulation of NuThrax™ (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant)
Company: Emergent BioSolutions (USA - MD) National Institute of Allergy and Infectious Diseases (NIAID) (USA)
Therapeutic area: Infectious diseases
Type agreement: development services
Action mechanism: NuThrax is comprised of BioThrax® (Anthrax Vaccine Adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909.
Disease: post-exposure prophylaxis of anthrax infection
Details: * On September 8, 2014, Emergent BioSolutions announced 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 NuThrax™ (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 FDA. 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.
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).
Financial terms:
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