ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS) 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).
About Emergent BioSolutions
Emergent BioSolutions is a 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. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements containing the words “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including availability of funding for our U.S. government grants and contracts and our manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
