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GAITHERSBURG, Md., March 24, 2015 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of NuThraxTM (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 U.S. 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 U.S. 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.
About Emergent BioSolutions
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. 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.
CONTACT: Investor Contact: Robert G. Burrows Vice President, Investor Relations 240-631-3280 BurrowsR@ebsi.com Media Contact: Tracey Schmitt Vice President, Global Public Affairs and Corporate Responsibility 240-631-3394 SchmittT@ebsi.com
Source:Emergent BioSolutions Inc.