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|FDA Accepts Emergent BioSolutions’ Supplemental Biologics License Application for Large-Scale Manufacturing of BioThrax in Building 55|
GAITHERSBURG, Md., June 17, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Emergent’s supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.
“Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually, is a response to the U.S. government’s desire to stockpile 75 million doses of a licensed anthrax vaccine,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to our continued collaboration with the U.S. government to help in its commitment to protect the nation against public health threats such as anthrax.”
The sBLA, submitted on April 15, 2016, is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. BioThrax, the only FDA-licensed anthrax vaccine, is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease.
This program is fully funded at $104 million under contract number HHSO100201000034C by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions
Safe Harbor Statement
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 the timing of and our ability to obtain and maintain approval for Building 55; appropriations for BioThrax procurement; our ability to obtain new BioThrax sales contracts or modifications to existing 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.