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Emergent (EBS) BioThrax sBLA Accepted for FDA Review
Emergent BioSolutions, Inc. (EBS - Free Report) announced that its supplemental Biologics License Application (sBLA) for manufacturing BioThrax (anthrax vaccine adsorbed) in Building 55 has been accepted for review by the FDA.
The agency has provided a Prescription Drug User Fee Act (PDUFA) action date of Aug 15, 2016.
Notably, Building 55 is located at the company’s manufacturing facility in Lansing, MI. The company believes that Building 55 has the potential to expand BioThrax manufacturing capacity to an estimated 20–25 million doses a year. In addition, manufacturing BioThrax at Building 55 will enable the company to meet government’s goal of stockpiling 75 million doses of a licensed anthrax vaccine.
The company said that the program is funded at $104 million by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response under the U.S. Department of Health and Human Services.
We note that BioThrax is the only FDA-licensed vaccine for anthrax. In the U.S., it is indicated for the treatment of both pre-exposure and post-exposure prophylaxis of anthrax. Last week, the FDA granted Orphan Drug status to BioThrax for post-exposure prophylaxis of anthrax, resulting from exposure (suspected or confirmed) to bacillus anthracis, thereby providing it seven years of marketing exclusivity through Nov 2022.
We remind investors that the company has initiated a tax-free spin-off of its Biosciences business into a separate publicly traded company, Aptevo Therapeutics. Aptevo will focus on cancer and hematology treatments, while Emergent BioSolutions will continue to operate as a specialty biopharmaceutical company. The spin-off is anticipated to close shortly.
Emergent BioSolutions currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
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