Emergent (EBS) BioThrax Gets Orphan Status In The U.S.

Emergent BioSolutions, Inc. (NYSE:EBS) announced that the FDA has granted Orphan Drug status to BioThrax (anthrax vaccine adsorbed) for post-exposure prophylaxis of anthrax, resulting from exposure (suspected or confirmed) to bacillus anthracis.

The status offers seven years of marketing exclusivity to BioThrax in the U.S. through Nov 2022. It is granted to drugs that have the potential to treat diseases that affect less than 200,000 people in the U.S.

Currently, BioThrax is the only FDA-licensed vaccine for anthrax. It is indicated in the U.S. for the treatment of both pre-exposure and post-exposure prophylaxis of anthrax.

We note that in Apr 2016, Emergent BioSolutions submitted a supplemental Biologics License Application (sBLA) in the U.S., seeking a regulatory nod for manufacturing BioThrax in Building 55, the company’s large-scale manufacturing facility. The company believes that Building 55 has the potential to expand manufacturing capacity to an estimated 20–25 million doses a year, from the 7–9 million doses produced out of the current licensed facility.

We remind investors that the company has initiated a tax-free spin-off of the 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. This 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 (NYSE:BMY) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Pfizer Inc. (NYSE:PFE) , each sporting a Zacks Rank #1 (Strong Buy).

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