THURSDAY, SEPTEMBER 29, 2016

Emergent will submit anthrax vaccine sBLA to FDA

Emergent BioSolutions, a global specialty pharmaceutical company, announced on Thursday that within the next two years it will submit a supplemental biologics license application for BioThrax, the company's anthrax vaccine.

Dan Abdun-Nabi, the president and CEO of Emergent BioSolutions, hosted the company's 2013 annual stockholders meeting on Thursday to update the attendees on the current status of the company. During the meeting, Abdun-Nabi said the company anticipates it will submit the license application to the U.S. Food and Drug Administration in either late 2014 or early 2015.

"We expect if things go according to plan to be able to submit an sBLA to the FDA to secure regulatory approval, again potentially late next year or into early 2015," Abdun-Nabi said. "Within expanded capacity, we think we'll be able to address not only the U.S. market potentially growing global market for the product."

Emergent currently has a five-year contract with the U.S. Centers for Disease Control and Prevention for the delivery of 44.75 million doses of BioThrax into the Strategic National Stockpile. BioThrax is the only vaccine licensed by the FDA for prevention of anthrax and the U.S. government is the company's primary customer.

Emergent was selected as a Center for Innovations in Advance Development of Manufacturing in 2012 and could receive up to $163 million to make improvements to its Baltimore facility to develop and manufacture biological countermeasures.