FDA approves extending BioThrax's shelf life to 4 years

ROCKVILLE, Md. — Emergent BioSolutions Inc. announced June 10, 2009, that its BioThrax anthrax vaccine has been granted a shelf life extension from three to four years by the U.S. Food and Drug Administration.

Based on this approval, Emergent BioSolutions has achieved a contract milestone warranting a payment of approximately $30 million for doses previously delivered to the Strategic National Stockpile under the terms of the company’s existing contracts with the Department of Health and Human Services.

This amount is expected to be recognized as revenue in the second quarter of 2009. In addition, FDA approval of a four-year expiration date results in an immediate price increase for the future delivery of BioThrax doses under the current contract as well as under the multiyear contract, valued at $405 million, for the delivery of 14.5 million doses of BioThrax.

“We are pleased that the FDA has approved the four-year expiry dating of BioThrax as this extends the ability of the U.S. government to store our product in the nation’s Strategic National Stockpile,” said Fuad El-Hibri, chairman and CEO of Emergent BioSolutions.

“We are continuing our efforts to further enhance the attributes of BioThrax, including research towards a further reduction in the vaccination schedule and an expanded label indication for post-exposure prophylaxis. We believe these enhancements, if approved, will advance the U.S. government’s preparedness efforts in response to anthrax as a potential weapon of bioterrorism.”

In addition to FDA approval of four-year dating for BioThrax, in December 2008, Emergent BioSolutions received FDA approval of a reduced vaccination regimen to a five-dose schedule and a change to an intramuscular route of administration.

To date, Emergent has supplied more than 33 million doses of BioThrax to the U.S. government, with additional deliveries to the SNS scheduled through the third quarter of 2011. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics. Its development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and Chlamydia.