Emergent Wins FDA Approval Extending Shelf Life of BioThrax To 4 Years

Emergent has announced that BioThrax (Anthrax Vaccine Adsorbed) has been granted a shelf life extension from 3 to 4 years by the FDA.

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

In addition, FDA approval of 4-year expiry dating results in an immediate price increase for the future delivery of BioThrax doses valued at $405 million, for the delivery of 14.5 million doses of BioThrax.

Fuad El-Hibri, Chairman and CEO of Emergent, said: “We are pleased that the FDA has approved the 4-year expiry dating of BioThrax as this extends the ability of the US government to store our product in the nation’s Strategic National Stockpile.”

“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 US government’s preparedness efforts in response to anthrax as a potential weapon of bioterrorism,” he added.