FDA expands indication of Emergent BioSolutions anthrax vaccine

Emergent BioSolutions ($EBS) already supplies its anthrax vaccine to the national stockpile under a 5-year contract that could be worth up to $1.25 billion. The Maryland-based biotech can potentially expand its earnings from the jab now that the FDA has expanded the indication of BioThrax for use in adults aged 18 to 65 in conjunction with antibiotic treatment, following confirmed or suspected exposure to Bacillus anthracis.

The vaccine, BioThrax, was previously approved by the FDA in 1970 for the prevention of anthrax disease in people "at high risk of exposure." It was the first vaccine to be approved by the FDA based on animal studies. There is no other FDA-licensed vaccine for anthrax.

"Over the years, we have enhanced the features of BioThrax to include intra-muscular route of administration, a streamlined vaccination schedule, extended shelf life, and now a post-exposure prophylaxis indication," said Adam Havey, executive vice president and president of the biodefense division at Emergent BioSolutions, in a statement. "We are proud of these achievements and look forward to continuing to supply the stockpile with this important medical countermeasure."

In March, Emergent inked a $31 million deal with the Department of Health and Human Services to take its new and improved anthrax vaccine, NuThrax, through Phase III. That same week, the FDA approved the company's anthrax infection treatment Anthrasil, triggering a $7 million milestone payment from the Biomedical Advanced Research and Development Authority.

And in August, rising competitor Pfenex ($PFNX) scored a BARDA contract worth up to $143.5 million to develop its own anthrax candidate, Px563L. PharmAthene ($PIP) and Soligenix ($SNGX) are working on candidates of their own.

- here's Emergent BioSolutions' release
- and here's the FDA release