Emergent Biosolutions Reveals sBLA Submission To FDA To Make BioThrax In Building 55

Emergent Biosolutions Inc EBS submitted a supplemental Biologics License Application or sBLA to the FDA that sought approval to manufacture BioThrax in Building 55. It was the big manufacturing facility for the company.

Emergent Biosolutions said that its sBLA was driven by data that indicated that BioThrax manufactured at a big scale in Building 55 was comparable to that of the drug manufactured in the currently-licensed facility. The company indicated the submission came on the heels of a successful completion of its re-analysis of data from comparability assays made in the new facility as sought by the regulator.

The company's EVP of biodefense division Adam Havey said, "Emergent is pleased to have reached this significant milestone in our BioThrax comparability program. Anticipating that a typical FDA review of such a submission is four months, we expect the review process to be completed in the fall of this year."

He said further, "We believe that our submission conveys the robustness of our large-scale manufacturing process, the comparable product attributes, and the efficacy and consistency of the product from our new facility, supported by a variety of developmental and pivotal nonclinical studies. This milestone reflects many years of steadfast dedication from our project team and their effective collaboration with the U.S. government."

Currently, BioThrax was the only FDA-licensed anthrax vaccine. The company indicated its Building 55 has the potential to expand manufacturing capacity of BioThrax to an estimated 20 to 25 million doses every year from the seven to nine million doses produced on an annualized basis from its currently-licensed facility.

On Friday, the stock closed higher by 2.33 percent.