Shares of Emergent BioSolutions (EBS) gained almost 6% following the completion of a pivotal study (non-interference study), which supported the company’s efforts to expand the label of BioThrax, the sole vaccine to be cleared by the U.S. Food and Drug Administration (:FDA) for the pre-exposure prophylaxis of anthrax disease. Emergent BioSolutions is now looking to get BioThrax approved for the post-exposure prophylaxis (PEP) indication in combination with antibiotics for treating patients with suspected or confirmed exposure to anthrax spores.
The last licensure-enabling trial in Emergent BioSolutions’ BioThrax (Anthrax Vaccine Adsorbed) PEP program was designed to evaluate the pharmacokinetic profile of ciprofloxacin (an antibiotic for treating bacterial infections) when administered before and after the administration of a three-dose series of BioThrax.
The study also evaluated the immune response to BioThrax when administered with or without ciprofloxacin. Data from the study, which met its primary and secondary endpoints, did not reveal any interaction between ciprofloxacin and BioThrax. While the primary endpoints of the study were defined as the ratio of maximum concentration (Cmax) and area under the curve (:AUC) for ciprofloxacin, the secondary endpoint was the ratio of the geometric mean titer of the antibody response to BioThrax a fortnight after the last dose.
The final report of the above study has been submitted by the company to the Biomedical Advanced Research and Development Authority (:BARDA) and the FDA. Emergent BioSolutions intends to seek approval for the vaccine’s expanded indication on the basis of data from the non-interference study (funded by the BARDA) in the final quarter of 2014.
Approval for the additional indication will also be sought on the basis of data from a previously completed pivotal study, which evaluated the immunogenicity and safety of a three-dose BioThrax regimen. This study was also funded by the BARDA. Before the submission, the company will hold a meeting (pre-biologics license application (:BLA)) with the U.S. regulatory body by Jun 30, 2014. We expect investor focus to remain on updates regarding Emergent BioSolutions’ efforts to expand BioThrax’s label.
Emergent BioSolutions carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector include Ziopharm Oncology (ZIOP), Amgen (AMGN) and Alexion Pharmaceuticals (ALXN). While Ziopharm and Amgen carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).