Emergent BioSolutions (EBS) announced that the U.S. Food and Drug Administration (:FDA) has awarded orphan drug designation to its vaccine BioThrax for the post-exposure prophylaxis (PEP) of anthrax resulting from exposure (suspected or confirmed) to bacillus anthracis.
We note that BioThrax is the sole vaccine to be cleared by the FDA for the pre-exposure prophylaxis of anthrax disease. Emergent BioSolutions is looking to get BioThrax approved for the PEP indication in combination with antibiotics for treating patients with suspected or confirmed exposure to anthrax spores.
The FDA’s decision to grant orphan status to BioThrax for the PEP will provide multiple incentives to the company on the vaccine’s development costs for the indication. The designation is granted by the FDA to indications being developed to treat/prevent rare diseases (affecting less than 200,000 people in the U.S.) having significant unmet medical needs. Moreover, the status makes the drug eligible for seven years of marketing exclusivity in the U.S. following approval for the orphan indication.
Emergent BioSolutions intends to seek FDA approval for the vaccine’s expanded indication on the basis of data from the recently completed non-interference study in the final quarter of 2014. Emergent BioSolutions will not be required to pay the fees for the filing of the supplemental biologics license application (sBLA) as a result of orphan status granted by the U.S. regulatory body.
Before the submission, the company will hold a meeting with the U.S. regulatory body next month. The FDA designation will facilitate discussions according to the company. 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 Regeneron Pharmaceuticals (REGN), Amgen (AMGN) and Alexion Pharmaceuticals (ALXN). While Regeneron and Amgen carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).