) 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
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.
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
). While Regeneron and Amgen carry a Zacks Rank #1 (Strong Buy),
Alexion holds a Zacks Rank #2 (Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis
AMGEN INC (AMGN): Free Stock Analysis Report
EMERGENT BIOSOL (EBS): Free Stock Analysis
REGENERON PHARM (REGN): Free Stock Analysis
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