Emergent BioSolutions Inc.
) recently announced positive results from its phase III study
(n=200) on BioThrax. The phase III study was evaluating the
immunogenicity and safety of BioThrax (three-dose regimen) for
post-exposure prophylaxis (PEP). The study met both its primary
and secondary objectives.
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Emergent has already submitted the final results from the phase
III study to the Biomedical Advanced Research and Development
Authority (BARDA) and the US Food and Drug Administration (FDA)
to support its supplemental Biologics License Application (sBLA)
for BioThrax. Emergent is looking to expand BioThrax' label into
the PEP indication.
We note that BioThrax is the only US approved vaccine for the
prevention of anthrax disease. The company's product sales come
solely from the sale of BioThrax to the US government.
Emergent currently has a contract with the Centers for Disease
Control and Prevention, which is an operating division of the US
Department of Health and Human Services. As per the contract,
Emergent will supply 44.75 million doses of BioThrax for a five
year period. We also note that BioThrax is yet to be licensed in
a post-exposure setting.
Emergent generated product sales of $30.4 million in the first
quarter of 2013, decreasing 11.6% from the first quarter of 2012.
Emergent expects to record product sales of $230−$240 million in
Meanwhile, Emergent received encouraging news from the
Paul-Ehrlich-Institut (Agency of the German Federal Ministry of
Health) earlier this month, when BioThrax' marketing
authorization application was approved for the prevention of
anthrax disease. With the approval, BioThrax became the only
approved vaccine for the treatment of anthrax disease in Germany.
Emergent presently carries a Zacks Rank #3 (Hold). However,
pharma stocks such as
) currently look better positioned with a Zacks Rank #1 (Strong