Emergent BioSolutions Inc. ( EBS ) 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.
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 2013.
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 Jazz Pharmaceuticals ( JAZZ ), Santarus, Inc. ( SNTS ) and Targacept, Inc. ( TRGT ) currently look better positioned with a Zacks Rank #1 (Strong Buy).