Maryland's Emergent BioSolutions ($EBS) won FDA approval for an injected treatment for anthrax infection, expanding the company's stable of biodefense products.
The treatment, to be sold as Anthrasil, is made from the plasma of people already vaccinated against anthrax, containing antibodies that neutralize the bacteria. Emergent picked up Anthrasil in its $222 million acquisition of Cangene in 2013, inheriting a $160 million contract with the federal Biomedical Advanced Research and Development Authority (BARDA). With the approval, BARDA is handing over a $7 million milestone payment, Emergent said.
Anthrasil is approved as a treatment for inhalational anthrax, a rare occurrence that usually results from exposure to contaminated plants and animals, according to the FDA. The approval is based largely on nonclinical data because, for ethical reasons, Emergent never tested Anthrasil for efficacy on humans. The plasma treatment did prove itself well tolerated in a safety study on healthy human volunteers, the agency notes.
The latest approval, coupled with BARDA's plans to stockpile Anthrasil, gives Emergent more cash to fund its pipeline of non-biodefense treatments. The company is at work on a Phase III factor-replacement therapy for hemophilia B, a Phase II antibody for leukemia and, under a $183 million collaboration with MorphoSys, an early-stage prostate cancer treatment.
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