Emergent receives BioThrax orphan drug designation Emergent BioSolutions that the U.S. Food and Drug Administration has granted orphan drug designation to BioThrax for post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. This designation provides incentives to the BioThrax PEP Program, including the waiver of the Biologics License Application supplemental regulatory filing fee and marketing exclusivity of up to seven years. Emergent recently announced completion of a non-interference study, results from which will be used to support a supplemental BLA seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. This study is fully funded under contract number HHSO100200700037C provided by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Emergent BioSolutions task order shows capabilities, says Summer Street Summer Street says the task order from the U.S. government regarding the manufacturing of ZMapp for treating Ebola shows Emergent BioSolutions' manufacturing capabilities and its working relationship with the government. The firm estimates the contract could be in the multi-$100M range and come as early as Q4, but admits it does not know who will win it. Summer Street views Emergent as undervalued and reiterates a Buy rating on the name with a $35 price target.