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April 21, 2014
07:08 EDTEBSEmergent 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.
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December 17, 2014
07:10 EDTEBSEmergent BioSolutions acquires antibiotics portfolio
Emergent BioSolutions announced that it has acquired the EV-035 series of molecules from Evolva Holding SA. EV-035 is a series of novel small molecule broad spectrum antibiotics of the 4-oxoquinolizine class and targets bacterial type IIa topoisomerase. The lead molecule in the series, GC-072, has demonstrated protection in vivo from lethal B. pseudomallei infection when administered orally. GC-072 is being developed as a potential oral and IV treatment for B. pseudomallei under a three-year, $15M contract with the Defense Threat Reduction Agency, or DTRA, of the U.S. Department of Defense. B. pseudomallei is a gram-negative pathogen classified by the Centers for Disease Control and Prevention as a Category B bioterrorism agent and a priority threat capable of being easily weaponized and disseminated. The scope of the DTRA contract includes investigating GC-072 as a treatment for B. pseudomallei in preclinical in vitro and in vivo studies, conducting formulation, manufacturing and toxicology studies, exploring efficacy in additional multi-drug resistant biodefense and commercial pathogens, and preparing an Investigational New Drug application for submission to the FDA.
05:24 EDTEBSEmergent BioSolutions to acquire EV-035 series from Evolva
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