Rockville, MD - Emergent BioSolutions Inc. (NYSE:EBS) announced recently that it has acquired the EV-035 series of molecules from Evolva Holding SA (SIX:EVE). EV-035 is a series of novel small molecule broad spectrum antibiotics of the 4-oxoquinolizine 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, $15 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense. B. pseudomallei is a gram-negative pathogen ified 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.
"Emergent's acquisition of the EV-035 series of broad spectrum antibiotics further aligns us with the U.S. government's strategic objective of combating antibiotic-resistant bacteria, which the Administration considers a national security priority that requires continued development funding," said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. "The unique feature of the EV-035 series is that it offers the potential for commercialization of broad spectrum antibiotics to protect against multi-drug resistant strains of bacterial infections for both biodefense and commercial application."
In vitro models have shown activity of the EV-035 series of molecules in gram-negative and gram-positive bacteria, including multi-drug resistant and quinolone-resistant bacteria (e.g., Escherichia coli, Acinetobacter baumannii, Staphylococcus aureus [including methicillin-resistant S. aureus or MRSA], Streptococcus pneumoniae, Enterococcus faecalis, Pseudomonas aeruginosa, and Haemophilus influenzae) and biodefense pathogens (e.g., Burkholderia pseudomallei, Bacillus anthracis, Francisella Tularensis, and Yersinia pestis).
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 U.S. Food and Drug Administration.
About Emergent BioSolutions Emergent BioSolutions is a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.
About GC-072 GC-072 is the lead compound in the EV-035 series of broad spectrum antibiotics. It is a novel bacterial type II topoisomerase inhibitor, belonging to the chemical of 4-oxoquinolizine, showing broad-spectrum activity against pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii and Haemophilus influenzae, as well as several potential biodefense pathogens such as Burkholderia pseudomallei, Bacillus anthracis, Francisella Tularensis, and Yersinia pestis. Most importantly, GC-072 shows activity not only on drug-sensitive strains, but also on those resistant to marketed antibiotics (including quinolones). It has a favorable safety profile and has demonstrated efficacy when dosed intravenously or orally in animals.
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