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Emergent BioSolutions Expands Biodefense Franchise; Acquires Portfolio of Broad Spectrum Antibiotics

• Lead antibiotic candidate currently under DTRA development contract, valued at up to $15 million, as an oral and IV treatment for Burkholderia pseudomallei as well as other bioterror agents
• In vitro models have shown activity of EV-035 series of molecules in multi-drug resistant and quinolone-resistant bacteria

ROCKVILLE, Md., Dec. 17, 2014 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today 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 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, $15 million contract with the Defense Threat Reduction Agency (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.

“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 class 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.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the potential opportunities of the EV-035 series of molecules and the financial impact of the transaction on our financial guidance, and any other statements containing the words “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to successfully integrate the business and realize the benefits of the transaction; appropriations for BioThrax^® procurement; our ability to obtain new BioThrax sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax; availability of funding for our U.S. government grants and contracts; our ability to identify and acquire or in-license products or late-stage product candidates that satisfy our selection criteria; whether anticipated synergies and benefits from an acquisition or in-license are realized within expected time periods or at all; our ability to enter into selective collaboration arrangements; our ability to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; and our commercialization, marketing and manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.