LEXINGTON, Mass.--(BUSINESS WIRE)-- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it submitted a Clinical Trial Application (CTA) to the Dutch Competent Authority and Ethics Committee to initiate a first-in-human study of CB-618 in the Netherlands. Discovered by Cubist, CB-618 is a novel, broad-spectrum beta-lactamase inhibitor (BLI) investigational compound. Based on in vitro studies, CB-618 has been shown to increase the spectrum of activity of certain beta-lactam antibiotics. (Beta-lactamases are enzymes produced by some bacteria that provide resistance to certain beta-lactam antibiotics.)

If approved by the Dutch Competent Authority and Ethics Committee, Cubist plans to conduct the proposed initial study during the first half of 2014. The purpose of the proposed study will be to evaluate the safety, tolerability and pharmacokinetics of CB-618 administered as single and multiple doses. The overall goal of the CB-618 development program is to enhance the spectrum of activity of beta-lactam antibiotics against resistant pathogens. CB-618 is part of a platform research approach by Cubist to identify new BLIs, which could potentially restore and expand the clinical utility of certain existing antibiotics. CB-618 is a product of research and development efforts at Cubist to combat multidrug resistance in Gram-negative pathogens.

"We are excited to announce a new compound discovered at Cubist which has the potential to address unmet medical needs. If successful, CB-618 could help combat resistance to certain beta-lactam antibiotics and serious infections, such as those caused by carbapenem-resistant bacteria, including CRE, and other resistant pathogens, which are a growing threat globally," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "We look forward to working with global regulatory authorities on pathways to advance into the clinic and potentially streamline development of this beta-lactamase inhibitor."

The filing of clinical trial and investigational new drug applications from the Company's own discovery efforts is part of Cubist's five-year strategic goals - Building Blocks of Growth - announced in 2012. Cubist is taking a comprehensive approach to the discovery of new antibiotics to treat serious bacterial infections, from blocking resistance mechanisms, such as with CB-618, that inactivate otherwise effective antibiotics to the discovery of new classes of antibacterials from natural product and medicinal chemistry-driven approaches. The Building Blocks of Growth are intended to help Cubist build on its momentum to deliver new medicines to patients and drive long-term value for its customers and shareholders.

About CB-618

Beta-lactamases are enzymes used by Gram-negative bacteria as the predominant mechanism of resistance to beta-lactam antibiotics. The spread of extended-spectrum

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