Cubist Submits Clinical Trial Application to Initiate First-in-Human Study of CB-618—A Beta-Lactamase Inhibitor Discovered to Combat Antibiotic Resistance

LEXINGTON, Mass.--(BUSINESS WIRE)--

Cubist Pharmaceuticals, Inc. 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 β-lactamases (ESBLs), AmpC beta-lactamases and carbapenemases, especially in the Enterobacteriaceae, is a threat to the utility of various beta-lactam antibiotics. Discovered by Cubist, CB-618 is a novel, broad-spectrum beta-lactamase inhibitor (BLI) investigational compound. CB-618 has been shown, in pre-clinical studies, to increase the spectrum of activity of beta-lactam antibiotics to include isolates known to produce carbapenemases, including in Enterobacteriaceae (such as carbapenem-resistant and carbapenemase-producing Enterobacteriaceae – CRE and CPE), Klebsiella pneumoniae carbapenemases (KPCs) and OXA-48, as well as ESBLs and AmpC beta-lactamases.

About Cubist

Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Massachusetts, with a central international office located in Zurich, Switzerland. Additional information can be found at Cubist's web site at www.cubist.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the development of CB-618, including the expected timing for commencing clinical studies and regarding engaging in discussions with global regulatory authorities regarding the development of CB-618; the therapeutic potential of CB-618; our research efforts, including our efforts to identify new BLIs for use with existing antibiotics and to discover new antibacterials; and our five-year Building Blocks of Growth strategic goals, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: the risk that the Dutch Competent Authority and Ethics Committee may not approve our CTA for CB-618; the fact that drug discovery and development is complex, time consuming, expensive, fraught with a high rate of failure and success in pre-clinical or early stage clinical trials does not mean that later stage trials will be successful; the timing and feasibility of any subsequent trials is dependent on our ability to successfully work with regulatory authorities on the design of the trials, among other things; clinical trials of CB-618 may produce negative or inconclusive results; we may experience delays in the commencement, enrollment, completion or analysis of clinical testing for CB-618, or significant issues regarding the adequacy of our clinical trial designs or the execution of our clinical trials, which could result in increased costs and delays, or limit our ability to obtain regulatory approval; the third parties upon whom we rely to conduct our clinical trials may not perform as expected; CB-618 may not receive regulatory approval or be successfully commercialized; our ability to maintain and enforce intellectual property protection for CB-618; competitive risks from current and future therapeutic alternatives to CB-618; technical difficulties or excessive costs relating to the manufacture or supply of CB-618, including our ability to work with and the performance of our third party contract manufacturers that we rely on to manufacture and supply CB-618; we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of CB-618; our ability to achieve our Building Blocks of Growth long-range goals, including as a result of our ability to continue to grow revenues from the sale of CUBICIN^®, DIFICID^® and ENTEREG^®, generic and other competition, manufacturing issues, our ability to successfully develop, gain marketing approval for and commercially launch our product candidates for their planned indications and on their expected timelines, and our ability to discover, in-license or acquire new products and product candidates; and those additional factors discussed in our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and we undertake no obligation to update or revise any of these statements.