Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing Authorization Application for Review

Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing Authorization Application for Review 

LEXINGTON, Mass., Aug 22, 2014 (BUSINESS WIRE) -- Cubist Pharmaceuticals, Inc. CBST, +0.19% today announced that the European Medicines Agency (EMA) has accepted for review the Company's Marketing Authorization Application (MAA) for its investigational antibiotic ceftolozane/tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission (EC) expected during the second half of 2015.

The MAA submission is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the EMA and U.S. Food and Drug Administration (FDA) specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials, ceftolozane/tazobactam demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in patients with complicated infections.

"We are pleased to receive MAA acceptance for ceftolozane/tazobactam and look forward to working with the EMA on this important review," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist. "As we continue to expand globally, this advancement further positions Cubist to respond to growing health threats and reinforces our commitment to bring new antibiotics to patients worldwide facing serious infections, including those caused by Gram-negative bacteria."

Prior to the EMA acceptance of the MAA, the FDA accepted the Company's New Drug Application (NDA) for ceftolozane/tazobactam with Priority Review and assigned an action date of December 21, 2014.

About Ceftolozane/Tazobactam

Ceftolozane/tazobactam, an antibiotic candidate being developed to treat certain Gram-negative infections, consists of ceftolozane, a novel cephalosporin that has demonstrated potent in vitro activity against Pseudomonas aeruginosa, with tazobactam, a well-established beta-lactamase inhibitor. The addition of tazobactam broadens coverage to include most extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli), Klebsiella pneumoniae, and other Enterobacteriaceae. Ceftolozane/tazobactam is under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the potential treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). Ceftolozane/tazobactam is also being developed for the potential treatment of hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).

About Gram-negative Bacteria

There has been a worldwide increase in the number of infections caused by Gram-negative bacteria. Highly adaptive pathogens that can develop resistance through several mechanisms, resistant Gram-negative bacteria are a serious global public health concern. Collectively, Escherichia coli(E. coli), Klebsiella pneumoniae (K. pneumoniae) and Pseudomonas aeruginosa (P. aeruginosa) account for 27% of all pathogens and 70% of all Gram-negative pathogens causing healthcare-associated infections (HAIs). Gram-negative bacteria are common causes of intra-abdominal infections (IAIs), urinary tract infections (UTIs), and nosocomial, or hospital-acquired, pneumonia, as well as bacteremia (bloodstream infections). E. coli is the most common cause of UTIs, and cases of UTI caused by extended-spectrum beta-lactamase (ESBL)-producing E. coli and K. pneumoniae, as well as P. aeruginosa, including drug-resistant strains, are increasing. ESBL-producing E. coli and K. pneumoniae are also frequently isolated in patients with complicated IAIs (cIAIs). Additionally, P. aeruginosa is the most common Gram-negative organism causing ventilator associated pneumonia and the second most common cause of catheter-associated UTIs. For more information reference a video on Gram-negative bacteria mechanisms of resistance.

About Cubist's Commitment to Antibiotic R&D

Cubist has a growing commitment to global public health through its leadership in the discovery, development, and commercialization of novel antibiotics to treat serious and potentially life-threatening infections caused by a broad range of increasingly drug-resistant bacteria. The Company hopes to deliver at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020. Cubist expects to invest approximately $400M USD in 2014 on antibacterial R&D and approximately 75% of its employee base is focused on the research, development, commercialization, and support of antibiotics.

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. Also, connect with Cubist on Twitter @cubistbiopharma and @cubistcareers, LinkedIn, or YouTube.

Forward Looking Statements

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the expected timing for a decision from the EC on our MAA for ceftolozane/tazobactam; positive results from our Phase 3 clinical trials of ceftolozane/tazobactam; working with the EMA on the review of the MAA for ceftolozane/tazobactam; our global expansion, including our commitment to bring new antibiotics to patients worldwide facing serious infections; the anticipated PDUFA action date for our NDA with the FDA for ceftolozane/tazobactam; the therapeutic potential of ceftolozane/tazobactam; our aspirations to achieve a portion of the IDSA goal of 10 new antibiotics by 2020; and the level of our financial and personnel commitments towards antibiotic research, development and commercialization, 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: regulatory developments in Europe and the U.S., including the risk that the EC and/or FDA may not approve on a timely basis or at all, our marketing applications for ceftolozane/tazobactam, may not agree with our interpretation of the results from the clinical studies of ceftolozane/tazobactam, or may require additional data, analysis, information or further studies that may not be clinically feasible or financially practicable; the review of our MAA and/or NDA may take longer than anticipated, including as a result of internal regulatory authority constraints; any marketing approval for ceftolozane/tazobactam may impose significant limitations on its use and additional post-marketing requirements; our ability to obtain adequate pricing and reimbursement levels for ceftolozane/tazobactam; our ability to successfully commercialize ceftolozane/tazobactam, including as a result of regulatory authorities' decisions regarding labeling and other matters, including adverse side effects, that could affect its availability or commercial potential; our ability to acquire, maintain and enforce intellectual property for ceftolozane/tazobactam; competitive risks from current and future therapeutic alternatives to ceftolozane/tazobactam; additional clinical trials of ceftolozane/tazobactam, including in HABP/VABP, may not be successful or initiated or conducted in a timely manner; technical difficulties or excessive costs relating to the manufacture or supply of ceftolozane/tazobactam, including our ability to work with our third party contract manufacturers that manufacture and supply ceftolozane/tazobactam on our behalf; our ability to work with, and the performance of our third party contract research organizations that help us conduct our clinical trials; we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of ceftolozane/tazobactam; and those additional factors discussed in our most recent annual report on Form 10-K and subsequent quarterly reports 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 press release, and we undertake no obligation to update or revise any of these statements.

SOURCE: Cubist Pharmaceuticals, Inc.

INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
[email protected]
or
MEDIA:
U.S. Media:
Cubist Pharmaceuticals, Inc.
Jennifer Baird, 781-860-1282
Director of Product Communications
[email protected]
or
Europe Media:
Weber Shandwick
Sally Green, +44 (0) 20 7067 0566
Account Executive, Health
[email protected]

Copyright Business Wire 2014

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