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Cubist Announces Acceptance of Ceftolozane/Tazobactam New Drug Application with Priority Review
[June 19, 2014]

Cubist Announces Acceptance of Ceftolozane/Tazobactam New Drug Application with Priority Review

LEXINGTON, Mass. --(Business Wire)--

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its investigational antibiotic ceftolozane/tazobactam with Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 21, 2014. Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections.

The NDA 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 FDA and the European Medicines Agency (EMA (News - Alert)) 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 that the FDA accepted the NDA with Priority Review for ceftolozane/tazobactam. We look forward to working with the FDA on the review, and hope to bring this potential new treatment option to physicians and their patients to address resistant Gram-negative infections," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist. "This important milestone reinforces our global commitment to advance the development of antibiotics to combat serious public health threats."

In 2013, the FDA designated ceftolozane/tazobactam as a Qualified Infectious Disease Product (QIDP), according to the Generating Antibiotic Incentives Now (GAIN) Act, for its potential indications of cUTI and cIAI. The QIDP designation for ceftolozane/tazobactam allows for certain incentives related to the development of new antibiotics, including eligibility for Fast Track status, Priority Review, and, if approved by the FDA, a five year extension of Hatch-Waxman exclusivity.

During the second half of 2014, Cubist expects to submit a Marketing Authorization Application (MAA) to the EMA for ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.

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) 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 resstance 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 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 Also, connect with Cubist on Twitter (News - Alert) @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 anticipated PDUFA action date for our NDA for ceftolozane/tazobactam; the therapeutic potential of ceftolozane/tazobactam; the anticipated favorable impact resulting from the FDA designating ceftolozane/tazobactam as a QIDP, including if ceftolozane/tazobactam is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity; positive results from our Phase 3 clinical trials of ceftolozane/tazobactam; working with the FDA on the review of the NDA; the expected timing of submitting an MAA for ceftolozane/tazobactam to the EMA; 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 the U.S. and Europe, including the risk that the FDA may not approve on a timely basis or at all, our NDA 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 NDA may take longer than anticipated, including as a result of internal FDA 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 maintain and enforce intellectual property protection for ceftolozane/tazobactam; competitive risks from current and future therapeutic alternatives to ceftolozane/tazobactam; we may not be able to submit an MAA for ceftolozane/tazobactam on our anticipated timeline; 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.

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