First look at detailed data from the ceftolozane/tazobactam Phase 3 clinical trials in complicated urinary tract and intra-abdominal infections

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it will present data from its late-stage antibiotics pipeline at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, May 10-13. Data highlighted will offer insights into Cubist’s research and development programs, which focus on Gram-positive and Gram-negative bacteria that cause serious and complicated infections. Presentations will include the first detailed results from the pivotal Phase 3 clinical trials of the Company’s investigational antibiotic ceftolozane/tazobactam being developed to treat complicated urinary tract infections and complicated intra-abdominal infections.

“We are excited to present new data at ECCMID on our investigational treatments that target a wide range of Gram-positive and Gram-negative bacteria,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “Collectively, the data in 42 posters or presentations demonstrate the depth and breadth of our portfolio and advancing pipeline to combat drug resistant bacterial infections that have become recognized global public health threats.”

Highlights include:

SIVEXTRO™ (tedizolid phosphate):

  • Oral session: Comparison of the microbiological efficacy of tedizolid and linezolid in the ESTABLISH-1 and ESTABLISH-2 Phase 3 clinical trials
    • Abstract/program number: O154
    • Presenter: Carisa De Anda, Cubist
    • Authors: De Anda C.; Fang E.; Das A.; Prokocimer P.
    • Session: New antibiotics in clinical trials, May 12, 15:06 CEST, Hall D
  • ePoster: Concordance between early and late response in ESTABLISH-1 and ESTABLISH-2: pooled results from two Phase 3 trials in acute bacterial skin and skin structure infections
    • Abstract/program number: eP434
    • Presenter: Edward Fang, Cubist
    • Authors: Fang E.; De Anda C.; Das A.; Prokocimer P.
    • Session: New and not so new antibiotics, May 10-13, 09:00-17:30 CEST, viewing stations

Ceftolozane/tazobactam:

  • Late-breaker: Efficacy and safety of ceftolozane/tazobactam versus meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalised adults: Results from the Phase 3 ASPECT-cIAI
    • Abstract/program number: P0266-a
    • Presenter: Christian Eckmann , Academic Hospital of Medical University, Hannover, Germany
    • Authors: Eckmann C.; Hershberger E.; Miller B.; Wooley M.; Friedland I.; Steenbergen J.; Collins S.; Yuan G.; Barie P.; Solomkin J.
    • Session: Antibiotic choices: Clinical studies, May 10, 15:30-16:30 CEST, poster area
  • ePoster: Efficacy and safety of ceftolozane/tazobactam versus levofloxacin in the treatment of complicated urinary tract infections (cUTI)/pyelonephritis in hospitalised adults: Results from the Phase 3 ASPECT-cUTI trial
    • Abstract/program number: eP449
    • Presenter: Florian Wagenlehner, Justus Liebig University, Geissen, Germany
    • Authors: Wagenlehner F.; Umeh O.; Huntington J.; Cloutier D.; Friedland I.; Steenbergen J.; Yuan G.; Yoon M.; Darouiche R.
    • Session: New and old beta-lactamase inhibitors, May 10-13, 09:00-17:30 CEST, viewing stations
  • ePoster: Ceftolozane/tazobactam activity against Gram-negative bacteria causing intra-abdominal infections in European hospitals (2011-2012): A report from an international antimicrobial surveillance programme
    • Abstract/program number: eP446
    • Presenter: Sandra McCurdy, Cubist
    • Authors: McCurdy S.; Petersen P.J.; Steenbergen J.; Farrell D.J.; Bassetti M.
    • Session: New and old beta-lactamase inhibitors, May 10-13, 09:00-17:30 CEST, viewing stations
  • ePoster: Ceftolozane/tazobactam activity against Gram-negative bacteria causing urinary tract infections in European hospitals (2011-2012): A report from an international antimicrobial surveillance programme
    • Abstract/program number: eP445
    • Presenter: Sandra McCurdy, Cubist
    • Authors: McCurdy S.; Petersen P.J.; Steenbergen J.; Farrell D.J.; Bassetti M.
    • Session: New and old beta-lactamase inhibitors, May 10-13, 09:00-17:30 CEST, viewing stations

Surotomycin:

  • Poster presentation: Antibiotic susceptibility of surotomycin and five other antibiotics against Clostridium difficile isolates, collected at a pan-European survey in 2008 (n=119)
    • Abstract/program number: P0792
    • Presenter: Ed J. Kuijper, Leiden University Medical Center, Leiden, Netherlands
    • Authors: Sanders I.M.; Harmanus C.; Debast S.; Kuijper E.J.
    • Session: C. difficile: antimicrobial susceptibility and treatment, May 11, 13:30-14:30 CEST, poster area
  • Poster presentation: In vitro activity of surotomycin (formerly CB-183,315) against 126 clinical isolates of Clostridium difficile
    • Abstract/program number: P0805
    • Presenter: Frédéric Barbut, Université Pierre et Marie Curie, Paris, France
    • Authors: Valentin O.; Eckert C.; Chesnel L.; Barbut F.
    • Session: C. difficile: antimicrobial susceptibility and treatment, May 11, 13:30 – 14:30 CEST, poster area

A full list of Cubist sessions, including symposia addressing Gram-positive organisms and Gram-negative infections, is available on the ECCMID website here. For more information about ECCMID visit: http://www.eccmid.org/

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 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 anticipated timing for presenting data related to our pipeline and portfolio of product candidates and products; the therapeutic potential of ceftolozane/tazobactam, SIVEXTRO and our other product candidates and portfolio assets; results from our Phase 3 clinical trials of ceftolozane/tazobactam and SIVEXTRO; 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, including the risk that the U.S. Food and Drug Administration and other regulatory authorities may not accept for filing, or approve on a timely basis or at all, our marketing approval applications for ceftolozane/tazobactam and SIVEXTRO (tedizolid phosphate), may not agree with our interpretation of the results from the clinical studies of ceftolozane/tazobactam and SIVEXTRO, or may require additional data, analysis, information or further studies that may not be clinically feasible or financially practicable; any marketing approval for ceftolozane/tazobactam and SIVEXTRO may impose significant limitations on its use and additional post-marketing requirements; our ability to obtain adequate pricing and reimbursement levels for ceftolozane/tazobactam and SIVEXTRO; our ability to successfully commercialize ceftolozane/tazobactam and SIVEXTRO, 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, SIVEXTRO and our other portfolio assets; competitive risks from current and future therapeutic alternatives to ceftolozane/tazobactam, SIVEXTRO and our other portfolio assets; additional clinical trials of ceftolozane/tazobactam, SIVEXTRO and our other portfolio assets 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, SIVEXTRO and our other portfolio assets, including our ability to work with our third party contract manufacturers that manufacture and supply ceftolozane/tazobactam, SIVEXTRO and our other portfolio assets 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, SIVEXTRO and our other portfolio assets; our ability to achieve our strategic goals, including as a result of our ability to continue to grow revenues from the sale of CUBICIN® (daptomycin for injection), DIFICID® (fidaxomicin) and ENTEREG® (alvimopan), 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 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.

INVESTORS:Cubist Pharmaceuticals, Inc.Eileen C. McIntyre, 781-860-8533Vice President, Investor Relationseileen.mcintyre@cubist.comorMEDIA:Cubist Pharmaceuticals, Inc.US Media:Jennifer Baird, 781-860-1282Mobile: 781-708-2309Director of Product Communicationsjennifer.baird@cubist.comorEurope Media:Weber ShandwickNivey Nocher, +44 (0) 207 067 0143Mobile: +44 (0) 779-617-5609Account Director, Healthnnocher@webershandwick.com