FDA Grants Fast Track Designation for Cubist's Late-Stage Antibiotic Candidate

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FDA Grants Fast Track Designation for Cubist's Late-Stage Antibiotic Candidate

Fast Track Status Provided for ceftolozane/tazobactam in HABP/VABP and cUTI

LEXINGTON, Mass.--(BUSINESS WIRE)-- Cubist Pharmaceuticals, Inc. (NAS: CBST) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's late-stage antibiotic candidate ceftolozane/tazobactam (CXA-201) Fast Track status in the previously granted Qualified Infectious Disease Product (QIDP) indications, Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI). The FDA granted Fast Track status for ceftolozane/tazobactam in Complicated Intra-Abdominal Infections (cIAI) in February 2013.


"We are pleased that ceftolozane/tazobactam has now received Fast Track designation in all of its potential indications," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "This incentive, enabled by the GAIN Act, will help us expedite the development of ceftolozane/tazobactam across many types of serious and potentially life-threatening infections."

The QIDP designation for ceftolozane/tazobactam allows Cubist to benefit from certain incentives for the development of new antibiotics, including Priority Review, the Fast Track status designation provided, and if ceftolozane/tazobactam is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which received strong bipartisan support in Congress and was signed into law by President Obama in July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth authorization of the Prescription Drug User Fee Act.

Ceftolozane/tazobactam is currently being studied in pivotal Phase 3 trials as a potential intravenous therapy for the treatment of cIAI and cUTI caused by Gram-negative pathogens, including those caused by multi-drug resistant Pseudomonas aeruginosa. Cubist expects to initiate a Phase 3 VABP program for ceftolozane/tazobactam by mid-year.

About The GAIN Act

The GAIN Act, Title VIII (Sections 801 through 806) of the FDASIA, provides pharmaceutical and biotechnology companies with incentives to develop new antibacterial and antifungal drugs for the treatment of life-threatening infectious diseases caused by drug resistant pathogens. Qualifying pathogens are defined by the GAIN Act to include multi-drug resistant Gram-negative bacteria, including Pseudomonas, Acinetobacter, Klebsiella, and Escherichia coli species; resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus; multi-drug resistant tuberculosis; and Clostridium difficile.

About Gram-negative bacteria

The diseases caused by Gram-negative bacteria include intra-abdominal infections, urinary tract infections, pneumonia, peritonitis, septicemia, neonatal meningitis, and burn and wound infections. In the US in 2003, Gram-negative bacteria were associated with many of the most frequent types of hospital-acquired infections, including 71% of urinary tract infections, 65% of pneumonia episodes, 34% of surgical site infections and 24% of bloodstream infections. Important Gram-negative bacteria include Pseudomonas, Escherichiacoli, Klebsiella and Acinetobacter.

About Cubist

Cubist Pharmaceuticals, Inc. is a 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, Mass. Additional information can be found at Cubist's website at www.cubist.com.

Cubist Safe Harbor Statement

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: (i) the anticipated favorable impact resulting from the FDA designating ceftolozane/tazobactam as a QIDP, including Priority Review and a five year extension of Hatch-Waxman exclusivity if ceftolozane/tazobactam is ultimately approved by the FDA, and the FDA granting ceftolozane/tazobactam Fast Track status, and (ii) the expected timing of beginning our Phase 3 program in ventilator-associated bacterial pneumonia for ceftolozane/tazobactam, 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: clinical trials of ceftolozane/tazobactam may not be successful or initiated or conducted in a timely manner; we plan to rely, to a significant extent, on third party clinical research organizations, or CROs, to help us conduct clinical trials, so the success and timing of these trials is dependent our ability to work with such CROs and their performance; 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; 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 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.



Cubist Pharmaceuticals, Inc.
INVESTORS:
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Julie DiCarlo, 781-860-8063
Senior Director, Corporate Communications
julie.dicarlo@cubist.com

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:

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