Cubist receives Fast Track designation from FDA for late-stage antibiotic candidate

May 8 2013

Cubist Pharmaceuticals, Inc. (NASDAQ: 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”

"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.