Cubist receives FDA QIDP designation for ceftolozane/tazobactam to treat HABP/ VABP, cUTI

Mar 1 2013

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the U.S. Food and Drug Administration (FDA) has designated the company's late-stage antibiotic candidate, ceftolozane/tazobactam, as a Qualified Infectious Disease Product (QIDP) for the indications of Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI).

Additionally, the company received from the FDA notification that Cubist's antibiotic candidates, ceftolozane/tazobactam and surotomycin, have been granted Fast Track status in their previously granted QIDP indications, Complicated Intra-Abdominal Infections (cIAI) and Clostridium difficile-Associated Diarrhea (CDAD) respectively.

"We are excited to receive the QIDP and Fast Track designations for ceftolozane/tazobactam and surotomycin, which further reinforce the importance the FDA places on helping to advance critically needed antibiotics," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "In a very short period of time, the GAIN Act has shown its value in helping to incentivize antibiotic development."

The QIDP designation for ceftolozane/tazobactam will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for Fast Track status, 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 first-line 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. Surotomycin, a rapidly bactericidal lipopeptide, is currently in Phase 3 being studied as a potential treatment for patients with a severe and sometimes life-threatening diarrhea caused by CDAD.