The US Food and Drug Administration (FDA) has granted Cubist Pharmaceuticals’ 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 III 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 III VABP programme for ceftolozane/ tazobactam by mid-year.

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.

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 per cent of urinary tract infections, 65 per cent of pneumonia episodes, 34 per cent of surgical site infections and 24 per cent of bloodstream infections. Important Gram-negative bacteria include Pseudomonas, Escherichiacoli, Klebsiella and Acinetobacter.

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.