Cubist Pharmaceuticals, Inc. announces that the Food and Drug Administration (FDA) has designated two of the company’s Phase 3 antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as Qualified Infectious Disease Products (QIDP).
The QIDP designations will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are 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.
CXA-201 is currently being studied in pivotal Phase 3 trials as a first-line intravenous therapy for the treatment of complicated intra-abdominal infections and complicated urinary tract infections caused by Gram-negative bacterial infections, including those caused by multidrug-resistant Pseudomonas aeruginosa. The FDA’s QIDP designation applies to CXA-201’s treatment of complicated intra-abdominal infections. CB-315 is currently being investigated in Phase 3 trials as an oral therapy for Clostridium difficile-associated diarrhea, or CDAD.
“We are delighted that both of our Phase 3 antibiotic candidates, ceftolozane/tazobactam and CB-315, have received QIDP designation under the GAIN Act,” says Cubist’s chief scientific officer Steve Gilman. “With antibiotic resistance rates on the rise and many companies having already left antibiotic R&D altogether, we believe the provisions of the bipartisan GAIN Act are a critical first step in our country’s efforts to spur meaningful investment into this space.”
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; multidrug-resistant tuberculosis; and Clostridium difficile.
Source: Cubist Pharmaceuticals, Inc.