FDA designates two of Cubist’s Phase 3 antibiotic candidates

Dec 6 2012

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the U.S. 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 multi-drug 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," said 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."