Forest Labs' Ceftazidime/avibactam Combination Gets QIDP Designation From FDA

(RTTNews) - Forest Laboratories, Inc. (FRX) said Thursday that the U.S. Food and Drug Administration has designated its investigational drug, ceftazidime/avibactam, a qualified infectious disease product.

The QIDP designation provides certain incentives for the development of new antibiotics, including priority review and eligibility for the FDA's fast track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.

Ceftazidime/avibactam is currently in Phase III trials to investigate efficacy in treating hospitalized patients with complicated intra-abdominal infections and complicated urinary tract infections, both serious Gram-negative bacterial infections.

Ceftazidime/avibactam has been granted the QIDP designation for complicated intra-abdominal infections, complicated urinary tract infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Ceftazidime/avibactam combines a broad-spectrum cephalosporin and a novel beta-lactamase inhibitor to treat the increasing number of Gram-negative infections, including extended-spectrum beta-lactamases and Klebsiella pneumoniae carbapenemases that are resistant to existing therapies.

In December 2009, Forest Laboratories acquired rights to ceftazidime/avibactam through a deal with AstraZeneca executed contemporaneously with AstraZeneca's announced acquisition of Novexel, S.A., a private infection research company in France that developed avibactam.

Forest Laboratories and AstraZeneca simultaneously announced an agreement to collaborate on the future co-development and commercialization of two late-stage antibiotic development programs: ceftazidime/avibactam and ceftaroline fosamil/avibactam.