FDA Grants Forest Drug Combo QIDP Status
Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product (QIDP) Designation from FDA
NEW YORK--(BUSINESS WIRE)--Sept. 12, 2013--Forest Laboratories, Inc. (NYSE:FRX), an international pharmaceutical manufacturer and marketer, today announced that the U.S. Food and Drug Administration (FDA) has designated its investigational drug, ceftazidime/avibactam, a qualified infectious disease product (QIDP). The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act (FDASIA), which was signed into law in 2012. 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 (cIAI) and complicated urinary tract infections (cUTI), both serious Gram-negative bacterial infections. Ceftazidime/avibactam has been granted the QIDP designation for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).
Ceftazidime/avibactam combines a broad-spectrum cephalosporin (ceftazidime) and a novel beta-lactamase inhibitor (avibactam, formerly NXL104) to treat the increasing number of Gram-negative infections, including extended-spectrum beta-lactamases and Klebsiella pneumoniae carbapenemases that are resistant to existing therapies.
Forest Laboratories and AstraZeneca Collaboration on Ceftazidime/avibactam
In December 2009, Forest Laboratories acquired rights to ceftazidime/avibactam through a transaction 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. These antibiotic combinations utilize the novel investigational beta-lactamase inhibitor avibactam to overcome antibiotic resistance due to extended-spectrum beta-lactamases and to treat the increasing number of infections resistant to existing therapies. Development costs for ceftazidime/avibactam will be shared between AstraZeneca and Forest Laboratories. Forest Laboratories has commercialization rights in North America while AstraZeneca has commercialization rights in the rest of the world.
About Forest Laboratories, Inc.
Forest Laboratories' (NYSE:FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.
Posted: September 2013