Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product (QIDP) Designation from FDA
September 12 2013 - 6:09PM
Business Wire
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.
Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice
President – Investor Relationsmedia.relations@frx.com
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