Forest Laboratories, Inc.
) recently announced that its antibiotic candidate,
ceftazidime/avibactam, has been designated a qualified infectious
disease product (QIDP) by the U.S. Food and Drug Administration
The QIDP designation is a part of the Generating Antibiotic
Incentives Now (GAIN) Act, which falls under the 2012 FDA Safety
and Innovation Act (FDASIA).
With ceftazidime/avibactam being designated a QIDP, Forest
Labs will benefit from incentives like priority review,
eligibility for the FDA's fast track program, and a five-year
extension of exclusivity under the Hatch-Waxman Act for the
The QIDP designation has been granted to ceftazidime/avibactam
for complicated intra-abdominal infections (cIAI), complicated
urinary tract infections (cUTI) and hospital-acquired bacterial
pneumonia/ventilator-associated bacterial pneumonia
We note that ceftazidime/avibactam is currently in phase III
development for the treatment of hospitalized patients with cIAI
and cUTI. Phase II data on ceftazidime/avibactam in patients with
cIAI and cUTI showed that ceftazidime/avibactam achieved high
clinical cure rates and was well tolerated.
Forest Labs is developing ceftazidime/avibactam under a Dec
2009 agreement with
). The companies are sharing the development costs for this
candidate. While Forest Labs has commercialization rights in
North America, rest of the world commercialization rights are
Forest Labs currently carries a Zacks Rank #2 (Buy). Forest
Labs is facing tough times with Lexapro losing exclusivity.
Moreover, the performance of new products, especially Teflaro,
has been below expectations. Meanwhile, Namenda will face generic
competition in early 2015 putting another $1+ billion at
Forest Labs has, however, made significant progress with its
pipeline. The company has launched several new products over the
past couple of years and is looking to launch additional products
Other companies that currently look well-positioned include
Questcor Pharmaceuticals, Inc.
). While Questcor is a Zacks Rank #1 (Strong Buy) stock, Elan is
a Zacks Rank #2 (Buy) stock.
ASTRAZENECA PLC (AZN): Free Stock Analysis
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QUESTCOR PHARMA (QCOR): Free Stock Analysis
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