) shares were up 2.3% with the company announcing positive top-line
results from the phase III RECLAIM-1 and -2 studies on
ceftazidime-avibactam. Shares increased an additional 0.13% in the
following trading session.
Ceftazidime/avibactam is being developed by Actavis in
collaboration with AstraZeneca (
) for the treatment of adult hospitalized patients with serious
gram-negative bacterial infections including complicated
intra-abdominal infections (cIAI).
The randomized, multi-center, double-blind, double-dummy,
parallel-group phase III studies evaluated the safety, efficacy and
tolerability of ceftazidime-avibactam (administered intravenously
as a two-hour infusion) plus metronidazole compared to meropenum
(administered intravenously as a 30-minute infusion).
Actavis and AstraZeneca said that ceftazidime-avibactam achieved
the primary endpoint - a clinical cure rate (28 to 35 days) after
randomization. Results showed statistical non-inferiority compared
to meropenum. Ceftazidime-avibactam was also found effective in
treating cIAI patients infected with ceftazidime-resistant
With the approval of the FDA and the European Medicines Agency,
data from both studies were examined as a single-pooled dataset.
Ceftazidime-avibactam was granted qualified infectious disease
product (QIDP) by the FDA in Sep 2013. The QIDP designation will
provide priority review, eligibility for the FDA's fast track
program, and a five-year extension of exclusivity under the
Hatch-Waxman Act for the candidate.
We remind investors that ceftazidime/avibactam became a part of
Actavis' portfolio through its recent acquisition of Forest
Laboratories. While Forest Labs has commercialization rights in
North America, rest of the world commercialization rights are with
Actavis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks
in the health care sector include Mallinckrodt plc (
) and Akorn, Inc. (
). Both hold a Zacks Rank #1 (Strong Buy).
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