Actavis plc’s (ACT) 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 (AZN) 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 bacteria.
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 AstraZeneca.
Actavis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Mallinckrodt plc (MNK) and Akorn, Inc. (AKRX). Both hold a Zacks Rank #1 (Strong Buy).
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