Allergan plc AGN announced that its supplemental new drug application for antibiotic Avycaz (ceftazidime and avibactam; ex-U.S. trade name: Zavicefta), has been accepted for review by the FDA. Allergan is looking to include data from a phase III study in Avycaz’s existing label. The phase III study had evaluated Avycaz in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens.
We note that the FDA has granted priority review status to the company’s regulatory application based on a prior Qualified Infectious Disease Product designation for the product. As a result, the company expects a response to be out in the first quarter of 2017.
We remind investors that Avycaz was approved in the U.S. in Feb 2015 for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, as well as for cUTI, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
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In Jun 2016, Avycaz’s label was updated to include data from the phase III cIAI study. The study evaluated the safety and efficacy of Avycaz in combination with metronidazole, for the treatment of cIAI. It also included data from a subset of patients with infections caused by ceftazidime-nonsusceptible pathogens and another with pathogens producing certain extended-spectrum beta-lactamases.
Avycaz raked in sales of $22.1 million in the first half of 2016. Apart from Avycaz, Allergan’s anti-infectives portfolio also consists of antibiotics like Teflaro and Dalvance.
We note that Avycaz is being developed by Allergan in collaboration with AstraZeneca plc AZN. While Allergan has commercialization rights to Avycaz in North America, rights to rest of the world are owned by AstraZeneca.
Allergan divested its generics business to Teva Pharmaceutical Industries Ltd TEVA in Aug 2016. The company has been working on expanding and strengthening its branded business.
Allergan currently carries a Zacks Rank #3 (Hold).
A Stock to Consider
A better-ranked stock in the health care sector is Amarin Corporation plc AMRN, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amarin’s loss estimates narrowed from 53 cents to 40 cents for 2016 and from 36 cents to 27 cents for 2017 over the last 60 days. The company’s share price has rallied 65.2% year to date.
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