Allergan plc announced that its supplemental new drug application (sNDA) for antibiotic Avycaz (ceftazidime and avibactam; ex-U.S. trade name: Zavicefta) has been approved by the FDA.
Allergan is looking to include new data from two phase III trials, RECAPTURE and REPRISE, in the drug’s label.
We remind investors that Avycaz is presently marketed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible pathogens, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Avycaz is also indicated for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole.
Shares of Allergan have outperformed the Zacks classified Medical-Generic Drugs industry in the last six months. The stock lost 16.9% during the period, while the industry registered a decline of 25.3%.
While Allergan has the commercialization rights to Avycaz in North America, rights in the rest of the world are owned by AstraZeneca plc (AZN - Free Report) .
In RECAPTURE (n=1020), Avycaz was non inferior to doripenem with regard to the primary endpoints. The symptomatic response rate at day 5 in the Avycaz arm was 70.2% compared to 66.2% for doripenem-treated patients. In the other trial, REPRISE, Avycaz demonstrated a higher combined clinical and microbiological cure rate compared with the best available therapy (BAT). The combined cure rates were 70.1% for patients treated with Avycaz compared to 54% for BAT-treated patients.
In Jun 2016, Avycaz’s label was updated to include data from a 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 one 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 $26.9 million in the nine months ended Sep 2016. Apart from Avycaz, Allergan’s anti-infectives portfolio consists of antibiotics like Teflaro and Dalvance.
We note that Allergan divested its generics business to Teva Pharmaceutical Industries Ltd (TEVA - Free Report) in Aug 2016. The company has been working on expanding and strengthening its branded business.
Zacks Rank & Key Picks
Allergan currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Anika Therapeutics, Inc. (ANIK - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Anika’s earnings estimates increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Anika’s share price increased 1.8% year to date.
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Allergan plc announced that its supplemental new drug application (sNDA) for antibiotic Avycaz (ceftazidime and avibactam; ex-U.S. trade name: Zavicefta) has been approved by the FDA.
Allergan is looking to include new data from two phase III trials, RECAPTURE and REPRISE, in the drug’s label.
We remind investors that Avycaz is presently marketed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible pathogens, including certain Enterobacteriaceae and Pseudomonas aeruginosa. Avycaz is also indicated for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole.
Shares of Allergan have outperformed the Zacks classified Medical-Generic Drugs industry in the last six months. The stock lost 16.9% during the period, while the industry registered a decline of 25.3%.
While Allergan has the commercialization rights to Avycaz in North America, rights in the rest of the world are owned by AstraZeneca plc (AZN - Free Report) .
In RECAPTURE (n=1020), Avycaz was non inferior to doripenem with regard to the primary endpoints. The symptomatic response rate at day 5 in the Avycaz arm was 70.2% compared to 66.2% for doripenem-treated patients. In the other trial, REPRISE, Avycaz demonstrated a higher combined clinical and microbiological cure rate compared with the best available therapy (BAT). The combined cure rates were 70.1% for patients treated with Avycaz compared to 54% for BAT-treated patients.
In Jun 2016, Avycaz’s label was updated to include data from a 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 one 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 $26.9 million in the nine months ended Sep 2016. Apart from Avycaz, Allergan’s anti-infectives portfolio consists of antibiotics like Teflaro and Dalvance.
We note that Allergan divested its generics business to Teva Pharmaceutical Industries Ltd (TEVA - Free Report) in Aug 2016. The company has been working on expanding and strengthening its branded business.
Zacks Rank & Key Picks
Allergan currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Anika Therapeutics, Inc. (ANIK - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Anika’s earnings estimates increased from $2.06 to $2.14 for 2016 and from $2.09 to $2.10 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Anika’s share price increased 1.8% year to date.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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