Allergan's sNDA for Anti-Infective Avycaz Accepted by FDA

Allergan plc AGN announced that a supplemental New Drug Application (sNDA) for its anti-infective drug, Avycaz, has been accepted and granted priority review by the FDA.

We remind investors that Avycaz is currently approved for the treatment of complicated urinary tract infections ("cUTI"), including pyelonephritis. The drug, in combination with metronidazole, is approved for treating complicated intra-abdominal infections ("cIAI").

The company is looking to get the label of the drug expanded to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP). A decision from the FDA is expected in first-quarter 2018.

Allergan shares are up 0.5% so far this year, outperforming the industry’s decline of 19.8% in the same period.

The sNDA submission was based on non-inferiority data from a pivotal REPROVE study, which evaluated safety and efficacy of Avycaz in adult patients with HABP/VABP. The study showed that Avycaz was non-inferior to meropenem in reducing death irrespective of cause.

The drug also showed in vitro (study in controlled environment outside human body) activity against certain gram negative bacteria, which causes HABP/VABP.

We remind investors that the FDA issued a refusal-to-file letter last month to the sNDA for Vraylar to expand its label to include negative symptoms associated with schizophrenia.

However, boosting its generic portfolio, the company received approval in September for the biosimilar version of Roche Holding AG’s RHHBY cancer drug, Avastin for the treatment of five types of cancer.

Allergan PLC. Price and Consensus

 

Allergan PLC. Price and Consensus | Allergan PLC. Quote

Zacks Rank & Stocks to Consider

Allergan carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Regeneron Pharmaceuticals, Inc. REGN and Biogen Inc. BIIB. While Regeneron sports a Zacks Rank #1 (Strong Buy), Biogen carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have increased from $13.84 to $14.99 for 2017 and from $15.79 to $16.65 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 25.9% year to date.

Biogen’s earnings per share estimates have moved up from $21.37 to $21.42 for 2017 and from $23.11 to $23.23 for 2018 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 6.41%. The share price of the company has increased 11.5% year to date.

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