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Allergan's Dalvance under FDA Review for Label Expansion

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Allergan plc 's AGN supplemental new drug application for its antibiotic, Dalvance (EU trade name: Xydalba), has been accepted by the FDA. The company is looking to get a single-dose administration of Dalvance approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus .

We note that Dalvance is approved both in the U.S. and EU for the treatment of adults suffering from ABSSSI. It is the first and only once-weekly intravenous antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg, followed a week later by 500 mg each administered over 30 minutes.

Though Allergan's infectious disease portfolio consists of antibiotics like Avycaz and Teflaro, we note that competition in this market is high given the presence of drugs like Merck & Co. Inc.'s MRK Sivextro and The Medicines Company's MDCO Orbactiv among others.

We remind investors that Dalvance became a part of Allergan's portfolio following the Nov 2014 acquisition of Durata Therapeutics.

Allergan has been actively looking to expand its branded product portfolio through a flurry of back-to-back deals. These include the Forest Labs acquisition (significantly boosted branded products portfolio) in Jul 2014 and the Mar 2015 Allergan Inc. acquisition among others. Recently concluded deals include the acquisition of companies like KYTHERA Biopharmaceuticals (an aesthetic products manufacturer), Naurex (a biotech company focused on treatments for the central nervous system including depression) and Oculeve (a medical device company focused on the development of treatments for dry eye disease).

Meanwhile, Allergan is also looking to acquire AqueSys, Inc., a clinical-stage eye care medical device company. The acquisition is expected to go through this quarter.

Allergan is a Zacks Rank #3 (Hold) stock. AstraZeneca plc AZN is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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