Credit: Shutterstock photoAllergan plcAGN recently announced that its marketed drug Restasis (cyclosporine ophthalmic emulsion) 0.05% is now available in multidose bottles in the U.S. It is the first and only prescription medication approved by the FDA to help patients with a type of chronic dry eye.
Restasis is already approved in the U.S. as an eye drop that helps to increase the natural ability of the eyes to produce tears that may be reduced by inflammation. It registered sales of $1.49 billion in 2016, up 42% from the year-ago figure.
Allergan's shares outperformed the Zacks classified Medical-Generic Drugs industry so far this year. Shares of the company gained 11.4% while the industry registered an increase of 1.5%.
Since its launch in 2003, Restasis was accessible only in single-use vials. We note that the multi-dose preservative-free (MDPF) bottle, which is a first of its kind container, is expected to provide patients with patented uni-directional valve and air filter technology.
We remind the investors that the FDA has issued a complete response letter (CRL) for its prior approval supplement (PAS) for Restasis in Mar 2016. In the CRL, the FDA has asked for additional Chemistry, Manufacturing, and Controls (CMC) information for the MDPF bottle. Subsequently, Allergan received approval from the FDA for Restasis in Oct 2016.
We are encouraged by the company's progress in the eye care area. Allergan's 510(k) premarket notification application for XEN45 - its ocular stent to treat glaucoma and oculeve tearbud and an intranasal neurostimulatory device for dry eye - was accepted for filing by the FDA in Jun 2016. In addition to this, the company is conducting a phase III study for bimatoprost SR for treatment of glaucoma. The drug is expected to be launched in 2021.
Moreover, with the sale of its generic business to Teva Pharmaceutical Industries Limited TEVA in Aug 2016, Allergan can now focus on the branded segment. The company has more than 65 projects in mid-to-late stage development. Meanwhile, Vraylar gained FDA approval in Sep 2015 for schizophrenia and bipolar disorder and Viberzi for irritable bowel syndrome-diarrhea in May 2015. Both Vraylar and Viberzi performed above expectations in 2016. The company is also working on expanding the labels of marketed products like Botox and Linzess and Restasis, to name a few.
Allergan PLC. Price
Allergan PLC. Price | Allergan PLC. Quote
Zacks Rank & Key Picks
Allergancurrently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Addus HomeCare Corporation ADUS and The Advisory Board Company ABCO . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
Addus HomeCare's earnings per share estimates increased from $1.38 to $1.41 for 2017 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 10.10%.
The Advisory Board's earnings per share estimates increased from $1.41 to $1.49 for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 33.41%.
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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.
