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Allergan (AGN) Presents Mixed Depression Data on Botox

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Allergan plc announced mixed top-line data from a mid-stage study evaluating its key drug Botox for the treatment of major depressive disorder (MDD).

Allergan’s share price is up 13.2% this year so far while the Zacks classified Medical-Generics Drug industry declined 3.4%.

Botox is already approved for therapeutic as well as aesthetic use. Therapeutic indications include overactive bladder, cervical dystonia, chronic migraine and strabismus among others while cosmetic indications include improvement in appearance of glabellar lines (frown lines between the brows) and severe lateral canthal lines.

Coming back to the latest Botox news, the phase II study (n=258) evaluated efficacy, safety and tolerability of two separate doses of Botox (30 units or 50 units) compared with placebo in adult female patients with MDD.

While the 30 unit dose of Botox demonstrated numerically superior efficacy over placebo in the primary endpoint - change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score - superior efficacy over placebo was not achieved by the 50 unit arm. Importantly, neither dose showed a statistically significant benefit at 6 weeks. However, both the doses were well tolerated in the study. Allergan said the data was encouraging enough to move into phase III studies.

Botox is a key revenue driver for Allergan and the drug generated sales of $2.79 billion in 2016, an increase of more than 41% year over year driven by strong demand trends. In fact, strong performance of key products like Botox and Linzess and new product launches partially are making up for lower sales of established products like Namenda IR/XR and Asacol HD sales due to the loss of exclusivity.

We remind investors that Botox became a part of Allergan’s portfolio following the Mar 2015 $77 billion acquisition of Allergan Inc. With the merger, Allergan, which was previously known for its strong presence in the generics market, found itself in the list of the top 10 pharma companies across the world based on sales. Later, Allergan sold its generics business in Aug 2016 and the Anda distribution business to Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) in Oct 2016. However, in Apr 2016, Pfizer, Inc. (PFE - Free Report) terminated its agreement to combine with Allergan.

Allergan has a Zacks Rank #3 (Hold). A better-ranked stock in the health care is Roche Holding AG (RHHBY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Roche have risen 12.2% this year so far while earnings estimates for 2017 went up almost 12% in the past 30 days.

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