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Endo International Reports Positive Phase II Data on Xiaflex


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Endo International plc's (ENDP - Analyst Report) subsidiary Endo Pharmaceuticals Inc. announced positive data from a phase II trial which evaluated the safety and efficacy of Xiaflex (collagenase clostridium histolyticum) injection for the treatment of palmar Dupuytren's disease nodules.

Endo International added Xiaflex to its portfolio after the acquisition of Auxilium Pharma in Jan 2015.

The randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 75 adult participants with Dupuytren's disease and at least 1 nodule. The participants received a single injection of CCH 0.40 mg or 0.60 mg. The majority of participants were satisfied with their treatment.

Meanwhile, 88.9% in 0.40 mg CCH group and 83.3% in the 0.60 mg CCH group were "very satisfied" or "quite satisfied" at week 8, compared to placebo. CCH was well tolerated during the study with only one adverse event reported as severe. However, no discontinuation was reported from the study because of an adverse event.

Meanwhile, Xiaflex is also being evaluated in a phase II study for the treatment of adhesive capsulitis.

We note that Xiaflex is currently approved in the U.S., EU, Canada and Australia for the treatment of Dupuytren's contracture (DC) in adult patients with a palpable cord, and approved in U.S. for Peyronie's disease (PD) in adult men with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy. Xiaflex enjoys Orphan drug status for both the indications in the U.S. and is the only FDA-approved treatment of adult patients with DC with a palpable cord.

Xiaflex recorded revenues of $86.4 million in the first six months of 2016, registering an increase of 27.2% compared to the first six months of 2015.

Moreover, additional studies on Xiaflex are expected to be initiated for other indications, such as plantar fibromatosis and lateral hip fat, later in 2016.

Zacks Rank & Key Picks

AbbVie Inc. currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include Anika Therapeutics Inc (ANIK - Snapshot Report) , ANI Pharmaceuticals, Inc. (ANIP - Snapshot Report) and Abbott Laboratories (ABT - Analyst Report) .

Anika Therapeutics – a Zacks Rank #1 (Strong Buy) stock – has seen its earnings estimates for 2016 and 2017 rise 9.4% and 11.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, with an average beat of 42.19%. Its share price jumped 25.6% year to date.

ANI Pharmaceuticals witnessed an increase of 9.5% and 4.7% in its earnings estimates for 2016 and 2017, respectively, in the last 60 days. It has beaten earnings estimates twice in the last four quarters, reaching the average to 46.85%. The company’s stock has rallied 50.6% year to date. The company also sports a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

Abbott Laboratories carries a Zacks Rank #2 (Buy). The earnings estimates for 2016 and 2017 almost remained unchanged over the past 60 days. The company recorded a positive earnings surprise in each of the last four quarters, with an average beat of 3.11%. Share price of the company has risen marginally on a year-to-date basis.

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