Innocoll Stock Gains On Favorable Phase III Data On Xaracoll

Shares of Innocoll Holdings plc (NASDAQ:INNL) surged 47.8% after the company announced positive data from two phase III studies – MATRIX-1 and MATRIX-2 – on Xaracoll (bupivacaine-collagen bioresorbable implant) for the treatment of postoperative pain relief.

The two identical, randomized, placebo-controlled, double-blinded studies evaluated the safety and efficacy of Xaracoll (300 mg dose) in the treatment of acute postoperative pain associated with hernia repair.

The studies met the primary endpoint, thereby demonstrating a statistically significant reduction in pain intensity over 24 hours after open abdominal hernia repair surgery. Xaracoll also showed consistency in treatment effect for both pain and opioid reduction. Moreover, the candidate was seen to be safe and generally well tolerated in both the studies, with no Xaracoll-related serious adverse events.

Full analysis of the MATRIX studies will be presented at future medical conferences and submitted for publication.

Innocoll plans to submit a New Drug Application (NDA) for Xaracoll in the U.S. in the third or early fourth quarter of 2016 and expects to launch the product in 2017.

According to Innocoll, the postoperative pain relief market presently has significant unmet need, with long-acting anesthetics comprising only 5%. The company believes that Xaracoll has an addressable market worth approximately $6 billion in the U.S.

Meanwhile, data from phase III studies on Xaracoll also validated the company’s collagen-based technology platform. Another candidate in Innocoll’s pipeline, Cogenzia, is being evaluated in phase III studies (COACT-1 and COACT-2) for the treatment of diabetic foot infections. Top-line data from the studies are anticipated later in 2016.

Currently, Innocoll carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company (NYSE:BMY) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Pfizer Inc. (NYSE:PFE) , each sporting a Zacks Rank #1 (Strong Buy).

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