Teva, Xenon Pain Drug Fails Phase IIb Study, Xenon Slumps - Analyst Blog

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Teva Pharmaceutical Industries Limited TEVA and Xenon Pharmaceuticals Inc. XENE reported disappointing top-line results from a phase IIb study on their pain management candidate, TV-45070 (4% and 8% w/w ointment). The study was being conducted for the treatment of patients suffering from chronic pain due to osteoarthritis (OA) of the knee. The news sent Xenon's shares down 17.4%.

The randomized, double-blind, placebo-controlled study involved 389 patients (aged between 40–85 years) with primary OA in a single knee who met pre-specified visual analog scale pain scores. The study evaluated whether TV-45070 4% and 8% when given for four weeks can help reduce patient-reported pain scores. Patients were randomized into three treatment arms: TV-45070 4% administered twice per day, TV-45070 8% administered twice per day and a placebo group (matched ointment without TV-45070) administered twice per day.

Results revealed that patients when treated with TV-45070 4% and 8% failed to demonstrate a statistically significant difference from placebo in efficacy endpoints of reduction in pain due to OA, thereby missing the primary endpoint of the study.

However, the safety and tolerability profile of the candidate was found to be favorable with no drug-related serious adverse events being reported during the course of the study. Considering the safety and tolerability profile, the companies continue to evaluate the candidate for other indications.  

Currently, TV-45070 is in a phase IIb study for the treatment of patients suffering from post-herpetic neuralgia. Top-line data is expected in the second half of 2016

We remind investors that Teva gained exclusive global rights to TV-45070 from Xenon under a collaborative development and license agreement entered into in 2012.

While Teva is a Zacks Rank #3 (Hold) stock, Xenon carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Adamas Pharmaceuticals, Inc. ADMS and Achillion Pharmaceuticals, Inc. ACHN. Both hold a Zacks Rank #1 (Strong Buy).

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