Market Exclusive

Teva Pharmaceutical Industries Ltd (NYSE:TEVA), Xenon Pharmaceuticals Inc (NASDAQ:XENE) Reveal TV-45070 Failure

Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) and Xenon Pharmaceuticals Inc (NASDAQ:XENE) announced yesterday that their mid-stage nerve pain drug, Topical TV-45070 failed to achieve its primary and secondary endpoints.

Teva and Xenon announced that TV-45070, their pipeline drug for treating patients with mid-pain nerve pain has failed to achieve its primary and secondary end-points during its Phase II study. The clinical trials failed to yield any significant changes during the four weeks of assessment under the numeric rating scale (NRS). The companies also revealed that the trials were not characterized by any safety concerns.

“While these results are disappointing for us from a scientific perspective and for patients needing new therapies to treat chronic neuropathic pain, Xenon remains focused on advancing its pipeline of neurology-related development candidates, with multiple programs anticipated to enter clinical development in 2017,” stated Xenon president and CEO, Dr. Simon Pimstone.

Is it the end of the road for TV-45070?

The Phase II trial for TV-45070 was a proof of concept study that sought to establish the potentialroute of Nav1.7 blockade in PHN. The two firms have plans to continue analyzing the data from the recent study to determine the future of the nerve pain treatment. They also intend to present the data at an upcoming scientific conference.

The TV-45070 drug is a small molecule inhibitor which Xenon licensed to Teva about five years ago. The Phase II trial for the drug was a multicenter study that was placebo-controlled, randomized, double blind and involved a parallel group. The aim of the trial was to determine the safety and efficacy of the treatment in patients with PHN. The patients were categorized into three groups that received 4 percent or 8 percent of the drug or placebo with two daily doses.

Xenon shares tanked by 21% following the announcement on Tuesday and have dropped by 16.5 percent over the last 3 months. Teva’s stock gained by 0.4% and has only registered a 0.2% drop in the last 3 months.

Teva stock closed the latest trading session on Tuesday at $32.16 after a 2.4% decline from the previous close.

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