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Teva/Xenon Nerve Pain Candidate Fails in Phase II Study

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Teva Pharmaceutical Industries Ltd.TEVA and partner Xenon Pharmaceuticals Inc. XENE announced that a mid-stage study evaluating their pipeline candidate, topical TV-45070 for post-herpetic neuralgia (PNH) did not meet the primary endpoint.

Shares of Xenon were down 21% on Tuesday while that of Teva declined 2.4%. In fact, Teva's shares have lost 11.3% so far this year against the Zacks classified Medical-Generics Drug industry's increase of 1%.

Top-line results from the phase II study showed that TV-45070 did not demonstrate a statistically significant change in pain from baseline to week four as assessed by the numeric rating scale (NRS), thereby failing to meet the primary endpoint. Secondary endpoints of the study were also not met. However, there were no safety concerns in the study.

The companies are evaluating the next steps for TV-45070 and are further analyzing the data.

Teva licensed TV-45070 from Xenon Pharmaceuticals Inc. in Dec 2012.

Teva has many other pain candidates in its pipeline. These include fasinumab for osteoarthritis pain (phase III) and fremanezumab/TEV-48125 for chronic/episodic migraine. Earlier this month, Teva announced that fremanezumab met the primary and secondary endpoints in two late-stage HALO studies, one each for prevention of episodic and chronic migraine.

Teva intends to seek FDA approval for fremanezumab later this year based on the HALO studies for both episodic and chronic migraine and expects approval in the second half of next year.

Teva carries a Zacks Rank #3 (Hold) while Xenon Pharmaceuticals has a Zacks Rank #4 (Sell).

Better-ranked stocks in the sector include Regeneron Pharmaceuticals, Inc. REGN and VIVUS, Inc. VVUS , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

Regeneron's earnings estimates have risen 3.4% for 2017 over the last 60 days. Shares of the company have risen 36.8% so far this year.

VIVUS' loss per share estimates narrowed 22% for 2017 in the last 60 days. The company delivered positive earnings surprises in all four trailing quarters with an average beat of 233.69%. Shares of Vivus have risen 4.4% this year so far.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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