Novartis/Amgen Migraine Drug Positive In Phase III Study

Novartis AG (NYSE:NVS) and partner Amgen Inc. (NASDAQ:AMGN) announced positive top-line data from the second pivotal phase III study (STRIVE) on their calcitonin gene-related peptide (CGRP) receptor, AMG 334 (erenumab), for the prevention of episodic migraine.

The multicenter, randomized 24-week, double-blind, placebo-controlled study evaluated the safety and efficacy of AMG 334 in patients with episodic migraine. Patients enrolled in the study received once-monthly subcutaneous placebo or one of two doses of AMG 334 – 70 mg or 140 mg – for six months.

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Data showed that both the doses achieved the primary endpoint of demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months in comparison to placebo. The safety profile of AMG 334 was found to be comparable with placebo across both treatment arms over the six-month double-blind evaluation and consistent with the previously reported study data.

In the press release, the companies stated that additional analysis of STRIVE data is currently underway and will be submitted in a future medical conference for publication.

Earlier this year, positive data from two other studies evaluating AMG 334 – a phase III study (ARISE) for the prevention of episodic migraine and a phase II study for the prevention of chronic migraine – were announced. These data will help support discussions with regulatory authorities with filing expected in 2017.

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We note that Novartis is developing AMG 334 in collaboration with Amgen. Under the collaboration agreement dated Aug 2015, the companies agreed to jointly develop and commercialize treatments in the field of Alzheimer's disease and migraine. While Amgen owns commercialization rights in the U.S., Canada and Japan, Novartis retains commercialization rights in Europe and the rest of the world.

Another migraine candidate being developed under this collaboration is AMG 301, which is currently in a phase I study.

We note that several companies, including Teva Pharmaceutical Industries Limited (NYSE:TEVA) , are looking to develop migraine treatments targeting CGRP.

Both Novartis and Amgen carry a Zacks Rank #3 (Hold).

A Stock to Consider

Anika Therapeutics Inc. (NASDAQ:ANIK) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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