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Teva to Discontinue a Fremanezumab Study on Cluster Headache

Zacks Equity Research
Updated

Teva Pharmaceutical Industries Ltd. TEVA announced that it will discontinue the phase III study evaluating its key pipeline candidate, fremanezumab for the treatment of chronic cluster headache. This decision was based on data from a pre-specified futility analysis of the study, which showed that the study is unlikely to meet its primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks over a 12-week period.

The ENFORCE Phase III clinical development program comprised the chronic cluster headache study, an episodic cluster headache analysis and a long-term safety study.

Notably, evaluation of the patients with chronic cluster headache in the long-term safety study will also be stopped. However, the study on episodic cluster headache will not be affected and carried out as planned.

Fremanezumab, an anti-calcitonin gene-related peptide (“CGRP”) candidate, is currently under review in the United States and Europe for the preventive treatment of migraine in adults as a quarterly or monthly injection. However in May, the company announced that the FDA has postponed the action date from June to September.

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Shares of the company slipped 0.8% including after-hours trading on Jun 15. However, the stock has rallied 25.4% so far this year compared with the industry’s increase of 2.2%.

 

Teva is focused on developing fremanezumab beyond migraine for indications like cluster headache and post traumatic headache disorder.

We saw Alder Biopharmaceuticals Inc’s ALDR share price rise 6.7% on Friday following the news of Teva’s decision to suspend the cluster headache study. We note that Alder is also developing an anti-CGRP candidate, eptinezumab, for the preventive treatment of migraine. The candidate is being evaluated in pivotal study with a Biologics License Application expected to be filed with the FDA during the first quarter of 2019.

Meanwhile, several other companies are developing treatments for treating migraine, a multi-billion dollar segment with high unmet need. In May, the FDA approved Amgen AMGN and its partner Novartis’ NVS anti-CGRP drug, Aimovig, for treating episodic migraine. Other anti-CGRP candidates under development include Eli Lilly’s galcanezumab and Allergan’s atogepant.Galcanezumab is under review in the United States for preventive treatment of migraine. Lilly is also developing the candidate for cluster headache.

Teva Pharmaceutical Industries Ltd. Price

 

Teva Pharmaceutical Industries Ltd. Price | Teva Pharmaceutical Industries Ltd. Quote

 

Teva currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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