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Biohaven (BHVN) Migraine Drug Meets Study Goals in China

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Biohaven Pharmaceutical Holding Company Ltd. (BHVN - Free Report) , along with partner Pfizer Inc. (PFE - Free Report) , announced positive top-line data from a phase III study evaluating the safety and efficacy of the orally dissolving tablet (“ODT”) formulation of rimegepant for the acute treatment of migraine in China and South Korea.

The study met the co-primary endpoints of freedom from pain and from the most bothersome migraine–induced symptoms after two-hours of an oral dose of rimegepant.

Data from the study showed that treatment with rimegepant (75 mg) offered significant relief from migraine symptoms and return to normal function at two hours and delivered sustained efficacy that lasted up to 48 hours for many patients.

The above-mentioned study is the first to be conducted in Asia Pacific to investigate rimegepant for the acute treatment of migraine. This is the fourth positive phase III study of rimegepant for the given indication.

Shares of Biohaven have rallied 64.4% in the past year against the industry’s decrease of 40.4%.

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Biohaven currently markets rimegepant ODT under the trade name — Nurtec ODT — an oral anti-CGRP drug, in the United States. The drug was approved for treating acute migraine in the United States in February 2020. The FDA also approved a label expansion of Nurtec ODT as a preventive treatment for migraine.

In the first nine months of 2021, Nurtec ODT generated sales worth $272.5 million. The drug is the only marketed product in the company’s portfolio.

In November 2021, Biohaven signed a strategic agreement with Pfizer for the commercialization of Nurtec ODT in ex-U.S. markets. Pfizer has commercialization rights to rimegepant outside the UNited States while Biohaven leads research and development globally and retains marketing rights in the country.

Nurtec ODT is the only oral CGRP receptor antagonist approved for both the acute and preventive treatments of migraine in adults. However, Nurtec ODT faces stiff competition from other anti-CGRP drugs for similar indications.

AbbVie’s (ABBV - Free Report) oral CGRP, Ubrelvy, is approved for treating acute migraine. In September 2021, the FDA approved AbbVie’s another oral CGRP receptor antagonist, Qulipta, as a preventive treatment of episodic migraine in adults.

AbbVie believes that Ubrelvy and Qulipta represent a $1-billion-plus peak sales opportunity each.

Eli Lilly’s (LLY - Free Report) Emgality is another CGRP medicine approved for preventive treatment of migraine. The drug has become a key contributor to Eli Lilly’s sales growth since its approval.

Eli Lilly is conducting a head-to-head study comparing once-monthly Emgality injection to Bohaven’s Nurtec ODT for the preventive treatment of episodic migraine in adults.

Zacks Rank

Biohaven currently has 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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