Biohaven Pharmaceutical Holding Company Ltd. ( BHVN Quick Quote BHVN - Free Report) announced positive top-line data from the second pivotal study evaluating the safety and efficacy of its intranasal CGRP receptor antagonist, zavegepant, for the acute treatment of migraine in adults. The study met its co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours.
A single intranasal dose of zavegepant led to ultra-rapid pain relief within 15 minutes and sustained efficacy through 48 hours.
Data from the study showed that treatment with intranasal zavegepant 10 mg demonstrated statistically significant superiority versus placebo on a total of 15 consecutive, prespecified primary and secondary outcome measures in the acute treatment of migraine.
Based on these encouraging data combined with prior positive data from a phase II/III study, Biohaven plans to file a new drug application for zavegepant to the FDA for the acute treatment of migraine in adults in the first quarter of 2022.
Per the company, if approved, zavegepant will become the first intranasal CGRP receptor antagonist indicated for the acute treatment of migraine.
Biohaven is also investigating zavegepant for other indications. The company is evaluating an oral formulation of zavegepant in a phase III study as a preventive treatment of migraine. The company is also evaluating the candidate in a phase II study as a potential treatment for pulmonary complications of the COVID-19 disease. The company plans to initiate clinical studies on the candidate to evaluate it in non-migraine indications.
Shares of Biohaven have rallied 17% so far this year against the
industry’s decline of 21.7%. Image Source: Zacks Investment Research
We remind investors that Biohaven currently markets Nurtec ODT (rimegepant) for the acute treatment of migraine and preventive treatment of episodic migraine in adults.
Nurtec ODT has witnessed a strong uptake since its launch in March 2020. A potential approval to zavegepant should help Biohaven diversify its migraine portfolio and drive sales growth.
In November 2021, Biohaven signed a strategic agreement with
Pfizer ( PFE Quick Quote PFE - Free Report) for the commercialization of Nurtec ODT in the ex-U.S. markets.
Per the agreement, Biohaven will receive an upfront payment of $500 million, including $150 million in cash and $350 million in equity investment from Pfizer. Under the agreement, Biohaven also granted ex-U.S. rights to zavegepant to Pfizer.
We note that, presently, Biohaven’s top line solely comprises sales of its only marketed drug, Nurtec ODT. The company remains heavily dependent on the successful commercialization of the drug. However, it faces stiff competition from other anti-CGRP drugs also approved for similar indications.
AbbVie’s ( ABBV Quick Quote 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 Quick Quote LLY - Free Report) Emgality is also a CGRP medicine approved for preventive treatment of migraine.
Last month, Eli Lilly announced that enrollment is now open in a head-to-head study comparing once-monthly Emgality injection to Bohaven’s Nurtec ODT for the preventive treatment of episodic migraine in adults. The study's primary endpoint is to see the percentage of patients with ≥50% reduction from baseline in monthly migraine headache days.
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