Biohaven Enrolls First Patient in Phase 2/3 Trial of Oral Zavegepant, Prompting $100 Million Milestone Funding Payment from Royalty Pharma

Rhea-AI Summary

Biohaven Pharmaceutical (NYSE: BHVN) announced that it has enrolled the first patient in a Phase 2/3 clinical trial for oral zavegepant, aimed at preventing migraines. This milestone has triggered a $100 million payment from Royalty Pharma, which previously funded $150 million for zavegepant's development. The study will involve around 2,900 participants to evaluate two doses of the drug. Biohaven aims to expand its CGRP product line, addressing the needs of those suffering from CGRP-related conditions.

Positive

• Enrollment of the first patient in Phase 2/3 trial of oral zavegepant signifies progress in migraine treatment.
• The trial will facilitate $100 million funding from Royalty Pharma.
• The potential to expand CGRP franchise could enhance market positioning and revenue streams.

Negative

• Uncertainties remain regarding the commercialization and regulatory approval of zavegepant.
• Dependence on FDA outcomes for product advancement poses risks.

NEW HAVEN, Conn., March 29, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a marketed drug for the acute treatment of migraine and a portfolio of innovative, late-stage product candidates targeting neurological diseases including rare disorders, today announced that it has enrolled the first patient in a Phase 2/3 clinical trial of oral zavegepant for the preventive treatment of migraine.  

In August 2020, Biohaven entered into a funding agreement with Royalty Pharma to secure up to $250 million to advance the development of zavegepant in migraine and other CGRP-mediated diseases.  Biohaven previously received $150 million in funding and will now receive $100 million with the enrollment of this first patient in the oral zavegepant Phase 3 clinical trial.

Elyse Stock, M.D., Chief Medical Officer of Biohaven commented, "We are excited to advance the oral formulation of zavegepant into this late-stage, clinical trial and broaden our CGRP franchise. We plan on following the science of CGRP receptor antagonism into pain related disorders and non-migraine indications. By expanding beyond our migraine franchise, we are hoping to meet the needs of people impacted by the debilitating aspects of multiple CGRP-mediated diseases."

The randomized, double-blind, placebo-controlled trial will enroll approximately 2,900 people with migraine and will evaluate the efficacy and safety of 100 mg and 200 mg doses of oral zavegepant. For more information about the trial, visit clinicaltrials.gov.

"We are pleased to see Biohaven progress oral zavegepent into Phase 3 for the prevention of migraine, as people suffering from frequent migraines continue to need additional treatment options," said Jim Reddoch, PhD, Royalty Pharma's Co-Head of Research & Investments and Chief Scientific Officer. "Our successful, multi-year partnership with Biohaven to support both the regulatory approval and commercialization of Nurtec as well as pipeline development is an excellent example of how Royalty Pharma can be a collaborative partner to innovative biopharma companies." 

The zavegepant program encompasses intranasal and oral formulations for migraine and non-migraine indications. Intranasal zavegepant previously demonstrated superior efficacy to placebo in a Phase 2/3 study for the acute treatment of migraine and the investigational agent is also being studied in an ongoing double blind, randomized, placebo-controlled trial in COVID-19 infected hospitalized patients requiring supplemental oxygen.

About Biohaven
Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and non-migraine CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "continue", "may", "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about zavegepant as an acute and preventive treatment for patients with migraine and non-migraine CGRP-mediated diseases. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively commercialize zavegepant, delays or problems in the supply or manufacture of zavegepant, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 1, 2021. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NOJECTION and NURTEC are trademarks of Biohaven Pharmaceutical Ireland DAC.

Contact:
Dr. Vlad Coric
Chief Executive Officer
Phone: (203) 404-0410
Email: vlad.coric@biohavenpharma.com

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.

FAQ

What is the purpose of the Phase 2/3 trial for oral zavegepant by Biohaven?

The trial evaluates the efficacy and safety of oral zavegepant for migraine prevention.

How many patients will be enrolled in the zavegepant trial?

Approximately 2,900 patients will participate in the trial.

What financial milestone did Biohaven achieve with the trial enrollment?

The enrollment triggered a $100 million payment from Royalty Pharma.

When was the first patient enrolled in the zavegepant trial?

The first patient was enrolled on March 29, 2021.

What are the expected outcomes of the zavegepant trial?

The trial aims to determine the effectiveness of 100 mg and 200 mg doses of oral zavegepant.