Biohaven Presents NURTEC™ (rimegepant) Clinical and Pharmacoeconomic Data at the American Headache Society (AHS) Virtual Annual Scientific Meeting

Rhea-AI Summary

On June 16, 2020, Biohaven Pharmaceuticals (NYSE: BHVN) presented 25 abstracts on the efficacy, safety, and economic benefits of NURTEC™ (rimegepant) at the AHS Virtual Annual Scientific Meeting. This data underscores NURTEC’s rapid efficacy and safety, particularly for patients with cardiovascular risks. NURTEC ODT is the first CGRP receptor antagonist in an orally disintegrating tablet approved for acute migraine treatment. The presentation included significant findings from Phase 3 trials, emphasizing its tolerability and low rescue medication usage.

Positive

• Presentation of 25 abstracts demonstrating efficacy and safety of NURTEC at the AHS meeting.
• NURTEC ODT shows rapid and sustained relief of migraine symptoms.
• Positive data for safety in patients with cardiovascular risk factors.

Negative

• None.

NEW HAVEN, Conn., June 16, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that it presented data from 25 accepted abstracts demonstrating the efficacy, safety, tolerability and pharmacoeconomic value of NURTEC™ (rimegepant) at the 2020 American Headache Society (AHS) Virtual Annual Scientific Meeting.

In lieu of an in-person annual meeting, the AHS has decided to present portions of the Annual Scientific Meeting via a Virtual Meeting platform, which launched Saturday, June 13.

Elyse Stock, M.D., Chief Medical Officer of Biohaven commented, "The extensive data set presented at the AHS Virtual Annual Meeting showcases the important benefits that NURTEC brings to patients.  The growing body of data continues to validate the rapid and durable efficacy of single dose NURTEC and safety in subpopulations with significant unmet need including people with cardiovascular risk and those who are currently taking preventive treatments for migraine."

NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. Rimegepant has also demonstrated efficacy in the preventive treatment of migraine and Biohaven is committed to advancing rimegepant as a "dual-acting" therapy with the goal of gaining approval as the first oral CGRP-targeting agent for both the acute and preventive treatment of migraine. In December 2019, the Company also announced positive topline results for its Phase 2/3 trial for vazegepant (BHV-3500), the first small molecule CGRP receptor antagonist to be administered in an intranasal formulation for the acute treatment of migraine.

Biohaven has one oral and 24 poster presentations that are being showcased as part of the AHS virtual platform. Key highlights include: 

Oral Presentation

• Rimegepant 75 mg Provides Early and Sustained Relief of Migraine With a Single Oral Dose:  Results from 3 Phase 3 Clinical Trials

Poster Presentations

• Oral Rimegepant 75 mg is Safe and Well Tolerated in Adults With Migraine and Cardiovascular Risk Factors: Results of a Multicenter, Long-Term, Open-Label Safety Study
• Low Rates of Rescue Medication Usage in Subjects Treated With a Single Dose of Rimegepant 75 mg for the Acute Treatment of Migraine: Results from 3 Phase 3 Clinical Trials
• Rimegepant is Safe and Tolerable for the Acute Treatment of Migraine in Patients Using Preventive Migraine Medications: Results from a Long-Term Open-Label Safety Study (Study 201)
• Lost-time is Associated with Total Health Care and Pharmaceutical Costs – A US-Based Real World Longitudinal Analysis
• MIDAS Disability Grades are Associated with Total Health Care and Pharmaceutical Costs – A US-Based Real World Longitudinal Analysis

A full list of presentations can be accessed here.

About NURTEC ODT
NURTEC™ ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. Nurtec ODT is not indicated for the preventive treatment of migraine. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. NURTEC ODT has a relatively rapid Tmax (1.5 hours) and relatively long half-life (11 hours) which may account for rapid and sustained efficacy demonstrated with statistically significant improvement vs placebo on pain relief and ability to function normally at 60 minutes and sustained through 48 hours. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit www.nurtec.com.

Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4. The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo).

About Migraine 
Nearly 40 million people in the U.S. suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute treatments as more than 90 percent of migraine sufferers are unable to work or function normally during an attack.

About CGRP Receptor Antagonism 
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, or who have a poor response to triptans or are intolerant to them.

Indication
NURTEC™ ODT (rimegepant) is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use 
NURTEC ODT is not indicated for the preventive treatment of migraine.

Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of its components.

Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.

Drug Interactions: Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Use in Specific Populations:

1. Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.  
2. Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.  
3. Renal impairment: Avoid use in patients with end-stage renal disease.

Please click here for full -1%26h%3D2771875747%26u%3Dhttps%253A%252F%252Fwww.biohavenpharma.com%252Fsites%252Fdefault%252Ffiles%252FNDA%25252021728%252520PI%25252027%252520FEB%2525202020%252520signed_wo%252520bm%25255B1%25255D.pdf%26a%3DPrescribing%2Binformation&a=Prescribing+information" rel="nofollow">Prescribing information.

You are encouraged to report side effects of prescription drugs to the FDA.

Visit -1%26h%3D2644627974%26u%3Dhttp%253A%252F%252Fwww.fda.gov%252Fmedwatch%26a%3Dwww.fda.gov%252Fmedwatch&a=www.fda.gov%2Fmedwatch" rel="nofollow">www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec. Please click here for full -1%26h%3D2771875747%26u%3Dhttps%253A%252F%252Fwww.biohavenpharma.com%252Fsites%252Fdefault%252Ffiles%252FNDA%25252021728%252520PI%25252027%252520FEB%2525202020%252520signed_wo%252520bm%25255B1%25255D.pdf%26a%3DPrescribing%2Binformation&a=Prescribing+information" rel="nofollow">Prescribing information and -1%26h%3D793526694%26u%3Dhttps%253A%252F%252Fwww.biohavenpharma.com%252Fsites%252Fdefault%252Ffiles%252FNURTEC-PI%252520PPI%25252027%252520FEB%2525202020%25255B2%25255D.pdf%26a%3DPatient%2BInformation.&a=Patient+Information." rel="nofollow">Patient Information.

About Biohaven
Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. 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; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.

Forward-looking Statement
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", and "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 NURTEC ODT as an acute treatment for patients with migraine. Forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, 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 filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 2020. 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.

Biohaven Contact:
Vlad Coric, M.D.
Chief Executive Officer
Vlad.Coric@biohavenpharma.com

Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com 
312-961-2502

NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.
Copyright © 2020 Biohaven. All rights reserved.

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.

FAQ

What were the key findings of Biohaven's presentation on NURTEC at the AHS meeting?

Biohaven presented 25 abstracts highlighting NURTEC's efficacy, safety, and pharmacoeconomic benefits, particularly its rapid relief and tolerability for patients with cardiovascular risks.

What is NURTEC ODT and how does it function?

NURTEC ODT (rimegepant) is a CGRP receptor antagonist approved for acute migraine treatment, working by blocking CGRP receptors to inhibit migraine symptoms.

Did Biohaven report any new clinical trial results for NURTEC?

Yes, findings from multiple Phase 3 clinical trials were shared, demonstrating the medication's efficacy and low rates of rescue medication use.

How does NURTEC compare to other migraine treatments?

NURTEC is notable for being the first oral CGRP receptor antagonist, providing an alternative for patients who cannot use traditional migraine medications.