Biohaven Data at 2022 American Academy of Neurology (AAN) Annual Meeting Demonstrate Leadership in Migraine and Commitment to Advancing Potential New Therapeutic Options in Neurological Diseases

• Migraine patients treated with Nurtec ODT had a reduction in total opioid prescriptions filled after initiation of therapy, according to an analysis of real-world administrative claims
• Single and multiple daily doses of intranasal zavegepant of up to 40 mg were well tolerated in Phase 1 study
• Rimegepant, atogepant and monoclonal antibody treatments determined to be effective options for the prevention of migraine when compared vs placebo

NEW HAVEN, Conn., March 31, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 13 abstracts, including two oral presentations, will be featured at the 2022 American Academy of Neurology (AAN) annual meeting being held April 2-7 in Seattle, WA and virtually from April 24-26. Building on its leadership in migraine, Biohaven is committed to advancing innovative treatments and transforming patient experiences while focusing on research that may drive better outcomes for people across the spectrum of neurological diseases.

Biohaven will be sharing 13 presentations from its clinical portfolio including Nurtec® ODT (rimegepant) and zavegepant nasal spray along with related health economic and outcomes research analyses that highlight real-world studies with rimegepant.

Elyse Stock, MD, Chief Medical Officer of Biohaven commented, "The research presented at AAN 2022 represents Biohaven's continuing efforts to further advance effective treatment options for those living with debilitating neurological and neuropsychiatric diseases. One of our most compelling presentations highlights Nurtec ODT's clinical utility as demonstrated by a reduction in opioid prescriptions filled and medication overuse headache following treatment. Nurtec ODT is the only dual indication therapy for the acute treatment of migraine and preventive treatment of episodic migraine in adults, and is highly relevant in the context of today's public health needs. Biohaven's new data highlight treatment options for migraine that are important to patients and clinicians; a favorable efficacy and safety profile without addictive or abuse potential. Biohaven is presenting results from our Phase 1 study of intranasal zavegepant. Zavegepant is the only late-stage CGRP receptor antagonist using intranasal administration for rapid onset of action starting at 15 minutes and potential utility in patients experiencing significant nausea/vomiting during an attack. The Phase 1 results underscore the safety and tolerability profile of this intranasal zavegepant and provides further support for its upcoming NDA filing."

Notable highlights include:

• Reduction in opioid use and medication overuse headache: Two real-world administrative claims analyses evaluated reduction in opioid use and medication overuse headache (MOH) prior to and following use of Nurtec ODT initiation. Results demonstrated a significant reduction in opioid use, measured by mean monthly fills and mean monthly MME dispensed, and MOH following Nurtec ODT initiation.
• Phase 1 results with zavegepant: A Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of intranasal zavegepant in single and multiple ascending doses showed that single and multiple daily doses of intranasal zavegepant of up to 40 mg were well tolerated. Doses ≥10 mg produced exposures predictive of efficacy in adults with migraine.
• Non-neurologist migraine management preferences: Results from a cross-sectional survey described the prevailing opinions of non-neurologists regarding migraine management based on their clinical experience and exposure to scientific data. The survey found that non-neurologists value simplicity and flexibility in managing migraine, which they perceive as relatively uncommon and complex. Improving knowledge and education in non-neurology settings may improve population outcomes among patients with migraine.
• Migraine prevention treatments: A systematic literature review and network meta-analysis that evaluated the relative efficacy of rimegepant, atogepant, and monoclonal antibody (mAb) treatments for the prevention of migraine. Results showed that all were effective treatment options for the prevention of migraine when compared vs placebo and generally showed similar effects when compared to one another.
• Healthcare Practitioner Satisfaction: A quantitative survey of people with migraine found that patient satisfaction with their Healthcare Practitioner (HCP) was related to HCPs actively listening and asking open-ended questions. Almost all "very satisfied" participants agreed that their HCPs offered ample time to discuss their needs during the appointment (98%) and clearly and thoroughly answered their questions (95%).

The complete list of accepted abstract titles is below. Full abstracts can be viewed online: https://index.mirasmart.com/aan2022/.

Oral Presentations:

• Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Intranasal Zavegepant in Healthy Adults (#1003)
• Reduction in Opioid Prescription Fills and Morphine Milligram Equivalent Dispensed Following Initiation of Nurtec ODT Treatment – A Real World Administrative Claims Study (#3807)

Poster Presentations:

• Rimegepant Versus Atogepant and Monoclonal Antibody Treatments for the Prevention of Migraine: A Systematic Literature Review and Network Meta-analysis (#2972)
• Low Levels of Rimegepant in Breast Milk After a Single 75-mg Dose (#658)
• An Open-label, Intermediate-sized, Expanded Access Protocol of Rimegepant in the Acute Treatment of Migraine (#874)
• Acute Treatment with Oral Rimegepant 75 mg Reduces Migraine-reduced Disability in Adults With and Without a History of Triptan Treatment Failure: Results from a One-year, Open-label Safety Study (#873)
• Effect of Strong P-gp and BCRP inhibition, Using Cyclosporin and Quinidine as Probes, on the Pharmacokinetics of Oral Rimegepant 75 mg in Healthy Subjects (#877)
• Reduction in Period Prevalence of Medication Overuse Headache following Initiation of Nurtec ODT Treatment – A Real World Administrative Claims Study (#3698)
• MSQ Utility Mapping of Rimegepant by Change in Monthly Migraine Days for Preventive Treatment of Migraine (#2972)
• Perspectives from Members of an Online Community on their Communications with Health Care Professionals about Migraine Treatment: A Social Listening Analysis (#725)
• Patient Satisfaction is Associated with Positive Communications with Health Care Professionals: Interim Results from a Survey of an Online Migraine Community (#998)
• Non-Neurologist Perspectives on Migraine: Results of a Cross-Sectional Survey (#1344)
• Characterizing the Natural History of Progression in Patients with Multiple System Atrophy (#350)

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 with or without aura and the preventive treatment of episodic migraine in adults. 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. For more information about NURTEC ODT, visit www.nurtec.com.

Indication
NURTEC ODT orally disintegrating tablets is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients. Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:

• have liver problems,
• have kidney problems,
• are pregnant or plan to become pregnant,
• breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

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

Visit www.fda.gov/medwatch or call 1–800–FDA–1088 or report side effects to Biohaven at 1–833–4NURTEC.

See full Prescribing Information and Patient Information.

About Zavegepant
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2 hour freedom from pain and freedom from a patients' most bothersome symptom (either nausea, photophobia or phonophobia). This is the second zavegepant pivotal clinical trial to meet these coprimary endpoints. For more information, visit www.biohavenpharma.com.

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 and preventive treatment of migraine and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: calcitonin gene related peptide (CGRP) receptor antagonism; glutamate modulation; myeloperoxidase (MPO) inhibition, Kv7 Ion Channel Activators (Kv7), and Myostatin. More information about Biohaven is available at 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. These forward-looking statements involve substantial risks and uncertainties, including statements regarding the safety and efficacy of Nurtec ODT or zavegepant. 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, 2021, filed with the Securities and Exchange Commission on February 25, 2022, and Biohaven's subsequent filings with the Securities and Exchange Commission. 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.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven Contact
Jennifer Porcelli
Vice-President, Investor Relations
[email protected] 
201-248-0741

Media Contact
Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502

SOURCE Biohaven Pharmaceutical Holding Company Ltd.