| | - 31 new and encore presentations, including three late-breakers and three oral presentations, spotlight robust Nurtec ODT, zavegepant and migraine HEOR data
- Late-breaking submissions showcase new data for Nurtec ODT in Chinese and Korean patients and patterns of medication utilization in adults using it as an acute and preventive treatment
- Results from long-term studies of Nurtec ODT as a preventive and acute treatment of migraine showed more than 80% of patients achieved ≥50% reduction in moderate or severe monthly migraine days and approximately half experienced a 100% reduction
- Other oral presentations included safety and efficacy of zavegepant nasal spray as an acute treatment of migraine and an analysis of placebo responses over time in oral migraine preventive trials
NEW HAVEN, Conn., June 9, 2022 /PRNewswire/ -- Biohaven Pharma Holding Company Ltd. (NYSE: BHVN), today announced that it will be presenting 31 abstracts, including three late-breakers and three oral presentations, at the 64th annual scientific meeting of the American Headache Society (AHS) being held from June 9-12 in Denver, CO. 
Biohaven will be showcasing key efficacy and safety data for its calcitonin gene-related peptide (CGRP) platform including full Phase 3 results for zavegepant nasal spray as an acute treatment of migraine; data from a 52-week open label extension study of Nurtec® ODT (rimegepant) evaluating every other day preventive treatment of migraine plus as an as-needed acute treatment – a first of its kind study assessing acute and preventive treatment with one medication; and estimated reductions in monthly migraine days (MMDs) with rimegepant acute treatment. The late-breakers will highlight new data about patterns of medication utilization and migraine frequency for adults using Nurtec ODT as a preventive and acute treatment; results from a Phase 1 trial of Nurtec ODT in healthy Chinese adults; and outcomes of a Phase 3 study of Nurtec ODT conducted in China and Korea as an acute treatment of migraine. Additional posters will share information from a Delphi Panel of migraine experts that established consensus around flexible, individualized migraine treatment and the utility of situational preventive migraine treatment for times when patients have predictable yet unavoidable triggers and for expected situations when migraine prevention is particularly desired, such as important life events. Several health economics and outcomes research (HEOR) posters notably highlight (1) reductions in the prevalence of medication overuse headache following Nurtec ODT initiation, (2) reduced mean monthly quantity of dispensed Nurtec ODT which is potentially reflective of MMD reductions, (3) patient survey studies that illustrate preference for ODT oral formulations versus injectable or IV treatments in prevention, (4) improvements in health-related quality of life with long-term Nurtec ODT treatment, (5) the high interictal burden of migraine, and (6) patient reported attenuation of effect with biologic treatment in prevention. Elyse Stock, MD, Chief Medical Officer of Biohaven commented, “The data presented at AHS 2022 highlights Biohaven’s leadership in pioneering migraine-related research and a deep commitment to helping patients who live with this debilitating disease. We are working to expand our migraine portfolio to continue to have a positive impact on the lives of people with migraine and offer the ability to individualize care depending on patient treatment needs. Data from the first of its kind long-term, open-label study for Nurtec ODT showed that it is a safe and effective, all-in-one FDA-approved medication that helped almost half of the subjects achieve 100% reduction in monthly migraine days. Additionally, the FDA has recently accepted for review an NDA for zavegepant nasal spray as potentially another effective treatment option for migraine.” A complete list of abstracts is available below along with details about the late-breakers and oral presentations by our investigators. Abstracts will also be published in the June edition of Headache journal or shared as a supplement along with the main edition. | Abstract Title | Presentation Details | | Late-Breakers | | Patterns of Medication Utilization and Migraine Frequency in Adults Using
Rimegepant for Both Preventive and Acute Treatment for Migraine: Results
From a 52-Week, Open-Label Extension Study | | | Efficacy, Safety, and Tolerability of Rimegepant 75 mg Orally Dissolving
Tablet for the Acute Treatment of Migraine: Results from a Phase 3, Double-
Blind, Randomized, Placebo-Controlled Trial in Adults From China and Korea | | | A Phase 1, Randomized, Placebo-controlled, Single- and Multiple- dose,
Double-blind Study to Evaluate the Pharmacokinetics and Safety of
Rimegepant Orally Disintegrating Tablets 75mg in Healthy Adult Chinese Subjects | | | Oral Presentations – Saturday, June 11 | | Efficacy and Safety of Zavegepant Nasal Spray for the Acute Treatment of
Migraine: Results of a Phase 3, Double-Blind, Randomized, Placebo
Controlled Trial | IOR-01 7:30 a.m. – 7:40 a.m. Dr. Jelena Pavlovic | | Increased Placebo Response Over Time in Oral Migraine Preventive Trials: A
Systematic Literature Review and Meta-Analysis | IOR-04 8:00 a.m. – 8:10 a.m. Dr. Stewart Tepper | | Safety and Tolerability of Rimegepant Every Other Day for Preventive
Treatment of Migraine Plus As-Needed for Acute Treatment of Migraine:
Results from a 52-week, Open-label Extension Study | IOR-09 8:50 a.m. – 9 a.m. Dr. Richard Lipton | | Rimegepant Posters – Friday, June 10 and Saturday, June 11 | | Estimated Change Over Time in Monthly Migraine Days (MMD) with Real-
World Rimegepant Treatment Based on Association of Monthly Pill Use and
MMD in Study BHV3000-201 | Poster #P-74 Health Services/Outcomes Research | | Real World Evidence of Reduction in Point Prevalence of Medication
Overuse Headache after Migraine Therapy with Rimegepant | Poster #P-90 Health Services/Outcomes Research | | Health State Utility Mapping of Rimegepant for the Preventive Treatment of
Migraine: BHV3000-305 Double Blind Treatment Phase and Open Label
Extension Study | Poster #P-124 Health Services/Outcomes Research | | Long-term Preventive and Acute Treatment of Migraine with Rimegepant
Improves Health Related Quality of Life | Poster #P-128 Other Clinical Studies | | Medication Preference, Satisfaction, and Clinical Improvement Among
Adults Receiving Long-term Treatment with Rimegepant for Migraine | Poster #P-130 Other Clinical Studies | | Acute Treatment with Rimegepant 75 mg Offers Improvements in Pain
Severity over 48-hours When Compared with Placebo – Post Hoc results
from a Randomized Placebo-controlled Trial (BHVN-3000-303) | Poster #P-151 Therapeutics | | Effects of Long-term Preventive Treatment with Oral Rimegepant 75 mg on
Migraine-Related Disability: A 52-week, Open-label Extension Study | Poster #P-158 Therapeutics | | Effects of Rimegepant 75 mg on Monthly Migraine Days; A 52-week Open-l
abel Extension Study | Poster #P-162 Other Clinical Studies | | Prevention Benefits of Repeated Acute Treatment with Rimegepant 75 mg –
Simulation Model Validated by an Open-label Safety Study (BHV3000-201) | Poster #P-187 Therapeutics | | Successful Treatment of Atypical Trigeminal Neuralgia Pain with Rimegepant,
an Orally Administered Calcitonin Gene-Related Peptide Receptor
Antagonist: A Case Study | Poster #P-201 Therapeutics | | Zavegepant Posters – Friday, June 10 and Saturday, June 11 | | Absorption, Distribution, Metabolism, and Elimination of 5 mg Zavegepant in
Healthy Male Subjects after a Single Intravenous Infusion Dose | Poster #P-112 Headache Education | | Concentration-QT Interval Modeling of Intranasally Administered
Zavegepant in Healthy Subjects Shows Absence of QT Prolongation | Poster #P-117 Other Clinical Studies | | Effects of Zavegepant and Concomitant Sumatriptan on Blood Pressure and
Pharmacokinetics in Healthy Adult Participants | Poster #P-122 Other Clinical Studies | | Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending
Doses Zavegepant Nasal Spray in Healthy Adults | Poster #P-142 Other Clinical Studies | | Effects of the Strong CYP3A4 and P-glycoprotein Inhibitor Itraconazole on
the Pharmacokinetics of Oral and Intranasal Zavegepant | Poster #P-163 Therapeutics | | Migraine and CGRP Posters – Friday, June 10 and Saturday, June 11 | | Delphi Panel to Establish Consensus Around Flexible, Individualized Migraine
Treatment | Poster #P-59 Headache Education | | Patients Report Greater Satisfaction, Quality of Communication, and
Medication-Specific Discussion with Headache Specialists than with Other
Health Care Professionals: Results from a Survey of an Online Migraine
Community | Poster #P-66 Headache Education | | Quality of Communication Between Patients and Their Health Care Providers
is Associated with Patient Satisfaction and Treatment Optimization
Outcomes: Results from a Survey of an Online Migraine Community | Poster #P-67 Headache Education | | Attitudes and Perspectives About Migraine Among Nonneurologist
Healthcare Providers: Results from a Cross-sectional Survey | Poster #P-70 Health Services/Outcomes Research | | Measuring Interictal Burden Amongst Migraine Sufferers: A Descriptive
Survey Study | Poster #P-81 Health Services/Outcomes Research | | Patient Preferences for Calcitonin Gene-Related Peptide (CGRP) Inhibitors in
the Preventive Treatment of Migraine: A Discrete Choice Experiment in the
US and Germany | Poster #P-85 Health Services/Outcomes Research | | Patterns of Medication Usage Among Adults with Migraine Following Initial
Prescription of a CGRP mAb: A Retrospective Database Cohort Study | Poster #P-87 Health Services/Outcomes Research | | Practice Patterns and Management of Migraine Among Nonneurologist
Healthcare Providers: Results from a Cross-Sectional Survey | Poster #P-89 Health Services/Outcomes Research | | Real World Treatment Experience and Satisfaction Among Migraine Patients:
A Descriptive Survey Study | Poster #P-94 Health Services/Outcomes Research | | Use of Medications for Acute Treatment and Healthcare Resource Utilization
Among Adults with Migraine Before and After At least 3 Months of Initial
Exposure to a CGRP mAb: A Noninterventional, Retrospective Database
Cohort Study | Poster #P-103 Health Services/Outcomes Research | 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. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4 or potent inhibitors of P-gp. 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,
- are 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 was the second zavegepant pivotal clinical trial to meet these coprimary endpoints. The U.S. Food and Drug Administration has accepted a new drug application for zavegepant with a Prescription Drug User Fee Act date in the first quarter of 2023. About Biohaven
Biohaven is a global 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 (EMA-approved as VYDURA® for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and other CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis; Kv7 ion channel activators for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com. NURTEC, NURTEC ODT and VYDURA are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation and NOJECTION are trademarks of Biohaven Pharmaceutical Holding Company Ltd. 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”, “will”, “anticipate”, “expect” 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 and preventive treatment for migraine. Factors that could affect these 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 forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2022, and in Biohaven’s subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of the date of this new release, 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
Jennifer Porcelli
201-248-0741
Vice-President, Investor Relations
jennifer.porcelli@biohavenpharma.com Media Contact
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
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