| | NEW HAVEN, Conn., May 18, 2020 /PRNewswire/ -- Biohaven Pharma Holding Company Ltd. (NYSE: BHVN), announced today that it will present data from 25 accepted abstracts demonstrating the efficacy, safety, tolerability, and pharmacoeconomic value of NURTEC (rimegepant) on the 2020 American Academy of Neurology (AAN) Science Highlights virtual platform. 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. In lieu of an in-person annual meeting, the AAN will be showcasing accepted abstract presentations on its virtual platform, AAN.com/2020science. The virtual platform is scheduled to launch today, May 18, 2020 at 4:00 PM ET and will be open for viewing by the general public at no charge. Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, “The large number of important clinical and health economic analyses highlight Biohaven’s leadership and commitment to advancing NURTEC with the goal of gaining approval as the first oral CGRP-targeting agent for both the acute and preventive treatment of migraine. The data presented add to the growing body of scientific evidence supporting NURTEC ODT as a differentiated treatment for migraine with a depth of response in several patient populations, including those who have tried triptans and those using migraine preventive treatment who are in need of effective acute therapy for breakthrough attacks.” Dr. Coric added, “NURTEC ODT is the only CGRP-targeting drug to have return to normal functioning within hours and sustained efficacy out to 48 hours after a single dose in the approved drug label. Our newly published expanded data from 1,800 patients treated up to 1 year in our safety study show reductions in migraine days after intermittent treatment of acute migraine attacks with NURTEC 75 mg. This data suggest long-term benefits on functional outcome measures, decreases in disability and reductions in migraine days when acute migraine attacks are effectively treated. We have always advocated that patients with migraine deserve new solutions and we are delivering on that promise with the broad and robust data being shared on the 2020 AAN Science Highlights virtual platform.” Notably, Biohaven will be presenting results from the rimegepant Phase 3 and long-term safety clinical trials highlighting rimegepant’s rapid onset and sustained duration of action, favorable long-term safety profile, concomitant use with anti-CGRP monoclonal antibodies, efficacy in triptan-experienced patients, reduction in monthly migraine days, and improvements in productivity. A total of 25 posters/presentations will be presented as part of the AAN virtual platform. Titles of all accepted abstracts are listed below. Key highlights include: - Concomitant use of rimegepant with anti-CGRP mAbs was evaluated in a subgroup of patients in the rimegepant long-term safety study. Thirteen patients who experienced 2-8 moderate-to-severe monthly attacks while taking a stable dose of an FDA-approved anti-CGRP mAb were included and instructed to treat attacks of any pain intensity with oral rimegepant 75 mg as needed up to once daily for 12 weeks. The study demonstrated favorable tolerability and no safety issues when using rimegepant as an oral acute treatment in adults with migraine while also receiving an injectable anti-CGRP mAb preventive treatment.
- A pooled analysis from three Phase 3 clinical trials evaluated the efficacy of rimegepant 75 mg in patients who had a history of triptan treatment failure or who were using triptans at the time of trial enrollment. Results demonstrated that in both groups of triptan-experienced patients, rimegepant was more effective than placebo on pain freedom, MBS freedom, and pain relief at 2 hours post-dose as well as other clinically meaningful secondary endpoints.
- Pooled results from three Phase 3 clinical trials with 3,507 patients (rimegepant n=1749, placebo n=1758) evaluating the efficacy of rimegepant for the acute treatment of migraine showed that a single oral dose of rimegepant 75 mg without repeat dosing or rescue medication was superior to placebo for sustained pain relief and ability to function normally from 2 to 48 hours post-dose. Additionally, rapid onset of action was demonstrated with rimegepant ODT with some patients experiencing pain relief as early as 15 minutes post-dose; effects were statistically superior to placebo on pain relief and ability to function normally at 60 minutes post-dose.
- A pooled, post-hoc analysis of long-term safety data demonstrated that acute treatment of migraine with rimegepant 75 mg provides significant improvements to absenteeism (ABS), presenteeism (PBS), and improves lost productivity time (LPT) by 44% (~11 fewer days per month) reflecting improvements in workplace productivity. In the study, patients were instructed to treat migraine attacks of any pain intensity with up to one dose of rimegepant 75 mg as needed, up to once daily, for 52 weeks. ABS, PRE and LPT were assessed at baseline and at weeks 12, 24, 36, and 52 using the validated Migraine Disability Assessment instrument.
- Results from post-hoc, pooled analysis of long-term safety data showed a reduction in monthly migraine days (MMD) across three rimegepant patient groups (n=1,800): Group 1 had 2-8 MMD and received as needed dosing (PRN), Group 2 had 9-14 MMD and also received PRN, and Group 3 had 4-14 MMD and dosed every other day (QOD) plus PRN. Results showed that treatment with rimegepant 75 mg was associated with notable reductions in MMD. The magnitude of MMD reduction was associated with the range of reported historic migraine frequency and the migraine frequency assessed during the 30-day pre-treatment observation period.
The full presentations will be available on the AAN Science Highlights virtual platform at AAN.com/2020science and include: - Rimegepant is Effective for the Acute Treatment of Migraine in Patients with a History of Triptan Treatment Failure: Pooled Analyses from 3 Phase 3 Clinical Trials
- Oral Rimegepant 75 mg is Well-tolerated When Used Concomitantly with Injectable Anti-CGRP Monoclonal Antibodies: Results From a Multicenter, Long-term, Open-label Safety Study
- Rimegepant 75 mg Provides Early and Sustained Relief of Migraine With a Single Dose: Results from 3 Phase 3 Clinical Trials
- Patient Preference and Improved Clinical Global Impression of Change with Rimegepant for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study (Study 201)
- Long-Term Safety of Rimegepant 75 mg for the Acute Treatment of Migraine (Study 201)
- Acute Treatment of Migraine with Oral Rimegepant 75 mg Confers Robust Improvement in Absenteeism, Presenteeism and Productivity: Results from a One Year, Open-Label, Safety Study (BHV3000-201)
- Rimegepant 75 mg Results in Reductions in Monthly Migraine Days: Secondary Analysis of a Multicenter, Open Label Long-term Safety Study of Rimegepant for the Acute Treatment of Migraine
- Comparative Efficacy and Safety of Rimegepant Versus Ubrogepant and Lasmiditan for Acute Treatment of Migraine: A Network Meta-analysis (NMA)
- Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP Monoclonal Antibodies (mAb) Examining Health-related Quality of Life (HRQoL).
- Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP-targeted Monoclonal Antibodies Examining Monthly Migraine Days in the Treatment of Migraine
- Migraine Patients Exhibit Increased Relative Risk for Medication Overuse Headache with Sustained Triptan Treatment - Results from a Real-World Claims Analysis
- Switching and Discontinuation Patterns Among Triptan Users: A Systematic Literature Review
- Acute Treatment of Migraine with Oral Rimegepant 75 mg Improves Health Related Quality of Life: Results from a Long-Term, Open-Label Safety Study (BHV3000-201)
- Acute Treatment with Oral Rimegepant 75 mg Reduces Migraine-Related Disability: Results from a One Year, Open-Label Safety Study (BHV3000-201)
- Cardiovascular Safety of Rimegepant 75 mg in 3 Randomized Clinical Trials and Systematic Evaluations from In Vitro, Ex Vivo, and In Vivo Nonclinical Assays
- Rimegepant is Effective for the Acute Treatment of Migraine in Subjects Taking Concurrent Preventive Medication: Results From 3 Phase 3 Trials
- Rimegepant 75 mg is Effective for the Acute Treatment of Migraine Regardless of Attack Frequency: Results From 3 Phase 3 Trials
- Rimegepant 75 mg Demonstrates Superiority to Placebo on Nausea Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3 Trials in the Acute Treatment of Migraine
- Rimegepant 75 mg Demonstrates Safety and Tolerability Similar to Placebo With No Effects of Age, Sex, or Race in 3 Phase 3 Trials
- Rimegepant 75 mg Is More Effective for Migraine Than Nonsteroidal Anti-inflammatory Drugs: Post Hoc Analysis of Data From 2 Phase 3 Trials
- Phase 1 and 2 Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose Rimegepant as Compared to the Predicted Clinically Efficacious Dose Range
- Oral Rimegepant Produces No Significant Effect on Blood Pressure When Administered Concomitantly with SC Sumatriptan
- Rimegepant has No Clinically Relevant Effect on ECG parameters at Therapeutic and Supratherapeutic Doses: A Thorough QT Study Versus Placebo and Moxifloxacin in Healthy Subjects
- Results of a Phase 1, Open-label, Single-dose, Parallel-group Study of Rimegepant 75 mg in Subjects with Hepatic Impairment
- Rimegepant 75 mg Exposure, Safety, and Tolerability are Similar in Elderly and Nonelderly Adults: a Phase 1, Open-Label, Parallel-Group, Single-Dose Study
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. 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. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). 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. 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: - Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.
- Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.
- Renal impairment: Avoid use in patients with end-stage renal disease.
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Visit 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 Prescribing information and 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 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 NURTEC ODT as an acute treatment for patients with migraine and potential 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 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, 2019, 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.
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