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Biopharmaceuticals FDA

 News Release - March 23, 2020

Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA

In previously reported positive topline results from pivotal Phase 2/3 clinical trial in December 2019, vazegepant achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours

Vazegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine Platform and the only intranasal CGRP receptor antagonist in late stage development


NEW HAVEN, Conn., March 23, 2020 -- (Healthcare Sales & Marketing Network) -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or, the "Company") today announced a successful end of Phase 2 clinical and nonclinical interaction with the U.S. Food and Drug Administration (FDA) for intranasal vazegepant for the acute treatment of migraine. The Company addressed all issues raised by the FDA and will advance the 10 mg dose of intranasal vazegepant into a double-blind, placebo-controlled Phase 3 clinical trial. Biohaven previously reported that intranasal vazegepant 10 and 20 mg achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours in a Phase 2/3 dose finding trial.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Based on this positive interaction with the FDA, we look forward to advancing our Phase 3 clinical trial of intranasal vazegepant 10 mg for the acute treatment of migraine mid-year. If approved, this novel intranasal formulation of vazegepant will complement our recently approved, NURTEC™ ODT (rimegepant) orally disintegrating tablet, currently marketed for acute treatment of migraine and could add another innovative treatment option to help those suffering with migraine obtain rapid relief." Dr. Coric added, "Biohaven has built a world-class field sales team that is fully equipped to deliver on our entire pipeline and if this planned Phase 3 trial is positive, we would have the potential of filing a New Drug Application (NDA) next year."

Vazegepant is the newest member of Biohaven's NOJECTION™ Migraine Platform to have demonstrated efficacy in a pivotal trial. On February 27, 2020, the FDA approved NURTEC ODT orally disintegrating tablets 75 mg for the acute treatment of migraine in adults. Biohaven believes that intranasal vazegepant will be complementary to other calcitonin gene-related peptide-targeting agents, including NURTEC ODT.

Robert Croop, M.D., Biohaven's Chief Development Officer – Neurology stated, "We are pleased to successfully complete our end of Phase 2 meeting with the FDA so that we can continue to advance the development of intranasal vazegepant. In the prior clinical trial, intranasal vazegepant showed evidence of rapid onset with pain relief as early as 15 minutes, return to normal function at 30 minutes and sustained benefits through 48 hours. Patients with migraine deserve multiple therapeutic options to better treat their migraines and return to their daily lives."

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.

CGRP Receptor Antagonism

Small molecule calcitonin gene-related peptide (CGRP) receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action offers an alternative to other treatments, particularly for patients who have contraindications to the use of triptans, those who have a poor response to triptans, or are intolerant to them.

About NURTEC ODT

NURTEC™ ODT (rimegepant) is indicated for the acute treatment of migraine with or without aura in adults. NURTEC ODT is not indicated for the preventive treatment of migraine. NURTEC ODT should not be taken by patients with hypersensitivity to NURTEC ODT or any of its components. 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.

In a clinical trial, 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.

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", "advancing" 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 the Company's management about vazegepant as an acute treatment for patients with migraine. Forward-looking statements include those related to: the Company's ability to advance vazegepant to a Phase 3 clinical trial, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of the Company'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 vazegepant and the Company's other product candidates, the potential for the Company's product candidates to be first in class or best in class therapies and the effectiveness and safety of the Company'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 the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2020. The forward-looking statements are made as of this date and the Company 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 Holding Company Ltd.


Source: Biohaven Pharmaceutical

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