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Biohaven Achieves Targeted Therapeutic Exposures of BHV-3500, a Third-Generation Small Molecule CGRP Receptor Agonist

NEW HAVEN, Conn., Feb. 4, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biotechnology company focused on advancing innovative therapies for neurological diseases, today announced that administration of intranasal BHV-3500 in a Phase 1 clinical trial has achieved targeted therapeutic exposures and that the compound will advance into a Phase 2 trial to evaluate efficacy for the acute treatment of migraine. BHV-3500 is a novel, third generation calcitonin gene-related peptide (CGRP) receptor antagonist being developed by Biohaven.

Intranasal BHV-3500 is administered using the Aptar Pharma Unit Dose System (UDS) designed to enable systemic delivery of drugs. The device is approved with multiple drug products marketed in the United States using the Aptar technology. (Photo credit: Aptar Pharma)

Vlad Coric, M.D., CEO of Biohaven, commented, "We are excited to report that intranasal administration of BHV-3500 in our Phase 1 trial achieved drug exposures that we believe will be therapeutic in the acute treatment of migraine. Additionally, the PK profile of intranasal BHV-3500 demonstrated the earliest Tmax that we have observed with a small molecule CGRP receptor antagonist and suggests the potential for an ultra-rapid onset of action without the need for an injection. BHV-3500 is complementary to our lead migraine asset rimegepant, which has shown efficacy and safety in three Phase 3 clinical trials. We are now a step closer to our goal of providing migraine sufferers with a range of noninvasive, CGRP receptor antagonist dosing options for both the acute and preventive treatment of migraine."

Intranasal BHV-3500 utilizes the Aptar Pharma Unit Dose System (UDS), which is designed to enable systemic delivery of drugs without the need for injection or administration by a healthcare professional. This device is FDA-approved with multiple drug products marketed in the United States using the Aptar technology and is used by thousands of people every day.  Biohaven's Phase 1 clinical trial of the intranasal administration of BHV-3500 explored a broad dose range to characterize the PK profile and initial safety of the drug candidate in humans.

Robert Croop, M.D., Biohaven's Chief Development Officer – Neurology, added, "We are pleased to advance our next generation of CGRP receptor antagonist into further clinical development.  If approved, this important component of our NOJECTION™ platform potentially offers patients a simple to use intranasal formulation in this new approach to treating migraine. We believe that intranasal BHV-3500 may provide people with migraine rapid onset of relief in a form that can easily be self-administered whenever and wherever a migraine strikes."

BHV-3500 is the second of Biohaven's CGRP receptor antagonist-targeting compounds to enter clinical trials. Biohaven's multiple CGRP receptor antagonist product candidates, including rimegepant, and formulations including oral tablet, Zydis® (Catalent) rapid dissolving tablet and intranasal delivery are designed to meet patients' needs across the spectrum from acute to preventive treatment of migraine.

About BHV-3500

BHV-3500 is a novel CGRP receptor antagonist and Biohaven's second small molecule migraine drug candidate from its NOJECTION™ platform. BHV-3500 is structurally distinct from rimegepant and has novel properties including high water solubility and a high free fraction.  The physicochemical properties of BHV-3500 make the drug candidate potentially suitable for multiple routes of delivery, including nasal, inhalation or oral administration. It is initially in development as an intranasal formulation for the acute treatment of migraine.

About Rimegepant

Rimegepant is Biohaven's orally-dosed CGRP receptor antagonist drug candidate being developed as an acute and preventative treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been observed across four randomized controlled trials to date: three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the Phase 3 trials are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA). Biohaven plans to submit a new drug application (NDA) for rimegepant to the FDA in 2019.

About Migraine

Over 36 million Americans suffer from migraine. Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling. More than 90 percent of migraine sufferers are unable to work or function normally during an attack. In the Global Burden of Disease Study, updated in 2015, migraine was ranked as the seventh highest cause worldwide of years lost due to disability. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class specific to the acute treatment of migraine in over 25 years. This unique and specific mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or who either do not respond or have inadequate or inconsistent response to triptans or are intolerant to them.

About Biohaven

Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase inhibitor platforms. Biohaven's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at 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. 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. All statements, other than statements of historical facts, included in this press release, including statements about the potential safety, efficacy and attractive mode of administration of BHV-3500 as a treatment for migraine, as well as its potential for ultra-rapid onset and sustained activity, the potential of the Company's CGRP receptor antagonist drug candidates, including rimegepant, to provide  an improved, effective and safe treatment option for the acute treatment of migraine and prevention of migraine, the potential for FDA approval of rimegepant and the Company's expected timelines for submissions to regulatory authorities, are forward-looking statements. The use of certain words, including "believe," "potential" and "will" and similar expressions, is intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on the Company's forward-looking statements. 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, including those described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018 and other filings Biohaven makes with the U.S. Securities and Exchange Commission from time to time. 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.

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

Posted: February 2019

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