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Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant

Update: Nurtec ODT (rimegepant) Now FDA Approved - February 27, 2020

NEW HAVEN, Conn., March 13, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the Company concluded its pre-New Drug Application ("NDA") meetings with the U.S. Food and Drug Administration ("FDA") for rimegepant Zydis® ODT (orally dissolving tablet) and tablet formulations for the acute treatment of migraine. The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements for the Company's NDA submission.

Biohaven submitted a pre-NDA briefing document to the FDA that outlined the Company's preliminary data package being prepared for the NDA submission, including clinical safety and efficacy, non-clinical results, CMC and other regulatory elements. Based on the feedback from the FDA, the Company believes its regulatory data package will be sufficient for submission, with acceptance of the final NDA subject to the FDA's review of the complete filing.

"Based upon Biohaven's in-person meeting and written communications with FDA regarding our pre-NDA briefing package, we believe that all the components of our upcoming rimegepant NDA are well positioned to fulfill the FDA's requirements for submission," said Vlad Coric, M.D, Chief Executive Officer of Biohaven. "Biohaven is excited to advance our development program to an NDA submission in the second quarter of 2019 and highlight the previously announced positive data from three pivotal Phase 3 trials and safety data from our ongoing long-term safety study. We look forward to working with the FDA to bring this much-needed, novel and differentiated treatment option to patients suffering from migraine."

Biohaven announced positive topline results from a randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the efficacy and safety of its Zydis ODT formulation of rimegepant in December of 2018. In this trial, rimegepant Zydis ODT was statistically superior to placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures pre-specified in hierarchical testing. Importantly, patients treated with the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes after dosing, and this difference was statistically significant at 60 minutes (p < 0.0001). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p = 0.0025). Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.0001), pain relief (p < 0.0001), freedom from the most bothersome symptom (p = 0.0018), and freedom from functional disability (p < 0.0001). The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.

The Company also announced initial positive results from its ongoing long-term, open-label safety study of rimegepant (Study 201) for the acute treatment of migraine in December 2018; over 91,000 doses of rimegepant 75 mg were administered across 1,780 patients with migraine. The safety and tolerability profile of rimegepant with up to one year of dosing in patients with migraine was consistent with previous clinical experience. No liver safety signal was detected, including a subset of patients with near-daily dosing (≥15 doses/month), as assessed by an external independent panel of liver experts. In addition to the interim safety analysis, preliminary open-label efficacy data from Study 201 suggest that rimegepant may be associated with a reduction in migraine days per month compared to the observational lead-in period, suggesting a potential preventive effect. A double-blind, placebo-controlled Phase 3 trial examining regularly scheduled dosing of rimegepant 75 mg for the preventive treatment of migraine is ongoing and the Company expects to report topline data from this trial in 2019.

In March of 2018, the Company announced successful achievement of co-primary regulatory endpoints along with key secondary outcome measures in two pivotal Phase 3 trials of rimegepant. In each trial, rimegepant 75 mg met the co-primary efficacy endpoints of superiority to placebo at two hours post-dose on the measures of pain freedom and freedom from the most bothersome symptom. In both trials, rimegepant demonstrated a safety and tolerability profile similar to placebo, including on liver function tests.

About Rimegepant

Rimegepant is Biohaven's orally-dosed CGRP receptor antagonist, which the Company is developing as a 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 established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the FDA and provide the basis for a planned submission of an NDA in the second quarter of 2019.

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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxide inhibition platforms. 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 regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing of the Company's planned NDA submission for rimegepant, the outcome of expected regulatory filings, the timing and results of the Company's planned and ongoing clinical trials and the potential commercialization of the Company's product candidates. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify 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. 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 28, 2019. 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: March 2019

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