U.S. Markets closed

Biohaven Announces Late-Breaking Oral Presentation Of Rimegepant Zydis® ODT Phase 3 Results At American Academy Of Neurology (AAN) 2019 Annual Meeting And New Data Release At Investor Event

- Late-Breaking oral presentation accepted at AAN: First public disclosure of the complete rimegepant Zydis® oral fast-dissolve tablet (ODT) Phase 3 clinical trial results showing single-dose, rapid and durable migraine relief

- New rimegepant data release and thought leader panel discussion at off-site investor event on Tuesday, May 7, 2019 at 7:00 pm Eastern Time

-Investor event to include presentation of the first case reports describing the use of rimegepant to treat breakthrough migraine attacks in patients taking preventive CGRP-targeting monoclonal antibodies, pooled analysis of the effect of rimegepant on nausea across all three Phase 3 trials, and safety and preventive efficacy data from the completed 12-week rimegepant 75 mg scheduled-dosing cohort (every other day plus as-needed use)

- Four additional presentations at AAN regarding product candidates from Biohaven's glutamate platform for Amyotrophic Lateral Sclerosis and Spinocerebellar Ataxia

NEW HAVEN, Conn., May 3, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN), today announced that results from the pivotal rimegepant Zydis® ODT Phase 3 clinical trial will be presented as a late-breaking oral presentation at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia, May 4-10, 2019. This presentation is 1 of only 11 abstracts accepted as part of the Emerging Science (Late-Breaking) program, and the only CGRP-targeting migraine data accepted for the Late-Breaking session. Rimegepant is an oral, single-dose, selective and potent small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine.

Biohaven Pharmaceuticals Logo (PRNewsfoto/Biohaven Pharmaceutical Holding)

AAN Emerging Science (Late-Breaking) Presentation Details:

Data Blitz Oral and Poster Presentation Title: 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, Study 303 (Data Blitz #005, Poster #075)

Presentation Date: May 7, 2019
Presentation Time: Oral at 11:57 a.m.; Poster displayed 11:30 a.m.-6:30 p.m.

Company Off-Site CGRP Presentation and Migraine Expert Panel, at 7:00 p.m. ET on May 7, 2019:
Richard Lipton, MD
Albert Einstein College of Medicine / Montefiore Headache Center

David Kudrow, MD
California Medical Clinic for Headache

Jelena Pavlovic, MD, PhD
Albert Einstein College of Medicine / Montefiore Headache Center

Moderated by: 
Kishen Mehta

Topics to be addressed at Investor Event:

  • Biohaven Portfolio Overview
  • Presentation of the rimegepant 75 mg Zydis® ODT Phase 3 trial
  • Safety and preventive efficacy results from the 12-week scheduled-dosing cohort of the rimegepant long-term safety study
  • Case reports of patients using oral rimegepant 75mg to successfully treat multiple breakthrough migraine attacks while taking injectable CGRP-targeting monoclonal antibodies for prevention

Live video webcast of the event starting at 7:00 p.m. ET. To access the video webcast with slides, please visit the "Events" page in the Investors section of the Company's website at https://www.biohavenpharma.com/investors/news-events/events-presentations. A replay will be available on Biohaven's website after the event. Institutional investors and analysts may RSVP to attend in person by contacting Biohaven@troutgroup.com.

Additional AAN presentations regarding Biohaven's glutamate modulating platform are as follows:

Oral Presentation Title: A Phase 1 Study to Evaluate Bioequivalence Between BHV-0223 40 mg Zydis® ODT Sublingual Formulation and Riluzole 50 mg Oral Tablet in Healthy Volunteers (Program #S5.005) 
Presentation Date: May 5, 2019
Presentation Time: 1:44 p.m.

Poster Presentation Title: Results from the Long-Term Open Label Extension Phase Analyses of BHV4157-201: A Phase IIb/III, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Troriluzole in Adult Subjects with Spinocerebellar Ataxia (Program #P1.8-001)
Presentation Date: May 5, 2019
Presentation Time: 11:30 a.m.-6:30 p.m.

Poster Presentation Title: Adherence to Riluzole Therapy Improves Time to and Frequency of All Cause Hospitalization in ALS Patients: A Claims-Based Longitudinal Comparative Effectiveness Analysis (Abstract #P4.4-022)
Presentation Date: May 8, 2019
Presentation Time: 11:30 a.m.-6:30 p.m.

Poster Presentation Title: Determinants of Mortality Among Hospitalized Patients with Amyotrophic Lateral Sclerosis – Results from the 2016 National Inpatient Sample (Abstract # P4.4-017)
Presentation Date: May 8, 2019
Presentation Time: 11:30 a.m.-6:30 p.m.

The Company will be hosting an investor event with a focus on the rimegepant Phase 3 program and long-term safety data at 7:00pm Eastern Time on May 7, 2019.  During the event, a panel of migraine experts will discuss the potential therapeutic benefits associated with the rimegepant Phase 3 clinical trial results.

About Rimegepant

Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (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 U.S. Food and Drug Administration (FDA) and provide the basis of the Company's New Drug Application (NDA) to the FDA.

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 myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.

About Catalent

Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Zydis® is a registered trademark of Catalent. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.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, 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 expected issuance of preferred stock to Royalty Pharma, the potential commercialization of the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects," "planned" 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.

For further information, contact Dr. Vlad Coric, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com

Cision

View original content to download multimedia:http://www.prnewswire.com/news-releases/biohaven-announces-late-breaking-oral-presentation-of-rimegepant-zydis-odt-phase-3-results-at-american-academy-of-neurology-aan-2019-annual-meeting-and-new-data-release-at-investor-event-300843373.html