NEW HAVEN, Conn., May 3, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: 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.
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
-
- Superiority over placebo on 21 consecutive, prespecified,
efficacy outcome measures
- Pooled analysis of Freedom from Nausea at 2 hours from all
three Phase 3 Trials
- 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
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.