NEW HAVEN, Conn., June 24, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced
it will be presenting 16 abstracts, including new efficacy and
safety analyses from the Phase 3 rimegepant studies along with
other important clinical results, at the 2019 American Headache
Society Annual Scientific Meeting in Philadelphia, July
11-14, 2019. 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. These 16 abstracts encompass the largest volume of
presentations for an oral, small molecule CGRP receptor antagonist
at this meeting.
"The extensive data set we are presenting at AHS showcases the
potential of rimegepant, our lead oral CGRP product candidate, as a
novel and differentiated acute treatment for migraine," said
Vlad Coric, M.D., Chief Executive
Officer of Biohaven.
Oral presentation details:
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 (Presentation #IOR05)
Presentation Date: Saturday, July
13
Presentation Time: 8:40 am – 8:50 am
Poster presentation details:
All posters will be on display Thursday,
July 11, 4:30 pm through
Saturday, July 13, 5:00 pm.
The following posters will have a Q&A session on
Friday, July 12, 1:15 pm – 2:15
pm:
Rimegepant 75 mg is Effective for the Acute Treatment of
Migraine Regardless of Attack Frequency: Results From 3 Phase 3
Trials (Poster #P236LB)
Acute Treatment Benefit from Oral CGRP Receptor Antagonist and
Monoclonal Antibody Combination: Rimegepant 75 mg for Acute
Treatment of Attacks During Preventive Therapy With Erenumab
(Poster #P238LB)
The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75
mg are Similar in Elderly and Nonelderly Adults: A Phase 1,
Open-Label, Parallel-Group, Single-Dose Study (Poster #P240LB)
A Single Dose of Rimegepant 75 mg Provides Pain Relief and
Return to Normal Function: Results from 3 Phase 3 Trials in Adults
With Migraine (Poster #P242LB)
A Single Dose of Rimegepant Demonstrates Sustained Efficacy and
Low Rescue Medication Use in the Acute Treatment of Migraine:
Results From 3 Phase 3 Trials (Poster #P244LB)
Rimegepant 75 mg Is More Effective Than Nonsteroidal
Anti-inflammatory Drugs for the Acute Treatment of Migraine: Post
Hoc Analysis of Data From 2 Phase 3 Trials (Poster
#P246LB)
Phase 1 Safety, Tolerability and Pharmacokinetics of Single and
Multiple Dose Rimegepant as Compared to the Predicted Clinically
Efficacious Dose Range (Poster #P280LB)
The following posters will have a Q&A session on
Saturday, July 13, 1:00 pm – 2:15
pm:
Rimegepant 75 mg Demonstrates Superiority to Placebo on Nausea
Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3
Trials in the Acute Treatment of Migraine (Poster #P41)
Long-Term, Open-Label Safety Study of Rimegepant 75 mg for the
Treatment of Migraine (Study 201): Interim Analysis of Safety and
Exploratory Efficacy (Poster #P235LB)
Cardiovascular Safety of Rimegepant 75 mg in 3 Randomized
Clinical Trials and Systematic Evaluations from In Vitro, Ex Vivo,
and In Vivo Nonclinical Assays (Poster #P237LB)
Rimegepant is Effective for the Acute Treatment of Migraine in
Subjects Taking Concurrent Preventive Medication: Results From 3
Phase 3 Trials (Poster #P239 LB)
Rimegepant 75 mg in Subjects with Hepatic Impairment: Results of
a Phase 1, Open-label, Single-dose, Parallel-Group
Study (Poster #P241LB)
The Safety and Tolerability of Rimegepant 75 mg Are Similar to
Placebo: Results from 3 Phase 3 Trials in Adults With Migraine
(Poster #P243LB)
Rimegepant Has No Clinically Relevant Effects on ECG Parameters:
A Thorough QT Study Versus Placebo and Moxifloxacin in Healthy
Subjects (Poster #P245LB)
Safety of Rimegepant 75 mg in Adults With Migraine: No Effects
of Age, Sex, or Race in 3 Phase 3 Trials (Poster #P247LB)
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
all three Phase 3 trials are consistent with regulatory guidance
from the FDA and form the basis of Biohaven's NDA submission 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.
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" 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.