NEW HAVEN, Conn., March 1, 2018 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the
"Company") announced positive results today from its bioequivalence
study with rimegepant Zydis® orally dissolving tablets
(ODT). Rimegepant is a small molecule, oral, calcitonin
gene-related peptide ("CGRP") receptor antagonist currently in two
pivotal Phase 3 trials for the acute treatment of migraine using a
tablet formulation. Biohaven has been working with Catalent
U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc. (NYSE:
CTLT) ("Catalent") to develop a new ODT formulation of rimegepant
which dissolves on the tongue without the need for fluid
intake.
The purpose of the bioequivalence study was to demonstrate
pharmacokinetic equivalence of the rimegepant Zydis® ODT
formulation compared to the rimegepant tablet formulation used in
the Phase 3 program. Topline results demonstrate that the
rimegepant Zydis® ODT achieves bioequivalent exposures
relative to the current Phase 3 tablet fomulation. In the study, 34
healthy volunteers were administered rimegepant 75mg
Zydis® ODT and the current rimegepant 75mg tablet. In
the pre-specified primary analysis, rimegepant Zydis®
ODT achieved area-under-the-curve and peak exposures of
approximately 97% and 105%, respectively, compared to those
generated by rimegepant tablet. The 90% confidence intervals were
within the 80% to 125% range that is commonly used to define
bioequivalence.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, commented, "We are very excited about the
favorable results from the study establishing the bioequivalence of
our innovative rimegepant Zydis® ODT with the tablet
formulation used in the Phase 3 trials. The fast-dissolving
Zydis® rimegepant formulation is designed to enable
patients with migraine to start their acute treatment promptly,
without a need for swallowing liquids. The characteristics of this
formulation are particularly advantageous for the acute treatment
of migraine because many individuals with migraine often experience
concurrent nausea or vomiting. Our rimegepant Zydis® ODT
is a convenient formulation that can be taken wherever and whenever
a migraine occurs. We are progressing multiple formulations across
our small molecule CGRP receptor antagonist platform in an effort
to meet patient needs across the spectrum of migraine
treatment."
Based upon these bioequivalence results, Biohaven is planning to
initiate a Phase 3 trial with rimegepant Zydis® ODT in
the first quarter of 2018 to assess onset of action and patient
satisfaction with the Zydis® ODT formulation. Biohaven's
development program enables the potential to bring rimegepant to
market with this new formulation while staying on track with its
original rimegepant development timeline. Biohaven expects to
receive topline results from its two pivotal Phase 3 trials
examining the efficacy of rimegepant 75mg oral tablet versus
placebo in the acute treatment of migraine by the end of the first
quarter of 2018.
Robert Croop, M.D., Chief
Development Officer – Neurology, added, "We are pleased with the
topline results from the bioequivalence study and look forward to
introducing the rimegepant Zydis® ODT into our Phase 3
clinical program. Our upcoming Phase 3 trial with the rimegepant
Zydis® ODT will enable the determination of the speed of
onset of rimegepant for the acute treatment of migraine using this
unique formulation. Because the Zydis® formulation
disperses almost instantly in the mouth, there is no need to take
it with water, potentially allowing for pre-gastric absorption and
rapid onset of action."
Biohaven has an exclusive worldwide license agreement with
Catalent to provide Catalent's Zydis® ODT
fast-dissolving technology for the development of Biohaven's lead
CGRP receptor antagonist product candidate, rimegepant. The
agreement also provides exclusive rights for developing additional
small molecule CGRP receptor antagonists with the Zydis®
ODT technology. Catalent's proprietary Zydis® technology
creates a unique, freeze-dried, oral solid dosage form that
disperses almost instantly in the mouth, without the need for
water. With more than 20 products launched in 50 countries and a
dispersion speed of three seconds or less, Zydis® ODT is
the world's fastest and best-in-class orally dissolving tablet.
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 and
glutamate modulation platforms. The Company'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.
About Catalent
More products. Better treatments. Reliably supplied.™
Catalent is the leading global provider of advanced delivery
technologies and development solutions for drugs, biologics and
consumer health products. With over 80 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
approximately 10,000 people, including over 1,400 scientists, at
more than 30 facilities across five continents, and in fiscal 2017
generated more than $2 billion in
annual revenue. 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, including the Company's expected timing of the
receipt of data from the ongoing Phase 3 clinical trials of
rimegepant tablet and the initiation of the Phase 3 clinical trial
of rimegepant Zydis® ODT, the overall development
timeline for rimegepant, and the expected benefits of the Zydis ODT
formulation of rimegepant in the acute treatment of migraine, are
forward-looking statements. The use of certain words, including the
"believe", "could", "expect" and "will" and similar expressions are
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 uncertainties relating to the timing of the
receipt and statistical analysis of clinical trial data from the
rimegepant trials and the initiation of the Phase 3 clinical trial
of rimegepant Zydis® ODT and the ability of the Zydis
ODT formulation of rimegepant to demonstrate efficacy in clinical
trials. Additional important factors to be considered in connection
with forward-looking statements are 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, 2017. 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, the Chief Executive
Officer, at Vlad.Coric@biohavenpharma.com.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.