NEW HAVEN, Conn., March 6, 2018 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today
that it has enrolled the first patient in a Phase 3 clinical trial
of the Zydis® orally dissolving tablet ("ODT")
formulation of rimegepant for the acute treatment of migraine.
Rimegepant is a potent, orally available small molecule calcitonin
gene-related peptide ("CGRP") receptor antagonist in late stage
development for the treatment of migraine.
The Phase 3 clinical trial will assess the onset of action,
patient satisfaction, efficacy and safety of the fast-dissolve
Zydis® ODT formulation of rimegepant. Biohaven has been
working with Catalent U.K. Swindon Zydis Limited, a subsidiary of
Catalent, Inc. (NYSE: CTLT) ("Catalent") to develop this new ODT
formulation of rimegepant and extend additional delivery
formulations across its CGRP platform. Biohaven has entered into an
exclusive agreement with Catalent for the use of the
Zydis® ODT formulation technology in the development of
small molecule CGRP receptor antagonists. The trial will randomize
approximately 850 patients across two treatment arms, rimegepant 75
mg ODT versus placebo.
Vlad Coric, M.D., Chief Executive
Officer at Biohaven, commented, "Biohaven is committed to
bringing the most differentiated oral, small molecule CGRP receptor
antagonist to patients suffering from migraine. The
fast-dissolving Zydis® ODT rimegepant formulation is
designed to conveniently enable people experiencing a migraine
attack to promptly initiate their acute treatment without the need
for taking with liquids. We believe that rimegepant
Zydis® ODT has the potential to be a best-in-class
therapy option for the acute treatment of migraine."
Robert Croop, M.D., Chief
Development Officer – Neurology, at Biohaven, added, "This clinical
trial with the new fast-dissolve Zydis® ODT formulation
complements our ongoing work with rimegepant. We are very pleased
to incorporate the trial into our ongoing Phase 3 clinical program.
We believe that the rimegepant Zydis® ODT will be a
desirable new approach for the acute treatment of migraine."
Biohaven continues to expect topline results from its two
pivotal Phase 3 trials examining the efficacy of rimegepant 75 mg
oral tablet versus placebo by the end of the first quarter of 2018,
and expects topline results from the Phase 3 trial with rimegepant
Zydis® ODT in the fourth quarter of 2018.
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 the Phase 3 clinical trial of rimegepant
Zydis® ODT 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 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.