NEW HAVEN, Conn., March 12, 2018 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the
"Company") announced today a restructuring of its global license
agreement with Bristol-Myers Squibb Company (NYSE: BMY) ("BMS") for
Biohaven's small molecule calcitonin gene-related peptide (CGRP)
receptor antagonist platform, which includes its product candidates
rimegepant, a potentially best-in-class CGRP receptor antagonist
for the acute treatment of migraine, and BHV-3500, a
third-generation antagonist for the acute treatment and prevention
of migraine. As part of the restructuring, Biohaven will pay BMS an
upfront payment of $50 million in
return for a low single digit reduction in the royalties payable on
net sales of rimegepant and a mid-single digit reduction in the
royalties payable on net sales of BHV-3500. Under the original
license agreement with BMS, Biohaven was obligated to make tiered
royalty payments based on annual worldwide net sales of licensed
products upon their approval and commercialization, with
percentages in the low- to mid-teens. The upfront payment for the
restructuring was financed through a private placement of Biohaven
common shares to leading institutional investors.
The restructuring also removes BMS's right of first negotiation
to regain its intellectual property rights or enter into a license
agreement with Biohaven following the Company's receipt of topline
data from its Phase 3 clinical trials with rimegepant, and
clarifies that antibodies targeting CGRP are not prohibited as
competitive compounds under the non-competition clause of the
agreement, thereby permitting Biohaven to potentially license
rimegepant or BHV-3500 to a company with a CGRP antibody program.
The license agreement, which was originally executed in
July 2016, continues to provide
Biohaven with exclusive global development and commercialization
rights to rimegepant, BHV-3500 and related CGRP molecules, as well
as related know-how and intellectual property. Biohaven's
obligations to make development and commercial milestone payments
to BMS remain unchanged.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, commented, "This license agreement
restructuring creates significant value for Biohaven and enhances
our strategic flexibility moving forward. We believe the revised
agreement, along with our recently announced exclusive license for
developing small molecule CGRP receptor antagonists with the
Zydis® ODT technology, significantly enhances our
position to create shareholder value through the ongoing
development of efficacious, differentiated and patient-friendly
therapies for both the acute treatment and prevention of migraine.
We were pleased to be able to finance this restructuring through
investments from a number of leading institutions."
Biohaven is progressing multiple formulations of its small
molecule CGRP receptor antagonists in an effort to meet patient
needs across the spectrum of acute treatment and prevention of
migraine. Biohaven has completed enrollment in two pivotal Phase 3
trials evaluating rimegepant as an acute treatment for patients
with migraine. In total, approximately 3,000 patients have been
enrolled and topline data for both trials is expected to be
received during the first quarter of 2018. A third Phase 3 trial of
rimegepant, evaluating a Zydis ODT formulation, commenced in
February 2018. A long-term safety
trial that allows dosing of rimegepant as frequently as once a day
began in August 2017 and currently
has over 1,000 patients enrolled and eligible to receive rimegepant
for up to one year. Biohaven's BHV-3500 will be concurrently
developed for the acute treatment of migraine and the prevention of
chronic and episodic migraine, and is scheduled to begin a Phase 1
clinical trial in the first half of 2018.
The restructuring was financed through a $55 million private placement of 2,000,000
Biohaven common shares at a price of $27.50 per share. The shares were placed with
leading institutional investors, including both new and existing
Biohaven investors. Biohaven intends to use the net proceeds from
the private placement to fund the $50
million upfront payment to BMS. The private placement is
expected to close on March 14, 2018,
subject to customary closing conditions.
The securities sold in the private placement have not been
registered under the Securities Act of 1933, as amended, and may
not be offered or sold in the U.S. absent registration or an
applicable exemption from registration requirements. As part of the
transaction, the Company has agreed to file a resale registration
statement on Form S-1 with the Securities and Exchange Commission
within 30 days of the closing for purposes of registering the
resale of the common shares issued in the private
placement.
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.
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 statements concerning the closing of
the private placement, the potential value to Biohaven and its
shareholders of the restructuring, the Company's expected timing of
the receipt of data from the ongoing Phase 3 clinical trials of
rimegepant, the expected benefits of the Zydis® ODT
formulation of rimegepant and the future clinical development of
BHV-3500, 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, the ability of rimegepant
and BHV-3500 to demonstrate safety and efficacy in clinical trials
and our ability to receive regulatory approval to commence our
Phase 1 clinical trial of BHV-3500. 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 March 6, 2018. 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.