NEW HAVEN, Conn. and
NEW YORK, Aug. 7, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Royalty Pharma
(Nasdaq: RPRX) announced today that Biohaven has secured up to
$250 million in funding to advance
the company's CGRP receptor antagonist program through the
development of zavegepant (formerly known as vazegepant). The
zavegepant program encompasses intranasal zavegepant as well as
oral zavegepant for migraine prevention and non-migraine
indications. In exchange for these funds, Royalty Pharma will
obtain a 0.4% royalty on annual worldwide net sales of Nurtec® ODT
and if certain zavegepant regulatory approvals are achieved,
a royalty of up to 3% on annual worldwide net sales of zavegepant
and success-based milestone payments. The success-based
milestone payments range from 0.6x to 2.95x of the zavegepant
funded amount depending on the number of regulatory approvals
achieved for zavegepant (including 1.9x for the first zavegepant
migraine regulatory approval) and would be paid over a ten-year
period. Biohaven will receive $150
million at closing and $100
million upon the start of the oral zavegepant Phase 3
program.
Royalty Pharma will also provide further support for the ongoing
launch of Nurtec ODT through the committed, non-contingent purchase
of Commercial Launch Preferred Equity from Biohaven for a total of
$200 million payable between 2021 and
2024. In return, Biohaven will pay to Royalty Pharma a series of
equal fixed payments between 2025 and 2030 with an internal rate of
return of approximately 12%.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven, commented, "Royalty Pharma is an industry
leader in funding innovative biopharmaceutical therapies and we are
pleased to expand our partnership. This transaction brings up to
$250 million in funding for
zavegepant and will allow us to quickly broaden our CGRP receptor
antagonist franchise into migraine adjacencies, non-migraine
indications and new formulations across the globe." Dr. Coric
added, "Our intranasal zavegepant is the first and only intranasal
CGRP receptor antagonist with the promise to deliver an ultra-rapid
onset of action for migraine and is also going to be studied in a
number of non-migraine indications including the ongoing study
investigating its efficacy in pulmonary complications associated
with COVID-19 infection."
Pablo Legorreta, Royalty Pharma's
Founder and Chief Executive Officer, stated, "We are excited to
further expand our partnership with Biohaven by providing
additional funding to support the commercial launch of Nurtec ODT
and the completion of the clinical development of zavegepant, two
innovative therapies for people suffering from migraine. The
impressive launch of Nurtec underscores the significant need for
new therapeutic options, such as oral CGRPs, to treat this
often-debilitating disease."
Cooley acted as legal advisor to Biohaven on the transaction.
Goodwin Procter, Jones Day and Maiwald acted as legal advisors to
Royalty Pharma.
About Biohaven
Biohaven is a biopharmaceutical company focused on the
development and commercialization of innovative best-in-class
therapies to improve the lives of patients with debilitating
neurological and neuropsychiatric diseases. Biohaven's
neuroinnovation portfolio includes FDA-approved NURTECâ„¢ ODT
(rimegepant) for the acute treatment of migraine and a broad
pipeline of late-stage product candidates across three distinct
mechanistic platforms: CGRP receptor antagonism for the acute and
preventive treatment of migraine; glutamate modulation for
obsessive-compulsive disorder, Alzheimer's disease, and
spinocerebellar ataxia; and myeloperoxidase inhibition for multiple
system atrophy and amyotrophic lateral sclerosis. For more
information, visit www.biohavenpharma.com.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of
biopharmaceutical royalties and a leading funder of innovation
across the biopharmaceutical industry, collaborating with
innovators from academic institutions, research hospitals and
not-for-profits through small and mid-cap biotechnology companies
to leading global pharmaceutical companies. Royalty Pharma has
assembled a portfolio of royalties which entitles it to payments
based directly on the top-line sales of many of the industry's
leading therapies. Royalty Pharma funds innovation in the
biopharmaceutical industry both directly and indirectly - directly
when it partners with companies to co-fund late-stage clinical
trials and new product launches in exchange for future royalties,
and indirectly when it acquires existing royalties from the
original innovators. Royalty Pharma's current portfolio includes
royalties on more than 45 commercial products, including AbbVie and
J&J's Imbruvica, Astellas and Pfizer's Xtandi, Biogen's
Tysabri, Gilead's HIV franchise, Merck's Januvia, Novartis'
Promacta, and Vertex's Kalydeco, Symdeko and Trikafta, and four
development-stage product candidates. For more information, visit
www.royaltypharma.com.
Biohaven's Forward-Looking Statements
This news release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
The use of certain words, including "believe", "continue", "may",
"will" and similar expressions, are intended to identify
forward-looking statements. These forward-looking statements
involve substantial risks and uncertainties, including statements
that are based on the current expectations and assumptions of
Biohaven's management about NURTEC ODT and zavegepant as an acute
treatment for patients with migraine and potential preventive
treatment for migraine. Factors that could affect these
forward-looking statements include those related to: Biohaven's
ability to effectively commercialize NURTEC ODT, delays or problems
in the supply or manufacture of NURTEC ODT, complying with
applicable U.S. regulatory requirements, the expected timing,
commencement and outcomes of Biohaven'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 potential commercialization of Biohaven's product
candidates, the potential for Biohaven's product candidates to be
first in class or best in class therapies and the effectiveness and
safety of Biohaven's product candidates. 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 Biohaven's Annual Report on Form 10-K for
the year ended December 31, 2019,
filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report
on Form 10-Q for the quarter ended March 31,
2020, filed with the Securities and Exchange Commission on
May 7, 2020. The forward-looking
statements are made as of this date and Biohaven 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.
Royalty Pharma plc's Forward-Looking Statements
This press release contains statements that constitute
"forward-looking statements" as that term is defined in
the United States Private
Securities Litigation Reform Act of 1995, including statements that
express Royalty Pharma's opinions, expectations, beliefs, plans,
objectives, assumptions or projections regarding future events or
future results, in contrast with statements that reflect historical
facts. Examples include discussion of our strategies, financing
plans, growth opportunities and market growth. In some cases, you
can identify such forward-looking statements by terminology such as
"anticipate," "intend," "believe," "estimate," "plan," "seek,"
"project," "expect," "may," "will," "would," "could" or "should,"
the negative of these terms or similar expressions. Forward-looking
statements are based on management's current beliefs and
assumptions and on information currently available to Royalty
Pharma. However, these forward-looking statements are not a
guarantee of our performance, and you should not place undue
reliance on such statements. Forward-looking statements are subject
to many risks, uncertainties and other variable circumstances, and
other factors. Such risks and uncertainties may cause the
statements to be inaccurate and readers are cautioned not to place
undue reliance on such statements. Many of these risks are outside
of Royalty Pharma's control and could cause its actual results to
differ materially from those it thought would occur. The
forward-looking statements included in this document are made only
as of the date hereof. Royalty Pharma does not undertake, and
specifically declines, any obligation to update any such statements
or to publicly announce the results of any revisions to any such
statements to reflect future events or developments, except as
required by law.
Certain information contained in this press release relates to
or is based on studies, publications, surveys and other data
obtained from third-party sources and Royalty Pharma's own internal
estimates and research. While Royalty Pharma believes these
third-party sources to be reliable as of the date of this press
release, it has not independently verified, and makes no
representation as to the adequacy, fairness, accuracy or
completeness of, any information.
Biohaven Contact:
For further information, contact
Dr. Vlad Coric, the Chief Executive
Officer, at Vlad.Coric@biohavenpharma.com.
Royalty Pharma Investor Relations and Communications
Contact:
+1 (212) 883-2295
ir@royaltypharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.