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 NURTEC™ 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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