NEW HAVEN, Conn. and
NEW YORK, Nov. 9, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc.
(NYSE: PFE), today announced a strategic commercialization
arrangement for rimegepant in markets outside of the United States upon approval.
Rimegepant is commercialized as Nurtec® ODT in the U.S., and is
indicated for the acute treatment of migraine attacks with or
without aura and the preventive treatment of episodic migraine in
adults. An application for the approval of rimegepant is currently
under review by the European Medicines Agency and several
additional regulatory authorities outside of the U.S.
"We believe this collaboration, which brings together the
winning combination of Biohaven's Neuroscience R&D with
Pfizer's industry-leading expertise and large global footprint will
help accelerate access to rimegepant for patients around the
world," said Vlad Coric MD, Chief
Executive Officer of Biohaven. "With this alliance, Biohaven
Pharmaceutical and Pfizer believe there is an opportunity to change
the paradigm in migraine treatment and potentially establish a new
standard of care."
Under the terms of the arrangement, Biohaven would remain
primarily responsible for further clinical development of
rimegepant and the parties will cooperate in regulatory activities
to secure approval for the product. Biohaven will continue to
solely commercialize Nurtec ODT in the U.S and Pfizer would
commercialize rimegepant, upon approval, in all regions outside the
U.S. Additionally, per the arrangement, Pfizer gains rights
outside of the U.S. to zavegepant, a third generation, high
affinity, selective and structurally unique, small molecule CGRP
receptor antagonist, currently being studied in an intranasal
delivery and a soft-gel formulation in Phase 3 clinical trials for
migraine indications.
"We are excited to join forces with Biohaven in the fight
against migraine and help those patients impacted by this
debilitating neurological disease," said Nick Lagunowich, Global President, Pfizer
Internal Medicine. "We believe our legacy in pain and Women's
Health combined with our experienced customer-facing colleagues,
will enable us to maximize this opportunity with Biohaven,
potentially bringing a valuable new treatment option to patients
living with migraine pain."
Terms of the Arrangement
Biohaven and Pfizer are entering into a collaboration and
license agreement and related sublicense agreement pursuant to
which Pfizer will acquire rights to commercialize rimegepant and
zavegepant outside of the U.S. Biohaven will continue to lead
research and development globally and Pfizer would execute
commercialization globally, outside of the U.S. Under the
financial terms of all transaction agreements, Pfizer will make an
upfront payment of $500 million,
consisting of $150 million cash and
$350 million in the purchase of
Biohaven equity at a 25 percent market premium. Biohaven is
also eligible to receive up to $740
million in milestones. In addition to the tiered
double-digit royalties owed to Biohaven on net sales outside of the
U.S., Pfizer will compensate Biohaven for the related royalties on
net sales outside of the U.S. owed under the Company's license and
funding agreements with Bristol-Myers Squibb Company and Royalty
Pharma.
As noted above, in connection with the transaction, Pfizer will
make a $350 million investment in the
common shares of Biohaven.
Closing of the license agreements and equity purchase are
contingent on completion of review under applicable antitrust laws,
including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of
1976 in the U.S. and equivalents outside the U.S., and other
customary closing conditions.
Biohaven and Pfizer global collaboration will be discussed on
Biohaven 3Q Earnings Investor Call 8:00AM
ET on November 9, 2021. To
access the call, please dial 877-407-9120 (domestic) or
412-902-1009 (international). The conference call webcast and
accompanying slide presentation can be accessed through the
"Investors" section of Biohaven's website at
www.biohavenpharma.com.
About Migraine
More than one billion people suffer from migraine worldwide, of
which 75 percent are women. The World Health Organization
classifies migraine as one of the 10 most disabling medical
illnesses. Migraine is characterized by debilitating headache
attacks lasting four to 72 hours with multiple symptoms, including
pulsating headaches of moderate to severe pain intensity that can
be associated with nausea or vomiting, and/or sensitivity to sound
(phonophobia) and sensitivity to light (photophobia). There is a
large unmet need for new acute and preventive treatments, as a
significant portion of migraine patients are unsatisfied with
current standard of care migraine treatments due to a lack of
efficacy or safety or tolerability burden.
About Rimegepant
Rimegepant targets a root cause of migraine by reversibly
blocking CGRP receptors, thereby inhibiting the biologic cascade
that results in a migraine attack. Rimegepant was approved by
the U.S. Food and Drug Administration (FDA) under the
trade name Nurtec® ODT for the acute treatment of migraine in
February 2020 and for the preventive
treatment of episodic migraine in May
2021. Nurtec ODT is the #1 prescribed migraine
treatment in its class with a cumulative launch to date of U.S. net
revenue of approximately $336 million
and with more than one million prescriptions. A single dose
of 75 mg Nurtec ODT provides fast pain relief, significant pain
reduction and return to normal function, and has a lasting effect
of up to 48 hours in some patients. Nurtec ODT is taken orally as
needed, up to 18 doses/month to stop migraine attacks or taken
every other day to help prevent migraine attacks and reduce the
number of monthly migraine days. Nurtec ODT does not have
addiction potential and is not associated with medication overuse
headache or rebound headache.
NURTEC ODT U.S. Important Safety
Information
Nurtec® ODT (orally disintegrating tablet)
is a prescription medicine that is used to treat migraine in
adults. It is for the acute treatment of migraine attacks with or
without aura and the preventive treatment of episodic migraine. It
is not known if Nurtec ODT is safe and effective in
children.
Do not take Nurtec ODT if you are allergic to Nurtec
ODT (rimegepant) or any of its ingredients.
Before you take Nurtec ODT, tell your healthcare provider
(HCP) about all your medical conditions, including if
you:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- breastfeeding or plan to breastfeed.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
Nurtec ODT may cause serious side effects including allergic
reactions, including trouble breathing and rash. This can happen
days after you take Nurtec ODT. Call your HCP or get emergency help
right away if you have swelling of the face, mouth, tongue, or
throat or trouble breathing. This occurred in less than 1% of
patients treated with Nurtec ODT.
The most common side effects of Nurtec ODT were
nausea (2.7%) and stomach pain/indigestion (2.4%). These are not
the only possible side effects of Nurtec ODT. Tell your HCP if you
have any side effects.
You are encouraged to report side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or
call 1–800–FDA–1088 or
report side effects to Biohaven at
1–833–4Nurtec.
Please click here for full Prescribing
Information and Patient Information.
About Pfizer: Breakthroughs That Change Patients'
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow
us on Twitter at @Pfizer and @Pfizer
News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in
this release is as of November 9,
2021. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about
rimegepant, zavegepant, and a commercialization arrangement between
Pfizer and Biohaven for markets outside the U.S., including their
potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the clinical studies; whether and
when any applications may be filed for rimegepant or zavegepant in
any jurisdictions; whether and when regulatory authorities may
approve any potential applications that may be pending or filed for
rimegepant or zavegepant in any jurisdictions (including the
application for rimegepant pending with the European Medicines
Agency), which will depend on myriad factors, including making a
determination as to whether the product's benefits outweigh its
known risks and determination of the product's efficacy and, if
approved, whether rimegepant and/or zavegepant will be commercially
successful; decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of rimegepant
and/or zavegepant; risks related to the satisfaction or waiver of
the conditions to closing the transaction in the anticipated
timeframe or at all; whether the collaboration between Pfizer and
Biohaven will be successful; uncertainties regarding the impact of
COVID-19 on Pfizer's business, operations and financial results;
and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in its
subsequent reports on Form 10-Q, including in the sections thereof
captioned "Risk Factors" and "Forward-Looking Information and
Factors That May Affect Future Results", as well as in its
subsequent reports on Form 8-K, all of which are filed with the
U.S. Securities and Exchange Commission and available
at www.sec.gov and www.pfizer.com
About Biohaven
Biohaven is a commercial-stage
biopharmaceutical company with a portfolio of innovative,
best-in-class therapies to improve the lives of patients with
debilitating neurological and neuropsychiatric diseases, including
rare disorders. Biohaven's neuro-innovation portfolio includes
FDA-approved NURTEC® ODT (rimegepant) for the acute and preventive
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 MPO inhibition
for amyotrophic lateral sclerosis. More information about Biohaven
is available at www.biohavenpharma.com.
Biohaven Forward-looking Statement
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 regarding the closing of the
collaboration with Pfizer, the receipt of upfront, milestone and
other payments under the Pfizer collaboration, the investment by
Pfizer in Biohaven common shares in connection with the
collaboration, the future development and potential marketing
approval and commercialization of Nurtec ODT(rimegepant),
rimegepant or zavegepant, the potential benefits of the
collaboration and the potential advantages and therapeutic benefits
of Nurtec ODT, rimegepant and zavegepant. 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, 2020,
filed with the Securities and Exchange Commission on March 1,
2021, and Biohaven's subsequent filings with the Securities and
Exchange Commission. 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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC.
Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding
Company Ltd.
Biohaven
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
Pfizer
Media Relations
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848
IR@pfizer.com
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