NEW HAVEN, Conn. and
NEW YORK, Jan. 5, 2022 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc.
(NYSE: PFE), today announced that the parties have completed the
collaboration transaction between the two companies. The
transaction agreements, including Pfizer's commercialization of
rimegepant and zavegepant outside of the U.S., have become
effective following the receipt of required regulatory approvals
and the satisfaction of other customary conditions, and BHVN shares
have been issued to Pfizer. Biohaven will continue to lead research
and development globally and retain rights to the U.S.
market.
In connection with the closing of the equity purchase and
effectiveness of the strategic transaction, Pfizer made an upfront
payment to Biohaven of $500 million,
consisting of $150 million cash and
$350 million in the purchase of
Biohaven equity. At close, Pfizer will own 3% of Biohaven. Biohaven
is also eligible to receive up to $740
million in future 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 a pro-rata share of
certain of its sales-based milestone obligations owed to
Bristol-Myers Squibb Company ("BMS"), and for the related
royalties on net sales outside of the U.S. owed under Biohaven's
license and funding agreements with BMS and Royalty Pharma.
"The successful closing of our collaboration agreements
represent an important and exciting step in expanding the impact of
rimegepant to people outside the U.S. with migraine," said
Nick Lagunowich, Global President,
Pfizer Internal Medicine. "We are enthusiastic about working with
the Biohaven team to bring this valuable new treatment option to
the millions of people across the globe suffering from
migraine."
Rimegepant is commercialized as Nurtec® ODT in the U.S. and is
the only oral CGRP (calcitonin gene-related peptide) receptor
antagonist approved for both the acute and preventive treatment of
migraine in adults. An application for the approval of rimegepant
is currently under review by the European Medicines Agency with a
decision expected in the first half of 2022. Rimegepant is already
approved for the acute treatment of migraine in Kuwait and the United Arab Emirates, and for the acute and
preventive treatment of migraine in Israel. Zavegepant is a third generation, high
affinity, selective and structurally unique, small molecule CGRP
receptor antagonist delivered in an intranasal spray which recently
achieved positive Phase 3 topline data in its second pivotal
clinical trial for the acute treatment of migraine in adults.
Zavegepant, if approved, would be the first intranasal CGRP
receptor antagonist for the acute treatment of migraine in adults.
Intranasal treatments like zavegepant offer additional potential
benefits including ultra-rapid speed of onset and a non-oral
delivery for patients who experience significant nausea or
vomiting.
Vlad Coric M.D., Chairman and CEO
of Biohaven commented, "Together we hope to establish a world-class
migraine business that can deliver on our promise of providing new
treatment options for people living with this debilitating
disease." Dr. Coric added, "We are excited to collaborate with
Pfizer given their global footprint and experience in the treatment
of pain and in Women's Health, which we believe may help establish
rimegepant as a leading novel treatment of migraine."
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 key
component 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. 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 many 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,
- are 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 Zavegepant
Zavegepant is a third generation,
high affinity, selective and structurally unique, small molecule
CGRP receptor antagonist from Biohaven's NOJECTION® Migraine
Platform and the only CGRP receptor antagonist in clinical
development with both intranasal and oral formulations. The
efficacy and safety of intranasal zavegepant was shown in two
pivotal clinical trials with statistical superiority to placebo on
the coprimary endpoints. Previously the efficacy and safety of
intranasal zavegepant was shown in a randomized controlled Phase
2/3 dose-ranging trial with more than 1000 patients treated. In
December 2021, zavegepant pivotal
data showed statistical superiority to placebo on a total of 15
consecutive, prespecified primary and secondary outcome measures in
the acute treatment of migraine. Topline results showed ultra-rapid
pain relief at the earliest measured time point of 15 minutes,
return to function at 30 minutes, 2 hour freedom from pain and
freedom from patients' most bothersome symptom (either nausea,
photophobia or phonophobia) and sustained efficacy through 48 hours
after a single intranasal dose. Biohaven plans to file a New Drug
Application for zavegepant with the U.S. Food and Drug
Administration in 1Q2022.
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 January 5,
2022. 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 collaboration agreement between
Pfizer and Biohaven for commercialization of rimegepant and
zavegepant 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; 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 success of the
collaboration with Pfizer, the receipt of milestone and other
payments under the Pfizer 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,Nurtec ODT and NOJECTION are registered trademarks of
Biohaven Pharmaceutical Ireland DAC.
Biohaven
Dr. Vlad Coric
Chairman and 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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