Pfizer to commercialize NURTEC® ODT
(rimegepant), an innovative compound for the prevention and acute
treatment of migraine, a condition with high unmet need
Expands Pfizer’s innovative Internal Medicine
pipeline to drive enhanced growth through 2030 and beyond
Biohaven common shareholders will receive
$148.50 per Biohaven share in cash, plus 0.5 of a share of a new
publicly traded company that retains Biohaven’s non-CGRP pipeline
compounds (“New Biohaven”)
Pfizer and Biohaven to hold analyst call at
10am ET today
Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding
Company Ltd. (NYSE: BHVN) today announced that the companies have
entered into a definitive agreement under which Pfizer will acquire
Biohaven, the maker of NURTEC® ODT, an innovative dual-acting
migraine therapy approved for both acute treatment and episodic
prevention of migraine in adults.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220510005676/en/
Under the terms of the agreement, Pfizer will acquire all
outstanding shares of Biohaven not already owned by Pfizer for
$148.50 per share in cash. Biohaven common shareholders, including
Pfizer, will also receive 0.5 of a share of New Biohaven, a new
publicly traded company that will retain Biohaven’s non-CGRP
development stage pipeline compounds, per Biohaven common share.
The boards of directors of both Biohaven and Pfizer have
unanimously approved the transaction. Pfizer will pay transaction
consideration totaling approximately $11.6 billion in cash. Pfizer
will also make payments at closing to settle Biohaven’s third party
debt and for the redemption of all outstanding shares of Biohaven’s
redeemable preferred stock. The $148.50 cash consideration
represents a premium of approximately 33% to Biohaven’s volume
weighted average selling price of $111.70 over the three months
prior to the announcement of the transaction.
The proposed transaction includes the acquisition of Biohaven’s
calcitonin gene-related peptide (CGRP) programs including:
- Rimegepant:
- Approved in the United States (U.S.) under the trade name,
NURTEC® ODT, for both the acute treatment of migraine and
preventive treatment of episodic migraine
- Approved in the European Union under the trade name, VYDURA®,
for both acute treatment of migraine and prophylaxis of episodic
migraine
- Zavegepant:
- On track for a 2Q2022 acceptance (based on March 2022
submission) in the U.S. as an intranasal spray for the acute
treatment of migraine and in development as an oral soft gel for
chronic migraine prevention
- A portfolio of five pre-clinical CGRP assets
“Today’s announcement builds on our legacy of delivering
breakthroughs for patients living with complex pain disorders and
diseases that disproportionately impact women,” said Nick
Lagunowich, Global President, Pfizer Internal Medicine. “NURTEC®
ODT, which is already the #1 prescribed migraine medicine in its
class in the United States, coupled with Biohaven’s CGRP pipeline,
offers hope for patients suffering from migraine worldwide. We
believe Pfizer is uniquely positioned to help the portfolio reach
its full potential given our leading scale and capabilities,
including comprehensive field force engagement with Primary Care
Physicians, specialists and health systems delivering the right
information at the right time.”
This agreement follows on the November 9, 2021 collaboration for
the commercialization of rimegepant and zavegepant outside the
United States, in connection with which Pfizer invested $350
million to acquire 2.6% of Biohaven’s common stock at $173 per
share.
“We are excited to announce Pfizer’s proposed acquisition of
Biohaven, recognizing the market leadership of NURTEC® ODT, our
breakthrough all in one migraine therapy, and the untapped
potential of our CGRP franchise,” said Vlad Coric, MD, Chairman and
Chief Executive Officer of Biohaven. “Pfizer’s capabilities will
accelerate our mission to deliver our migraine medicines to even
more patients, while the new R&D company is well positioned to
bring value to patients and shareholders by focusing on our
innovative pipeline for neurological and other disorders. We
believe this transaction represents significant future value
creation for patients and our collective shareholders.”
Following the closing, New Biohaven will continue to operate
under the Biohaven name. New Biohaven will be led by Vlad Coric,
MD, as Chairman and CEO, and include other members of the current
management team of Biohaven. Biohaven common shareholders will
receive, for each Biohaven share, 0.5 of a share of New Biohaven
distributed via a pro rata distribution of SEC-registered, publicly
listed shares. At distribution, New Biohaven will be capitalized
with $275 million of cash. New Biohaven will also have the right to
receive tiered royalties from Pfizer on any annual net sales of
rimegepant and zavegepant in the United States in excess of $5.25
billion.
Pfizer expects to finance the transaction with existing cash on
hand.
Pfizer’s acquisition of Biohaven is subject to the completion of
the New Biohaven spin-off transaction and other customary closing
conditions, including receipt of regulatory approvals and approval
by Biohaven’s shareholders. The companies expect the transaction to
close by early 2023.
Due to the proposed transaction, Biohaven will not hold a
conference call to discuss its first quarter 2022 financial results
and will issue a press release and file a quarterly report on Form
10-Q with the U.S. Securities and Exchange Commission announcing
those results on May 10, 2022.
J.P. Morgan acted as Pfizer’s financial advisor for the
transaction with Ropes & Gray LLP acting as its legal advisor.
Centerview Partners acted as Biohaven’s financial advisor for the
transaction with Sullivan & Cromwell LLP acting as its legal
advisor.
Investor Call Details
Pfizer and Biohaven will host an analyst and investor call today
at 10am EDT to discuss the proposed transaction.
Webcast Details | Pfizer Analyst and Investor Call | May 10
When you add these details to your invite, copy the Webcast
link, then right-click where you want to place it and select Keep
Text Only to paste it
Webcast
- Pfizer Analyst and Investor Call
- STARTS: May 10, 2022 10:00 AM
- ENDS: May 10, 2022 11:00 AM
- WEBCAST LINK:
https://pfizer.rev.vbrick.com/#/events/97005988-ae33-4a4b-b3e9-667a6f82e835
- If viewing on an iPad, iPhone or Android: Your meeting
experience is completely dependent upon Internet connection or
cellular signal quality in your area
Audio Conference:
Participant Event Plus Dial-In Number: (833) 708-1779 (in U.S.
and Canada)
Participant Event Plus Toll Dial-In Number: (602) 585-9859
(outside U.S. and Canada)
Global Dial in Numbers
Passcode: 051022
About Migraine
Around one billion people
suffer from migraine across the globe, of which 75 percent are
women. The World Health Organization classifies migraine as one of
the 10 most disabling medical illnesses. 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.
In April 2022, the European Commission (EC) granted marketing
authorization for VYDURA® (rimegepant) for both the acute treatment
of migraine with or without aura, and prophylaxis of episodic
migraine in adults who have at least four migraine attacks per
month. NURTEC® ODT is the #1 prescribed migraine treatment in its
class with a cumulative launch to date of U.S. net revenue of
approximately $650 million and with more than two 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.
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 profile of intranasal
zavegepant for the acute treatment of migraine, as compared to
placebo, was shown in a randomized controlled Phase 2/3
dose-ranging trial with a total of over 1000 patients who received
zavegepant. In this study, zavegepant showed statistical
superiority to placebo on the coprimary endpoints of 2-hour freedom
from pain and freedom from a patients' most bothersome symptom
(either nausea, photophobia or phonophobia). This was the second
zavegepant pivotal clinical trial to meet these coprimary
endpoints. Biohaven plans to file a new drug application with the
U.S. Food and Drug Administration for zavegepant in the second
quarter of 2022.
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 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
Neuroinnovation™ portfolio includes FDA-approved NURTEC® ODT
(rimegepant) for the acute and preventive treatment of migraine
(EMA-approved as Vydura® for the acute treatment of migraine with
or without aura, and prophylaxis of episodic migraine in adults who
have at least four migraine attacks per month) and a broad pipeline
of late-stage product candidates across five distinct mechanistic
platforms: CGRP receptor antagonism for the acute and preventive
treatment of migraine; glutamate modulation for
obsessive-compulsive disorder, and spinocerebellar ataxia;
myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis;
Kv7 ion channel activators for focal epilepsy and neuronal
hyperexcitability, and myostatin inhibition for neuromuscular
diseases. More information about Biohaven is available at
www.biohavenpharma.com and NURTEC® ODT at www.nurtec.com.
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.
Disclosure Notice
The information contained in this release is as of May 10,
2022.
This release contains forward-looking information about Pfizer’s
proposed acquisition of Biohaven, Biohaven’s related spin-off of
its development stage pipeline compounds, Biohaven’s commercial and
pipeline portfolio, including rimegepant and zavegepant, expected
best-in-class and growth potential, and Pfizer’s Internal Medicine
portfolio and growth potential, including their potential benefits,
that involve 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, risks related to the satisfaction or waiver of the
conditions to closing the proposed acquisition (including the
failure to obtain necessary regulatory approvals and failure to
obtain the requisite vote by Biohaven shareholders) in the
anticipated timeframe or at all, including the possibility that the
proposed acquisition does not close; the possibility that competing
offers may be made; risks related to the ability to realize the
anticipated benefits of the proposed acquisition, including the
possibility that the expected benefits from the acquisition will
not be realized or will not be realized within the expected time
period; the risk that the businesses will not be integrated
successfully; disruption from the transaction making it more
difficult to maintain business and operational relationships; risks
related to diverting management’s attention from Biohaven’s ongoing
business operation; negative effects of this announcement or the
consummation of the proposed acquisition on the market price of
Pfizer’s common stock, Biohaven’s common shares and/or their
respective operating results; significant transaction costs;
unknown liabilities; the risk of litigation and/or regulatory
actions related to the proposed acquisition, spin-off or Biohaven’s
business; risks and costs related to the implementation of the
separation of New Biohaven, including timing anticipated to
complete the separation and any changes to the configuration of the
businesses included in the separation if implemented; the risk that
the integration of Biohaven and Pfizer will be more difficult, time
consuming or costly than expected; other business effects and
uncertainties, including the effects of industry, market, business,
economic, political or regulatory conditions; future exchange and
interest rates; changes in tax and other laws, regulations, rates
and policies; future business combinations or disposals; 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; risks associated with interim 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 drug
applications may be filed in particular jurisdictions for
rimegepant or zavegepant or any other investigational products;
whether and when any such applications may be approved by
regulatory authorities, 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, zavegepant
or any such other products 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,
zavegepant or any such other products; uncertainties regarding the
impact of COVID-19; and competitive developments.
You should carefully consider the foregoing factors and the
other risks and uncertainties that affect the businesses of Pfizer
and Biohaven described in the “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results” sections of
their respective Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and other documents filed by either of them from time to
time with the U.S. Securities and Exchange Commission (the “SEC”),
all of which are available at www.sec.gov. These filings identify
and address other important risks and uncertainties that could
cause actual events and results to differ materially from those
contained in the forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and Pfizer and Biohaven assume no obligation to, and do not intend
to, update or revise these forward-looking statements, whether as a
result of new information, future events, or otherwise, unless
required by law. Neither Pfizer nor Biohaven gives any assurance
that it will achieve its expectations.
Additional Information and Where to Find It
In connection with the proposed transaction, Biohaven will be
filing documents with the SEC, including preliminary and definitive
proxy statements relating to the proposed transaction. The
definitive proxy statement will be mailed to Biohaven’s
shareholders in connection with the proposed transaction. This
communication is not a substitute for the proxy statement or any
other document that may be filed by Biohaven with the SEC. BEFORE
MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE
URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS AND
ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE
PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE IN THE PROXY
STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Any vote in
respect of resolutions to be proposed at Biohaven’s shareholder
meeting to approve the proposed transaction or other responses in
relation to the proposed transaction should be made only on the
basis of the information contained in Biohaven’s proxy statement.
Investors and security holders may obtain free copies of these
documents (when they are available) and other related documents
filed with the SEC at the SEC’s web site at www.sec.gov or on
Biohaven’s website at https://www.biohavenpharma.com/investors.
No Offer or Solicitation
This communication is for information purposes only and is not
intended to and does not constitute, or form part of, an offer,
invitation or the solicitation of an offer or invitation to
purchase, otherwise acquire, subscribe for, sell or otherwise
dispose of any securities, or the solicitation of any vote or
approval in any jurisdiction, pursuant to the proposed transaction
or otherwise, nor shall there be any sale, issuance or transfer of
securities in any jurisdiction in contravention of applicable
law.
Participants in the Solicitation
Biohaven and certain of its directors, executive officers and
employees may be deemed to be participants in the solicitation of
proxies in connection with the proposed transaction. Information
about Biohaven’s directors and executive officers is set forth in
its proxy statement for its 2022 annual meeting of shareholders,
which was filed with the SEC on March 11, 2022. Other information
regarding participants in the proxy solicitations in connection
with the proposed transaction, and a description of any interests
that they have in the proposed transaction, by security holdings or
otherwise, will be included in the proxy statement described above.
These documents are available free of charge at the SEC’s web site
at www.sec.gov and by going to Biohaven’s website at
https://www.biohavenpharma.com/investors.
Category: Investments
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220510005676/en/
Pfizer Media Contact:
+1 (212) 733-1226
PfizerMediaRelations@Pfizer.com
Pfizer Investor Contact:
+1 (212) 733-4848
IR@Pfizer.com Biohaven Investor Contact:
Jen Porcelli, VP, Investor
Relations jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741 Biohaven
Media Contact: Mike Beyer, Sam
Brown Inc. mikebeyer@sambrown.com +1 (312)
961-2502
Biohaven (NYSE:BHVN)
Historical Stock Chart
From Apr 2024 to May 2024
Biohaven (NYSE:BHVN)
Historical Stock Chart
From May 2023 to May 2024