Acquisition adds breakthrough calcitonin gene-related peptide
portfolio, including NURTEC® ODT, to address needs of millions of
migraine patients worldwide
Pfizer Inc. (NYSE: PFE) announced today the completion of its
acquisition of Biohaven Pharmaceutical Holding Company Ltd., the
maker of NURTEC® ODT (rimegepant), an innovative migraine therapy
approved for both acute treatment and prevention of episodic
migraine in adults.
The acquisition brings to Pfizer a portfolio of promising
calcitonin gene-related peptide (CGRP) receptor antagonists
including:
- Rimegepant:
- Approved in the United States under the trade name NURTEC® ODT,
in adults for both the acute treatment of migraine with or without
aura and the preventive treatment of episodic migraine
- Approved in the European Union under the trade name VYDURA® for
both the acute treatment of migraine with or without aura in adults
and the preventive treatment of episodic migraine in adults who
have at least 4 migraine attacks per month
- Zavegepant:
- New Drug Application (NDA) for intranasal spray for the acute
treatment of migraine under U.S. Food and Drug Administration (FDA)
review, with a Prescription Drug User Fee Act (PDUFA) goal date in
1Q 2023
- A portfolio of pre-clinical CGRP assets
"We are proud to build on Pfizer’s legacy of delivering
breakthrough medicines for patients living with complex pain
disorders,” said Aamir Malik, Executive Vice President, Chief
Business Innovation Officer, Pfizer. “The success of NURTEC® ODT
coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s
innovative Internal Medicine pipeline through 2030, and beyond.
Combined with Pfizer’s global reach, this acquisition increases our
potential to bring new treatment options to patients with migraine
– a disease which affects over 1 billion people worldwide.”i
Pfizer acquired all of the outstanding shares of Biohaven not
already owned by Pfizer for $148.50 per share in cash, for a total
transaction consideration of approximately $11.6 billion. As a
result of the acquisition, Biohaven became a wholly-owned
subsidiary of Pfizer.
Effective immediately prior to the closing of the acquisition,
Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN),
distributing Biohaven Ltd.’s shares to Biohaven’s shareholders.
Biohaven Ltd., a new company that retained Biohaven’s non-CGRP
development stage pipeline compounds, holds the Kv7 ion channel
activators, glutamate modulation, and myostatin inhibition
platforms, preclinical product candidates, and certain corporate
infrastructure assets excluded from the Pfizer acquisition. Pfizer,
a Biohaven shareholder, received a pro rata portion of Biohaven
Ltd.’s shares in the distribution and owns approximately 3% of
Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York
Stock Exchange under the ticker “BHVN”.
For additional background on the acquisition, please read the
announcement press release here.
About Migraine
Worldwide, more than one billion people suffer from migraine,
which predominately affects women.i Findings from the 2019 Global
Burden of Disease study indicate that migraine is one of the worlds
leading causes of disability.ii Migraine is characterized by
debilitating 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).iii
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 adults in
February 2020 and for the preventive treatment of episodic migraine
in adults in May 2021. Nurtec® ODT is taken orally as needed, up to
once daily for acute treatment, and every other day for preventive
treatment. The maximum dose in a 24 hour period is 75 mg.
NURTEC® ODT U.S. IMPORTANT SAFETY INFORMATION
Contraindications: Hypersensitivity to Nurtec® ODT or any
of its components.
Warnings and Precautions: If a serious hypersensitivity
reaction occurs, discontinue Nurtec® ODT and initiate appropriate
therapy. Serious hypersensitivity reactions have included dyspnea
and rash, and can occur days after administration.
Adverse Reactions: The most common adverse reactions were
nausea (2.7% in patients who received Nurtec® ODT compared to 0.8%
in patients who received placebo) and abdominal pain/dyspepsia
(2.4% in patients who received Nurtec® ODT compared to 0.8% in
patients who received placebo). Hypersensitivity, including dyspnea
and rash, occurred in less than 1% of patients treated with Nurtec®
ODT.
Drug Interactions: Avoid concomitant administration of
Nurtec® ODT with strong inhibitors of CYP3A4 or strong or moderate
inducers of CYP3A. Avoid another dose of Nurtec® ODT within 48
hours when it is administered with moderate inhibitors of CYP3A4 or
potent inhibitors of P‑gp.
Use in Specific Populations: Pregnancy: It is not known
if Nurtec® ODT can harm an unborn baby. Lactation: The transfer of
rimegepant into breastmilk is low (<1%). Hepatic impairment:
Avoid use of Nurtec® ODT in persons with severe hepatic impairment.
Renal impairment: Avoid use in patients with end-stage renal
disease.
INDICATIONS
Nurtec® ODT is indicated in adults for the:
- acute treatment of migraine with or without aura
- preventive treatment of episodic migraine
Please click here for full Prescribing Information.
About Zavegepant
Zavegepant is a third generation, high affinity, selective and
structurally unique, small molecule CGRP receptor antagonist from
the NOJECTION® Migraine Platform and the only CGRP receptor
antagonist in clinical development with both intranasal and oral
formulations. The FDA has accepted for review a New Drug
Application (NDA) for zavegepant nasal spray, with a PDUFA date in
1Q 2023.
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 October 3,
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 Pfizer’s
acquisition of Biohaven, the spin off of Biohaven Ltd., Biohaven’s
commercial and pipeline portfolios, including rimegepant and
zavegepant, expected growth and breakthrough 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 ability to realize the anticipated benefits of the
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; negative effects of the
consummation of the acquisition on the market price of Pfizer’s
common stock and/or operating results; significant transaction
costs; unknown liabilities; the risk of litigation and/or
regulatory actions related to the acquisition, spin off of Biohaven
Ltd. or Biohaven’s business; risks and costs related to the
implementation of the separation of Biohaven Ltd.; 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
divestitures; 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 any 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.
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, 2021 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.
i Ashina et al, Lancet; 2021; 397:1485-95 ii Steiner et al, The
Journal of Headache and Pain; 2020; 21:137 iii Ferrari et al,
Nature Review Disease Primers; 2022; 8(1):2
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