Proposed acquisition drives growth by bringing
leading sickle cell disease expertise, portfolio and pipeline to
Pfizer with potential combined worldwide peak sales of more than $3
billion
Potential to address the full spectrum of
critical needs in the underserved sickle cell community
Transaction valued at $68.50 per Global Blood
Therapeutics share in cash, for a total enterprise value of
approximately $5.4 billion
Pfizer Inc. (NYSE: PFE) and Global Blood Therapeutics, Inc.
(GBT) (NASDAQ: GBT) today announced the companies have entered into
a definitive agreement under which Pfizer will acquire GBT, a
biopharmaceutical company dedicated to the discovery, development
and delivery of life-changing treatments that provide hope to
underserved patient communities, starting with sickle cell disease
(SCD). The acquisition complements and further enhances Pfizer’s
more than 30-year heritage in rare hematology and reinforces the
company’s commitment to SCD by bringing expertise and a leading
portfolio and pipeline with the potential to address the full
spectrum of critical needs in this underserved community. Pfizer
intends to continue to build on the companies’ shared commitment to
and engagement with the SCD community.
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Under the terms of the transaction, Pfizer will acquire all the
outstanding shares of GBT for $68.50 per share in cash, for a total
enterprise value of approximately $5.4 billion, including debt and
net of cash acquired. The Boards of Directors of both companies
have unanimously approved the transaction.
SCD is a lifelong, devastating inherited blood disorder
impacting millions of people worldwide, predominantly in
populations of African, Middle Eastern and South Asian descent. GBT
developed Oxbryta® (voxelotor) tablets, a first-in-class medicine
that directly targets the root cause of SCD. Oxbryta was approved
in the United States in November 2019 and is also approved in the
European Union, United Arab Emirates, Oman and Great Britain. Net
sales for Oxbryta were approximately $195 million in 2021.
Leveraging its global platform, Pfizer plans to accelerate
distribution of GBT’s innovative treatment to parts of the world
most impacted by SCD.
In addition, GBT is developing GBT021601 (GBT601), an oral,
once-daily, next-generation sickle hemoglobin (HbS) polymerization
inhibitor in the Phase 2 portion of a Phase 2/3 clinical study.
GBT601 has the potential to be a best-in-class agent targeting
improvement in both hemolysis and frequency of vaso-occlusive
crisis (VOC). GBT’s promising pipeline also includes inclacumab, a
fully human monoclonal antibody targeting P-selectin which is being
evaluated in two Phase 3 clinical trials as a potential quarterly
treatment to reduce the frequency of VOCs and to reduce hospital
readmission rates due to VOCs. Both GBT601 and inclacumab have
received Orphan Drug and Rare Pediatric Disease designations from
the U.S. Food and Drug Administration (FDA). If approved, GBT’s
pipeline and Oxbryta have the potential for an SCD franchise that
could achieve combined worldwide peak sales of more than $3
billion.
“Sickle cell disease is the most common inherited blood
disorder, and it disproportionately affects people of African
descent. We are excited to welcome GBT colleagues into Pfizer and
to work together to transform the lives of patients, as we have
long sought to address the needs of this underserved community,”
said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“The deep market knowledge and scientific and clinical capabilities
we have built over three decades in rare hematology will enable us
to accelerate innovation for the sickle cell disease community and
bring these treatments to patients as quickly as possible.”
“Today is an exciting milestone that accelerates GBT’s mission
to discover, develop and deliver life-changing treatments that
provide hope to underserved patient communities,” said Ted W. Love,
M.D., President and Chief Executive Officer, GBT. “Pfizer will
broaden and amplify our impact for patients and further propel
much-needed innovation and resources for the care of people with
sickle cell disease and other rare diseases, including populations
in limited-resource countries. We look forward to working together
with Pfizer to serve our communities and advance our shared goal of
improving health equity and expanding access to life-changing
treatments to create a healthier future for all.”
Pfizer expects to finance the transaction with existing cash on
hand. The proposed transaction is subject to customary closing
conditions, including receipt of regulatory approvals and approval
by GBT’s stockholders.
Due to the proposed transaction, GBT will not hold its
previously scheduled conference call to discuss its second quarter
2022 financial results. The company will file its quarterly report
on Form 10-Q for the quarter ending June 30, 2022 with the U.S.
Securities and Exchange Commission announcing those results on
August 8, 2022.
Pfizer’s financial advisors for the transaction are Morgan
Stanley & Co. LLC and Goldman Sachs & Co. LLC, with
Wachtell, Lipton, Rosen & Katz acting as its legal advisor.
GBT’s financial advisors for the transaction are J.P. Morgan
Securities LLC and Centerview Partners LLC, with Cravath, Swaine
& Moore LLP and Goodwin Procter LLP acting as legal
advisors.
About Sickle Cell Disease
Sickle cell disease (SCD) is a lifelong, debilitating inherited
blood disorder characterized by hemolytic anemia, acute pain crises
and progressive end organ damage. Acute pain crisis, or
vaso-occlusive crisis (VOC), occurs when sickled red blood cells
irritate the lining of blood vessels and cause an inflammatory
response leading to vascular occlusion, tissue ischemia and pain.
Complications of SCD begin in early childhood and are associated
with shortened life expectancy. Early intervention and treatment of
SCD have shown potential to modify the course of this disease,
reduce symptoms and events, prevent long-term organ damage, and
extend life expectancy. Historically, there has been a high unmet
need for therapies that address the root cause of SCD and its acute
and chronic complications. While rare in developed markets, there
are 4.5 million people living with SCD globally and more than 45
million people living with the sickle cell trait. SCD occurs
particularly among those whose ancestors are from sub-Saharan
Africa, though it also occurs in people of Hispanic, South Asian,
Southern European and Middle Eastern ancestry.
About Oxbryta® (voxelotor)
Oxbryta (voxelotor) is an oral, once-daily therapy for patients
with sickle cell disease (SCD). Oxbryta works by increasing
hemoglobin’s affinity for oxygen. Since oxygenated sickle
hemoglobin does not polymerize, Oxbryta inhibits sickle hemoglobin
polymerization and the resultant sickling and destruction of red
blood cells leading to hemolysis and hemolytic anemia, which are
primary pathologies faced by every single person living with SCD.
Through addressing hemolytic anemia and improving oxygen delivery
throughout the body, GBT believes that Oxbryta has the potential to
modify the course of SCD.
In November 2019, the FDA granted accelerated approval for
Oxbryta tablets for the treatment of SCD in adults and children 12
years of age and older, and in December 2021, the FDA expanded the
approved use of Oxbryta for the treatment of SCD in patients 4
years of age and older in the United States. As a condition of
accelerated approval for patients ages 4 and older in the United
States, GBT will continue to study Oxbryta in the HOPE-KIDS 2
Study, a post-approval confirmatory study using transcranial
Doppler (TCD) flow velocity to assess the ability of the therapy to
decrease stroke risk in children 2 to 14 years of age.
In recognition of the critical need for new SCD treatments, the
FDA granted Oxbryta Breakthrough Therapy, Fast Track, Orphan Drug,
and Rare Pediatric Disease designations for the treatment of
patients with SCD. Additionally, Oxbryta received the prestigious
2021 Prix Galien USA award for “Best Biotechnology Product” from
The Galien Foundation.
Oxbryta has been granted Priority Medicines (PRIME) designation
from the European Medicines Agency (EMA), Oxbryta was designated by
the European Commission (EC) as an orphan medicinal product for the
treatment of patients with SCD, and Oxbryta was granted Promising
Innovative Medicine (PIM) designation in the United Kingdom from
the Medicines and Healthcare products Regulatory Agency (MHRA). In
February 2022, the European Commission (EC) granted Marketing
Authorization for Oxbryta for the treatment of hemolytic anemia due
to SCD in adult and pediatric patients 12 years of age and older as
monotherapy or in combination with hydroxycarbamide (hydroxyurea).
The MHRA has granted Oxbryta marketing authorization in Great
Britain for the treatment of hemolytic anemia due to SCD in adult
and pediatric patients 12 years of age and older. In addition, the
Ministry of Health and Prevention (MOHAP) in the United Arab
Emirates (UAE) has granted marketing authorization for Oxbryta for
the treatment of SCD in adults and children 12 years of age and
older.
Please click here for Important Safety Information and full
Prescribing Information including Patient Information for Oxbryta
in the U.S.
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.
About Global Blood Therapeutics
Global Blood Therapeutics, Inc. (GBT) is a biopharmaceutical
company dedicated to the discovery, development and delivery of
life-changing treatments that provide hope to underserved patient
communities, starting with sickle cell disease (SCD). Founded in
2011, GBT is delivering on its goal to transform the treatment and
care of SCD, a lifelong, devastating inherited blood disorder. The
company has introduced Oxbryta® (voxelotor), the first FDA-approved
medicine that directly inhibits sickle hemoglobin (HbS)
polymerization, the root cause of red blood cell sickling in SCD.
GBT is also advancing its pipeline program in SCD with inclacumab,
a P-selectin inhibitor in Phase 3 development to address pain
crises associated with the disease, and GBT021601 (GBT601), the
company’s next generation HbS polymerization inhibitor. In
addition, GBT’s drug discovery teams are working on new targets to
develop the next generation of treatments for SCD. To learn more,
please visit www.gbt.com and follow the company on Twitter
@GBT_news.
Disclosure Notice
The information contained in this release is as of August 8,
2022.
This release contains forward-looking information about Pfizer’s
proposed acquisition of GBT, Oxbryta, GBT’s pipeline portfolio,
including inclacumab and GBT021601 (GBT601), and potential peak
sales, and expected best-in-class 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 GBT
stockholders) 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; negative effects of this announcement or the
consummation of the proposed 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 proposed acquisition or
GBT’s business; 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; uncertainties regarding the
commercial success of Oxbryta; 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 inclacumab, GBT601 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 inclacumab, GBT601
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 inclacumab,
GBT601 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 GBT 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 GBT 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 GBT gives any assurance that it
will achieve its expectations.
Additional Information and Where to Find It
In connection with the proposed transaction, GBT 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 GBT’s stockholders 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 GBT 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 GBT’s stockholder 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 GBT’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 by contacting GBT’s Investor Relations at
+1 833-428-2677.
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
GBT and its directors, executive officers and other members of
management and employees, under SEC rules, may be deemed to be
“participants” in the solicitation of proxies from stockholders of
GBT in favor of the proposed transaction. Information about GBT’s
directors and executive officers is set forth in GBT’s proxy
statement on Schedule 14A for its 2022 Annual Meeting of
Stockholders, which was filed with the SEC on April 28, 2022.
Additional information concerning the interests of GBT’s
participants in the solicitation, which may, in some cases, be
different than those of GBT’s stockholders generally, will be set
forth in GBT’s proxy statement relating to the proposed transaction
when it becomes available. These documents are available free of
charge at the SEC’s web site at www.sec.gov and by contacting GBT’s
Investor Relations at +1-833-428-2677.
Category: Investments
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Pfizer Inc.
Media Relations: +1 (212) 733-1226
PfizerMediaRelations@Pfizer.com
Investor Relations: +1 (212) 733-4848 IR@Pfizer.com
GBT
Media: Steven Immergut +1 650-410-3258 simmergut@gbt.com
Investors: Courtney Roberts +1 650-351-7881 croberts@gbt.com
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