Acquisition brings leading sickle cell disease
portfolio and pipeline to Pfizer with potential to address critical
needs in an underserved patient community
Pfizer Inc. (NYSE: PFE) announced today the completion of its
acquisition of Global Blood Therapeutics, Inc. (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 reinforces Pfizer’s commitment to SCD,
building on a 30-year legacy in the rare hematology space.
GBT brings a portfolio and pipeline that has the potential to
address the full spectrum of critical needs for this underserved
community. GBT discovered and developed Oxbryta® (voxelotor), a
first-in-class medicine that directly targets the root cause of
SCD. In addition, GBT’s promising pipeline of preclinical and
clinical investigational assets focused in SCD includes GBT021601
(GBT601) and inclaclumab, both of which have received Orphan Drug
and Rare Pediatric Disease designations from the U.S. Food and Drug
Administration (FDA).
“With Global Blood Therapeutics’ talent, portfolio, and pipeline
now part of Pfizer, we look forward to accelerating innovation and
expeditiously bringing multiple potential best-in-class treatments
to people living with sickle cell disease,” said Aamir Malik, Chief
Business Innovation Officer, Executive Vice President, Pfizer. “In
line with our value of equity, Pfizer is committed to addressing
the underserved needs of the sickle cell disease community. We are
excited about these potential breakthroughs and the opportunity to
transform the lives of these patients.”
SCD is a lifelong, devastating inherited blood disorder
impacting millions of people worldwide, predominantly in
populations of African, Middle Eastern and South Asian descent.
Pfizer will continue to build on the companies’ shared commitment
to and engagement with the SCD community.
Additional Transaction Details
Pfizer has completed its acquisition of all the outstanding
shares of common stock of GBT for $68.50 per share in cash for an
estimated total enterprise value of approximately $5.4 billion,
including debt and net of cash acquired. GBT is now a wholly owned
subsidiary of Pfizer. In connection with the acquisition, GBT’s
shares of common stock ceased trading on the NASDAQ Global Select
Market.
For additional background on the acquisition, please read the
announcement press release here.
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. 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.
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,
Oxbryta has received marketing authorization for the treatment of
SCD in adults and children 12 years of age and older in the Gulf
Cooperation Council countries of Kuwait, Oman and the United Arab
Emirates (UAE).
Important Safety Information
Oxbryta should not be taken if the patient has had an allergic
reaction to voxelotor or any of the ingredients in Oxbryta. See the
end of the patient leaflet for a list of the ingredients in
Oxbryta. Oxbryta can cause serious side effects, including serious
allergic reactions. Patients should tell their healthcare provider
or get emergency medical help right away if they get rash, hives,
shortness of breath (difficult breathing) or swelling of the
face.
The most common side effects of Oxbryta include headache,
diarrhea, stomach-area (abdominal) pain, nausea, rash or hives, and
fever. The most common side effects of Oxbryta in children ages 4
to less than 12 years of age include fever, vomiting, rash,
stomach-area (abdominal) pain, diarrhea, and headache. These are
not all the possible side effects of Oxbryta. Before taking
Oxbryta, patients should tell their healthcare provider about all
medical conditions, including if they have liver problems; if they
are pregnant or plan to become pregnant as it is not known if
Oxbryta can harm an unborn baby; or if they are breastfeeding or
plan to breastfeed as it is not known if Oxbryta can pass into
breastmilk or if it can harm a baby. Patients should not breastfeed
during treatment with Oxbryta and for at least 2 weeks after the
last dose.
Patients should tell their healthcare provider about all the
medicines they take, including prescription and over-the-counter
medicines, vitamins and herbal supplements. Some medicines may
affect how Oxbryta works. Oxbryta may also affect how other
medicines work and may affect the results of certain blood
tests.
Patients are advised to call their doctor for medical advice
about side effects. Side effects can be reported to FDA at
1-800-FDA-1088. Side effects can also be reported at
1-833-428-4968.
Full Prescribing Information for Oxbryta is available at
Oxbryta.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 October 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, among
other things, Pfizer’s acquisition of GBT, Oxbryta, GBT’s pipeline,
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
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 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 additional jurisdictions
for Oxbryta or 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.
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.
Category: Investments
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