GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced US government contracts totaling
approximately $1 billion1 (USD) to purchase sotrovimab, an
investigational monoclonal antibody for the early treatment of
COVID-19, which the US Food and Drug Administration (FDA) granted
Emergency Use Authorization (EUA) in May 2021. GSK will supply
these doses to the US government by December 17, 2021, enabling
further expanded nationwide access to sotrovimab for
patients
.
In addition to the doses that will be supplied
this year, the US government will have the option to purchase
additional doses through March 2022.
Including the contracts announced today, GSK and
Vir have received binding agreements for the sale of more than
750,000 doses of sotrovimab worldwide, with additional doses
reserved through other agreements including the previously
announced Joint Procurement Agreement with the European
Commission.
Sotrovimab is an FDA EUA-authorized
investigational single-dose intravenous (IV) infusion SARS-CoV-2
monoclonal antibody. Under the EUA, sotrovimab can be used for the
treatment of mild-to-moderate COVID-19 in adults and pediatric
patients (12 years of age and older weighing at least 40 kg) with
positive test results for COVID-19, and who are at high risk for
progression to severe COVID-19, including hospitalization or
death.
Dr. Hal Barron, Chief Scientific
Officer and President R&D, GSK,
said: “Given the large number of
patients who continue to become ill with COVID-19 across many
regions in the US, there is an ongoing need for access to effective
treatments. We are proud to work with the US government to help
make sotrovimab available for these patients.”
George Scangos, Ph.D., Chief
Executive Officer of Vir, said:
“Monoclonal antibodies play an essential role in the treatment of
certain patients with COVID-19, and we’re grateful that this
agreement will allow more healthcare providers and patients who are
at high risk for progression to severe COVID-19 to access
sotrovimab. Given ongoing evidence, which demonstrates its ability
to maintain activity against the tested circulating variants of
concern, including Delta, we are confident sotrovimab will continue
to be important in the fight against COVID-19.”
The US government purchase was funded by
the Biomedical Advanced Research and Development Authority
(BARDA), part of the U.S. Department of
Health and Human Services Office of the
Assistant Secretary for Preparedness and Response
through Department of Defense – contract numbers W58P0521C0008
and W58P0522C0002.
In June 2021, GSK and Vir announced confirmatory
full results for the COMET-ICE Phase 3 trial, which resulted in a
79% reduction (adjusted relative risk reduction) (p<0.001) in
hospitalizations for more than 24 hours or death due to any cause
by Day 29 compared to placebo, meeting the primary endpoint of the
trial.
The companies also recently announced headline
data from the randomized, multi-center, open-label COMET-TAIL
Phase 3 trial, which achieved its primary endpoint, demonstrating
intramuscular (IM) administration of sotrovimab was non-inferior to
IV administration for the early treatment of mild-to-moderate
COVID-19 in high-risk, non-hospitalized adults and adolescents (12
years of age and older). The companies plan to progress
regulatory submissions globally.
GSK and Vir are committed to ongoing evaluation
of sotrovimab as the COVID-19 landscape continues to evolve at
different rates across the globe and new variants of concern and
interest emerge. Updated in vitro data, published in bioRxiv,
demonstrate that sotrovimab retains activity against all current
variants of concern and interest of the SARS-CoV-2 virus as defined
by the World Health Organization, plus others, including, but not
limited to, Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu
(B.1.621).
About sotrovimab Sotrovimab is
an investigational SARS-CoV-2 neutralizing monoclonal antibody. The
antibody binds to an epitope on SARS-CoV-2 that is shared with
SARS-CoV-1 (the virus that causes SARS), indicating that the
epitope is highly conserved, which may make it more difficult for
resistance to develop. Sotrovimab, which incorporates Xencor’s
Xtend™ technology, has also been designed to achieve high
concentration in the lungs to ensure optimal penetration into
airway tissues affected by SARS-CoV-2 and to have an extended
half-life.
About global access to
sotrovimab
- Sotrovimab is authorized for
emergency use in the United States and received a positive
scientific opinion under Article 5(3) of Regulation 726/2004 from
the Committee for Human Medicinal Products (CHMP) in the European
Union (EU). Sotrovimab has been granted a provisional marketing
authorization in Australia and a conditional marketing
authorization in Saudi Arabia. In Japan, it has been approved via
the Special Approval for Emergency Pathway. Temporary
authorizations have been granted in Bahrain, Brazil, Canada, Egypt,
Italy, Kuwait, Oman, Qatar, Singapore, Switzerland, Thailand and
the United Arab Emirates (UAE).
- Sotrovimab is supplied in several
countries around the world, including through national agreements
in the United States, Japan, Australia, Canada, Singapore and the
UAE. We have also signed a Joint Procurement Agreement with the
European Commission to supply doses of sotrovimab. Additional
agreements are yet to be announced due to confidentiality or
regulatory requirements.
About the sotrovimab clinical
development program
- COMET-ICE: a Phase 3, multi-center,
double-blind, placebo-controlled trial investigated IV infusion of
sotrovimab in adults with mild-to-moderate COVID-19 at high risk of
progression to severe disease, who are not hospitalized and not
requiring oxygen. The final COMET-ICE trial results in the full
trial population of 1,057 participants demonstrated a 79% reduction
(adjusted relative risk reduction) (p<0.001) in hospitalization
for more than 24 hours or death due to any cause by Day 29 compared
to placebo, meeting the primary endpoint of the trial. Interim data
were published in The New England Journal of Medicine on October
27, 2021 and final data were pre-published on November 8, 2021 on
medRxiv.
- COMET-TAIL: a Phase 3, randomized,
multi-center, open-label, non-inferiority trial of IM versus IV
administration of sotrovimab for the early treatment of
mild-to-moderate COVID-19 in high-risk non-hospitalized adult and
pediatric patients (12 years of age and older). The trial’s primary
endpoint was met, and headline data demonstrated that
intramuscularly administered sotrovimab was non-inferior and
offered similar efficacy to intravenous administration for
high-risk populations. The companies plan to submit the full
COMET-TAIL data set to a peer-reviewed journal for publication
in the first quarter of 2022.
- COMET-PEAK: a Phase 2, randomized,
multi-center, parallel group trial evaluating IV and IM
administration of sotrovimab in outpatients with mild-to-moderate
COVID-19. Data available to date from open-label Part B of the
trial (500mg IV vs. 500mg IM) demonstrated equivalence on the
virological response between the IM and IV arms. The companies plan
to submit the full COMET-PEAK data set to a peer-reviewed journal
for publication.
- GSK and Vir are also partnering to
investigate the use of sotrovimab in uninfected immunocompromised
adults to determine whether sotrovimab can prevent symptomatic
COVID-19 infection. GSK and Vir are supporting
investigator-sponsored studies and fostering scientific
collaborations with both experienced investigators and networks,
who are involved in the continuum of care of immunocompromised
patients, to understand the role sotrovimab for prophylaxis could
play in this population. Discussions with regulatory authorities
regarding the prophylaxis program will take place in due
course.
Sotrovimab in the United
StatesThe following is a summary of information for
sotrovimab. Healthcare providers in the U.S. should review the Fact
Sheets for information about the authorized use of sotrovimab and
mandatory requirements of the EUA. Please see the FDA Letter of
Authorization, full Fact Sheet for Healthcare Providers and full
Fact Sheet for Patients, Parents, and Caregivers.
Sotrovimab has been authorized by the U.S.
FDA for the emergency use described below. Sotrovimab is not
FDA-approved for this use.
Sotrovimab is authorized only for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of sotrovimab under
section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
Authorized UseThe U.S. Food and
Drug Administration (FDA) has issued an Emergency Use Authorization
(EUA) to permit the emergency use of the unapproved product
sotrovimab for the treatment of mild-to-moderate coronavirus
disease 2019 (COVID-19) in adults and pediatric patients
(12 years of age and older weighing at least 40 kg) with
positive results of direct SARS-CoV-2 viral testing, and who are at
high risk for progression to severe COVID-19, including
hospitalization or death.
Limitations of Authorized
UseSotrovimab is not authorized for use in patients:
- who are hospitalized due to
COVID-19, OR
- who require oxygen therapy due to
COVID-19, OR
- who require an increase in baseline
oxygen flow rate due to COVID-19 (in those on chronic oxygen
therapy due to underlying non-COVID-19 related comorbidity)
Benefit of treatment with sotrovimab has not
been observed in patients hospitalized due to COVID‑19. SARS-CoV-2
monoclonal antibodies may be associated with worse clinical
outcomes when administered to hospitalized patients with COVID‑19
requiring high flow oxygen or mechanical ventilation.
Important Safety
Information
CONTRAINDICATIONSSotrovimab is
contraindicated in patients who have a history of anaphylaxis to
sotrovimab or to any of the excipients in the formulation.
WARNINGS AND PRECAUTIONSThere are limited
clinical data available for sotrovimab. Serious and unexpected
adverse events may occur that have not been previously reported
with sotrovimab use.
Hypersensitivity Including Anaphylaxis
and Infusion-Related ReactionsSerious hypersensitivity
reactions, including anaphylaxis, have been observed with
administration of sotrovimab. If signs and symptoms of a clinically
significant hypersensitivity reaction or anaphylaxis occur,
immediately discontinue administration and initiate appropriate
medications and/or supportive care.
Infusion-related reactions, occurring during the
infusion and up to 24 hours after the infusion, have been observed
with administration of sotrovimab. These reactions may be severe or
life threatening.
Signs and symptoms of infusion-related reactions
may include: fever, difficulty breathing, reduced oxygen
saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation,
sinus tachycardia, bradycardia), chest pain or discomfort,
weakness, altered mental status, nausea, headache, bronchospasm,
hypotension, hypertension, angioedema, throat irritation, rash
including urticaria, pruritus, myalgia, vaso-vagal reactions (eg,
pre-syncope, syncope), dizziness and diaphoresis.
Consider slowing or stopping the infusion and
administer appropriate medications and/or supportive care if an
infusion-related reaction occurs.
Hypersensitivity reactions occurring more than
24 hours after the infusion have also been reported with the use of
SARS-CoV-2 monoclonal antibodies under Emergency Use
Authorization.
Clinical Worsening After SARS-CoV-2
Monoclonal Antibody AdministrationClinical worsening of
COVID‑19 after administration of SARS-CoV-2 monoclonal antibody
treatment has been reported and may include signs or symptoms of
fever, hypoxia or increased respiratory difficulty, arrhythmia (eg,
atrial fibrillation, tachycardia, bradycardia), fatigue, and
altered mental status. Some of these events required
hospitalization. It is not known if these events were related to
SARS-CoV-2 monoclonal antibody use or were due to progression of
COVID‑19.
Limitations of Benefit and Potential for
Risk in Patients with Severe
COVID‑19Benefit of
treatment with sotrovimab has not been observed in patients
hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may
be associated with worse clinical outcomes when administered to
hospitalized patients with COVID‑19 requiring high-flow oxygen or
mechanical ventilation. Therefore, sotrovimab is not authorized for
use in patients: who are hospitalized due to COVID‑19, OR who
require oxygen therapy due to COVID‑19, OR who require an increase
in baseline oxygen flow rate due to COVID‑19 in those on chronic
oxygen therapy due to underlying non‑COVID‑19 related
comorbidity.
ADVERSE EVENTSHypersensitivity
adverse reactions have been observed in 2% of patients treated with
sotrovimab and 1% with placebo in COMET-ICE.
The most common treatment-emergent adverse
events observed in the sotrovimab treatment group in COMET-ICE were
rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or
Grade 2 (moderate). No other treatment-emergent adverse events were
reported at a higher rate with sotrovimab compared to placebo.
USE IN SPECIFIC POPULATIONS
PregnancyThere are insufficient
data to evaluate a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcome. Sotrovimab
should be used during pregnancy only if the potential benefit
justifies the potential risk for the mother and the fetus.
LactationThere are no available
data on the presence of sotrovimab in human milk, the effects on
the breastfed infant, or the effects on milk production.
Individuals with COVID-19 who are breastfeeding should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
About the Vir and GSK
CollaborationIn April 2020, Vir and GSK entered
into a collaboration to research and develop solutions for
coronaviruses, including SARS-CoV-2, the virus that causes
COVID-19. The collaboration uses Vir’s proprietary monoclonal
antibody platform technology to accelerate existing and identify
new anti-viral antibodies that could be used as therapeutic or
preventive options to help address the current COVID-19 pandemic
and future outbreaks. The companies will leverage GSK’s expertise
in functional genomics and combine their capabilities in CRISPR
screening and artificial intelligence to identify anti-coronavirus
compounds that target cellular host genes. They will also apply
their combined expertise to research SARS-CoV-2 and other
coronavirus vaccines.
GSK Commitment to Tackling
COVID-19GSK’s response to COVID-19 has been one of the
broadest in the industry, with potential treatments in addition to
our vaccine candidates in development with partner
organizations.
GSK is collaborating with several organizations
on COVID-19 vaccines by providing access to our adjuvant
technology. We are working with Sanofi, Medicago and SK bioscience
to develop adjuvanted, protein-based vaccine candidates,
and all are now in Phase 3 clinical
trials. The use of an adjuvant can be of particular importance in a
pandemic since it may reduce the amount of vaccine protein required
per dose, allowing more vaccine doses to be produced and
contributing to protect more people in need.
GSK is also working with mRNA specialist,
CureVac, to jointly develop next generation, optimized mRNA
vaccines for COVID-19 with the potential to address multiple
emerging variants in one vaccine.GSK is also exploring treatments
for COVID-19 patients, collaborating with Vir Biotechnology to
investigate monoclonal antibodies that could be used as therapeutic
or preventive options for COVID-19.
Vir’s Commitment to
COVID-19Vir was founded with the mission of
addressing the world’s most serious infectious diseases. In 2020,
Vir responded rapidly to the COVID-19 pandemic by leveraging our
unique scientific insights and industry leading antibody platform
to explore multiple monoclonal antibodies as potential therapeutic
or preventive options for COVID-19. Sotrovimab is the first
SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was
carefully selected for its demonstrated promise in preclinical
research, including an anticipated high barrier to resistance and
potential ability to both block the virus from entering healthy
cells and clear infected cells. Vir is continuing to pursue novel
therapeutic and prophylactic solutions to combat SARS-CoV-2 and
future coronavirus pandemics, both independently and in
collaboration with its partners.
About GSKGSK
is a science-led global healthcare company. For further information
please visit
www.gsk.com/about-us.
About Vir
BiotechnologyVir Biotechnology is a
commercial-stage immunology company focused on combining
immunologic insights with cutting-edge technologies to treat and
prevent serious infectious diseases. Vir has assembled four
technology platforms that are designed to stimulate and enhance the
immune system by exploiting critical observations of natural immune
processes. Its current development pipeline consists of product
candidates targeting COVID-19, hepatitis B virus, influenza A and
human immunodeficiency virus. For more information, please visit
www.vir.bio.
GSK cautionary statement regarding
forward-looking statementsGSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Such factors include, but are not limited to,
those described in the Company's Annual Report on Form 20-F for
2020, GSK’s Q3 Results and any impacts of the COVID-19
pandemic.
Vir Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “may,” “will,” “plan,”
“potential,” “aim,” “promising” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Vir’s expectations
and assumptions as of the date of this press release.
Forward-looking statements contained in this press release include,
but are not limited to, statements regarding the ability of
sotrovimab to treat and/or prevent COVID-19 either through IV or IM
administration, Vir’s collaboration with GSK, whether or not the US
government will exercise their option, the timing and expected
number of therapeutic doses that Vir and GSK will be able to supply
to governments and patients, planned discussions with regulatory
authorities, the timing of availability of clinical data, program
updates and data disclosures, the clinical development program for
sotrovimab, and the ability of sotrovimab to maintain activity
against circulating variants of concern and interest. Many factors
may cause differences between current expectations and actual
results, including unexpected safety or efficacy data observed
during preclinical or clinical studies, challenges in the treatment
of hospitalized patients, difficulties in collaborating with other
companies or government agencies, challenges in accessing
manufacturing capacity, successful development and/or
commercialization of alternative product candidates by Vir’s
competitors, changes in expected or existing competition, delays in
or disruptions to Vir’s business or clinical trials due to the
COVID-19 pandemic, geopolitical changes or other external factors,
and unexpected litigation or other disputes. Other factors that may
cause actual results to differ from those expressed or implied in
the forward-looking statements in this press release are discussed
in Vir’s filings with the U.S. Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as required by law, Vir assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
¹Editor’s Note:
Financial considerationsThe total value of the two
current agreements with the US government for supply of sotrovimab
in 2021 is about $1 billion, with GSK supplying the agreed number
of doses to the US government by December 17, 2021. This new
agreement is included within GSK’s financial guidance of an
expected contribution to 2021. Adjusted EPS from COVID-19 solutions
of 7% to 9% at CER.
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MiddlesexTW8 9GS
Vir Biotechnology Contacts:
Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1 415 915 4228
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
GSK inquiries:
Media inquiries:
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