a9654z
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of May 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 26 May 2021, London UK and San Francisco US
GSK and Vir Biotechnology announce sotrovimab (VIR-7831)
receives Emergency Use Authorization from the US FDA for
treatment of mild-to-moderate COVID-19 in high-risk adults and
paediatric patients
●
Treatment
with sotrovimab resulted in an 85% reduction in the risk of
hospitalisation or death in high-risk adult outpatients compared to
placebo, based on interim results from Phase 3 COMET-ICE
trial
●
In
vitro data indicate sotrovimab maintains activity against all known
variants of concern, including the variant from India
●
Sotrovimab
will be available for appropriate patients diagnosed with COVID-19
in the U.S. in the coming weeks
●
Discussions
with global regulators regarding authorisations in additional
countries continue to advance
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced the U.S. Food and Drug Administration
(FDA) granted an Emergency Use Authorization (EUA) for sotrovimab
(previously VIR-7831), an investigational
single-dose monoclonal antibody, for the treatment of
mild-to-moderate COVID-19 in adults and paediatric 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 hospitalisation
or death.
Adrienne E. Shapiro, M.D., Ph.D., an infectious disease
specialist at Fred Hutchinson Cancer Research Center and
investigator in the COMET-ICE trial, said: "Monoclonal antibodies
like sotrovimab are potentially one of our most effective
tools for fighting COVID-19. While preventive measures, including
vaccines, can reduce the total number of cases, sotrovimab is an
important treatment option for those who become ill with COVID-19
and are at high risk - allowing them to avoid hospitalisation or
worse."
George Scangos, Ph.D., Chief Executive Officer of Vir,
said: "Our distinctive
scientific approach has led to a single monoclonal antibody that,
based on an interim analysis, resulted in an 85% reduction in
all-cause hospitalisations or death, and has demonstrated, in
vitro, that it retains activity against all known variants of
concern, including the emerging variant from India. I believe that
sotrovimab is a critical new treatment option in the fight against
the current pandemic and potentially for future coronavirus
outbreaks, as well. At Vir, our aim is not only to deliver a
clinically effective therapy for COVID-19, but also to provide
effective therapy against SARS-CoV-2 variants and potential
pandemics of tomorrow."
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK,
said: "The fast pace of
COVID-19 vaccinations in the U.S. is encouraging, yet, despite
these aggressive efforts, there is still a need to help prevent
infected patients from developing complications. In just over a
year since starting our collaboration and in less than 10 months
since beginning clinical trials, we are delighted that, as of
today, the benefits of this unique monoclonal antibody will now be
available to patients in need."
Sotrovimab has been granted an EUA by the FDA to facilitate the
availability and use of this investigational monoclonal antibody
for the treatment of COVID-19 in the U.S. while the pandemic
remains a public health emergency. The FDA Fact Sheet for
Healthcare Providers regarding the emergency use of sotrovimab
reflects the recently updated definition of high risk for
COVID-19 to include additional medical conditions and factors
associated with increased risk for progression to severe
disease. The EUA for sotrovimab also includes
post-authorisation commitments as specified in the Letter of
Authorization.
Sotrovimab is continuing to be studied in ongoing clinical trials.
An analysis of safety and efficacy data at day 29 for the full
population from the COMET-ICE trial is expected as early as the
first half of 2021. GSK and Vir plan to submit a Biologics License
Application (BLA) to the FDA in the second half of
2021.
Evidence of Sotrovimab's Profound Clinical Efficacy
The EUA was granted to sotrovimab based on an interim analysis of
efficacy and safety data from the Phase 3 COMET-ICE (COVID-19
Monoclonal antibody Efficacy Trial - Intent to Care Early) trial in
high-risk adult outpatients, which was stopped early by an
independent data monitoring committee in March 2021 due to evidence
of profound clinical efficacy. As previously announced, interim
study results demonstrated an 85% (p=0.002) reduction in
hospitalisation for more than 24 hours or death in those receiving
sotrovimab compared to placebo, the primary endpoint of the trial.
The most common adverse events observed in the sotrovimab treatment
group in COMET-ICE were rash (2%) and diarrhoea (1%), 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. The EUA includes a warning for
hypersensitivity including anaphylaxis and infusion-related
reactions.
In Vitro Data Indicate Sotrovimab Maintains Activity Against All
Known Variants of Concern
Sotrovimab targets a conserved epitope of the spike protein that is
less likely to mutate over time. The EUA submission also included
data from published in vitro studies, which demonstrated that
sotrovimab maintains activity against all known circulating
variants of concern, including the variants from Brazil (P.1),
California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526),
South Africa (B.1.351) and the UK (B.1.1.7). GSK and Vir will
continue to evaluate the ability of sotrovimab to maintain activity
against new and emerging variants. The clinical impact of these in
vitro variant data is not yet known. Data collection and analysis
is still ongoing.
GSK and Vir's Commitment to Patient Access to
Sotrovimab
GSK and Vir are working to make sotrovimab available to U.S.
patients in the coming weeks with the intent that all appropriate
patients will have access to it, with little to no out-of-pocket
costs. Patients and healthcare professionals can access more
information about eligibility, availability and financial support
at gskcovidcontactcenter.com or
by calling 866-GSK-COVID (866-475-2684).
GSK and Vir are actively working with government agencies around
the world to make sotrovimab available to patients in need of
treatment.
●
On 21 May 2021, the European Medicines Agency's (EMA) Committee for
Human Medicinal Products (CHMP) issued a positive scientific
opinion following the referral of sotrovimab to the CHMP under
Article 5(3) of Regulation 726/2004. The opinion relates to the use
of sotrovimab for the treatment of adults and adolescents (aged 12
years and over and weighing at least 40 kg) with COVID-19 who do
not require oxygen supplementation and who are at risk of
progressing to severe COVID-19.
●
The
EMA has also started a rolling review of data on sotrovimab that
will continue until enough evidence is available to support the
filing of a formal marketing authorisation
application.
●
In
April, Health Canada initiated a review of sotrovimab under the
expedited Interim Order application pathway for COVID-19
drugs.
●
GSK and
Vir are continuing
discussions with other global regulators on the regulatory
pathways available so that sotrovimab can be made
available to patients with COVID-19 as soon as
possible.
About the COMET-ICE Study Design
The multi-center, double-blind, placebo-controlled, Phase 3
COMET-ICE trial investigated intravenous (IV) infusion of
sotrovimab in adults with mild or moderate COVID-19 at high risk of
progression to severe disease.
This ongoing trial evaluated the safety and efficacy of a single IV
infusion of sotrovimab (500 mg) or placebo in non-hospitalised
participants globally. The safety of sotrovimab is primarily
based on an interim analysis from 868 patients (430 patients in the
treatment arm and 438 in the placebo arm) through day 15. Among
those studied, 63% were Hispanic or Latino and 7% were Black or
African American. According to the Centers for Disease Control
and Prevention, these populations are approximately three times
more likely to be hospitalised and approximately two times more
likely to die of COVID-19[1]. The
primary efficacy endpoint was the proportion of patients who have
progression of COVID-19 as defined by the need for hospitalisation
for greater than 24 hours for acute management of illness or
death.
In March 2021, an Independent Data Monitoring Committee recommended
that the COMET-ICE trial be stopped for enrolment due to evidence
of profound efficacy.
About the Sotrovimab Clinical Development Program
In addition to the COMET-ICE trial, the full COMET clinical
development program for sotrovimab includes:
●
COMET-PEAK:
An ongoing Phase 2 trial with two parts: to compare the safety and
viral kinetics of 500 mg intramuscularly (IM)
administered sotrovimab to 500 mg
intravenously administered sotrovimab among low-risk
adults with mild to moderate COVID-19 and to evaluate the
similarity in pharmacokinetics between sotrovimab manufactured by
different processes
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COMET-TAIL:
A Phase 3 trial expected to begin in the second quarter of 2021 as
an early treatment for COVID-19 in high-risk adults, to
assess whether IM-administered sotrovimab can reduce
hospitalisation or death due to COVID-19
●
COMET-STAR:
A Phase 3 trial expected to begin in the second half of 2021 in
uninfected adults at high risk to determine whether
IM-administered sotrovimab can prevent
symptomatic infection.
Sotrovimab was also evaluated in the outpatient setting in BLAZE-4,
a Phase 2 trial sponsored by Eli Lilly and Company, designed to
assess the safety and efficacy of bamlanivimab (LY-CoV555) alone
and bamlanivimab with other neutralising antibodies, including
sotrovimab, versus placebo in low-risk adults with mild to moderate
COVID-19. An interim analysis found that bamlanivimab (700 mg)
co-administered with sotrovimab (500 mg)
demonstrated a 70% relative reduction in patients with persistently
high viral load at day 7 compared to placebo, meeting the primary
endpoint.
Additionally, sotrovimab, along with
VIR-7832 is being evaluated in the Phase 1b/2a National
Health Service-supported AGILE trial in adults with mild to
moderate COVID-19. VIR-7832 is the second monoclonal antibody from
the Vir-GSK collaboration to be investigated as a potential
COVID-19 treatment.
About Sotrovimab (previously VIR-7831)
Sotrovimab is an
investigational SARS-CoV-2 monoclonal antibody. Preclinical data
suggest it has the potential to both block viral entry into healthy
cells and clear infected cells. 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, also has 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 VIR-7832 / GSK4182137
VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal
antibody. Preclinical data suggest it has the potential to both
block viral entry into healthy cells and an enhanced ability to
clear infected cells. 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. VIR-7832, which
incorporates Xencor's Xtend and other Fc technologies, has 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. Importantly, VIR-7832 also has been
engineered to potentially enhance virus-specific T cell function,
which could help treat and/or prevent COVID-19
infection.
The following is a summary of information for sotrovimab.
Healthcare providers should review the Fact Sheets for information
on the authorized use of sotrovimab and mandatory requirements of
the EUA. Please see the FDA Letter of
Authorization, Fact Sheet for
Healthcare Providers,
and Fact Sheet for
Patients, Parents, and Caregivers.
Important Information about Sotrovimab
Sotrovimab has been authorized by the 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 Use
The 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 Use
●
Sotrovimab
is not authorized for use in patients:
o
who
are hospitalized due to COVID-19, OR
o
who
require oxygen therapy due to COVID-19, OR
o
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 for Sotrovimab
Warnings
There are limited clinical data available
for sotrovimab. Serious and unexpected adverse events may
occur that have not been previously reported with use
of sotrovimab.
Hypersensitivity Including Anaphylaxis and Infusion-Related
Reactions
Serious 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 (e.g., 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 (e.g.,
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
Administration
Clinical 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, arrythmia (e.g., 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-19
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. 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 Events
The most common treatment-emergent adverse events observed in the
sotrovimab treatment group in COMET-ICE were rash (2%) and diarrhea
(1%), 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
Pregnancy
There 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.
Lactation
There 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 Collaboration
In 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-19
GSK's response to COVID-19 has been one of the broadest in the
industry, with three potential treatments in addition to our
vaccine candidates in development with partner
organisations.
GSK is collaborating with several organisations on COVID-19
vaccines by providing access to our adjuvant technology. In
addition to our work with Medicago, we recently announced positive
Phase 2 data from our collaboration with Sanofi to develop an
adjuvanted, protein-based vaccine candidate and expect to begin a
Phase 3 trial in Q2. An earlier stage collaboration with SK
Bioscience is also ongoing. SK Bioscience receives funding from
CEPI and the Bill and Melinda Gates Foundation to develop
differentiated, affordable COVID-19 vaccines for supply globally
through the COVAX facility. 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 protecting more people. Based on
experience with other adjuvanted vaccines, there is potential for
increased cross protection against COVID-19 variants which will be
further studied.
GSK is also working with mRNA specialist, CureVac, to jointly
develop next generation, multi-valent mRNA vaccines for COVID-19
with the potential to address multiple emerging variants in one
vaccine. GSK will also support manufacturing of up to 100m doses of
CureVac's first generation COVID-19 vaccine. GSK is also providing
manufacturing support for up to 60m doses of Novavax' COVID-19
vaccine in the UK.
GSK is also exploring potential therapeutic or treatment options
for COVID-19 patients. We are collaborating with Vir Biotechnology
to develop existing and identify new anti-viral antibodies that
could be used as therapeutic or preventive options for COVID-19. We
recently reported that an Independent Data Monitoring Committee
recommended that the Phase 3 COMET-ICE trial
evaluating sotrovimab as monotherapy
for the early treatment of COVID-19 in adults at high risk of
hospitalisation be stopped for enrolment due to evidence of
profound efficacy, based on an interim analysis of data from the
trial. We have received Emergency Use Authorization in the U.S. and
are seeking authorisations in other countries. We are also
assessing whether an investigational monoclonal antibody, otilimab,
can help severely ill COVID-19 patients aged over 70 who experience
an overreaction of their immune system.
Vir's Commitment to COVID-19
Vir 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 GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us.
About Vir Biotechnology
Vir Biotechnology is a clinical-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 enquiries:
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Media
enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Analyst/Investor
enquiries:
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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Vir Biotechnology Contacts:
Neera Ravindran, MD
VP, Head of Investor Relations & Strategic
Communications
nravindran@vir.bio
+1 415 506 5256
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
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GSK
Cautionary Statement Regarding Forward-Looking
Statements
GSK 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 and any impacts of the COVID-19
pandemic.
Vir Forward-Looking Statements
This 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 timing and availability of sotrovimab to
providers and patients, the timing and availability of clinical
data, program updates and data disclosures related to sotrovimab,
the ability of sotrovimab and VIR-7832 to treat and/or prevent
COVID-19, the potential of sotrovimab in the hospitalized
population, the ability of sotrovimab to neutralize the SARS-CoV-2
live virus, the ability of sotrovimab to maintain activity against
all known variants of concern, including the variant from India,
and other potential pandemics, statements related to the planned
full analysis of the COMET-ICE trial, and statements related to
regulatory authorizations and approvals, including plans and
discussions with the FDA, EMA and other global regulators. 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.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
[1] Data
source: U.S. Centers for Disease Control and Prevention: Risk for
COVID-19 Infection, Hospitalization, and Death By
Race/Ethnicity(https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html).
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: May
27, 2021
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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