a8047u
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 December 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: 07 December 2021, London UK and San Francisco
US
Preclinical studies demonstrate sotrovimab retains
activity against the full combination of mutations in the spike
protein of the Omicron SARS-CoV-2 variant
● New preclinical findings generated through in
vitro testing of sotrovimab against the complete pseudo-virus,
updated to bioRxiv
● Data build on promising signal published last
week, underscoring the importance of sotrovimab for early treatment
of COVID-19
● Sotrovimab is authorised and
available for the treatment of early COVID-19 in the US and
multiple countries around the world
LONDON and SAN FRANCISCO, Dec. XX, 2021 - GlaxoSmithKline plc
(LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today
announced an update to preclinical data on
bioRxiv[1], a
preprint server, demonstrating that sotrovimab, an investigational
monoclonal antibody, retains in vitro activity against the full
known Omicron spike protein, the new SARS-CoV-2 variant
(B.1.1.529). The preclinical data was generated through
pseudo-virus testing of the combined known mutations of the Omicron
variant, which included the maximum number of changes (37
mutations) identified to date in the spike protein. These findings
build on the initial preclinical data generated through
pseudo-virus testing, provided last
week, showing sotrovimab
retained in vitro activity against key individual mutations of the
Omicron variant, including those found in the binding site of
sotrovimab. These data add to the growing body of preclinical
evidence demonstrating that sotrovimab retains activity against all
tested variants of concern.
George Scangos, PhD, Chief Executive Officer of Vir,
said: "Sotrovimab is the
first monoclonal antibody to report preclinical data demonstrating
activity against all tested SARS-CoV-2 variants of concern and
interest to date, including Omicron, as well as the still prevalent
and highly contagious Delta variant. Given the less than three-fold
neutralization shift demonstrated in the pre-clinical pseudo-virus
assay, which falls below the FDA authorized fact sheet guidance of
less than a 5-fold change, we are confident that sotrovimab will
continue to provide significant benefit for the early treatment of
patients hoping to avoid the most severe
consequences of COVID-19."
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK,
said: "From the outset of
our collaboration with Vir we hypothesized that sotrovimab would
have a high barrier to resistance and thus could deliver
best-in-class potential for the early treatment of patients with
COVID-19. These pre-clinical data demonstrate the potential for our
monoclonal antibody to be effective against the latest variant,
Omicron, plus all other variants of concern defined to date by the
WHO, and we look forward to discussing these results with
regulatory authorities around the world."
About sotrovimab
Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal
antibody. The antibody binds to an epitope on SARS-CoV-2 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,
Inc.'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.
Pre-clinical data, published in bioRxiv, demonstrate that
sotrovimab retains activity against all currently tested variants
of concern and interest of the SARS-CoV-2 virus as defined by WHO,
plus others, including but not limited to Delta (B.1.617.2), Delta
Plus (AY.1 or AY.2), Mu (B.1.621) and Omicron
(B.1.1.529).
About the sotrovimab clinical development program
● COMET-ICE:
a phase III, multi-centre, double-blind, placebo-controlled trial
investigated an intravenous (IV) infusion of sotrovimab in adults
with mild-to-moderate COVID-19 at high risk of progression to
severe disease, who are not hospitalised 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 hospitalisation 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 III, randomised, multi-centre, open-label, non-inferiority
trial of intramuscular (IM) versus IV administration of
sotrovimab for the early treatment of mild-to-moderate
COVID-19 in high-risk non-hospitalised adult and paediatric
patients (12 years of age and older). The trial's primary endpoint
was met, and headline data demonstrated that IM administered
sotrovimab was non-inferior and offered similar efficacy to IV
administration for high-risk populations. The companies plan
to submit the complete COMET-TAIL data set to a
peer-reviewed journal for publication in the first quarter of
2022.
● COMET-PEAK:
a phase II, randomised, multi-centre, 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 complete COMET-PEAK data set to a peer-reviewed
journal for publication in due course.
● GSK and Vir are also partnering to assess the use
of sotrovimab in uninfected immunocompromised adults to determine
whether sotrovimab can prevent symptomatic COVID-19 infection. GSK
and Vir support investigator-sponsored studies and foster
scientific collaborations with experienced investigators and
networks 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 occur in due
course.
About global access to sotrovimab
Sotrovimab is authorised for emergency use in the United
States. Xevudy (sotrovimab) received
a positive scientific
opinion under
Article 5(3) of Regulation 726/2004 from the Committee for Human
Medicinal Products in the EU, conditional marketing authorisation
by the UK Medicines and Healthcare Products Regulatory Agency,
provisional marketing authorisation in Australia, and conditional
marketing authorisation in Saudi Arabia. It has been approved via
the Special Approval for Emergency Pathway in Japan. Temporary
authorisations for sotrovimab have been granted in a dozen
countries.
GSK and Vir also recently submitted the Marketing Authorisation
Application to the European Medicines Agency
for Xevudy for the treatment of adults and adolescents
(aged 12 years and over and weighing at least 40kg) with
coronavirus disease 2019 (COVID-19) who do not require oxygen
supplementation and who are at risk of progressing to severe
COVID-19.
Sotrovimab is supplied in several countries worldwide, including
through national agreements in the United States, United Kingdom,
Japan, Australia, Canada, Singapore, Switzerland, and the United
Arab Emirates. The companies 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.
Sotrovimab in the United States
The following is a summary of information for sotrovimab.
Healthcare providers in the US should review the Fact Sheets for
information about the authorized use of sotrovimab and mandatory
requirements of the EUA. Please see the Food and Drug
Administration (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 US 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. 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:
●
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
CONTRAINDICATIONS
Sotrovimab is contraindicated in patients who have a history of
anaphylaxis to sotrovimab or to any of the excipients in the
formulation.
WARNINGS AND PRECAUTIONS
There 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
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,
arrhythmia (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
Hypersensitivity 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
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 GSK and Vir 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 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. We are working
with Sanofi SA, Medicago Inc. and SK bioscience Co., Ltd.
to develop adjuvanted, protein-based vaccine candidates,
and all are now in phase III 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 protecting
more people in need.
GSK is also working with mRNA specialist, CureVac NV, to
jointly develop next-generation, optimised 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-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. For further
information please visit www.gsk.com/aboutus.
About Vir Biotechnology
Vir 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.
Reference
1Cathcart
AL, Havenar-Daughton C, Lempp FA, et al. The dual function
monoclonal antibodies VIR-7831 and VIR-7832 demonstrate potent in
vitro and in vivo activity against
SARS-CoV-2. bioRxiv.
2021. Updated manuscript submitted and
online pre-print publication pending.
GSK inquiries:
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Media
inquiries:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Madeleine
Breckon
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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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Analyst/Investor
inquiries:
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Nick
Stone
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+44 (0)
7717 618834
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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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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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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:
Heather
Rowe Armstrong
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Cara
Miller
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VP,
Investor Relations
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VP,
Corporate Communications
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harmstrong@vir.bio
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cmiller@vir.bio
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+1
415 915 4228
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+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, GSK's Q3 Results 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 ability of sotrovimab to treat
and/or prevent COVID-19 either through IV or IM administration,
Vir's collaboration with GSK, plans to progress
regulatory submissions globally, including with the FDA regarding
the existing EUA for sotrovimab, planned discussions with other global regulatory
agencies, 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, including
Omicron. 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] Cathcart AL,
Havenar-Daughton C, Lempp FA, et al. The dual function monoclonal
antibodies VIR-7831 and VIR-7832 demonstrate potent in vitro and in
vivo activity against SARS-CoV-2. bioRxiv. 2021. Updated manuscript
submitted and online pre-print publication
pending.
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: December
07, 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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