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: 21 May 2021, London UK
EMA issues positive scientific opinion on GSK and Vir
Biotechnology's sotrovimab for the early treatment of
COVID-19
●
Opinion
based on the EMA's Committee for Human Medicinal Products (CHMP)
review of available data on sotrovimab (previously VIR-7831) for
the early treatment of COVID-19.
●
EU member states can use the CHMP positive scientific opinion when
making national decisions about the early use of sotrovimab prior
to EMA marketing authorisation.
●
Discussions
with global regulators regarding authorisations in additional
countries continue to advance.
GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced
that the European Medicines Agency's (EMA) Committee for Human
Medicinal Products (CHMP) has 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 CHMP opinion under Article 5(3) can now be considered by the
national authorities in EU member states when taking evidence-based
decisions on the early use of the medicine prior to marketing
authorisation.
Christopher Corsico, Senior Vice President, Development, GSK,
said: "As the COVID-19 pandemic
continues and the virus generates new variants of concern,
including those that recently emerged in India, the need for
therapies that can slow the progression of disease in patients who
are at high risk for developing severe complications remains a top
priority. Monoclonal antibody treatments are a critical part of a
comprehensive solution to COVID-19, especially as less than 40% of
adults across EU member states have received at least one dose of a
vaccine to date[1].
We are encouraged by this positive scientific opinion from the EMA,
as it hopefully brings us closer to making sotrovimab available for
patients across Europe."
George Scangos, Ph.D., chief executive officer of Vir,
said: "Today's opinion is great
news for patients across Europe, as EU member states are now more
easily able to move forward with their own temporary authorisations
for sotrovimab. Based on our most recent in vitro
data, sotrovimab continues to combat COVID-19 as it evolves and has
retained activity against all circulating variants of
concern. We look forward to continuing to work with regulators
around the world to make sotrovimab available to more patients in
need and help bring an end to the pandemic."
The CHMP reached its opinion following a review of data including
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, which evaluated sotrovimab as monotherapy for
the early treatment of COVID-19 in adults at high risk of
hospitalisation. Efficacy results of the interim analysis, based on
data from 583 randomised patients, demonstrated an 85% (p=0.002)
reduction in hospitalisation or death in those receiving sotrovimab
compared to placebo, the primary endpoint of the trial. As a
result, the Independent Data Monitoring Committee recommended that
the trial be stopped for enrolment due to evidence of profound
efficacy. The CHMP also considered data on the medicine's quality
and safety.
The CHMP also reviewed data from several in vitro studies which
demonstrated that sotrovimab maintains activity against multiple
circulating variants of concern, including the variants from Brazil
(P.1), California (B.1.427/B.1.429), South Africa (B.1.351) and the
UK (B.1.1.7), based on in vitro data from live virus and
pseudotyped virus assays. Additional in vitro data demonstrating
activity against variants from New York (B.1.526) and India
(B.1.617) were also recently published by bioRxiv. The
clinical impact of these variants is not yet known. Sotrovimab
targets a conserved epitope of the spike protein which is less
likely to mutate over time. Data collection and analysis is
still ongoing.
The CHMP's review took place in parallel to the EMA's ongoing
rolling review process, which is used to speed up the formal
marketing application assessment of a promising medicine during a
public health emergency. The rolling review will continue
until enough evidence is
available to support a formal Marketing Authorisation
Application.
An Emergency Use Authorization (EUA) application for sotrovimab has
been submitted to the US Food and Drug Administration (FDA) and it
is also under review by other global regulators including Health
Canada under the expedited Interim Order application pathway for
COVID-19 drugs.
Sotrovimab is an investigational compound and has not been granted
a marketing authorisation anywhere in the world.
About the COMET-ICE Study Design
The multi-centre, 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-hospitalized
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 29. Among
those studied, 63% were Hispanic or Latino and 7% were Black or
African American. According to the US Centers for Disease
Control and Prevention, these populations are approximately three
times more likely to be hospitalized and approximately two times
more likely to die[2] of
COVID-19. The primary efficacy endpoint was the proportion of
patients who have progression of COVID-19 as defined by the need
for hospitalisation for at least 24 hours or death within 29 days
of randomisation.
The only event to occur with a frequency of greater than 1% in the
sotrovimab arm was diarrhoea (less than 1% in placebo group). All
other adverse events with a frequency of greater than 1% occurred
in the placebo arm. No other treatment-emergent adverse events were
reported at a higher rate with sotrovimab compared to
placebo. Sotrovimab's safety and
efficacy is continuing to be studied in ongoing clinical trials
with analysis of safety and efficacy data at Day 29 for the full
population from COMET-ICE expected as early as the first half of
2021.
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
●
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 third quarter 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 neutralizing 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 of 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 (GSK4182137) 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 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.
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.
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 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.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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
+1 415 506 5256
Cara Miller
VP, Corporate Communications
+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, including arrangements with commercial
payers, the timing of 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 variants of concern,
including the Indian variant, and other potential pandemics, and
statements related to regulatory authorizations and approvals,
including plans and discussions with global regulators in
additional countries. 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] European Centre for Disease
Prevention and Control. COVID-19 Vaccine Tracker: European Centre
for Disease Prevention and Control.
www.vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab.
18 May 2021.
[2] Data
source: Centers for Disease Control and Prevent: 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
21, 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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