a1017y
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 January 2022
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: 11 January 2022, London UK and San Francisco,
US
GSK and Vir Biotechnology announce United States government
agreement to purchase additional supply of sotrovimab, authorised
for the early treatment of COVID-19
●
600,000 additional doses to be
supplied to the US Government for distribution in Q1 2022, enabling
further access to sotrovimab nationwide
●
Brings total number of doses
secured to date through binding agreements to approximately 1.7
million globally
●
Preclinical data generated
through both pseudo-virus and live virus testing demonstrate
sotrovimab retains activity against all tested SARS-CoV-2 variants
of concern including Delta and Omicron
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today
announced that the US Government will purchase an additional
600,000 doses of sotrovimab, an investigational monoclonal antibody
for the early treatment of COVID-19, enabling further nationwide
access to sotrovimab for patients. The additional 600,000 doses
will be delivered throughout the first quarter of 2022. This
agreement is an amendment to earlier commitments announced with the
US Government in November 2021.
Including the commitments announced today, GSK and Vir have
received binding agreements for the sale of approximately 1.7
million doses of sotrovimab worldwide. In addition, today's
agreement also includes the option for the US government to
purchase further additional doses in the second quarter of
2022.
Sotrovimab, which was granted Emergency Use Authorization
(EUA) by the US Food and Drug Administration (FDA) in May
2021, is an 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 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.
GSK and Vir expect to manufacture approximately 2 million doses
globally in the first half of 2022 and additional doses in the
second half of the year.
Maya Martinez-Davis, President, US Pharmaceuticals, GSK,
said: "We are proud to
continue to work with the US government to bring sotrovimab to
patients who need it, especially as the Omicron variant continues
to grow in prevalence across the country. We understand the
role we can play in supporting the ongoing pandemic response, and
our teams are working with urgency to explore options to expand our
supply capacity so we can support more patients in
2022."
George Scangos, PhD, chief executive officer of Vir,
said: "As the Omicron
variant continues its rapid spread alongside the still prevalent
Delta variant, we are pleased to once again work with the US
government to provide more access to sotrovimab for people in the
US at high risk of progression to severe COVID-19. Data from
multiple pseudo-virus and live virus preclinical studies, generated
by industry and academia, continue to demonstrate that sotrovimab
retains activity against all tested variants of concern and
interest. We are proud of our ongoing contributions to the fight
against the COVID-19 pandemic here in the US and around the
world."
The Biomedical Advanced Research and Development Authority (BARDA),
part of the Department of Health and Human Services (HHS) Office of
the Assistant Secretary for Preparedness and Response (ASPR),
collaborated with the Department of Defense Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND) and Army Contracting Command to purchase contract
numbers W58P0521C0008 and W58P0522C0002.
In June 2021, GSK and Vir announced confirmatory full results for
the COMET-ICE Phase III trial examining use of sotrovimab for early
treatment of mild-to-moderate COVID-19 in high-risk,
non-hospitalised adults. The trial met the primary endpoint with
a 79% reduction (adjusted relative risk reduction)
(p<0.001) in all-cause hospitalisations for more than 24 hours
or death due to any cause by Day 29 compared to placebo. In
absolute numbers, 30 (6%) of the 529 patients in the placebo arm
progressed, compared to six (1%) of the 528 patients receiving
sotrovimab. In clinical trials conducted to date, sotrovimab
has been well-tolerated. The most common adverse reactions are
hypersensitivity and infusion-related reactions, seen in
approximately 2% and 1% of cases, respectively.
GSK and Vir are committed to the 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.
Preclinical pseudo-virus data, published in bioRxiv, demonstrate
that sotrovimab retains activity against all tested variants of
concern and interest of the SARS-CoV-2 virus as defined by the
World Health Organization, including, but not limited to, Omicron
(B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu
(B.1.621). Preclinical live virus testing has also been completed
with data, recently published in bioRxiv, further demonstrating
that sotrovimab retains activity against the Omicron
variant.
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.
About global access to sotrovimab
Sotrovimab is authorised for emergency use in the US and has been
granted a marketing authorisation in the EU, conditional marketing
authorisation in Great Britain, provisional marketing authorisation
in Australia, and conditional marketing authorisation in Saudi
Arabia. It has also been approved via Japan's Special Approval for
Emergency Pathway. Temporary authorisations for sotrovimab have
also been granted in 12 other countries.
Sotrovimab is supplied in several countries worldwide, including
through national agreements in the US, UK, Japan, Australia,
Canada, Singapore, Switzerland, and the United Arab Emirates. The
companies are also supplying sotrovimab to participating Member
States of the EU through a Joint Procurement Agreement with the
European Commission. Additional agreements are yet to be disclosed
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 US FDA has issued an 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 40kg) 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 COVID19. SARS-CoV-2 monoclonal
antibodies may be associated with worse clinical outcomes when
administered to hospitalized patients with COVID19 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 (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
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 (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-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, GSK and Vir 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 the Company's
vaccine candidates in development with partner
organisations.
GSK is collaborating with several organisations on COVID-19
vaccines by providing access to its adjuvant
technology. The Company is
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.
GSK inquiries:
|
|
|
|
Media inquiries:
|
Tim Foley
|
+44 (0) 20 8047 5502
|
(London)
|
|
Madeleine Breckon
|
+44 (0) 20 8047 5502
|
(London)
|
|
Kristen Neese
|
+1 804 217 8147
|
(Philadelphia)
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington DC)
|
|
|
|
|
Analyst/Investor inquiries:
|
Nick Stone
|
+44 (0) 7717 618834
|
(London)
|
|
Sonya Ghobrial
|
+44 (0) 7392 784784
|
(Consumer)
|
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
Josh Williams
|
+44 (0) 7385 415719
|
(London)
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
Frannie DeFranco
|
+1 215 751 4855
|
(Philadelphia)
|
Vir Biotechnology Contacts:
Heather Rowe
Armstrong
Cara Miller
VP, Investor Relations
VP, Corporate Communications
harmstrong@vir.bio
cmiller@vir.bio
+1 415 915
4228
+1 415 941 6746
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 2021 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, the timing and expected number of therapeutic doses
that Vir will be able to supply to patients, whether or not
the US government will exercise their option, and the ability
of sotrovimab to maintain activity against circulating variants of
concern and interest, including Delta and 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
###
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.
|
GlaxoSmithKline plc
|
|
(Registrant)
|
|
|
Date: January
11, 2022
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
Victoria Whyte
|
|
Authorised
Signatory for and on
|
|
behalf
of GlaxoSmithKline plc
|