TIDMGSK
RNS Number : 1013Y
GlaxoSmithKline PLC
11 January 2022
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(TM) 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 (London)
5502
Madeleine Breckon +44 (0) 20 8047 (London)
5502
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 (London)
2406
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
###
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCGZGMMZMVGZZM
(END) Dow Jones Newswires
January 11, 2022 07:08 ET (12:08 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2023 to Apr 2024