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 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.
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, Ph.D., 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 3 trial examining use of
sotrovimab for early treatment of mild-to-moderate COVID-19 in
high-risk, non-hospitalized adults. The trial met the primary
endpoint with a 79% reduction (adjusted relative risk reduction)
(p<0.001) in all-cause hospitalizations 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 pseudovirus 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 SotrovimabSotrovimab is
an investigational SARS-CoV-2 neutralizing 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
SotrovimabSotrovimab is authorized for emergency use in
the US and has been granted a marketing authorization in the EU,
conditional marketing authorization in Great Britain, provisional
marketing authorization in Australia, and conditional marketing
authorization in Saudi Arabia. It has also been approved via
Japan’s Special Approval for Emergency Pathway. Temporary
authorizations 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
StatesThe 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 UseThe 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
UseSotrovimab 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
CONTRAINDICATIONSSotrovimab is
contraindicated in patients who have a history of anaphylaxis to
sotrovimab or to any of the excipients in the formulation.
WARNINGS AND PRECAUTIONSThere
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 ReactionsSerious 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 AdministrationClinical 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‑19Benefit 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 EVENTSHypersensitivity
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
POPULATIONSPregnancyThere 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.
LactationThere 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
CollaborationIn 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-19GSK’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-19Vir
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 GSKGSK is a science-led
global healthcare company. For further information please visit
www.gsk.com/aboutus.
About Vir BiotechnologyVir
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 Cautionary Statement Regarding
Forward-Looking StatementsGSK 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
StatementsThis 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 US 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 RoadBrentford,
MiddlesexTW8 9GS
Vir Biotechnology Contacts:
Investors
Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1 415 915 4228
Media
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
GSK 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)
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