REG - GlaxoSmithKline PLC - US Govt buys additional 600,000 sotrovimab doses

GSKAnnouncement

11/01/2022 12:10

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220111:nRSK1013Ya&default-theme=true

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™ 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
(https://www.sotrovimab.com/content/dam/cf-pharma/hcp-sotrovimab-phase2/en_US/sotrovimab-fda-letter-of-authorization.pdf)
, full Fact Sheet for Healthcare Providers
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Sotrovimab/pdf/SOTROVIMAB-EUA.PDF#nameddest=HCPFS)
and full Fact Sheet for Patients, Parents, and Caregivers
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Sotrovimab/pdf/SOTROVIMAB-PATIENT-FACT-SHEET.PDF)
.

 

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 (https://www.gsk.com/en-gb/about-us/) .

 

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 (http://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

 

###

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCGZGMMZMVGZZM