GSK GlaxoSmithKline PLC

44.15
-0.22  -1%
Previous Close 44.37
Open 44.49
52 Week Low 33.53
52 Week High 46.855
Market Cap $111,077,186,059
Shares 2,515,904,554
Float 2,506,758,779
Enterprise Value $140,067,977,152
Volume 4,039,838
Av. Daily Volume 4,159,106
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Upcoming Catalysts

Drug Stage Catalyst Date
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-PEAK)
COVID-19
Phase 2
Phase 2
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COVID-19 (Medicago) vaccine
COVID-19 vaccine
Phase 3
Phase 3
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VIR-7832 (AGILE)
COVID-19 vaccine/therapeutic
Phase 2
Phase 2
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Gepotidacin (EAGLE)
Uncomplicated urinary tract infection (uUTI)
Phase 3
Phase 3
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BLENREP (belantamab mafodotin) and KEYTRUDA (Pembrolizumab) -DREAMM-4
Multiple Myeloma
Phase 2
Phase 2
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JEMPERLI (Dostarlimab) -(RUBY)
Endometrial Cancer
Phase 3
Phase 3
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VOCABRIA (cabotegravir) - (HPTN 083)
HIV
PDUFA priority review
PDUFA priority review
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BLENREP (belantamab mafodotin) - (DREAMM-3)
Multiple Myeloma
Phase 3
Phase 3
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Otilimab (MOR103/GSK3196165) - (ContRAst)
Rheumatoid Arthritis
Phase 3
Phase 3
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BLENREP (belantamab mafodotin) and POMALYST (Pomalidomide) and Dexamethasone - (DREAMM-8)
Multiple Myeloma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
LYL132
Solid Tumors
Phase 1
Phase 1
IND cleared by FDA, noted January 24, 2022.
Ensovibep (VIR-7831 / GSK4182136) - (ACTIV-3)
Mild to moderate COVID-19
Phase 3
Phase 3
Independent Data and Safety Monitoring Board (DSMB) recommended that enrollment to be closed - raised concerns about the magnitude of potential benefit. November DSMB meeting resulted in an assessment that the trial has not met the thresholds required to continue enrollment of adults with COVID-19 in the hospitalized setting, noted November 16, 2021.
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-TAIL)
COVID-19
Phase 3
Phase 3
Phase 3 data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations, noted November 12, 2021. EUA application submitted, noted January 13, 2022.
VAT0002 (booster)
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 trial initiation announced May 27, 2021. Phase 3 data reported that the vaccine is well tolerated, with a safety profile similar to currently approved COVID-19 vaccines, noted December 15, 2021.
BLENREP (belantamab mafodotin) - (DREAMM 5)
Multiple Myeloma
Phase 3
Phase 3
Phase 3 trial initiated expansion cohort, noted October 27, 2021.
Apretude
HIV
Approved
Approved
Approved December 21, 2021.
ARO-HSD (AROHSD1001)
Non-alcoholic Steatohepatitis (NASH)
Phase 1/2
Phase 1/2
Phase 1 data showed a dose-dependent pharmacodynamic effect was observed in all patients. At 200 mg, all patients showed more than 90% mRNA reductions. Patients (9/18) had liver fat reductions on MRI-PDFF of 4-41% and (6/18) had reduction in liver stiffness (kPa) on FibroScan of 4-37%. The dose was well-tolerated with no adverse events related to the drug, noted November 12, 2021.
CABENUVA (Cabotegravir + rilpivirine) - ATLAS2M
HIV
sNDA Filing
sNDA Filing
sNDA filing announced February 24, 2021.
Bintrafusp alfa
Non-small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial unlikely to meet primary endpoint - to be discontinued.
DUVROQ (Daprodustat) - ASCEND
Anaemia in chronic kidney disease
Phase 3
Phase 3
Phase 3 study demonstrated primary efficacy and safety results confirm the potential dose to be a new oral treatment for patients with anaemia due to chronic kidney disease (CKD) in both non-dialysis and dialysis settings, noted November 5, 2021.
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine
Phase 2/3
Phase 2/3
Phase 2/3 interim analysis showed primary and secondary endpoints met. 100% efficacy against severe COVID-19 & hospitalization and 84% efficacy against moderate-to-severe COVID-19 , and 79% efficacy against COVID-19 of any severity caused by the Delta variant, noted September 22, 2021.
ZEJULA (Niraparib) and JEMPERLI (dostarlimab) - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
Phase 2 trial no longer in development, July 28, 2021.
CV2CoV
Covid-19 Vaccine
Phase 1
Phase 1
Clinical development expected to commence in the next months, with regulatory approval for market readiness expected 2022, noted October 12, 2021.
Bamlanivimab (LY-CoV555) and Sotrovimab (VIR-7831 / GSK4182136) - BLAZE-4
COVID-19 antibody
Phase 2
Phase 2
Phase 2 data released March 29, 2021 - 70 percent (p<0.001) relative reduction in persistently high viral load.
JEMPERLI (Dostarlimab)
Mismatch repair deficient (dMMR) solid tumors
Approved
Approved
FDA Approval announced August 17, 2021.
NUCALA (Mepolizumab)
Chronic rhinosinusitis with nasal polyps
Approved
Approved
FDA approval announced July 29, 2021.
Sotrovimab (VIR-7831 / GSK4182136) - (COMET-ICE)
COVID-19 antibody
Approved
Approved
FDA Emergency Use Authorization filing approval announced May 26, 2021.
BLENREP (belantamab mafodotin)
Multiple myeloma
Approved
Approved
FDA approval granted August 5, 2020.
FLUARIX QUADRIVALENT
Influenza A - children 6-35 months of age.
Approved
Approved
Approval announced January 11, 2018.
DOVATO (Dolutegravir + lamivudine)
HIV
Approved
Approved
FDA approval announced August 6, 2020.
DOVATO (Dolutegravir and lamivudine)
HIV
Approved
Approved
FDA approval announced April 8, 2019.
JULUCA (dolutegravir and rilpivirine)
HIV
Approved
Approved
FDA approval announced January 21, 2021.
JULUCA (dolutegravir and rilpivirine)
HIV
Approved
Approved
Approval announced November 21, 2017.
KRINTAFEL (Tafenoquine)
Malaria
Approved
Approved
FDA Approval announced July 23, 2018.
TRELEGY ELLIPTA
Asthma
Approved
Approved
FDA approval announced September 9, 2020.
TRELEGY ELLIPTA (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
Approval announced September 18, 2017.
RUKOBIA (Fostemsavir)
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
VARUBI (Rolapitant)
Prevention of chemotherapy induced nausea and vomiting, or CINV
Approved
Approved
Approved September 2, 2015.
VARUBI (Rolapitant) - intravenous
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
CRL January 11 2017. FDA Approval announced October 25, 2017 following resubmission.
VARUBI (Rolapitant)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
Approved September 2, 2015.
ZEJULA (Niraparib)
Ovarian cancer
Approved
Approved
FDA Approval announced October 23, 2019.
ZEJULA (Niraparib)
Cancer - ovarian
Approved
Approved
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
ZEJULA (Niraparib)
Ovarian cancer
Approved
Approved
FDA Approval announced April 29, 2020.
NUCALA (Mepolizumab)
Severe eosinophilic asthma (6-11 yrs)
Approved
Approved
FDA approval announced September 12, 2019.
NUCALA (Mepolizumab)
Severe hypereosinophilic syndrome (HES)
Approved
Approved
FDA approval announced September 25, 2020.
NUCALA (Mepolizumab)
Severe eosinophilic asthma - pediatric
Approved
Approved
FDA Approval announced June 6, 2019.
SHINGRIX
Shingles
Approved
Approved
Approval announced October 20, 2017.
BENLYSTA (belimumab)
Lupus Nephritis
Approved
Approved
FDA approval announced December 17, 2020.
NUCALA (Mepolizumab)
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
CRL
CRL
Advisory Committee July 25, 2018 voted 3-16 against recommending approval. CRL issued September 7, 2018.
NUCALA (Mepolizumab)
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Approved
Approved
Approval announced December 12, 2017.
BENLYSTA (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
Approved
Approved
Approval announced July 21, 2017.
JEMPERLI (Dostarlimab)
dMMR endometrial cancer
Approved
Approved
FDA approval announced April 22, 2021.
GSK3359609 and KEYTRUDA (pembrolizumab) - (INDUCE-4)
Head and Neck Squamous Cell Carcinoma
Phase 2
Phase 2
Phase 2 trial to be discontinued - April 14, 2021.

Latest News

  1. Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced that the exclusive license agreement between Arrowhead and GlaxoSmithKline (NYSE:GSK) announced on November 22, 2021, has now closed. Closing of the transaction was subject to customary closing conditions and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

    Safe Harbor Statement under the Private Securities Litigation Reform Act:

    This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting

    Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced that the exclusive license agreement between Arrowhead and GlaxoSmithKline (NYSE:GSK) announced on November 22, 2021, has now closed. Closing of the transaction was subject to customary closing conditions and expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

    Safe Harbor Statement under the Private Securities Litigation Reform Act:

    This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate," or "continue" are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

    Source: Arrowhead Pharmaceuticals, Inc.

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    • The pandemic continues to negatively impact routine immunizations in the United States
    • Cumulatively, from January 2020–July 2021, teens and adults may have missed an estimated 37.1 million doses of recommended vaccines compared to 2019

    Centers for Disease Control and Prevention (CDC)-recommended vaccinations for teens and adults continued to lag in 2020 and into the summer of 2021, according to a follow-up claims analysis commissioned by GSK and conducted by Avalere Health, an Inovalon company. This assessment follows two previous reports tracking the pandemic's significant effect on routine vaccination.

    Key findings include:

    • From January 2020-July 2021, monthly vaccine claims decreased on average 32% for adults and 36% for adolescents
    • The pandemic continues to negatively impact routine immunizations in the United States
    • Cumulatively, from January 2020–July 2021, teens and adults may have missed an estimated 37.1 million doses of recommended vaccines compared to 2019

    Centers for Disease Control and Prevention (CDC)-recommended vaccinations for teens and adults continued to lag in 2020 and into the summer of 2021, according to a follow-up claims analysis commissioned by GSK and conducted by Avalere Health, an Inovalon company. This assessment follows two previous reports tracking the pandemic's significant effect on routine vaccination.

    Key findings include:

    • From January 2020-July 2021, monthly vaccine claims decreased on average 32% for adults and 36% for adolescents when compared to the same months in 2019.
    • Cumulatively, adults and teens may have missed an estimated 37.1 million doses of recommended vaccines compared to 2019.

    "It's very concerning to continue to see millions of missed CDC-recommended vaccinations among both vulnerable age groups," said Barbara Howe, MD, Vice President and Director, Vaccines Medical and Clinical, US at GSK. "We know the ongoing pandemic presents challenges to important efforts to catch up and then exceed pre-pandemic vaccination levels, but we must not become complacent. Lower vaccination rates cannot become the norm, or we may find ourselves grappling with a number of public health crises for diseases that could have been prevented."

    The latest analysis was conducted as follow-up to a series of analyses in February and June 2021 that found persistent and sometimes steep declines in vaccination claims for CDC-recommended teen and adult vaccines since the start of the pandemic. The analysis compared claims for CDC-recommended vaccines across commercial, managed Medicaid, Medicare Advantage and Medicare fee-for-service Part B for December 2020–July 2021 compared to the same months in 2019.

    "In the US, the pandemic has elevated the value, impact and understanding of vaccines in helping to prevent disease and death, especially in the adult and older adult populations," said Judy Stewart, GSK Senior Vice President and Head of US Vaccines. "We must not lose sight of the longstanding recommendations for routine vaccines across all age groups that are often underutilized, leading to significant medical, economic and societal costs that could otherwise be prevented by timely vaccination."

    The CDC recommends vaccines to protect teens against certain types of meningitis and HPV, and adults against pneumonia, shingles, hepatitis A, and hepatitis B, among others. Diphtheria, tetanus, pertussis (Tdap) vaccine and an annual influenza shot are recommended for both teens and adults. In May of 2021, the CDC issued guidance that COVID-19 vaccines and other vaccines can be administered to people on the same day.

    Study Methodology

    The methodology employed is consistent with the previously reported analysis. Avalere analyzed changes in administration of ACIP-recommended adult (≥19 years of age) and adolescent (7-18 years of age) vaccines using pre-adjudicated medical benefit Medicare fee-for-service (FFS) claims and the Inovalon MORE2 Registry®, a large scale, real-world dataset consisting of medical, pharmacy, and lab claims and clinical data on more than 338 million de-identified patients.

    Specifically, vaccines were identified using Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) for vaccine products, general vaccine administration HCPCS codes and National Drug Codes (NDCs) when product codes were not available. Avalere compared vaccine claims in 2020 and 2021 to vaccine claims in 2019 to identify the potential impact of the COVID-19 pandemic on vaccine administration.

    Claims for nearly all vaccines covered in this analysis are observed in the Medicare Part B data. While Part D claims were not included in the analysis of FFS Medicare claims, some claims for Part D vaccines that were administered in the provider setting may have been captured. Due to variability across states in billing requirements for vaccines provided through the Vaccines for Children program, this analysis may not fully capture teen vaccine utilization in the Managed Medicaid market.

    To estimate missed doses at a national level, Avalere used a market-specific, rate-based methodology to extrapolate the number of vaccine claims to the national population. The 2019 claims-based vaccination rate applied to the national sample was considered the baseline for vaccination volumes, and missed doses were estimated as a difference between the baseline and the 2020 and 2021 claims-based rate applied to the 2020 and 2021 national population estimates.

    About GSK

    GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.

    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 Q3 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

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  2. – If authorized, would provide the option for intramuscular administration of sotrovimab, in addition to currently authorized intravenous administration –

    –  Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered  similar efficacy to intravenous administration for high-risk populations –

    PHILADELPHIA and SAN FRANCISCO, Jan. 13, 2022 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the submission of an application to the US Food and Drug Administration (FDA) requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab, an investigational monoclonal antibody for the early treatment of…

    – If authorized, would provide the option for intramuscular administration of sotrovimab, in addition to currently authorized intravenous administration –

    –  Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered  similar efficacy to intravenous administration for high-risk populations –

    PHILADELPHIA and SAN FRANCISCO, Jan. 13, 2022 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the submission of an application to the US Food and Drug Administration (FDA) requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, to include intramuscular (IM) administration. The EUA for sotrovimab was granted by the FDA in May 2021 as an investigational single-dose intravenous (IV) (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment of COVID-19, and the companies are requesting an expansion to the EUA to also include IM administration (500 mg).

    Under the current 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.

    This submission is based on the Phase 3, randomized, open-label, non-inferiority COMET-TAIL trial, which achieved its primary endpoint, demonstrating that 500mg IM administration of sotrovimab (n=376) was non-inferior and offered similar efficacy to 500 mg IV administration (n=378) for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents. Low rates of serious adverse events (≤1% in both arms) were observed in the headline data.

    About Sotrovimab

    Sotrovimab 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 the Sotrovimab Clinical Development Program

    • COMET-ICE: a Phase 3, multi-center, double-blind, placebo-controlled trial investigated IV infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalized and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalization for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. Interim data were published in The New England Journal of Medicine on October 27, 2021 and final data were pre-published on November 8, 2021 on medRxiv.



    • COMET-TAIL: an ongoing Phase 3, randomized, multi-center, open-label, non-inferiority trial of IM versus IV administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalized adult and pediatric patients (12 years of age and older). The trial's primary endpoint was met, and headline data demonstrated that 500mg IM-administered sotrovimab was non-inferior and offered similar efficacy to IV administration for high-risk populations. In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalization for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg). The adjusted difference between the IM and IV arms of the trial was 1.07% with a 95% confidence interval (CI) of -1.25% to 3.39%. The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial's primary endpoint. Low rates of serious adverse events (≤1% in both arms) were observed in the headline data. The trial originally included three arms: 500mg of sotrovimab given intravenously, and two intramuscular arms, consisting of 500mg and a low dose of 250mg. An independent safety monitoring committee recommended enrollment in the 250mg arm be discontinued after a greater number of hospitalizations in that arm was noted. The 500mg dose arms were recommended to continue with enrollment as planned. The companies plan to submit the complete COMET-TAIL data set to a peer-reviewed journal for publication in the first quarter of 2022.



    • COMET-PEAK: a Phase 2, randomized, multi-center, parallel group trial evaluating IV and IM administration of sotrovimab in outpatients with mild-to-moderate COVID-19. The companies plan to submit the full COMET-PEAK data set to a peer-reviewed journal for publication.



    • Additionally, GSK and Vir are partnering to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection. GSK and Vir are supporting investigator sponsored studies and fostering scientific collaborations with both experienced investigators and networks, who are involved in the continuum of care of immunocompromised patients, to understand the role sotrovimab for prophylaxis could play in this population. Discussions with regulatory authorities regarding the prophylaxis program will occur in due course.



    • Sotrovimab is also being studied by the University of Oxford among patients hospitalized with COVID-19 in the United Kingdom as part of the Randomized Evaluation of COVID-19 Therapy (RECOVERY) Trial.

    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 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 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 COVID-19 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 COVID19

    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 organizations.

    GSK is collaborating with several organizations 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 3 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, optimized 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 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, and the clinical development program for sotrovimab. 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 



    Vir Biotechnology Contacts:
    
    Investors
    Heather Rowe Armstrong
    VP, Investor Relations
    
    +1 415 915 4228
    
    Media
    Cara Miller
    VP, Corporate Communications
    
    +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)

    Primary Logo

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  3. 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

    LONDON and SAN FRANCISCO, Jan. 11, 2022 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (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…

    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

    LONDON and SAN FRANCISCO, Jan. 11, 2022 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (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 Sotrovimab

    Sotrovimab 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 Sotrovimab

    Sotrovimab 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 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 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

    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 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 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 Road

    Brentford, Middlesex

    TW8 9GS



    Vir Biotechnology Contacts:
    
    Investors
    Heather Rowe Armstrong                
    VP, Investor Relations                         
                             
    +1 415 915 4228                        
    
    Media
    Cara Miller
    VP, Corporate Communications
    
    +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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  4. 908 Devices (NASDAQ:MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biomolecular analysis, today announced that GlaxoSmithKline (NYSE:GSK) has purchased an additional REBEL™ cell culture media analyzer. GSK will now have a total of five REBEL analyzers being used by its biologics and vaccine process development teams.

    "We are pleased that GSK has once again chosen our REBEL desktop device as part of its process development efforts to bring promising therapeutics to market," said Dr. Kevin J. Knopp, CEO and co-founder of 908 Devices. "The REBEL analyzer enables our biopharma customers to make critical decisions on optimizing cell cultures in minutes, and its small desktop footprint fits alongside bioreactors…

    908 Devices (NASDAQ:MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biomolecular analysis, today announced that GlaxoSmithKline (NYSE:GSK) has purchased an additional REBEL™ cell culture media analyzer. GSK will now have a total of five REBEL analyzers being used by its biologics and vaccine process development teams.

    "We are pleased that GSK has once again chosen our REBEL desktop device as part of its process development efforts to bring promising therapeutics to market," said Dr. Kevin J. Knopp, CEO and co-founder of 908 Devices. "The REBEL analyzer enables our biopharma customers to make critical decisions on optimizing cell cultures in minutes, and its small desktop footprint fits alongside bioreactors in process development labs."

    908 Devices notes there are now 15 customers owning multiple REBEL devices, more than double from one year ago. In addition, all 20 of the top 20 pharmaceutical companies are now using the company's desktop devices, which include REBEL and ZipChip®, in their development process.

    About the REBEL analyzer

    REBEL is the first miniature CE-MS-based analyzer that enables biopharma researchers to accelerate process development cycles and maximize bioreactor utilization by running media analysis at-line. Key benefits include:

    • Samples can be run in minutes, eliminating core lab wait time of days and even weeks.
    • Quantitate over 30 components in cell culture media, including amino acids, dipeptides, water-soluble vitamins and amines.
    • Easy to use with an intuitive user interface and touchscreen, and the REBEL's small footprint permits flexibility in the lab layout.

    For more information, visit www.908devices.com.

    About 908 Devices

    908 Devices Inc. (NASDAQ:MASS) is democratizing laboratory mass spectrometry with its simple handheld and desktop devices, addressing critical-to-life applications. The Company's devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in life sciences research, bioprocessing, pharma / biopharma, forensics and adjacent markets. The Company is headquartered in the heart of Boston, where it designs and manufactures innovative products that bring together the power of mass spectrometry, microfluidic separations, software automation and machine learning.

    Forward Looking Statements

    This press release includes "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and assumptions which may cause actual results to differ materially from any results expressed or implied by any forward-looking statement, including the risks outlined under "Risk Factors" and elsewhere in the Company's filings with the Securities and Exchange Commission which are available on the SEC's website at www.sec.gov. Additional information will be made available in the Company's annual and quarterly reports and other filings that it makes from time to time with the SEC. Although the Company believes that the expectations reflected in its forward-looking statements are reasonable, it cannot guarantee future results. The Company has no obligation, and does not undertake any obligation, to update or revise any forward-looking statement made in this press release to reflect changes since the date of this press release, except as may be required by law.

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