GSK GlaxoSmithKline PLC

39.59
+0.51  (+1%)
Previous Close 39.08
Open 39.25
52 Week Low 33.26
52 Week High 42.77
Market Cap $99,597,439,443
Shares 2,515,722,138
Float 2,506,701,214
Enterprise Value $126,906,039,687
Volume 4,702,228
Av. Daily Volume 5,034,929
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Upcoming Catalysts

Drug Stage Catalyst Date
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine
Phase 2/3
Phase 2/3
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Adjuvanted COVID-19 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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Zejula and dostarlimab - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
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Cobolimab (TSR-022) AMBER
Solid tumors
Phase 1
Phase 1
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Dostarlimab Plus Carboplatin-paclitaxel (RUBY)
Endometrial Cancer
Phase 3
Phase 3
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Daprodustat
Anemia
Phase 3
Phase 3
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Belantamab Mafodotin (DREAMM 5)
Multiple Myeloma
Phase 3
Phase 3
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Belantamab mafodotin (DREAMM-3)
Multiple Myeloma
Phase 3
Phase 3
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Gepotidacin
Uncomplicated urinary tract infection (uUTI)
Phase 3
Phase 3
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Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (DREAMM-8)
Multiple Myeloma
Phase 3
Phase 3
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Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
VIR-7831 / GSK4182136 (COMET-ICE)
COVID-19 antibody
Phase 3
Phase 3
Phase 3 data released March 10, 2021. 85% reduction in hospitalization or death. Trial to be stopped. FDA Emergency Use Authorization filing announced March 26, 2021.
Cabotegravir HPTN 083
HIV
NDA Filing
NDA Filing
NDA rolling submission announced May 4, 2021.
Belantamab mafodotin (GSK2857916) - DREAMM-4
Multiple Myeloma
Phase 2
Phase 2
Phase 2 trial completed 2H 2020.
Otilimab
COVID-19
Phase 2a
Phase 2a
Phase 2a data noted treatment difference but did not reach statistical significance.
Dostarlimab
dMMR endometrial cancer
Approved
Approved
FDA approval announced April 22, 2021.
Bamlanivimab (LY-CoV555) and 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.
GSK3359609 and Pembrolizumab (INDUCE-4)
Head and Neck Squamous Cell Carcinoma
Phase 2
Phase 2
Phase 2 trial to be discontinued - April 14, 2021.
GSK3359609 and Pembrolizumab (INDUCE-3)
Head and Neck Squamous Cell Carcinoma
Phase 2
Phase 2
Phase 2 trial to be discontinued following a recommendation by the Independent Data Monitoring Committee - April 14, 2021.
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.
Cabotegravir + rilpivirine - ATLAS2M
HIV
sNDA Filing
sNDA Filing
sNDA filing announced February 24, 2021.
Dolutegravir + rilpivirine
HIV
Approved
Approved
FDA approval announced January 21, 2021.
Bintrafusp alfa
Non-small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial unlikely to meet primary endpoint - to be discontinued.
Benlysta (belimumab)
Lupus Nephritis
Approved
Approved
FDA approval announced December 17, 2020.
Mepolizumab (NUCALA)
Nasal polyps
Phase 3
Phase 3
Regulatory filing submitted 2H 2020.
Nucala (Mepolizumab)
Severe hypereosinophilic syndrome (HES)
Approved
Approved
FDA approval announced September 25, 2020.
Closed Triple - CAPTAIN
Asthma
Approved
Approved
FDA approval announced September 9, 2020.
Dolutegravir + lamivudine
HIV
Approved
Approved
FDA approval announced August 6, 2020.
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma
Approved
Approved
FDA approval granted August 5, 2020.
Fostemsavir
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
Niraparib - PRIMA
Ovarian cancer
Approved
Approved
FDA Approval announced April 29, 2020.
M72/AS01E
Pulmonary tuberculosis
Phase 2b
Phase 2b
Phase 2b data significantly reduced incidence of pulmonary tuberculosis disease - October 29, 2019.
Niraparib - (QUADRA trial)
Ovarian cancer
Approved
Approved
FDA Approval announced October 23, 2019.
Mepolizumab
Severe eosinophilic asthma - pediatric
Approved
Approved
FDA Approval announced June 6, 2019.
Mepolizumab
Severe eosinophilic asthma (6-11 yrs)
Approved
Approved
FDA approval announced September 12, 2019.
Rolapitant - intravenous (IV)
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.
Danirixin
Chronic obstructive pulmonary disease (COPD)
Phase 2b
Phase 2b
Development discontinued due to lack of efficacy.
Dolutegravir + lamivudine
HIV
Approved
Approved
FDA approval announced April 8, 2019.
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved
Approved September 2, 2015.
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
Approved
Approved
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
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.
Tafenoquine
Malaria
Approved
Approved
FDA Approval announced July 23, 2018.
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
Approval announced April 24, 2018 for expanded label.
Closed Triple
COPD
Approved
Approved
Approval announced September 19, 2017.
Benlysta (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
Approved
Approved
Approval announced July 21, 2017.
Shingrix
Shingles
Approved
Approved
Approval announced October 20, 2017.
Dolutegravir + rilpivirine
HIV
Approved
Approved
Approval announced November 21, 2017.
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
Approval announced September 18, 2017.
Fluarix Quadrivalent (Influenza Vaccine)
Influenza A - children 6-35 months of age.
Approved
Approved
Approval announced January 11, 2018.
Mepolizumab
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Approved
Approved
Approval announced December 12, 2017.

Latest News

  1. – Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –

    – Review will support a formal Marketing Authorization Application –

    – GSK and Vir continue discussions with global regulators to make sotrovimab
    available to patients with COVID-19 –

    LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years…

    – Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –

    – Review will support a formal Marketing Authorization Application –

    – GSK and Vir continue discussions with global regulators to make sotrovimab

    available to patients with COVID-19 –

    LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

    The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine's compliance with the usual standards for efficacy, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.

    The review of the data is being carried out by the EMA's Committee for Medicinal Products for Human Use (CHMP). The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalizations over 24 hours or deaths in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.

    Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization.

    Sotrovimab is an investigational compound and has not been granted a marketing authorization anywhere in the world.

    An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs.

    About the COMET-ICE Study Design

    The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease.

    This Phase 3 trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalized participants globally. The efficacy interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

    In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of efficacy and is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed and will be published in a peer reviewed medical journal. In COMET-ICE, infusion-related reactions were reported at a low frequency (1%) in sotrovimab-treated patients and was comparable to the incidence in the placebo arm (1%). These infusion-related reactions occurring within 24 hours of study treatment included pyrexia, chills, dizziness, dyspnea, pruritus and rash, which were Grade 1 (mild) or Grade 2 (moderate) and no events consistent with antibody dependent enhancement (ADE) were observed.

    About the Sotrovimab Clinical Development Program

    In addition to the COMET-ICE trial, the full COMET clinical development program for sotrovimab includes:

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered sotrovimab to 500 mg intravenously administered sotrovimab among low-risk adults with mild to moderate COVID-19, and to evaluate the similarity in pharmacokinetics between sotrovimab manufactured by different processes
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 as an early treatment in high-risk adults to assess whether IM-administered sotrovimab can reduce hospitalization or death due to COVID-19
    • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered sotrovimab can prevent symptomatic infection.

    Sotrovimab was also evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including sotrovimab, versus placebo in low-risk adults with mild to moderate COVID-19. An interim analysis found that bamlanivimab (700 mg) co-administered with sotrovimab (500 mg) demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo, meeting the primary endpoint. The three companies are engaging with the FDA regarding the possible co-administration of bamlanivimab and sotrovimab for the treatment of COVID-19.

    Additionally, sotrovimab, along with VIR-7832, is being evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    About Sotrovimab

    Sotrovimab is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, and less likely to mutate over time. Sotrovimab, which incorporates Xencor's Xtend™ technology, also has 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 VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    About the Vir and GSK Collaboration

    In April 2020, Vir and GSK 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 three potential treatments in addition to our vaccine candidates in development.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. 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.

    GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of efficacy, based on an interim analysis of data from the trial. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

    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 we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. Sotrovimab has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. 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 our partners.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-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 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 timing and availability of sotrovimab to providers and patients, including arrangements with commercial payers, the timing of availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalized population, the ability of sotrovimab to neutralize the SARS-CoV-2 live virus, statements related to the planned full analysis of the COMET-ICE trial, and statements related to marketing authorizations and regulatory authorizations and approvals, including plans and discussions with the EMA, FDA, Health Canada and other global regulators. 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:
    Cara Miller
    VP, Corporate Communications
    
    +1 415 941 6746
    
    GSK Contacts:
    
    Media:
    
    Simon Steel
    +44 (0) 20 8047 5502
    (London)
    
    Tim Foley
    +44 (0) 20 8047 5502
    (London)
    
    Kristen Neese
    +1 804 217 8147
    (Philadelphia)
    
    Kathleen Quinn
    +1 202 603 5003
    (Washington DC)
    
    Lyndsay Meyer
    +1 202 302 4595
    (Washington DC)
    
    Analysts/Investors:
    
    James Dodwell
    +44 (0) 20 8047 2406
    (London)
    
    Sonya Ghobrial
    +44 (0) 7392 784784
    (Consumer)
    
    Mick Readey
    +44 (0) 7990 339653
    (London)
    
    Jeff McLaughlin
    +1 215 751 7002
    (Philadelphia)
    
    Frannie DeFranco
    +1 215 751 4855
    (Philadelphia)

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  2. WARREN, N.J., May 3, 2021 /PRNewswire/ -- GSK Consumer Healthcare (NYSE:GSK), the makers of Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1%) today revealed new data that uncovers a painful truth: for people with osteoarthritis (OA), mornings can be the most difficult part of the day. The study, conducted by OnePoll on behalf of Voltaren, found that among 1,000 people with OA surveyed, 67% of Americans reported their joint pain makes it difficult for them to get out of bed in the morning based on their activities from the previous day. This May, national Arthritis Awareness Month, Voltaren is empowering those with joint pain and stiffness to feel the joy of movement and help them take on their day.

    WARREN, N.J., May 3, 2021 /PRNewswire/ -- GSK Consumer Healthcare (NYSE:GSK), the makers of Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1%) today revealed new data that uncovers a painful truth: for people with osteoarthritis (OA), mornings can be the most difficult part of the day. The study, conducted by OnePoll on behalf of Voltaren, found that among 1,000 people with OA surveyed, 67% of Americans reported their joint pain makes it difficult for them to get out of bed in the morning based on their activities from the previous day. This May, national Arthritis Awareness Month, Voltaren is empowering those with joint pain and stiffness to feel the joy of movement and help them take on their day.

    After a night of inactivity, aches and pains can be at their worst first thing in the morning. In fact, a painful morning can throw off your entire day, the study shows. Nearly three-quarters of respondents reported that feeling OA pain when they wake up ruins their entire morning, and more than three-quarters of those surveyed reported OA negatively affects them three or more days a week. While 35% described themselves as early birds prior to being diagnosed with OA, only one-quarter are still early risers since learning they have OA.

    Joint pain can also impact the livelihoods of people with OA. For the millions of Americans who wake up for work with the sun, OA poses real challenges. The study found that 56% of employed Americans living with OA have shown up late to work because of their pain, and more than half have even had to change their jobs because of it.

    "Our research has helped us understand the authentic experience of people with OA, and shows just how difficult mornings can be, especially those who are up and moving very early," said Rishi Mulgund, Pain Portfolio Brand Director at GSK Consumer Healthcare, "As a brand, we want to support people with OA in the mornings, with a topical option that is an alternative to pain relief pills."

    Voltaren, the #1 doctor-recommended topical pain relief brand, is the first full prescription strength, clinically-proven nonsteroidal anti-inflammatory (NSAID) gel available over the counter. An alternative to pills, Voltaren is applied directly to the site of pain, delivering powerful arthritis pain relief. It is indicated for the treatment of arthritis pain in the hand, wrist, elbow, foot, ankle or knee. To date, millions of patients around the world have relied on Voltaren as a powerful, well-tolerated and convenient therapeutic alternative for treating arthritis pain.

    During Arthritis Awareness Month, Voltaren is proud to feature the stories of real people living with osteoarthritis who wake up and power through early mornings. Stay tuned throughout the month of May for Voltaren's three-part content series, which will air on local and national broadcast and online news outlets, featuring people with OA who refuse to let pain hold them back, and pain relief experts who will offer their advice on how people everywhere can experience the joy of less painful mornings.

    Additionally, as part of a multi-year partnership with the Arthritis Foundation to support scientific research, advocacy and community connections for people with arthritis, Voltaren is matching donations made to the Arthritis Foundation (up to $100,000) throughout Arthritis Awareness Month and lending its support to the Arthritis Foundation's annual Walk to Cure Arthritis events.

    Voltaren Arthritis Pain Gel is available online and at most major retailers nationwide. To learn more about Voltaren, visit www.voltarengel.com.

    About Voltaren Arthritis Pain Gel

    An alternative to pills, Voltaren Arthritis Pain Gel targets pain directly at the source to deliver clinically-proven nonsteroidal anti-inflammatory medicine for powerful arthritis pain relief with a proven safety profile. For more information, visit https://www.VoltarenGel.com/.

    About osteoarthritis

    Osteoarthritis (OA) is the most common form of arthritis. OA occurs when the cartilage between joints begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently with age, and the pain can gradually worsen over time. The most common symptoms associated with OA include joint pain, stiffness, and decreased range of motion.

    GSK's commitment to pain relief

    We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

    Important safety information about Voltaren Arthritis Pain

    Before using the product, consumers should read the Voltaren Arthritis Pain Gel Drug Facts Label. 

    * Methodological Notes

    The GSK Voltaren Survey was conducted by OnePoll (www.onepoll.us) throughout the month of April 2021. The survey sampled a random group of 1,000 employed Americans diagnosed with osteoarthritis.

    This random double-opt-in survey was conducted by OnePoll – a market research company and corporate member of both the American Association for Public Opinion Research (AAPOR) and the European Society for Opinion and Marketing Research (ESOMAR) – and adheres to the MRS code of conduct. For more information about OnePoll's research in the media, navigate to their portfolio here.

    About GSK Consumer Healthcare

    GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust and experts recommend for oral health, pain relief, respiratory and wellness. For further information please visit www.gsk.com.

    Media Inquiries:















    GSK Consumer Healthcare

    Caitlin Kormann

    +1 617 448 0557

    (Warren)

    Edelman

    Jessica Moschella

    +1 201 953 1547

    (New York City)    

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/voltaren-arthritis-pain-gel-empowers-early-morning-risers-living-with-osteoarthritis-301282039.html

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  3. LONDON, April 22, 2021 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company's Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description…

    LONDON, April 22, 2021 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company's Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 

    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year and these women currently have limited treatment options if their disease progresses on or after first-line therapy. Today's approval of JEMPERLI by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynecologic cancers."

    Around 1 in 4 women with endometrial cancer may experience a recurrence or be diagnosed with advanced disease.i,ii For women whose disease recurs after platinum-based chemotherapy, there is generally no accepted standard of care.iii,iv,v Additionally, endometrial cancer has the highest rate of dMMR among tumor typesvi,vii at approximately 25%,vii and increased rates of recurrence have been reported for women with dMMR endometrial cancer.viii

    Dr Jubilee Brown, Professor and Division Director of Gynecologic Oncology at Levine Cancer Institute, Atrium Health, and investigator on the GARNET study, noted: "The approval of JEMPERLI has the potential to change the way we've been treating dMMR advanced or recurrent endometrial cancer after standard platinum-based chemotherapy, especially given the overall response rate and durability of response that we saw in the GARNET trial."

    The approval is based on results from the dMMR endometrial cancer cohort of the ongoing GARNET trial, a large, multicenter, non-randomized, multiple parallel-cohort, open-label study, representing the largest dataset to date evaluating an anti-PD-1 antibody as monotherapy treatment in women with endometrial cancer.v The approval was granted under the FDA's Real-Time Oncology Review pilot program, and JEMPERLI was initially granted breakthrough therapy designation in May of 2019 for recurrent or advanced dMMR endometrial cancer. 

    The primary endpoints in the GARNET trial were overall response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR). Results showed an ORR of 42.3% (95% CI; 30.6-54.6) with a complete response (CR) rate of 12.7% and partial response rate (PR) of 29.6% among the 71 evaluable patients with dMMR advanced or recurrent endometrial cancer who had progressed on or after treatment with a platinum-containing regimen. Of those that responded, 93.3% demonstrated a DOR of 6 months or more. After a median follow-up of 14.1 months, the median duration of response was not reached (2.6-22.4+).

    Patients received 500 mg of JEMPERLI as an intravenous infusion once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression or unacceptable toxicity. Among the 104 patients evaluable for safety, the most commonly reported adverse reactions (occurring in 20% or more of patients) were fatigue/asthenia (48%), nausea (30%), diarrhea (26%), anemia (24%) and constipation (20%). The most common Grade 3 or 4 adverse reactions (≥2%) were anemia and transaminases increase. JEMPERLI was permanently discontinued due to adverse reactions in 5 (4.8%) patients. No deaths attributed to JEMPERLI were reported in the study.

    Dr Sue Friedman, Executive Director of Facing Our Risk of Cancer Empowered (FORCE), commented: "We applaud GSK and their ongoing efforts to support women with endometrial cancer, the most common gynecologic malignancy in the US and the sixth most common cancer in women worldwide. For many women whose disease is dMMR and has progressed after platinum-based chemotherapy, the approval of JEMPERLI brings a new treatment option to an underserved patient population."

    GSK is also studying JEMPERLI for endometrial cancer in earlier treatment lines and in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer as we work to expand our oncology pipeline and reinforce our portfolio of cancer treatments.

    Making our products affordable and accessible

    GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals can access more information about our oncology specific resources on insurance coverage and financial support at: www.TogetherwithGSKOncology.com or call: 1-844-4GSK-ONC (1-844-447-5662).

    About Endometrial Cancer

    Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium.ix Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy.ix Nearly 60,000 new cases of endometrial cancer are expected in the US in 2021, making endometrial cancer the most common gynecologic malignancy in the US.x,xi Approximately 25% of women with endometrial cancer will be diagnosed with advanced disease or will experience a recurrence.i,ii  

    About GARNET

    The ongoing phase I GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. Part 2B of the study includes five expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair proficient/microsatellite stable (MMRp/MSS) endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial or POLE-mut solid tumor basket cohort (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is still enrolling patients.

    About JEMPERLI (dostarlimab-gxly)

    JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.xiii In addition to GARNET, JEMPERLI is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens for women with recurrent or primary advanced endometrial cancer stage III or IV non-mucinous epithelial ovarian cancer for patients with advanced solid tumors or metastatic cancer.

    JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: JEMPERLI (GSK4057190), a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialization, and manufacture of each of these Products under the Agreement.

    Important Safety Information for JEMPERLI

    Immune-Mediated Adverse Reactions

    • Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue and can occur at any time during or after treatment with a PD-1/PD-L1–blocking antibody, including JEMPERLI.
    • Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. For suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
    • Based on the severity of the adverse reaction, withhold or permanently discontinue JEMPERLI. In general, if JEMPERLI requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to ≤Grade 1. Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids.

    Immune-Mediated Pneumonitis

    • JEMPERLI can cause immune-mediated pneumonitis, which can be fatal. The incidence of pneumonitis in patients receiving PD-1/PD-L1 inhibitors, including JEMPERLI, may be increased in patients who have received prior thoracic radiation.
    • Immune-mediated pneumonitis occurred in 1.1% (5/444) of patients, including Grade 2 (0.9%) and Grade 3 (0.2%) pneumonitis. Pneumonitis led to discontinuation of JEMPERLI in 0.7% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 80% of the 5 patients. Three patients reinitiated JEMPERLI after symptom improvement; of these, 33% had recurrence of pneumonitis.

    Immune-Mediated Colitis

    • JEMPERLI can cause immune-mediated colitis. Cytomegalovirus infection/reactivation occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
    • Immune-mediated colitis occurred in 1.4% (6/444) of patients, including Grade 3 (0.7%) and Grade 2 (0.7%). Colitis did not lead to discontinuation of JEMPERLI in any patients. Systemic corticosteroids were required in 17% (1/6) of patients with colitis. Colitis resolved in 50% of the 6 patients. Of the 2 patients in whom JEMPERLI was withheld for colitis, both reinitiated JEMPERLI.

    Immune-Mediated Hepatitis

    • JEMPERLI can cause immune-mediated hepatitis, which can be fatal. Immune-mediated Grade 3 hepatitis occurred in 0.2% (1/444) of patients. Systemic corticosteroids were required, and the event resolved.

    Immune-Mediated Endocrinopathies

    • Adrenal Insufficiency
      • JEMPERLI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold JEMPERLI if not clinically stable. Adrenal insufficiency occurred in 0.9% (4/444) of patients, including Grade 3 (0.5%) and Grade 2 (0.5%). Adrenal insufficiency resulted in discontinuation in 1 (0.2%) patient and resolved in 25% of the 4 patients.
    • Hypophysitis
      • JEMPERLI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold JEMPERLI if not clinically stable.
    • Thyroid Disorders
      • JEMPERLI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold JEMPERLI if not clinically stable.
      • Thyroiditis occurred in 0.5% (2/444) of patients; both were Grade 2. Neither event of thyroiditis resolved; there were no discontinuations of JEMPERLI due to thyroiditis.
      • Hypothyroidism occurred in 5.6% (25/444) of patients, all of which were Grade 2. Hypothyroidism did not lead to discontinuation of JEMPERLI and resolved in 40% of the 25 patients. Systemic corticosteroids were not required for any of the 25 patients with hypothyroidism.
      • Hyperthyroidism occurred in 1.8% (8/444) of patients, including Grade 2 (1.6%) and Grade 3 (0.2%). Hyperthyroidism did not lead to discontinuation of JEMPERLI and resolved in 63% of the 8 patients. Systemic corticosteroids were not required for any of the 8 patients with hyperthyroidism.
    • Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis
      • JEMPERLI can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue JEMPERLI depending on severity.

    Immune-Mediated Nephritis with Renal Dysfunction

    • JEMPERLI can cause immune-mediated nephritis, which can be fatal. Nephritis occurred in 0.5% (2/444) of patients; both were Grade 2. Nephritis did not lead to discontinuation of JEMPERLI and resolved in both patients. Systemic corticosteroids were required in 1 of the 2 patients experiencing nephritis.

    Immune-Mediated Dermatologic Adverse Reactions

    • JEMPERLI can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue JEMPERLI depending on severity.

    Other Immune-Mediated Adverse Reactions

    • The following clinically significant immune-mediated adverse reactions occurred in <1% of the 444 patients treated with JEMPERLI or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
      • Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy
      • Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
      • Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur.
      • Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis
      • Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
      • Endocrine: Hypoparathyroidism
      • Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection

    Infusion-Related Reactions

    • Severe or life-threatening infusion-related reactions have been reported with PD-1/PD-L1–blocking antibodies. Severe infusion-related reactions (Grade 3) occurred in 0.2% (1/444) of patients receiving JEMPERLI. All patients recovered from the infusion-related reactions.
    • Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue JEMPERLI based on severity of reaction.

    Complications of Allogeneic HSCT after PD-1/PD-L1–Blocking Antibody:

    • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1–blocking antibody. These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

    Embryo-Fetal Toxicity and Lactation:

    • Based on its mechanism of action, JEMPERLI can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after their last dose. Because of the potential for serious adverse reactions from JEMPERLI in a breastfed child, advise women not to breastfeed during treatment with JEMPERLI and for 4 months after their last dose.

    Common Adverse Reactions

    • The most common adverse reactions (Grades 1-4) in ≥10% of 104 dMMR endometrial cancer patients who received JEMPERLI as monotherapy were fatigue (48%), nausea (30%), diarrhea (26%), anemia (24%), constipation (20%), vomiting (18%), pruritus (14%), cough (14%), decreased appetite (14%), urinary tract infection (13%), and myalgia (12%).
    • JEMPERLI was permanently discontinued due to adverse reactions in 5 (4.8%) patients, including transaminases increased, sepsis, bronchitis, and pneumonitis. Dosage interruptions due to an adverse reaction occurred in 23% of patients who received JEMPERLI. Adverse reactions that required dosage interruption in ≥1% of patients who received JEMPERLI were anemia, diarrhea, increased lipase, and pyrexia.

    Please see full Prescribing Information

    GSK in Oncology

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    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 and any impacts of the COVID-19 pandemic.

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    i CancerMPact® Patient Metric, Kantar. Available from www.cancermpact.com. Accessed 18 March 2020.

    ii NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms V1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed 17 April 2020. SGO Clinical Practice Endometrial Cancer Working Group.

    iii Burke WM, Orr J, Leitao M, et al. Endometrial Cancer: a review and current management strategies: part II. Gynecol Oncol. 2014;134(2):393-402.

    iv Brooks RA, Flemming GF, Lastra RR, et al. Current recommendations and recent progress in endometrial cancer. CA Cancer J Clin. 2019;69(4):258-279.

    v Oaknin A, Tinker AV, Gilbert L, et al. Clinical activity and safety of the anti–programmed death 1 monoclonal antibody dostarlimab for patients with recurrent or advanced mismatch repair–deficient endometrial cancer: a nonrandomized phase 1 clinical trial. JAMA Oncol. 2020;6(11):1766-1772.

    vi Le DT, Durham JN Smith KN, et al.  Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357(6349):409-413.

    vii Lorenzi M, Amonkar M, Zhang J, et al.  Epidemiology of microsatellite instability high (MSI-H) and deficient mismatch repair (dMMR) in solid tumor: a structured literature review. Journal of Oncology. 2020; Article ID 18079.

    viii Backes FJ, Haag J, Cosgrove CS, et al. Mismatch repair deficiency identifies patients with high-intermediate risk (HIR) endometrioid endometrial cancer at the highest risk of recurrence: a prognostic biomarker. Cancer. 2019;125(3):398-405.

    ix Endometrial Cancer Treatment (PDQ®) – Health Professional Version. National Cancer Institute. https://www.cancer.gov/types/uterine/hp/endometrial-treatment-pdq. Accessed May 2020.

    x Cancer Facts & Figures 2021. American Cancer Society.  Accessed 30 March 2021. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf.

    xi Fung-Kee-Fung M, Dodge J, Elit L, et al. Follow-up after primary therapy for endometrial cancer: a systematic review. Gynecol Oncol. 2006;101(3):520-529.

     

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  4. WARREN, N.J., April 19, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK), the maker of Advil, today announced its commitment to reducing the plastic in over 80 million Advil bottles1 by 20%, which will result in a reduction of nearly 500,000 pounds of plastic in the environment. By 2022, Advil will have reduced the plastic in nearly all bottles available in stores and online.2

    The initiative is a first-of-its-kind sustainable plastic technology for over-the-counter (OTC) medicines. This new barrier resin technology reduces the amount of resin required to mold and craft the bottles, while maintaining the same barrier protection properties. It allows for a 20% reduction in material usage for high-density polyethylene (HDPE) bottles that will never enter the environmental waste stream, without a reduction to critical performance characteristics of the bottle.

    The new sustainability goal set by Advil is part of GSK's ambition for all consumer product packaging to be recyclable or reusable, including eliminating all problematic and unnecessary plastics when permitted, while ensuring the quality, safety and efficacy of our products, by 2025.

    "As a world leader in pain relief, we at GSK are proud to transition Advil to a more environmentally friendly packaging, further supporting GSK's commitment to sustainability," said Sarah McDonald, VP of Sustainability, GSK Consumer Healthcare. "With the new technology available to us, we saw this as an opportunity to invest in the future of our brands and sustainability goals.  Advil's switch to 20% less plastic is a first in the OTC category, and kicks off a series of plastic reduction initiatives across the product portfolio at GSK."

    The focus on plastics and packaging is informed by the leading requirements set by the Ellen Macarthur Foundation. GSK joined the Ellen MacArthur Network in 2020 and is committed to playing its part in mobilizing a shift towards a circular economy for plastics.

    As part of their 2025 sustainability commitment, GSK also joined the Action for Sustainable Derivatives (ASD), which aims to increase the transparency and traceability of palm oil derivatives supply chains. In collaboration with ASD, GSK introduced the Sustainable Palm Index (SPI), an evaluation scorecard for suppliers of palm oil and palm kernel oil derivatives, intended to support procurement decisions.

    Further, last year GSK announced ambitious new environmental sustainability goals in both climate and nature, aiming to have a net zero impact on climate and a net positive impact on nature by 2030.

    GSK has already begun transitioning Advil's bottles to 20% less plastic, and the Advil portfolio will have transitioned by 2022, online and on retail shelves nationwide. To learn more about Advil and GSK's sustainability initiatives, visit GSK.com.

    GSK's commitment to pain relief

    We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

    About Advil

    Patients and doctors have trusted Advil to deliver powerful relief from several kinds of pain, including headache, muscle aches, minor arthritis and other joint pain, and backache for more than 35 years. No other OTC pain reliever has been proven stronger on pain than Advil. Advil's line of products includes Advil Liqui-Gels, Advil Migraine, Advil PM, Children's Advil Allergy & Congestion Relief, and the brand's latest innovation, Advil Dual Action.

    Important Safety Information

    For more than 30 years, extensive consumer use and numerous clinical studies have shown that, ibuprofen, the active ingredient in Advil, when used as directed, is a safe and effective OTC pain reliever and fever reducer.

    Please refer to the full product labeling for additional safety information related to Advil.

    About GSK Consumer Healthcare 

    GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust and experts recommend for oral health, pain relief, respiratory and wellness.  For further information please visit www.gsk.com.

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    1 Annual volume

    2 Does not include Advil "easy open" bottles

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  5. LONDON and SAN FRANCISCO, April 15, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

    The review is being carried out by the EMA's Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-wide recommendations for national authorities who may take evidence-based…

    LONDON and SAN FRANCISCO, April 15, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

    The review is being carried out by the EMA's Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorization Application.

    The review will include data from an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. The CHMP review will also consider data on the medicine's quality and safety.

    This week, the Australian Therapeutic Goods Administration (TGA), part of the Department of Health, granted VIR-7831 a provisional determination. VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody to have been granted this designation, which provides a formal and transparent mechanism for accelerating the registration of promising new medicines with preliminary clinical data.

    VIR-7831 is an investigational compound and has not been granted a marketing authorization anywhere in the world. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the U.S. Food and Drug Administration (FDA).

    Preclinical data suggest VIR-7831 targets a highly conserved epitope of the SARS-CoV-2 spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional preclinical data published in bioRxiv, VIR-7831 also appears to maintain activity against the California variant.

    GSK is planning to submit a full Marketing Authorization Application (MAA) to the EMA which will include the data from the COMET-ICE trial.

    About COMET-ICE

    The multi-center, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 2 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States. In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.

    In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy but is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

    The Phase 3 portion of the trial assessed the safety and efficacy of a single IV infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

    About the VIR-7831 Clinical Development Program

    In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

    • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
    • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
    • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

    VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Topline data announced in March 2021 showed that in combination, the two monoclonal antibodies demonstrated a 70% relative reduction of patients with persistently high viral load at day 7 compared to placebo.

    Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

    VIR-7831 and VIR-7832 are investigational compounds and have not been granted marketing authorizations anywhere in the world.

    About VIR-7831 / GSK4182136

    VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is 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. VIR-7831, which incorporates Xencor's Xtend™ technology, also has 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 VIR-7832 / GSK4182137

    VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is 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. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has 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. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

    About the Vir and GSK Collaboration

    In April 2020, Vir and GSK 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 three potential treatments in addition to our vaccine candidates in development.

    GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. 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.

    GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Vir Biotechnology

    Vir Biotechnology is a clinical-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.

    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 EMA's review of VIR-7831, the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19 (as monotherapy and in combination with bamlanivimab), the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, 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 our competitors, changes in expected or existing competition, delays in or disruptions to our 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.

    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 and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

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    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    Vir Biotechnology Contacts:

    Cara Miller

    VP, Corporate Communications

     

    +1-415-941-6746

    GSK Contacts:



       
    Media:Simon Steel+44 (0) 20 8047 5502(London)
     Tim Foley+44 (0) 20 8047 5502(London)
     Kristen Neese+1 804 217 8147(Philadelphia)
     Kathleen Quinn+1 202 603 5003(Washington DC)
        
    Analysts/Investors:James Dodwell+44 (0) 20 8047 2406(London)
     Sonya Ghobrial+44 (0) 7392 784784(Consumer)
     Jeff McLaughlin+1 215 751 7002(Philadelphia)
     Frannie DeFranco+1 215 751 4855(Philadelphia)



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