GSK GlaxoSmithKline PLC

41.22
+0.36  (+1%)
Previous Close 40.86
Open 41.15
52 Week Low 31.43
52 Week High 48.25
Market Cap $103,405,967,016
Shares 2,508,635,784
Float 2,508,635,784
Enterprise Value $134,491,600,994
Volume 2,713,845
Av. Daily Volume 3,135,605
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Upcoming Catalysts

Drug Stage Catalyst Date
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma
PDUFA priority review
PDUFA priority review
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Closed Triple - CAPTAIN
Asthma
PDUFA
PDUFA
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SCB-2019 + adjuvant system
COVID-19 vaccine
Phase 1
Phase 1
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Mepolizumab
Severe hypereosinophilic syndrome (HES)
PDUFA priority review
PDUFA priority review
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Daprodustat
Anemia
Phase 3
Phase 3
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Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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Bintrafusp alfa
Biliary tract cancer
Phase 2/3
Phase 2/3
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Zejula and dostarlimab - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
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TSR-022 + TSR-042 AMBER
Solid tumors
Phase 1
Phase 1
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Gepotidacin
Uncomplicated urinary tract infection (uUTI)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Fostemsavir
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
Benlysta (belimumab)
Lupus Nephritis
BLA Filing
BLA Filing
Phase 3 trial met primary endpoint - December 18, 2019. BLA filed 2Q 2020.
Niraparib (Galahad)
Castration-Resistant Prostate Cancer
Phase 2
Phase 2
Phase 2 initial data to be presented at ASCO GU February 14, 2019. ORR 40%.
Cabotegravir HPTN 083
HIV
Phase 3
Phase 3
Phase 3 trial stopped early due to sufficient efficacy.
Adjuvanted COVID-19 vaccine
COVID-19 Coronavirus vaccine
Phase 1
Phase 1
Phase 1 trial to commence September 2020. Late-stage trial to potentially commence late-2020 or early-2021.
Mepolizumab
Nasal polyps
Phase 3
Phase 3
Regulatory filing due 2H 2020.
Niraparib - PRIMA
Ovarian cancer
Approved
Approved
FDA Approval announced April 29, 2020.
Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis
Phase 3
Phase 3
Phase 3 ContRAst trial initiation announced July 3, 2019.
TSR-042 - GARNET
Endometrial cancer
BLA Filing
BLA Filing
BLA filed 2H 2019.
Dolutegravir + rilpivirine
HIV
CRL
CRL
Complete Response Letter issued December 21, 2019.
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.
Dolutegravir + lamivudine TANGO
HIV
sNDA Filing
sNDA Filing
sNDA filing announced October 16, 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.
Cabotegravir + rilpivirine - ATLAS2M
HIV
Phase 3
Phase 3
Phase 3 primary endpoint met - August 22, 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.
Niraparib and Keytruda (TOPACIO)
Triple-negative Breast Cancer or Ovarian Cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing. Data at ASCO 2018 noted ORR 25%.
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.
Closed Triple - IMPACT
COPD
Phase 3
Phase 3
Phase 3 data released September 20, 2017 - primary endpoint met.

Latest News

  1. WARREN, N.J., June 11, 2020 /PRNewswire/ -- GlaxoSmithKline (NYSE:GSK) announced that Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever) recently became available over-the-counter (OTC) online and in stores nationwide, providing the over 30 million1 osteoarthritis patients across the country broader access to a leading pain relief option.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8731451-gsk-partners-with-paula-abdul-to-launch-voltaren-arthritis-pain-gel/

    To launch the OTC offering, Voltaren is teaming up with music superstar Paula Abdul, who uses Voltaren for her arthritis pain. Staying active is important for arthritis patients everywhere…

    WARREN, N.J., June 11, 2020 /PRNewswire/ -- GlaxoSmithKline (NYSE:GSK) announced that Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever) recently became available over-the-counter (OTC) online and in stores nationwide, providing the over 30 million1 osteoarthritis patients across the country broader access to a leading pain relief option.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8731451-gsk-partners-with-paula-abdul-to-launch-voltaren-arthritis-pain-gel/

    To launch the OTC offering, Voltaren is teaming up with music superstar Paula Abdul, who uses Voltaren for her arthritis pain. Staying active is important for arthritis patients everywhere, and together, Voltaren and Paula Abdul will inspire people to "rediscover the joy of movement".

    "I'm excited to partner with Voltaren Arthritis Pain Gel to share my personal journey with arthritis and success using Voltaren," Paula said. "I've put my joints through a lot over the years. Dancing, jumping, flipping – it's my heart and soul, but I've been pushing my joints to the limit for decades as a result. When I was diagnosed with arthritis, my doctor prescribed Voltaren which made a huge difference in relieving my pain and helping me move with ease. I am so excited it's now available OTC at stores nationwide."

    Joint pain due to arthritis symptoms is a daily reality for millions of people in the United States, and with many people across the country staying at home more often, finding arthritis pain relief is more important than ever. In a recent study of 1,000 U.S. adults aged 35+ suffering from joint pain* conducted by Voltaren in partnership with Wakefield Research, 82 percent of respondents said their physical activity has decreased as a result of more time at home, and 92 percent of respondents report that their joint pain is the same or more severe during this time.

    "Stay-at-home orders led to a unique set of challenges for those with arthritis," said Jissan Cherian, Director, U.S. OTC Marketing at GSK Consumer Healthcare. "Now, more than ever, we need to offer solutions that help ease the challenge of joint pain and inspire arthritis patients to rediscover the joy of movement, even as we adapt to changing routines and a new way of life."

    Additional results from the survey revealed:

    • 78 percent of joint pain sufferers are finding ways to incorporate new ways of moving into their routine since the start of stay-at-home orders, including walking, stretching and stair climbing
    • With many changing their daily routines to adjust to the new normal, 31 percent expressed they are unhappy about straying from their usual pain management routine
    • 54 percent have felt more knee pain due to walking around on surfaces that offer less support
    • 65 percent are looking for strategies to incorporate more exercise in their households, like using soup cans as dumbbells, or furniture as makeshift gym equipment
    • More screen time on smartphones means increased finger pain –nearly three in five joint pain sufferers age 35-55 report an increase due to typing/holding devices while at home
    • 51 percent are feeling joint pain due to new quarantine activities, including bread kneading, knitting, gardening, DIY projects, stretching and walking

    Voltaren Gel, a doctor-prescribed arthritis treatment in the U.S. for over 10 years with a proven safety profile, was approved by the Food and Drug Administration (FDA) as an OTC treatment in February, making it the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States. As an alternative to pills, Voltaren treats joint pain by delivering medicine at the source, and is absorbed through the skin and not through the stomach like most oral medicines. 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.

    "As the world leader in pain relief, we have seen how Voltaren has helped people with osteoarthritis treat their pain and improve their quality of life" Cherian said. "The OTC availability of Voltaren Arthritis Pain helps to provide greater access to an effective topical treatment option for joint pain patients, so more people with osteoarthritis pain can find relief."

    Voltaren Arthritis Pain Gel is now available online and at most major retailers nationwide.

    About Voltaren Arthritis Pain Gel

    The active ingredient in Voltaren Arthritis Pain Gel, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. Voltaren penetrates through the skin at the application site to deliver arthritis pain relief. Voltaren offers consumers who suffer from OA a well-tolerated alternative to oral analgesics.  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 Wakefield Research (www.wakefieldresearch.com) between May 7th and May 15th, 2020, among 1,000 US adults ages 35+ suffering from joint pain, plus an additional oversample of 500 joint pain sufferers in each of three states: Georgia, Oklahoma, Louisiana, using an email invitation and an online survey.

    Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. For the interviews conducted in this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 3.1 percentage points from the result that would be obtained if the interviews had been conducted with all persons in the universe represented by the sample.

    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 GSK Consumer Healthcare

    We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer Consumer Healthcare. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

    Media Inquiries:















    GSK Consumer Healthcare

    Caitlin Kormann

    +1 617 448 0557

    (Warren)

    Edelman

    Jessica Moschella

    +1 201 953 1547

    (New York City)    









     

    1 https://www.cdc.gov/arthritis/basics/osteoarthritis.htm

    Voltaren teams up with music superstar Paula Abdul to inspire people everywhere to rediscover the joy of movement.

     

    Voltaren teams up with music superstar Paula Abdul to inspire people everywhere to rediscover the joy of movement.

     

    Voltaren teams up with music superstar Paula Abdul to inspire people everywhere to rediscover the joy of movement.

     

    Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever) available over-the-counter (OTC) online and in stores nationwide.

     

    Cision View original content:http://www.prnewswire.com/news-releases/gsk-consumer-healthcare-teams-up-with-paula-abdul-for-the-launch-of-voltaren-arthritis-pain-gel-301074754.html

    SOURCE GSK Consumer Healthcare

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  2. LONDON and SONGDO, South Korea, May 21, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) and Samsung Biologics (207940.KS) have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK's innovative biopharmaceutical therapies.

    Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK's future needs and will supplement GSK's existing manufacturing network.

    Regis Simard, President, Pharmaceuticals Supply Chain, GSK, said, "Today's agreement with Samsung Biologics complements and reinforces our existing world-class pharmaceutical manufacturing capability and will…

    LONDON and SONGDO, South Korea, May 21, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) and Samsung Biologics (207940.KS) have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK's innovative biopharmaceutical therapies.

    Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK's future needs and will supplement GSK's existing manufacturing network.

    Regis Simard, President, Pharmaceuticals Supply Chain, GSK, said, "Today's agreement with Samsung Biologics complements and reinforces our existing world-class pharmaceutical manufacturing capability and will help ensure we can continue to deliver the transformative medicines that patients need."

    "We are very proud and excited to announce this long-term agreement with GSK," said Dr. Tae Han Kim, CEO of Samsung Biologics. "Samsung Biologics entered the biopharma industry with the goal to help our clients bring valuable biological medicines to patients faster. We are thrilled to partner with GSK, a company who shares the vision."

    The agreement is worth more than $231 million USD over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.

    About Samsung Biologics Co. Ltd.

    Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and analytical testing services. With a proven regulatory approvals record, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.

    About GlaxoSmithKline

    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

    Press Contact:
    Samsung Biologics | Claire Kim sung.com
    GSK | Tim Foley:

    Cision View original content:http://www.prnewswire.com/news-releases/gsk-partners-with-samsung-biologics-to-secure-additional-manufacturing-capacity-for-innovative-biopharmaceutical-portfolio-301064072.html

    SOURCE Samsung Biologics

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    • Human antibody potently neutralizes SARS-CoV-2 and related viruses, suggesting high barrier to resistance
       
    • Clinical testing expected to begin this summer in collaboration with GSK

    SAN FRANCISCO, May 18, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of research findings from the company's efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled "Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody" (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent…

    • Human antibody potently neutralizes SARS-CoV-2 and related viruses, suggesting high barrier to resistance
       
    • Clinical testing expected to begin this summer in collaboration with GSK

    SAN FRANCISCO, May 18, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of research findings from the company's efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled "Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody" (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831 and VIR-7832, in collaboration with GlaxoSmithKline plc (NYSE:GSK).

    "Remarkably, we believe S309 likely covers the entire family of related coronaviruses, which suggests that, even as SARS-CoV-2 continues to evolve, it may be quite challenging for it to become resistant to the neutralizing activity of S309," said Herbert "Skip" Virgin, M.D., Ph.D., Chief Scientific Officer, Vir. "In addition, S309 exhibits potent effector function in vitro, potentially allowing the antibody to engage and recruit the rest of the immune system to kill off already infected cells. We have seen in animal models of other respiratory infections, such as influenza, that effector function significantly enhances the activity of antibodies that are already potently neutralizing."

    "Potency, coupled with a high barrier to resistance, are hallmarks of a superior antiviral," said Phillip S. Pang, M.D., Ph.D., Chief Medical Officer, Vir. "We have seen this with mAb114, a single, potent monoclonal antibody that has been shown in a Phase 2/3 trial in the Democratic Republic of Congo to markedly reduce mortality from Ebola."

    mAb114 is a monoclonal antibody that was isolated by Vir scientists in collaboration with the National Institutes of Health (NIH) and other government agencies using the same approach used to discover and develop S309. mAb114 is being developed by Ridgeback Biotherapeutics LP and the NIH.

    The paper can be accessed on the Nature website here. To learn more about Vir's efforts to develop therapies for COVID-19, visit https://investors.vir.bio/press-releases.

    About VIR-7831

    VIR-7831 is a monoclonal antibody that has demonstrated the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7831 has been engineered to have an extended half-life.

    About VIR-7832

    VIR-7832 is a monoclonal antibody that has demonstrated the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered to have an extended half-life and to potentially function as a T cell vaccine.

    About Vir's Antibody Platform
    Vir has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This platform has been used to identify and develop antibodies for pathogens including Ebola (mAb114, currently in use in the Democratic Republic of Congo), hepatitis B virus, influenza A, malaria, and others.

    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 hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio

    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," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "potential," "candidate," "continuing," "developing" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials of the company's antibodies to treat and prevent COVID-19, the ability of the company's antibodies to neutralize the SARS-CoV-2 virus, the company's efforts to identify additional antibodies, the ability of S309 to cover the entire family of related coronaviruses or S309's ability to recruit the rest of the immune system to kill off already infected cells, as well as statements about the highly conserved nature of VIR-7831 and VIR-7832 making it more difficult for escape mutants to develop.  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 neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. 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.

    Contact:
    Vir Biotechnology, Inc.

    Investors
    Neera Ravindran, MD
    Head of Investor Relations & Strategic Communications

    +1-415-506-5256

    Media
    Lindy Devereux
    Scient Public Relations

    +1-646-515-5730

     

    Primary Logo

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  3. LONDON, April 29, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.i

    LONDON, April 29, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.i

    Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress."

    Zejula is the only once-daily PARP inhibitor approved in the US as monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first-line and recurrent maintenance treatment settings, as well as late-line primary treatment settings.

    This new indication is supported by data from the phase III PRIMA study (ENGOT-OV26/GOG-3012), which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status. The PRIMA study enrolled women who had higher risk of disease progression, a population with high unmet needs and limited treatment options. 

    Dr. Bradley Monk, PRIMA investigator, US Oncology, University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph's Hospital Phoenix, said: "PRIMA was designed for patients with ovarian cancer who have a high unmet need. The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population. This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance."

    The primary endpoint in the PRIMA study was progression-free survival (PFS) analysed sequentially, first in the homologous recombination deficient (HRd) population, then in the overall population. The PRIMA study significantly improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula resulted in a 57% reduction in the risk of disease progression or death vs. placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001), and a 38% reduction in the risk of disease progression or death vs. placebo in the overall population (HR 0.62; 95% CI, 0.50 to 0.76; p<0.0001).  

    Zejula's safety profile, as demonstrated by the PRIMA results, was consistent with clinical trial experience. The most common grade 3 or higher adverse events with Zejula included thrombocytopenia (39%), anaemia (31%) and neutropenia (21%).

    At initiation of the PRIMA study, patients received a fixed starting dose of 300 mg of Zejula once-daily. The study was later amended to incorporate an individualised starting dose of either 200 mg or 300 mg of Zejula once-daily based on the patient's baseline weight and/or platelet count. Lower rates of grade 3 and 4 haematologic treatment-emergent adverse events were observed with an individualised starting dose, compared to the overall population, including thrombocytopenia (21% compared to 39%), anaemia (23% compared to 31%) and neutropenia (15% compared to 21%).

    The Zejula US prescribing information has been updated to include the individualised starting dose of 200 mg or 300 mg once-daily based on patients' baseline weight and/or platelet count for the first-line maintenance treatment indication. The starting dose for recurrent ovarian cancer and late-line treatment settings is 300 mg once-daily.

    "It's so important for patients with ovarian cancer to have treatment options, and this approval is positive news for our community," said Audra Moran, President and CEO, Ovarian Cancer Research Alliance. "PARP inhibitors represent a major advancement in the fight against ovarian cancer, and having a new first-line maintenance option for platinum-responsive advanced ovarian cancer patients — regardless of BRCA mutation status — is especially exciting. We are determined to keep funding research and partnering with scientists who are on the frontline of finding new treatments like this one to help those impacted by this disease."

    PRIMA study results were previously presented at the 2019 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.

    Zejula is not approved for use in first-line maintenance treatment outside the US.

    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 Ovarian Cancer

    In the US, ovarian cancer impacts nearly 222,000 women annually,ii and it is the fifth most frequent cause of cancer death among women.iii Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.iv Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.

    About Zejula (niraparib)

    Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including a phase III study as a first-line triplet maintenance treatment in ovarian cancer (FIRST).

    GSK in Oncology

    GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cell therapy, either alone or in combination.

    Indications and Important Safety Information for ZEJULA

    Indications

    ZEJULA is indicated:

    • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
    • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
    • for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: 
      • a deleterious or suspected deleterious BRCA mutation, or
      • genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.

    Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.

    Important Safety Information

    Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in 15 patients (0.8%) out of 1785 patients treated with ZEJULA monotherapy in clinical trials. The duration of therapy in patients who developed secondary MDS/cancer therapy-related AML varied from 0.5 months to 4.9 years. These patients had received prior chemotherapy with platinum agents and/or other DNA-damaging agents including radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed.

    Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients receiving ZEJULA. The overall incidence of Grade ≥3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA in PRIMA; 29%, 25%, and 20% of patients receiving ZEJULA in NOVA; and 28%, 27%, and 13% of patients receiving ZEJULA in QUADRA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients in PRIMA; 3%, 1%, and 2% of patients in NOVA; and 4%, 2%, and 1% of patients in QUADRA. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count in PRIMA, Grade ≥3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations.

    Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo in PRIMA, with no reported discontinuations. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in NOVA, with discontinuation occurring in <1% of patients. Grade 3-4 hypertension occurred in 5% of ZEJULA-treated patients in QUADRA, with discontinuation occurring in <0.2% of patients. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose, if necessary.

    Embryo-Fetal Toxicity and Lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of ZEJULA. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women to not breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose.

    First-line Maintenance Advanced Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of all patients who received ZEJULA in PRIMA were thrombocytopenia (66%), anemia (64%), nausea (57%), fatigue (51%), neutropenia (42%), constipation (40%), musculoskeletal pain (39%), leukopenia (28%), headache (26%), insomnia (25%), vomiting (22%), dyspnea (22%), decreased appetite (19%), dizziness (19%), cough (18%), hypertension (18%), AST/ALT elevation (14%), and acute kidney injury (12%).

    Common lab abnormalities (Grades 1-4) in ≥25% of all patients who received ZEJULA in PRIMA included: decreased hemoglobin (87%), decreased platelets (74%), decreased leukocytes (71%), increased glucose (66%), decreased neutrophils (66%), decreased lymphocytes (51%), increased alkaline phosphatase (46%), increased creatinine (40%), decreased magnesium (36%), increased AST (35%) and increased ALT (29%).

    Maintenance Recurrent Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of patients who received ZEJULA in NOVA were nausea (74%), thrombocytopenia (61%), fatigue/asthenia (57%), anemia (50%), constipation (40%), vomiting (34%), neutropenia (30%), insomnia (27%), headache (26%), decreased appetite (25%), nasopharyngitis (23%), rash (21%), hypertension (20%), dyspnea (20%), mucositis/stomatitis (20%), dizziness (18%), back pain (18%), dyspepsia (18%), leukopenia (17%), cough (16%), urinary tract infection (13%), anxiety (11%), dry mouth (10%), AST/ALT elevation (10%), dysgeusia (10%), palpitations (10%).

    Common lab abnormalities (Grades 1-4) in ≥25% of patients who received ZEJULA in NOVA included: decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%) and increase in ALT (28%).

    Treatment of Advanced HRD+ Ovarian Cancer

    Most common adverse reactions (Grades 1-4) in ≥10% of patients who received ZEJULA in QUADRA were nausea (67%), fatigue (56%), thrombocytopenia (52%), anemia (51%), vomiting (44%), constipation (36%), abdominal pain (34%), musculoskeletal pain (29%), decreased appetite (27%), dyspnea (22%), insomnia (21%), neutropenia (20%), headache (19%), diarrhea (17%), acute kidney injury (17%), urinary tract infection (15%), hypertension (14%), cough (13%), dizziness (11%), AST/ALT elevation (11%), blood alkaline phosphatase increased (11%).

    Common lab abnormalities (Grades 1-4) in ≥25% of patients who received ZEJULA in QUADRA included: decreased hemoglobin (83%), increased glucose (66%), decreased platelets (60%), decreased lymphocytes (57%), decreased leukocytes (53%), decreased magnesium (46%), increased alkaline phosphatase (40%), increased gamma glutamyl transferase (40%), increased creatinine (36%), decreased sodium (34%), decreased neutrophils (34%), increased aspartate aminotransferase (29%), and decreased albumin (27%).

    Please see accompanying Prescribing Information 

    About GSK
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    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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:
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    TW8 9GS

    i Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D'Andrea AD. Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer. Cancer Discov. 2015; 5(11): 1137-54.
    ii SEER Cancer Stat Facts: Ovarian Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed October 10, 2018.
    iii American Cancer Society "Key Statistics for Ovarian Cancer." https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html 
    iv Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer [published online August 5, 2012]. Int J Surg Oncol. 2012. doi:10.1155/2012/613980

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-approves-zejula-niraparib-as-the-only-once-daily-parp-inhibitor-in-first-line-monotherapy-maintenance-treatment-for-women-with-platinum-responsive-advanced-ovarian-cancer-regardless-of-biomarker-status-301049691.html

    SOURCE GlaxoSmithKline plc

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    • Data accepted as a late-breaking abstract and presented as a webinar as part of the Society of Gynecologic Oncology 2020 virtual congress
    • Patients in the updated analysis of GARNET include women with recurrent or advanced endometrial cancer who have progressed on or after platinum-based chemotherapy

    GlaxoSmithKline plc (NYSE:GSK) today announced data from an updated analysis of the GARNET trial, which demonstrated that dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based regimen.

    This updated analysis included patients with dMMR endometrial…

    • Data accepted as a late-breaking abstract and presented as a webinar as part of the Society of Gynecologic Oncology 2020 virtual congress
    • Patients in the updated analysis of GARNET include women with recurrent or advanced endometrial cancer who have progressed on or after platinum-based chemotherapy

    GlaxoSmithKline plc (NYSE:GSK) today announced data from an updated analysis of the GARNET trial, which demonstrated that dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based regimen.

    This updated analysis included patients with dMMR endometrial cancer who had measurable disease at baseline and ≥6 months of follow-up by the data cutoff (n=71). Patients received 500 mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression. The primary endpoints were confirmed objective response rate (ORR) and duration of response (DOR), as assessed against RECIST v 1.1 by blinded independent central review. GARNET is the largest dataset evaluating an anti-PD-1 in endometrial cancer.

    Treatment with dostarlimab showed an ORR of 42% (95% CI; 31-55) and a disease control rate of 58% (95% CI; 45-69). Overall, 13% of patients had a complete response and 30% of patients had a partial response. At the time of data cutoff, with a median follow up of 11.2 months, the median DOR had not been reached (1.87+ to 19.61+ months).

    Dr. Axel Hoos, Senior Vice President and Head Oncology R&D, GSK said: "We are committed to developing medicines for patients who face high unmet medical need. We believe in the clinical potential of dostarlimab for women with advanced or recurrent dMMR endometrial cancer who urgently need additional treatment options for this incurable disease."

    Dr. Ana Oaknin, Head of the Gynaecologic Cancer Program at Vall d'Hebron Institute of Oncology, Barcelona, and primary investigator for GARNET said: "There are limited treatment options for women with advanced or recurrent endometrial cancer, and prognosis of these patients is poor. The results observed in the GARNET trial indicate the potential of dostarlimab to offer a new treatment option for women with this challenging disease."

    The safety population included all patients with dMMR endometrial cancer who received at least one dose of dostarlimab (n=104). Results showed that dostarlimab was well tolerated with a low discontinuation rate (2%) due to treatment-related adverse events (TRAEs), consistent with the safety profiles of other anti-PD-1 therapies. The most commonly reported TRAEs were asthenia (15%), diarrhea (15%), fatigue (14%), and nausea (13%). No deaths associated with dostarlimab were reported in the study.

    Dostarlimab is not currently approved for use anywhere in the world.

    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/microsatellite instability-high (MSI-H) endometrial cancer (cohort A1), mismatch repair-proficient endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial cancer (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is still enrolling patients.i,ii

    About Dostarlimab

    Dostarlimab is an investigational humanized anti-PD-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.iii

    In addition to GARNET, dostarlimab is being investigated for women with recurrent or primary advanced endometrial cancer in combination with standard of care (chemotherapy) in the phase III RUBY trial.iv Dostarlimab is also being evaluated in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer.

    About Endometrial Cancerv

    Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy. Endometrial cancer is the sixth most common cancer in women worldwide.vi

    GSK in Oncology

    GSK is focused on maximizing patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilizing modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

    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.

    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 under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2019.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    __________________________________________

    i A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (GARNET). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02715284. Accessed February 2020.

    ii Oaknin A, Duska LR, Sullivan RJ, et al. Preliminary safety, efficacy, and pharmacokinetic/pharmacodynamic characterization from GARNET, a phase I/II clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-H and MSS endometrial cancer. Presented at 2019 SGO Annual Meeting; March 16-19, 2019; Honolulu, HI. Abstract 33.

    iii Laken H, Kehry M, Mcneeley P, et al. Identification and characterization of TSR-042, a novel anti-human PD-1 therapeutic antibody. European Journal of Cancer. 2016;69,S102. doi:10.1016/s0959-8049(16)32902-1.

    iv A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer (RUBY). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03981796. Accessed February 2020.

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

    vi Endometrial cancer. World Cancer Research Fund. https://www.wcrf.org/dietandcancer/endometrial-cancer. Published September 12, 2018. Accessed February 2020.

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