GSK GlaxoSmithKline PLC

39.26
-0.21  -1%
Previous Close 39.47
Open 39.78
52 Week Low 31.43
52 Week High 48.25
Market Cap $98,490,853,867
Shares 2,508,681,963
Float 2,508,681,963
Enterprise Value $129,718,594,724
Volume 3,683,948
Av. Daily Volume 2,897,472
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Upcoming Catalysts

Drug Stage Catalyst Date
Mepolizumab
Severe hypereosinophilic syndrome (HES)
PDUFA priority review
PDUFA priority review
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SCB-2019 + adjuvant system (Clover)
COVID-19 vaccine
Phase 1
Phase 1
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Adjuvanted COVID-19 vaccine
COVID-19 vaccine
Phase 1/2
Phase 1/2
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VIR-7831 / GSK418213
COVID-19 antibody
Phase 2/3
Phase 2/3
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Mepolizumab (NUCALA)
Nasal polyps
Phase 3
Phase 3
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Dostarlimab
dMMR pan-tumor
Phase 3
Phase 3
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Daprodustat
Anemia
Phase 3
Phase 3
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Otilimab
COVID-19
Phase 2a
Phase 2a
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Bintrafusp alfa
Biliary tract cancer
Phase 2/3
Phase 2/3
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Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
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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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Dostarlimab Plus Carboplatin-paclitaxel (RUBY)
Endometrial Cancer
Phase 3
Phase 3
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Zejula and dostarlimab - MOONSTONE
Ovarian cancer
Phase 2
Phase 2
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Belantamab mafodotin (DREAMM-3)
Multiple Myeloma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Closed Triple - CAPTAIN
Asthma
Approved
Approved
FDA approval announced September 9, 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%.
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.
Benlysta (belimumab)
Lupus Nephritis
BLA Filing
BLA Filing
Phase 3 trial met primary endpoint - December 18, 2019. BLA filed 2Q 2020.
Cabotegravir HPTN 083
HIV
Phase 3
Phase 3
Phase 3 trial stopped early due to sufficient efficacy.
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.
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.
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.
Shingrix
Shingles
Approved
Approved
Approval announced October 20, 2017.
Benlysta (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
Approved
Approved
Approval announced July 21, 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. New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment paradigm

    GlaxoSmithKline plc (NYSE:GSK) and Innoviva, Inc. (NASDAQ:INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI') for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200909006117/en/

    The FDA-approved strength for both COPD and…

    New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment paradigm

    GlaxoSmithKline plc (NYSE:GSK) and Innoviva, Inc. (NASDAQ:INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI') for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200909006117/en/

    The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.

    The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the US. Today's announcement marks GSK's sixth major medicine approval in 2020 across areas of significant unmet medical need including cancer, HIV, respiratory and chronic kidney disease.

    Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Millions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms. Today's approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once-a-day."

    Trelegy's approval for the maintenance treatment of asthma in patients aged 18 years and older introduces a new paradigm for managing the approximately 30% of adult asthma patients who still experience symptoms despite being adherent to inhaled corticosteroids/ long-acting beta agonist (ICS/LABA) combination therapy.

    Tonya Winders, President, Global Allergy and Airways Patient Platform (GAAPP) commented: "In the US there are almost 20 million adultsi living with asthma and we know that many of those continue to live with and adapt their lives around ongoing symptoms, despite taking medication as prescribed by their physician. We welcome the news that for appropriate patients, Trelegy Ellipta will now be available as a new treatment option."

    Today's approval was based on a supplemental New Drug Application which included data from the CAPTAIN study showing that in patients uncontrolled on ICS/LABA, the additional bronchodilation provided by Trelegy demonstrated significant improvements in lung function compared with FF/VI, in a single daily dose in an easy-to-use inhaler. The results from CAPTAIN were presented at the European Respiratory Society (ERS) Congress this week, reinforcing the potential of once-daily single inhaler triple therapy in asthma management.

    Pavel Raifeld, Chief Executive Officer of Innoviva, said: "In 2017, Trelegy Ellipta was approved in the US as the first once-daily single inhaler triple therapy for the treatment of COPD, and it remains the market leader with strong continued growth. Today's approval in asthma is another successful outcome for our long-standing partnership with GSK and a testament to our commitment to make innovative medicines accessible to patients with respiratory diseases."

    About asthma

    Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily lives.

    The causes of asthma are not completely understood but likely involve an interaction between a person's genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

    About the CAPTAIN Study

    CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication.

    About Trelegy Ellipta (FF/UMEC/VI) in the US

    FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK's Ellipta dry powder inhaler.

    FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta in September 2017 for the long-term, once-daily maintenance treatment of patients with COPD. Trelegy Ellipta was approved in the US on 9 September 2020 for the maintenance treatment of asthma in patients aged 18 years and older. Trelegy Ellipta is not indicated for relief of acute bronchospasm.

    US Prescribing Information for Trelegy Ellipta.

    Important Safety Information (ISI) for Trelegy Ellipta

    The following ISI is based on the Highlights section of the US Prescribing Information for Trelegy Ellipta. Please consult the full Prescribing Information for all the labelled safety information.

    Trelegy Ellipta is NOT indicated for the relief of acute bronchospasm.

    Trelegy Ellipta is contraindicated in primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any of the ingredients.

    LABA monotherapy increases the risk of serious asthma-related events.

    Trelegy Ellipta should not be initiated in patients experiencing episodes of acutely deteriorating COPD or asthma. Do not use Trelegy Ellipta to treat acute symptoms

    Trelegy Ellipta should not be used in combination with other medicines containing LABA because of risk of overdose.

    Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.

    There is an increased risk of pneumonia in patients with COPD taking Trelegy Ellipta. Monitor patients for signs and symptoms of pneumonia.

    Patients who use corticosteroids are at risk for potential worsening of infections (e.g. existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex). Use Trelegy Ellipta with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

    There is a risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Trelegy Ellipta.

    Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of Trelegy Ellipta in susceptible individuals. If such changes occur, discontinue Trelegy Ellipta slowly.

    If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta and institute alternative therapy.

    Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.

    Use Trelegy Ellipta with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.

    Assess patients for decrease in bone mineral density initially and periodically thereafter after prescribing Trelegy Ellipta.

    Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY ELLIPTA long term. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.

    Worsening of urinary retention may occur in patients taking Trelegy Ellipta. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

    Use Trelegy Ellipta with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

    Be alert to hypokalemia and hyperglycemia in patients taking Trelegy Ellipta.

    Orally inhaled corticosteroids may reduce growth velocity in children and adolescents. Trelegy Ellipta is not indicated for use in children and adolescents.

    COPD: The most common adverse reactions reported for Trelegy Ellipta 100/62.5/25 mcg (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhoea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

    Asthma: The most common adverse reactions (incidence ≥2%) are nasopharyngitis, upper respiratory tract infection, bronchitis, viral respiratory tract infection, sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.

    GSK's commitment to respiratory disease

    For 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world's first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today's industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won't stand still until the simple act of breathing is made easier for everyone.

    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.

    Trade marks are owned by or licensed to the GSK group of companies.

    Editor's Note: In addition to the FDA's approval of Trelegy Ellipta in asthma, GSK has received five major medicine approvals to date in 2020 for CABENUVA (cabotegravir and rilpivirine) in Canada, DUVROQ (daprodustat) in Japan, and ZEJULA (niraparib), RUKOBIA (fostemsavir) and BLENREP (belantamab mafodotin) in the US.

    About Innoviva

    Innoviva is focused on royalty management. Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and TRELEGY® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for TRELEGY® ELLIPTA® and earlier-stage programs partnered with Theravance Biopharma, Inc. For more information, please visit Innoviva's website at www.inva.com.

    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 as set out in GSK's Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Innoviva forward-looking statements

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events, including the development, regulatory and commercial plans for closed triple combination therapy and the potential benefits and mechanisms of action of closed triple combination therapy. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks, uncertainties and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" contained in Innoviva's Annual Report on Form 10-K for the year ended December 31, 2018, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors are described in those sections of Innoviva's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. In addition to the risks described above and in Innoviva's other filings with the SEC, other unknown or unpredictable factors also could affect Innoviva's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    i https://www.cdc.gov/nchs/fastats/asthma.htm

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  2. WARREN, N.J., Sept. 9, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced Advil, a leading OTC pain reliever worldwide, is teaming up with actress Angela Kinsey for the launch of Advil Dual Action, a first of-its-kind pain fighting formula and the biggest over-the-counter (OTC) innovation in the oral pain category within the U.S. in 25 years. Advil Dual Action is the first and only Food and Drug Administration (FDA) approved formula that combines two of the best-known pain relievers, ibuprofen and acetaminophen, to fight pain in two ways: ibuprofen works throughout the body, targeting pain at the source, while acetaminophen blocks pain signals to the brain.

    Experience the interactive Multichannel News Release here…

    WARREN, N.J., Sept. 9, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced Advil, a leading OTC pain reliever worldwide, is teaming up with actress Angela Kinsey for the launch of Advil Dual Action, a first of-its-kind pain fighting formula and the biggest over-the-counter (OTC) innovation in the oral pain category within the U.S. in 25 years. Advil Dual Action is the first and only Food and Drug Administration (FDA) approved formula that combines two of the best-known pain relievers, ibuprofen and acetaminophen, to fight pain in two ways: ibuprofen works throughout the body, targeting pain at the source, while acetaminophen blocks pain signals to the brain.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8763651-advil-taps-angela-kinsey-for-launch-of-advil-dual-action/

    To support the innovative launch, Advil is teaming up with actress Angela Kinsey, who has long relied on Advil to help combat everyday aches and pains. Kinsey, perhaps most recognized as her character Angela Martin on NBC's "The Office," has been playing the role of busy leading lady in every aspect of her active life: as a mom, actress on Netflix's "Tall Girl," professional podcaster, avid basketball player and roller skating enthusiast.

    "Whether I'm working as an actress, keeping up with my kids, or playing my favorite sports, I don't like to sit on the sidelines. Like anyone, I experience everyday aches and pains, but I never let them hold me back," Kinsey said. "I've used Advil for a long time and am thrilled to work with them on their latest innovation, Advil Dual Action, which helps relieve my pain so I can keep doing the things I love!"

    As part of the partnership, Kinsey stars in a new video series where fans can watch her stretching, diving, jumping and flipping, without letting pain – or self-doubt – get in her way, thanks to Advil Dual Action.

    "I want to show people that aches and pains don't have to stop you doing the things you love," Kinsey said. "For me, that's jumping on the trampoline with my kids, strapping on my roller skates, or crafting for hours on end. I know I can rely on Advil Dual Action to alleviate my pain."

    While Kinsey has found relief in new Advil Dual Action since she began using it this summer, other pain sufferers have not. A survey of 1,000 U.S. adults ages 25 to 65, conducted by Advil in partnership with Wakefield Research*, revealed that while 95% of people experience everyday aches and pains, 80% do not always find complete relief with existing OTC pain treatment options.

    "It's clear consumers are looking for a new option to treat aches and pains," said Albert Shiue, Brand Manager at GSK. "We are excited to bring that to market in our newest innovation, Advil Dual Action, so people everywhere can find relief. Like Angela Kinsey, we want to encourage our consumers to live life to the fullest, pain free."

    Fans can watch Angela Kinsey's content series over the coming months on Advil's Instagram (@advilrelief) and Facebook (@advil), as well as on Angela's social channels (@AngelaKinsey). Visit Advil.com to learn more about Advil Dual Action, now available online and on retail shelves nationwide.

    About Advil Dual Action

    Advil Dual Action is an exclusive pain-fighting formula, combining ibuprofen and acetaminophen to fight pain in two ways. Ibuprofen is a nonsteroidal anti-inflammatory (NSAID) that targets pain at the source, temporarily reducing the production of prostaglandins, which cause swelling and pain signals. Acetaminophen is a pain reliever that blocks the transmission of pain signals to the brain. Advil Dual Action will be available over-the-counter nationwide in 2020.

    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 Advil Dual Action

    Before using the product, consumers should read the Advil Dual Action drug facts label.

    About GSK

    We are 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. The new drug application for Advil Dual Action was approved under the Pfizer name. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

    *Methodological Notes

    The Advil Survey was conducted by Wakefield Research (www.wakefieldresearch.com) among 1,000 nationally representative US adults ages 25-65, between July 16th and July 22nd, 2020, using an email invitation and an online survey. Quotas have been set to ensure reliable and accurate representation of the US adult population ages 25-65.

    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 interviews had been conducted with all persons in the universe represented by the sample.

    Media Inquiries:















    GSK Consumer Healthcare

    Caitlin Kormann

    +1 617 448 0557

    (Warren)

    Edelman

    Jessica Moschella

    +1 201 953 1547

    (New York City)

     

     

    Advil Taps Leading Lady and Super Mom Angela Kinsey for the Launch of Major Pain Innovation, Advil Dual Action

     

    To support the innovative launch of Advil Dual Action, Advil is teaming up with actress Angela Kinsey, who has long relied on Advil to help combat everyday aches and pains.

     

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/advil-taps-leading-lady-and-super-mom-angela-kinsey-for-the-launch-of-major-pain-innovation-advil-dual-action-301126381.html

    SOURCE GSK Consumer Healthcare

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  3. WARREN, N.J., Sept. 8, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of new Advil Dual Action, an exclusive formula that combines two of the most powerful pain fighting ingredients: ibuprofen and acetaminophen. In February, the Food and Drug Administration (FDA) approved Advil Dual Action as the first and only over-the-counter medication that combines ibuprofen and acetaminophen. The widely used, effective ingredients help to manage pain in two ways: ibuprofen works through the body, targeting pain at the source, while acetaminophen blocks pain signals to the brain. The innovation takes these two powerful pain fighting ingredients and combines them into one tablet to offer fast, strong pain relief.

    WARREN, N.J., Sept. 8, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of new Advil Dual Action, an exclusive formula that combines two of the most powerful pain fighting ingredients: ibuprofen and acetaminophen. In February, the Food and Drug Administration (FDA) approved Advil Dual Action as the first and only over-the-counter medication that combines ibuprofen and acetaminophen. The widely used, effective ingredients help to manage pain in two ways: ibuprofen works through the body, targeting pain at the source, while acetaminophen blocks pain signals to the brain. The innovation takes these two powerful pain fighting ingredients and combines them into one tablet to offer fast, strong pain relief.

    Advil is launching the new

    Physical pain is unique to each person who experiences it and it comes in many forms, yet, the ways we treat and even talk about pain can be outdated and insufficient. Advil surveyed 1,000 U.S. adults ages 25 to 65, in partnership with Wakefield Research*, to understand our relationship with pain: how we experience it, how frequently, how we treat it and even how we describe it to others. The results were clear: although 95% of people in America experience everyday aches and pains, there is no singular, universal experience surrounding pain.

    "With the majority of people who experience body aches and pains unable to find full relief from just one medication, Advil recognized that there is so much more potential within the pain relief category, and it starts with gaining a comprehensive understanding of how people experience pain," said Albert Shiue, Brand Manager at GSK. "Driven by GSK's commitment to provide safe and effective pain relief options and our continued efforts to innovate within the pain category, we are excited to launch Advil Dual Action, the most innovative OTC oral pain relief product to hit the market in over 25 years, and provide people with the tools they need to understand and talk about their pain."

    To explore findings, Advil is launching the new "Next Generation Pain Report" which offers a deep dive into unique, emerging trends that point to opportunities for us to understand, address and treat everyday pain. The report reveals:

    • OTC Medications aren't getting the job done: 95% of people experience everyday aches and pains, but 80% do not always find complete relief with existing OTC pain treatment options.
    • No Pain is the Same: Nearly three-quarters (72%) of U.S. adults experience what they would consider "multidimensional pain," getting different types of body pain at different times. In addition to the physical sensation of pain, psychological, social and cultural factors all contribute to an individual's pain experience.
    • Age Is Just a Number: Younger people report experiencing just as much pain as older generations. One-third (34%) of Millennials report experiencing pain every day, nearly equal to that of Gen Xers (36%) and Boomers (35%).
    • Over-The-Counter Pain Medications are Misunderstood: When presented with both true and false statements about the effects of ibuprofen and acetaminophen, the active ingredients in the most commonly-used, top recommended pain fighters, 81% answered at least one question incorrectly about the effects of these medications.
    • A Loss for Words: 62% of U.S. adults feel they aren't able to effectively communicate the everyday pain they experience – to their friends, partners and even their doctors.

    To help consumers better identify and address their own everyday aches and pains, Advil is introducing a more modern way to talk about it. No longer will a rigid sad-to-happy-face scale guide how we describe our pain. Instead, a modernized scale will expand our pain lexicon with the common symbols we already use every day: emojis.

    To help consumers better identify and address their own everyday aches and pains, Advil is introducing a modernized scale to expand our pain lexicon with the common symbols we already use every day: emojis.

    Most adults favor putting a digital-era spin on the traditional graphic scale that was initially developed for use with children. More than half (53%) say an emoji chart with multiple types of pain depicted better represents the pain they feel from a body pain than a sad-to-happy face scale. With Advil's new pain scale, consumers will be better able to express their pain, and with Advil Dual Action, people everywhere have a new option for fast, powerful pain relief.

    Advil Dual Action is now available online and on retail shelves nationwide.

    About Advil Dual Action

    Advil Dual Action is an exclusive pain-fighting formula, combining ibuprofen and acetaminophen to fight pain in two ways. Ibuprofen is a nonsteroidal anti-inflammatory (NSAID) that targets pain at the source, temporarily reducing the production of prostaglandins, which cause swelling and pain signals. Acetaminophen is a pain reliever that blocks the transmission of pain signals to the brain. Advil Dual Action will be available over-the-counter nationwide in 2020.

    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 Advil Dual Action

    Before using the product, consumers should read the Advil Dual Action drug facts label.

    About GSK

    We are 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. The new drug application for Advil Dual Action was approved under the Pfizer name. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

    *Methodological Notes

    The Advil Survey was conducted by Wakefield Research (www.wakefieldresearch.com) among 1,000 nationally representative US adults ages 25-65, between July 16th and July 22nd, 2020, using an email invitation and an online survey. Quotas have been set to ensure reliable and accurate representation of the US adult population ages 25-65.

    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 interviews had been conducted with all persons in the universe represented by the sample.

    Media Inquiries:















    GSK Consumer Healthcare

    Caitlin Kormann

    +1 617 448 0557

    (Warren)

    Edelman

    Jessica Moschella

    +1 201 953 1547

    (New York City)

     

    GSK Consumer Healthcare (PRNewsFoto/GSK Consumer Healthcare) (PRNewsfoto/GSK Consumer Healthcare)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gsk-consumer-healthcare-introduces-the-biggest-innovation-in-the-us-over-the-counter-oral-pain-relief-category-in-25-years-new-advil-dual-action-with-acetaminophen-301125691.html

    SOURCE GSK Consumer Healthcare

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    • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- The CEOs of AstraZeneca (NYSE:AZN), BioNTech SE (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed…

    • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- The CEOs of AstraZeneca (NYSE:AZN), BioNTech SE (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.



    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.



    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.



    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    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/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273.  If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others:  no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September 8, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions,  cost containment initiatives and subsequent changes thereto, and  the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

    AstraZeneca Media Contact:

    Michele Meixell

    +1 (302) 885-2677

    BioNTech Media Contact:

    Jasmina Alatovic

    +49 (0)6131 9084 1513 or +49 (0)151 1978 1385

    GlaxoSmithKline Media Contact:

    Simon Moore

    +44 (0)20 8047 5502

    Johnson & Johnson Media Contact:

    Jake Sargent

    +1 (202) 569-5086

    Merck Media Contact:

    Patrick Ryan

    +1 (973) 275-7075

    Moderna Media Contact:

    Colleen Hussey

    +1 (203) 470-5620

    Novavax Media Contacts:

    Edna Kaplan



    Amy Speak

    Pfizer Media Contact:

    Amy Rose

    +1 (212) 733-7410

    Sanofi Media Contact:

    Ashleigh Koss

    +1 (908) 205-2572

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  4. -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned…

    -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.
    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    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/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others: no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September [8], 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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