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Novartis AG (NVSEF)

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82.84-0.81 (-0.97%)
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Previous Close83.65
Open82.84
Bid0.00 x 0
Ask0.00 x 0
Day's Range82.84 - 82.84
52 Week Range68.65 - 98.00
Volume70,595
Avg. Volume34,075
Market Cap189.725B
Beta (5Y Monthly)0.41
PE Ratio (TTM)26.41
EPS (TTM)3.14
Earnings DateN/A
Forward Dividend & Yield3.08 (3.69%)
Ex-Dividend DateMar. 03, 2020
1y Target EstN/A
  • Pharma Stock Roundup: ABBV, MRK Q2 Earnings & Coronavirus Updates in Focus
    Zacks

    Pharma Stock Roundup: ABBV, MRK Q2 Earnings & Coronavirus Updates in Focus

    Sanofi (SNY)/Glaxo (GSK) and J&J (JNJ) sign deals with U.S. government for coronavirus vaccine candidate. Several drugmakers announce second-quarter results.

  • Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis
    GlobeNewswire

    Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

    * Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1   * ASCLEPIOS I and II demonstrated significant reductions in risk of relapses, confirmed disability worsening and profound reduction of active or new brain lesions1   * The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults   * If approved, ofatumumab will be the first B-cell therapy that can be self-administered at home and has the potential to become a first-choice treatment for use in RMS patients The digital press release with multimedia content can be accessed here: Basel, August 5, 2020 — Novartis today announced that The New England Journal of Medicine (NEJM) published the positive results from the ASCLEPIOS I and II studies evaluating the safety and efficacy of ofatumumab (OMB157) 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with relapsing forms of multiple sclerosis (RMS). Both studies met the primary endpoints where ofatumumab showed a significant reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR)1.“ASCLEPIOS I and II demonstrate the efficacy and safety of ofatumumab and its potential to become a first-choice treatment option that offers RMS patients the flexibility as they continue to live their lives,” said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis. “Ofatumumab is a testament to our commitment to advance science and investigate potential treatments that reimagine care and address significant unmet needs at all parts of the RMS journey.”Results from the ASCLEPIOS I and II studies showed that compared with teriflunomide, ofatumumab: * Significantly reduced the ARR by 51% (0.11 vs 0.22) and 58% (0.10 vs 0.25) in ASCLEPIOS I and II, respectively (P<.001 in both studies) (primary endpoints)1 * Showed a relative risk reduction of 34% (P=.002) in 3-month confirmed disability worsening (CDW) and 32% (P=.01) in 6-month CDW in a pre-specified meta-analysis, as defined in ASCLEPIOS (disability-related secondary endpoints)1 * Showed significant reduction of both gadolinium enhancing (Gd+) T1 lesions with a 97% and 94% relative reduction in ASCLEPIOS I and II, respectively, (both P<.001), and an 82% and 85% relative reduction in new or enlarging T2 lesions in ASCLEPIOS I and II, respectively (both P<.001) (MRI-related secondary endpoints)1 * Showed superiority in reducing neuroaxonal damage in both studies, as measured by neurofilament light chain (NfL) serum concentrations (biomarker secondary endpoint)1; axonal loss, which begins at disease onset, is a detrimental consequence of central nervous system (CNS) inflammation and is a major determinant of irreversible neurological disability in MS patients2 * Demonstrated a favorable trend in rate of 6-month confirmed disability improvement (CDI) events but did not reach significance (disability-related secondary endpoint)1 * Showed the annual rate of brain volume loss was not significantly different (MRI-related secondary endpoint)1 * Demonstrated an overall safety profile similar to teriflunomide, the frequency of serious infections and neoplasms was similar across both treatment groups. Injection-related reactions, nasopharyngitis, headache, injection-site reactions, upper respiratory tract infection and urinary tract infection were the most commonly observed adverse events across both treatment groups, occurring in ≥10% of patients1,3“The ASCLEPIOS studies found that ofatumumab produced a significant reduction in new inflammation, as well as fewer clinical relapses and progression events,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies. “A separate post hoc analysis demonstrated that nearly 9 out of 10 patients experienced no evidence of disease activity in the second year of treatment4. Ofatumumab represents a potential new option for RMS patients with greater efficacy compared to teriflunomide, a comparable safety profile, and the convenience of once monthly self-administration without the need for infusions."These data were published in the August 6, 2020 issue of The New England Journal of Medicine.In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. If approved, ofatumumab will be the first B-cell therapy that can be self-administered at home and has the potential to become a first-choice treatment for use in RMS patients.Regulatory approval for ofatumumab in the US is expected in September 2020 and in Europe by Q2 2021. Novartis is committed to bringing ofatumumab to patients worldwide and additional regulatory filings are currently underway.About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously1,3. As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion5. The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen6. Once-monthly dosing of ofatumumab also allows faster repletion of B-cells and offers flexibility7. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20158.About ASCLEPIOS I and II studies The ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with RMS. The ASCLEPIOS I and II studies enrolled 1882 patients with MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.51. The studies were conducted in over 350 sites in 37 countries9. Ofatumumab demonstrated a significant reduction in ARR by 51% (0.11 vs 0.22) and 58% (0.10 vs 0.25) compared with teriflunomide (P<.001 in both studies) in ASCLEPIOS I and II, respectively (primary endpoint). Ofatumumab also showed a relative risk reduction of 34% (P=.002) in 3-month CDW and 32% (P=.01) in 6-month CDW compared with teriflunomide in a pre-specified meta-analysis, as defined in ASCLEPIOS1. Ofatumumab showed significant reduction of both Gd+ T1 lesions and new or enlarging T2 lesions. It significantly reduced the mean number of both Gd+ T1 lesions (97% and 94% relative reduction in ASCLEPIOS I and II, respectively, both P<.001) and new or enlarging T2 lesions (82% and 85% relative reduction in ASCLEPIOS I and II, respectively, both P<.001) vs teriflunomide1. Ofatumumab demonstrated that it lowered NfL levels in serum at the first assessment at Month 3 compared with teriflunomide. There was no difference in slope of brain volume change from baseline between treatments. In a measure of 6-month CDI events, a favorable trend for ofatumumab was seen but this did not reach significance vs teriflunomide1. Ofatumumab had a similar safety profile to teriflunomide, with the frequency of serious infections and neoplasms also being similar across both treatment groups1. Injection-related reactions, nasopharyngitis, headache, injection-site reactions, upper respiratory tract infection and urinary tract infection were the most commonly observed adverse events across both treatment groups, occurring in ≥10% of patients1.Overall, ofatumumab, a fully-human antibody targeting CD20 positive B-cells, delivered superior efficacy and demonstrated a safety profile with infection rates similar to teriflunomide1. About Multiple Sclerosis Multiple sclerosis (MS) is a chronic inflammatory disease of the CNS characterized by myelin destruction and axonal damage of the brain, optic nerves and spinal cord10. MS, which affects approximately 2.3 million people worldwide11, can be characterized into four main types of MS: clinically isolated syndrome (CIS), relapsing remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)12. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease10.Novartis in Neuroscience Novartis has a strong ongoing commitment to neuroscience and to bringing innovative treatments to patients suffering from neurological conditions where there is a high unmet need. We are committed to supporting patients and physicians in multiple disease areas, including MS, migraine, Alzheimer's disease, Parkinson's disease, epilepsy and attention deficit hyperactivity disorder, and have a promising pipeline in MS, Alzheimer's disease, spinal muscular atrophy and specialty neurology. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.Dr. Hauser’s statements reflect his professional opinion and not necessarily the views of The Regents of the University of California. Nothing in his statements shall be construed to imply any support or endorsement of Novartis, or any of its products, by The Regents of the University of California.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at  https://www.novartis.com.Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.comReferences 1.    Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med 2020;383:546-57.https://www.nejm.org. 2.    Bjartmar C, Wujek JR, Trapp BD. Axonal loss in the pathology of MS: consequences for understanding the progressive phase of the disease. J Neurol Sci. 2003;206(2):165–71. 3.    Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at: ACTRIMS; February 2020; West Palm Beach, FL. 4.    Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(S1). 5.    Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presentation at: ECTRIMS; September 2016; London, UK. 6.    Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: ECTRIMS; September 2016; London, UK. 7.    Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-Cell recovery time following discontinuation of anti-CD20 therapies. ePoster presentation at: ECTRIMS; October 2017; Paris, FR. 8.    Genmab Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Accessed June 17, 2020. https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d 9.    Kappos L, Bar-Or A, Comi G, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: baseline characteristics of two pivotal phase 3 trials (ASCLEPIOS I and ASCLEPIOS II). Poster presentation at: ECTRIMS; October 2018; Berlin, Germany. 10.  Guthrie E. Multiple sclerosis: a primer and update. Adv Studies Pharm. 2007;4(11):313-317. 11.  Multiple Sclerosis International Federation. Atlas of MS 2013-Mapping Multiple Sclerosis Around the World. Accessed July 10, 2020. http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf 12.  National MS Society. Types of MS. Accessed May 20, 2020. https://www.nationalmssociety.org/What-is-MS/Types-of-MS Novartis Media Relations E-mail: media.relations@novartis.comAntonio Ligi Novartis External Communications +41 79 723 3681 (mobile) antonio.ligi@novartis.com     Eric Althoff Novartis US External Communications +1 862 778 3243 +1 646 438 4335 eric.althoff@novartis.com Michael Amos Novartis Global Pharma Communications +41 61 324 2705 (direct) +41 79 123 7806 (mobile) michael.amos@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.comCentral   North America   Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052 Thomas Hungerbuehler  Isabella Zinck +41 61 324 8425 +41 61 324 7188

  • GlobeNewswire

    Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma

    * Global ELARA trial demonstrated clinically meaningful benefit in patients with relapsed or refractory (r/r) follicular lymphoma (FL) as measured by complete response rate   * Kymriah previously received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for this cancer type   * ELARA trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following. Results will be presented at an upcoming medical meeting   * Interim analysis comes alongside milestones of 3,000th batch of CAR-T cells manufactured for patients worldwide and approval for commercial manufacturing at two additional sites in EuropeBasel, August 4, 2020 — Novartis today announced positive results from the Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. CRR is a standard measure of patient response to therapy in FL. No new Kymriah safety signals were observed. Results from the ELARA trial will be presented at an upcoming medical meeting and included in US and EU regulatory submissions.Kymriah was the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients’ immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1.“We are pleased that Kymriah is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “These results further support our efforts to reimagine medicine in this incurable malignancy and reach this underserved patient population, who are historically burdened with several years of various treatments.”Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia, which was first-of-its-kind in CAR-T research and development.Kymriah is currently approved for use in at least one indication in more than 25 countries and at more than 250 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need. As Novartis prepares for the launch of a potential third indication for Kymriah, manufacturing capacity continues to ramp up. The Novartis global CAR-T manufacturing footprint spans seven facilities total, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the manufacturing and supply chain. With recent approvals from the European Medicines Agency (EMA), commercial manufacturing of Kymriah is now ongoing at the Novartis-owned facilities in Stein, Switzerland and Les Ulis, France, joining the Novartis-owned facility in Morris Plains, New Jersey, USA.About Follicular Lymphoma Follicular lymphoma, the second most common form of non-Hodgkin lymphoma (NHL), is an indolent lymphoma, and represents approximately 22% of NHL cases2,3. Despite new treatments that improve overall survival, FL is regarded as an incurable malignancy with a relapsing and remitting pattern4,5. Throughout the lifetime of a patient with relapsing FL, they may be exposed to a median of five lines of prior treatment, with an upper range of 12 lines6,7. Although patients in third or later line treatment for FL have multiple systemic therapies available, the efficacy of these regimens drops off rapidly in later lines5. Additionally, because of this relapsing and remitting pattern, patients who are refractory to treatment or quickly relapse may exhaust available treatment options5.About the ELARA trial ELARA is a Phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of Kymriah in adult patients with r/r FL. This international trial has enrolled patients from over 30 sites in 12 countries worldwide.In Q2 2020, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah in r/r FL, based on preliminary results from the ELARA trial. RMAT designation is intended to expedite the development and review of Kymriah as a regenerative therapy for this underserved patient population.About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis’ commitment to CAR-T cell therapy.Kymriah® (tisagenlecleucel) US Important Safety information Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient's healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.  Please see the full Prescribing Information for Kymriah, including Boxed WARNING, and Medication Guide at www.Kymriah.comDisclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.comNovartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.comReferences 1. Kymriah Prescribing Information. 2. The Non-Hodgkin’s Lymphoma Classification Project. Blood. 1997;89:3909–3918. 3. Anderson J., et al. Epidemiology of the non-Hodgkin’s lymphomas: distributions of the major subtypes differ by geographic locations. Non-Hodgkin’s Lymphoma Classification Project. Ann Oncol. 1998;9(7):7;17–720. 4. Wudhikarn, K., et al. Comparative effectiveness research in follicular lymphoma: current and future perspectives and challenges. J Comp Eff Res. 2014. 5. Sutamtewagul, G. & Link, B.K. Novel treatment approaches and future perspectives in follicular lymphoma. Ther Adv Hematol. 2019;10:1–20. 6. Data on File, Novartis, 2020. 7. Schuster, S., et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas. NEJM. 2017;377(26):2545–2554. Novartis Media Relations E-mail: media.relations@novartis.comAnja von Treskow Novartis External Communications +41 79 392 8697 anja.von_treskow@novartis.com   Eric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.comFiona Phillips Novartis Oncology Communications +1 862 217 9396 fiona.phillips@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.comCentral North America  Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052 Thomas Hungerbuehler+41 61 324 8425   Isabella Zinck+41 61 324 7188