Novartis AG (Novartis) operates as a medicines company engages in the research, development, manufacturing, distribution, marketing, and sale of a broad range of innovative pharmaceutical medicines.
The company’s strategy is to focus on high-value, innovative medicines that alleviate society’s greatest disease burdens through technology leadership in R&D and novel access approaches. To support the company’s strategy, it has clear focus areas where it commits most of its time, energy and resourc...
Novartis AG (Novartis) operates as a medicines company engages in the research, development, manufacturing, distribution, marketing, and sale of a broad range of innovative pharmaceutical medicines.
The company’s strategy is to focus on high-value, innovative medicines that alleviate society’s greatest disease burdens through technology leadership in R&D and novel access approaches. To support the company’s strategy, it has clear focus areas where it commits most of its time, energy and resources. These core therapeutic areas are cardiovascular, renal and metabolic; immunology; neuroscience; and oncology.
The company’s products are sold in approximately 120 countries around the world.
The company’s operations are organized into the following five organizational units:
Biomedical Research is the company’s innovation engine, focused on creating new ways of fighting disease and turning scientific breakthroughs into new medicines with the potential to change lives.
Development oversees the development of potential new medicines through clinical trials to confirm their safety and efficacy and steers the way to regulatory approval for use by patients.
Operations manufactures and delivers its medicines to customers, while also overseeing the global functions of IT, procurement, and real estate services.
The two commercial units, U.S. and International, focus on their respective geographic areas. They work with customers to provide innovative medicines and services that improve treatment options and raise the quality of care for patients.
Key marketed products
The following summaries describe certain Novartis key marketed products in certain indications:
While the company typically seek to sell its marketed products throughout the world, not all products and indications are available in every country. The indications described in these summaries may therefore vary by country. In addition, a product may be available under different brand names depending on country and indication.
Entresto (sacubitril/valsartan) is an oral, first-in-class angiotensin receptor-neprilysin inhibitor. Entresto enhances the protective effects of a hormone system called the natriuretic peptide system, and simultaneously suppresses the harmful effects of a hormone system called the renin-angiotensin-aldosterone system. It is approved:
In the U.S, the EU and other countries to treat adults who have symptomatic chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a disease in which the heart cannot pump blood efficiently.
In the U.S and other countries to treat adult patients with chronic heart failure with preserved ejection fraction (HFpEF). HFpEF is a disease in which the heart’s main pumping chamber (left ventricle) becomes stiff and unable to fill properly with blood.
In the U.S, the EU and other countries to treat children and adolescents aged 1 year and older who have symptomatic chronic heart failure with left ventricular systolic dysfunction.
In China, Japan and other countries to treat adult patients with essential hypertension (abnormally high blood pressure that is not the result of a medical condition).
Cosentyx (secukinumab) is an injectable, fully human monoclonal antibody that selectively inhibits interleukin-17A (IL-17A), a cytokine involved in several immunological diseases. It is approved in the U.S., the EU and other countries to treat:
Adults and children aged 6 years and older with moderate-to-severe plaque psoriasis (this indication is also approved in China). Psoriasis is a debilitating systemic inflammatory disease that is characterized by the appearance of raised, red patches on the skin.
Adults with active non-radiographic axial spondyloarthritis (nr-axSpA). nr-axSpA is a long-term inflammatory disease that is characterized by chronic back pain and is not visible on X-rays.
Adults and children (aged 2 years and older in the U.S. and 6 years and older in the EU) with active psoriatic arthritis (PsA). PsA is a type of progressive inflammatory arthritis that results in swollen and painful joints and tendons, which can cause structural damage to the bones and joints.
Adults with active ankylosing spondylitis (AS). AS is a progressive inflammatory disease that is characterized by chronic back pain, is generally visible on X-rays, and can cause structural damage to the bones and joints.
Children (aged 4 years and older in the U.S. and 6 years and older in the EU) with active enthesitis-related arthritis (ERA) and children (aged 2 years and older in the U.S. and 6 years and older in the EU) with active juvenile psoriatic arthritis (JPsA). ERA and JPsA are subtypes of juvenile idiopathic arthritis. If left untreated, they can lead to high levels of pain and disability.
Adults with moderate to severe hidradenitis suppurativa (HS). HS is a chronic skin disease that causes recurring boil-like lumps that may burst into open wounds and cause irreversible scarring, often in the most intimate parts of the body.
An intravenous formulation of Cosentyx is approved in the U.S. for the treatment of adults with active PsA, AS and nr-axSpA.
Kesimpta (ofatumumab) is an anti-CD20 monoclonal antibody that enables the targeted depletion of B-cells, specifically in lymph nodes. Kesimpta is the only B-cell treatment for relapsing multiple sclerosis that is self-administered once-monthly via the Sensoready autoinjector pen, following three weekly starter doses. It is approved:
In the U.S. to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis. Multiple sclerosis is a disease in which the immune system attacks the protective covering of nerves (known as myelin).
In the EU to treat adults with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features (i.e., relapse, disability, or lesions detected by MRI scans).
Approved indications vary across other countries. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline (GSK). Novartis obtained the rights to ofatumumab from GSK across all indications.
Kisqali (ribociclib) is a selective oral cyclin-dependent inhibitor of kinases 4 and 6 (CDK4/6) – two enzymes involved in the control of cell cycle progression. Kisqali is approved in the U.S., the EU and other countries to treat:
Pre-, peri- and postmenopausal women, and men (U.S. and other countries), with locally advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, in combination with an aromatase inhibitor as initial endocrine-based therapy. HR+/HER2- breast cancer is the most common subtype of breast cancer.
Pre-, peri- (EU) and postmenopausal women, and men (U.S.), with locally advanced or metastatic HR+/HER2- breast cancer, in combination with fulvestrant, as a first- or second-line therapy.
Adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as an adjuvant treatment in combination with an aromatase inhibitor (U.S.).
Patients with HR+/HER2- early breast cancer at high risk of recurrence, as an adjuvant treatment in combination with an aromatase inhibitor (EU).
Kisqali was developed by the company’s Biomedical Research organizational unit (formerly the Novartis Institutes for BioMedical Research) under a research collaboration with Astex Pharmaceuticals.
Promacta/Revolade (eltrombopag) is a once-daily oral thrombopoietin receptor agonist that works by stimulating bone marrow cells to produce platelets. It is approved in the U.S., the EU and other countries to treat:
Immune thrombocytopenia (ITP) in patients who have had an insufficient response to or have failed previous therapies. ITP is a bleeding disorder caused by an unusually low number of platelets.
Thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
Patients with severe aplastic anemia (SAA). SAA is a condition in which the body does not produce enough blood cells.
Promacta/Revolade is marketed under a research, development and license agreement between Novartis and RPI Finance Trust (dba Royalty Pharma), as assignee of Ligand Pharmaceuticals.
Tafinlar + Mekinist (dabrafenib + trametinib) is an oral combination therapy. Tafinlar and Mekinist are kinase inhibitors of the BRAF and MEK1/2 proteins, respectively, approved in combination to treat patients who have certain types of cancer with a change in the BRAF gene (called a BRAF V600 mutation), including:
Adults in the U.S., the EU and other countries with unresectable or metastatic melanoma with a BRAF V600 mutation. Melanoma is a form of skin cancer; unresectable melanoma cannot be removed with surgery and metastatic melanoma has spread to other parts of the body. Tafinlar and Mekinist are also approved as single agents for this indication.
Adults in the U.S., the EU and other countries with stage III melanoma with a BRAF V600 mutation as an adjuvant treatment (following surgery).
Adults in the U.S., the EU and other countries with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. NSCLC is the most common type of lung cancer.
Adults and children aged 1 year and older in the U.S. and other countries with unresectable or metastatic solid tumors with a BRAF V600E mutation whose cancer has progressed following prior treatment and who have no satisfactory alternative treatment options.
Children aged 1 year and older in the U.S., the EU and other countries with low-grade glioma with a BRAF V600E mutation who require systemic therapy. Low grade gliomas are tumors that develop from brain cells.
Approved indications and pharmaceutical forms vary by country. Tafinlar is provided in capsules and dispersible tablets. Mekinist is provided in tablets and powder for oral solution. Novartis has worldwide exclusive rights to develop, manufacture and commercialize trametinib granted by Japan Tobacco Inc.
Jakavi (ruxolitinib) is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases. It is the first JAK1/JAK2 inhibitor approved in the EU and other countries to treat:
Adults with myelofibrosis (MF), including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. MF is a rare blood cancer characterized by abnormal blood cell production and scarring in the bone marrow, which can lead to an enlarged spleen.
Adults with polycythemia vera (PV) who are resistant or intolerant to a medication called hydroxyurea. PV is a rare blood cancer in which the bone marrow produces too many red blood cells, resulting in serious problems like clots.
Patients aged 12 years and older with acute or chronic graft-versus-host disease (GvHD) and who have had an inadequate response to corticosteroids or other systemic therapies. GvHD occurs in stem-cell transplant patients when donor cells see the recipient’s healthy cells as foreign and attack them.
Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization in the indications of oncology, hematology and GvHD outside the U.S. Incyte Corporation markets ruxolitinib as Jakafi in the U.S.
Tasigna (nilotinib) is a twice-daily oral tyrosine kinase inhibitor that acts by blocking the BCR-ABL protein. It is approved in the U.S, the EU and other countries to treat:
Patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic and/or accelerated phase who are resistant or intolerant to existing treatment. Ph+ CML is a cancer that starts in the blood-forming cells of bone marrow.
Newly diagnosed adults and children with Ph+ CML in the chronic phase.
Xolair (omalizumab) is an injectable prescription medicine, and the only approved antibody designed to target and block immunoglobulin E (IgE). It is approved in the U.S., the EU and other countries to treat:
Adults and children aged 6 years and older with moderate-to-severe, or severe, persistent allergic asthma.
Adults and children aged 12 years and older with chronic spontaneous urticaria/chronic idiopathic urticaria (hives).
Adults with nasal polyps or severe chronic rhinosinusitis with nasal polyps (CRSwNP). CRSwNP is a chronic inflammation of the nose and the sinuses with the presence of benign lesions (nasal polyps) on the lining of the nasal sinuses or nasal cavity.
Approved indications and pharmaceutical forms vary by country. Xolair is provided as lyophilized powder for reconstitution, and as liquid formulation in a pre-filled syringe and pre-filled pen. Novartis co-promotes Xolair with Genentech in the U.S. and shares a portion of operating income, but Novartis does not record any U.S. sales. Novartis records all the sales of Xolair outside the U.S.
Ilaris (canakinumab) is an injectable, selective, high-affinity, fully human monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), a key cytokine in the inflammatory pathway. It is approved in the U.S., the EU and other countries to treat patients with certain debilitating rare autoinflammatory disorders, including:
Adults and children with periodic fever syndromes. Periodic fever syndromes are a set of rare disorders characterized by recurrent episodes of illness, with fever as the main symptom.
Patients with Still’s disease, including systemic juvenile idiopathic arthritis and adult-onset Still’s disease. Still’s disease is a disorder that causes fevers, rash, and joint pain.
Adults with acute gouty arthritis (a non-rare indication). Gouty arthritis is a type of arthritis characterized by pain, redness, tenderness, and swelling in one or more joints. Approved indications vary by country.
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). Pluvicto delivers beta radiation selectively to PSMA-positive cells and the surrounding cells while minimizing off-target effects. It is approved in the U.S., the EU and other countries to treat:
Adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC), a type of advanced cancer that has spread to other parts of the body (metastatic). These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).
Sandostatin SC (octreotide acetate for injection) and Sandostatin LAR (octreotide acetate for injectable suspension) are somatostatin analogs approved in the U.S., the EU and other countries to treat:
Adults with acromegaly that is inadequately controlled by surgery or radiotherapy. Acromegaly is a chronic disease caused by the oversecretion of growth hormone.
Patients with certain symptoms associated with carcinoid tumors and other types of functional gastrointestinal and pancreatic neuroendocrine tumors.
Sandostatin LAR is also approved in the EU and other countries to treat patients with advanced neuroendocrine tumors of the midgut or of unknown primary tumor origin.
Zolgensma (onasemnogene abeparvovec) is a one-time intravenous gene therapy designed to address the genetic root cause of spinal muscular atrophy (SMA) by replacing the function of the missing or nonworking SMN1 gene. Zolgensma delivers a new working copy of the human SMN gene into a patient’s cells. It is approved in the U.S., the EU and other countries to treat:
Babies and young children who have SMA with biallelic mutations in the SMN1 gene. SMA is a rare, genetic neuromuscular disease resulting in the progressive and irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing, and basic movement. Approved indications vary by country.
Lucentis (ranibizumab) is a humanized, high-affinity antibody fragment that binds to vascular endothelial growth factor A (VEGF-A), a protein that can cause the growth of blood vessels in the eye, potentially leading to vision loss. Lucentis is an anti-VEGF therapy that is injected into the eye. It is approved in the EU and other countries to treat patients with certain eye conditions, including:
Adults with neovascular (wet) age-related macular degeneration (AMD). Wet AMD develops when abnormal blood vessels grow under the macula and leak blood and other fluids in the back of the eye, which damages the macula.
Adults with proliferative diabetic retinopathy, moderately severe to severe non-proliferative diabetic retinopathy, and/or visual impairment due to diabetic macular edema. These conditions are complications of diabetes.
Adults with visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). Retinal vein occlusion is a blockage of the branch or central retinal veins, which carry blood away from the retina.
Approved indications vary by country. Lucentis is licensed from Genentech, and Novartis holds the rights to commercialize the product outside the U.S. Genentech holds the rights to commercialize Lucentis in the U.S.
Leqvio (inclisiran) is the first and only approved small-interfering RNA therapy to reduce LDL cholesterol, a risk factor for atherosclerotic cardiovascular disease (ASCVD), which is caused by plaque buildup in the arteries. Leqvio is administered by a healthcare professional twice a year as an injection, except in the first year of treatment where, following an initial dose, another dose is required after three months. It is approved:
In the EU and other countries to treat adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia as an adjunct to diet. Leqvio is used in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL cholesterol goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated. Primary hypercholesterolemia and mixed dyslipidemia are disorders characterized by high levels of fats (lipids) in the blood.
In the U.S. to treat adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), as an adjunct to diet and statin therapy to reduce LDL cholesterol. Primary hyperlipidemia, also known as high cholesterol, is characterized by high levels of fats in the blood.
Novartis obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, Inc.
Lutathera (lutetium Lu 177 dotatate/lutetium (177Lu) oxodotreotide) is an intravenous targeted radioligand therapy approved in the U.S., the EU and other countries to treat:
Patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). GEP-NETs are rare tumors found in the digestive tract. Approved indications vary by country.
Scemblix (asciminib) is an oral kinase inhibitor that works by binding to a part of the BCR-ABL protein called the ABL myristoyl pocket. It is approved:
In the EU and other countries to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) who have previously been treated with two or more tyrosine kinase inhibitors (TKIs). Ph+ CML is a cancer that starts in the blood-forming cells of bone marrow.
In the U.S. to treat both newly diagnosed, and previously treated adults with Ph+ CML in CP.
In the U.S. and other countries to treat adults with Ph+ CML in the chronic phase with the T315I mutation. The T315I mutation causes resistance to most available TKI therapies and, as a result, patients with this mutation would otherwise have limited treatment options.
Fabhalta (iptacopan) is an oral Factor B inhibitor of the alternative complement pathway, a part of the innate immune system involved in triggering inflammation and fighting infections. It is approved:
In the U.S., the EU and other countries to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare chronic blood disorder in which red blood cells are susceptible to premature destruction by the complement system.
In the U.S., for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression (generally UPCR =1.5 g/g). IgAN is a progressive, rare disease in which the immune system attacks the kidneys, which can cause glomerular inflammation and proteinuria.
Principal Markets
Novartis sells products in approximately 120 countries worldwide. Net sales are primarily concentrated in the U.S. and Europe.
Production
The manufacturing of the company’s product is highly regulated by governmental health authorities around the world, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). In addition to regulatory requirements, many of its products involve technically complex manufacturing processes or require highly specialized raw materials.
The company is continuing to integrate ADACAP manufacturing sites into its existing manufacturing and supply structure for radioligand therapies. The company manufactures its products across the following technologies at facilities worldwide: large molecules, small molecules, cell and gene therapy, xRNA therapy and radioligand therapy. It produces raw materials for manufacturing in-house or purchase them from third-party suppliers.
In the company’s manufacturing network, it maintains state-of-the-art processes, with quality as a priority, and require its suppliers to adhere to the same high standards it expects from its own people and processes. These processes include chemical and biological syntheses; radioisotope handling; sterile processing, including CAR-T cell processing; gene modification and delivery; and formulation and packaging.
Marketing and sales
Although specific distribution patterns vary by country, Novartis generally sells its prescription drugs primarily to drug wholesalers, retailers, private health systems, government agencies, managed care providers, pharmacy benefit managers, and government-supported healthcare systems. The company reaches healthcare professionals and patients in many markets and across its core therapeutic areas through integrated channels, including field force operations, patient support programs and Novartis-owned digital platforms. In the U.S., Novartis advertises certain products via digital and traditional media channels, including the internet, television, newspapers and magazines. Novartis also pursues co-promotion or co-marketing opportunities, as well as licensing and distribution agreements with other companies in various markets. Novartis is responding by adapting its business practices to engage appropriately with patients, customer groups and other stakeholders, including by delivering innovative solutions to drive education, access and improved patient care. The growing number of so-called specialty drugs in its portfolio, such as Cosentyx and Kesimpta, has resulted in increased engagement with specialty pharmacies.
Alliances and Acquisitions
In May 2024, Novartis acquired Mariana Oncology, a U.S. based, preclinical biotechnology company focused on developing novel radioligand therapies across a range of solid tumors. The acquisition brings a robust portfolio of RLT programs, including MC-339, an actinium-based RLT being investigated in small cell lung cancer.
In May 2024, Novartis acquired an 89.7% interest in MorphoSys AG, a German based biopharmaceuticals company, which owns the following assets: pelabresib (late-stage BET inhibitor for myelofibrosis) and tulmimetostat (early-stage dual EZH2 and EZH1 inhibitor for solid tumors or lymphomas). In October 2024, Novartis completed the acquisition of the remaining outstanding shares of MorphoSys AG, making MorphoSys AG a wholly-owned subsidiary of Novartis.
Additionally in October 2024, Novartis acquired Kate Therapeutics, Inc., a U.S. based, preclinical biotechnology company focused on developing adeno-associated viruses (AAV)-based gene therapies to treat genetically defined muscle and heart diseases.
Regulation
After receiving the marketing authorizations, the company must submit periodic safety reports to the relevant health authority (EMA for the centralized procedure, national health authorities for DCP or MRP).
Research and Development
The company’s research and development spending from continuing operations totaled USD 10.0 billion (non-IFRS measure core research and development from continuing operations USD 9.3 billion) for the year ended December 31, 2024.
Customers
A significant portion of the company’s global sales is made to a relatively small number of drug wholesalers, retail chains, and other purchasing organizations. For example, the company’s three most important customers globally accounted for approximately 17%, 13%, and 7%, respectively, of net sales from continuing operations in 2024.
Established Brands
Lucentis faces generic competition in the EU.
Sandostatin SC, there is generic competition in the U.S. and the EU.
Sandostatin LAR, there is generic competition in the U.S. and in most EU countries.
History
Novartis AG was incorporated in 1996 under the laws of Switzerland as a stock corporation (Aktiengesellschaft) with an indefinite duration.
