Year Established: 1996
Revenue: $48,659 (+3%)
Net Income: $8,071 (+13)
R&D Expenses: $8,980 (-4%)
TOP SELLING DRUGS
|Cosentyx||Psoriasis, Arthritis psoriatic, Ankylosing spondylitis||$3,995||13%|
|Entresto||Chronic heart failure (CHF)||$2,497||45%|
|Tasigna||Leukaemia, chronic myeloid (CML)||$1,958||4%|
|Lucentis||Wet age-related macular degeneration||$1,933||-7%|
|Promacta||Thrombocytopaenic purpura, idiopathic||$1,738||23%|
|Tafinlar + Mekinist||Melanoma, Non-small cell lung cancer||$1,542||15%|
Maintaining its innovation momentum in 2020, Novartis received 26 approvals for new treatments as well as new indications for existing treatments in the U.S., EU, Japan and China. Additionally, the company continued the expansion of its manufacturing network for CAR-T therapies and business services and is progressing its next wave of medicines with key new approvals for Kesimpta and Tabrecta in the U.S., and Leqvio for hyperlipidemia and Zolgensma in the EU, and Cosentyx in non-radiographic axial spondyloarthritis, and Adakveo and Piqray in the EU. Novartis also added assets via acquisitions in neuroscience, gene therapy and oncology.
Pharmaceutical sales growth for the year was mainly driven by Entresto, Zolgensma and Cosentyx, partly offset by price erosion and the negative impact from generic competition, while COVID-19 negatively impacted demand, particularly in ophthalmology, dermatology and Sandoz retail. Innovative Medicines sales were up 3% to $39 billion in 2020 with Entresto sales up 45%, Zolgensma sales reached $0.9 billion, Cosentyx sales were up 13% and Ilaris sales were up 31%. Growth was partly offset by declines in Gilenya, and lower demand for Lucentis due to COVID-19. In August, the US District Court for the District of Delaware upheld validity of Gilenya (fingolimod) dosage regimen patent. In oncology, sales growth was driven by Promacta/Revolade, up 23%, Jakavi up 20%, Kisqali up 45%, Tafinlar + Mekinist up 16%, and Piqray reached $0.3 billion, partly offset by generic competition mainly for Afinitor and Exjade.
Moving up the top seller list, Tafinlar (dabrafenib) + Mekinist (trametinib) was confirmed as standard-of-care, targeted therapy for advanced BRAF-mutated melanoma, based on unprecedented progression-free survival results. Data show positive durable responses and progression-free survival benefit for patients treated with the combo therapy.
Novartis expanded its Kymriah manufacturing footprint this past October, with the Foundation for Biomedical Research and Innovation (FBRI) in Kobe, Japan becoming the first CAR-T cell therapy commercial manufacturing site in Asia. The company’s global CAR-T manufacturing footprint now spans four continents and the recent FDA approval for further capacity expansion in the U.S. enables increased production of Kymriah.
Additionally, Novartis recently received approval from the Therapeutic Goods Administration (TGA) for Cell Therapies to manufacture and supply its CAR-T therapies commercially for eligible patients in Australia. The Cell Therapies manufacturing facility in the Peter MacCallum Cancer Center in Melbourne is the first and only approved commercial manufacturing site for CAR-T cell therapies in the country.
Novartis’ CAR-T manufacturing network comprises seven facilities and includes commercial and clinical trial manufacturing at facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, NJ, as well as at contract manufacturing sites at Fraunhofer-Institut for Cell Therapy and Immunology facility in Leipzig, Germany, FBRI in Kobe, Japan, and now Cell Therapies in Australia.
Furthering its advanced therapy efforts, the company renamed the previously acquired AveXis to Novartis Gene Therapies. Building on the success of Zolgensma (onasemnogene abeparvovec), a therapy for children with spinal muscular atrophy, the division will be responsible for the research, development, manufacturing and commercialization of the next wave of AAV-based gene therapies, and will also provide manufacturing support for gene therapy work conducted by other Novartis units.
Bolstering its generis biz, this past February, Sandoz, a Novartis division, signed an agreement to acquire GSK’s cephalosporin antibiotics business for $350 million, plus potential milestones of up to $150 million. The acquisition includes three established brands sold in more than 100 markets, including leading global brand Zinnat, which aligns with Sandoz antibiotics strategy following plans to expand its manufacturing site in Kundl, Austria, where Novartis invested €150 million to help ensure long-term antibiotic manufacturing and supply resilience. The transaction bolsters Sandoz leadership in generic penicillins with cephalosporins, the largest antibiotic segment by global sales.
Novartis joined the pharma-wide effort to meet global demand for COVID-19 vaccines to help alleviate manufacturing bottlenecks. Even though Novartis no longer has a vaccine business, it does have extensive and diverse manufacturing operations. The company is collaborating to help manufacture two different mRNA-based COVID-19 vaccines, Pfizer-BioNTech’s vaccine and CureVac’s vaccine, leverage its manufacturing capacity and capabilities at its aseptic facilities in Stein, Switzerland.
Additional COVID endeavors include an ongoing partnership with Molecular Partners to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin program for potential medicines for the prevention and treatment of COVID-19. DARPin therapeutics are a new class of custom-built protein drugs and recent results suggest COVID-19 antiviral candidate, Ensovibep, maintains potent neutralization against emerging viral variants in vitro. An ongoing Phase II Study in ambulatory patients is now expanding into a second cohort.
Novartis agreed to acquire Cambridge, MA-based neuroscience company, Cadent Therapeutics, adding two new clinical stage programs, one for schizophrenia and the other for movement disorders, and MIJ821, a clinical stage molecule previously licensed by Novartis for treatment-resistant depression.
Also, in October, Novartis acquired Vedere Bio, adding novel optogenetic gene therapy technology for treating blindness, expanding it footprint in ophthalmology with two pre-clinical optogenetic programs, and enhancing its position in the AAV-based gene therapy arena with novel delivery technology for treating inherited retinal dystrophies and atrophy.
Lastly, Novartis expanded its oncology pipeline in-licensing tislelizumab from BeiGene, and a library of Fibroblast Activation Protein (FAP) assets, including FAPI-46 and FAPI-74, from iTheranostics. Tislelizumab is an anti-PD-1 monoclonal antibody for monotherapy and in combination with cancer therapies in Novartis’ portfolio. It’s anticipated Tislelizumab will be key asset in Novartis’ immuno-oncology combination strategy. Tislelizumab is approved for Hodgkin’s lymphoma and metastatic urothelial carcinoma in China, and 15 trials are under way in non-small cell lung cancer (NSCLC) and other solid tumors.
Novartis gained exclusive worldwide rights to develop and commercialize FAP assets FAPI-46 and FAPI-74 in tumors or in tumor stroma. These targeted radioligand therapies are a type of precision medicine with high-affinity for specific tumor cells, while surrounding healthy tissue is less affected.
Of the more than 40 assets in development, several significant pipeline advances include Beovu, Jakavi, asciminib and iptacopan, including FDA Breakthrough Therapy Designations (BTD) for asciminib, iptacopan, and ligelizumab.
A Phase III study in diabetic macular edema (DME) met its primary endpoint, with Beovu demonstrating non-inferiority to aflibercept in change in best-corrected visual acuity at year one. Following positive results from another phase III study in DME, a submission is planned for 1H21.
Asciminib, an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP), was granted BTD for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, and for the treatment of Ph+ CML harboring the T315I mutation.
Additionally, results from a Phase III study demonstrate Jakavi significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy. Results also demonstrate significant improvements in failure-free survival and patient-reported symptoms.