Novartis reported Tuesday that it has a leading portfolio of projects based on scale, innovation and future value, including 116 assets in phase I or II, 49 in phase III or in the process of registration and more than 65 new molecular entities.
The Novartis portfolio is expected to drive growth in the medium and long term, with around 90% of potential first-in-class/first-on-indication drugs and around 80% of targets in areas of high unmet need from patients.
The company is strengthening its advanced therapy platforms throughout the value chain with 20 advanced platform therapies in clinical development alongside a host of preclinical projects.
Novartis is also making significant progress in the manufacturing and commercialization of these advanced therapy platforms.
The total value of estimated sales of products launched from 2020 to 2026 places Novartis as number two in replacement energy projects in the global pharmaceutical industry.
The company is advancing sustained lifecycle management for many assets with five key programs highlighted at the meeting:
- Entresto (sacubitril/valsartan) is under review for the treatment of heart failure with preserved ejection fraction (HFpEF) with a US regulatory decision expected in the first quarter of 2021. Phase III results are expected in the first half of next year from the PARADISE MI trial studying Entresto in patients with acute myocardial infarction (AMI).
- Cosentyx (secukinumab) continues to show strength in dermatology and findings from a Phase III trial in hidradenitis suppurativa (HS) are expected in the second half of 2021.
- Kisqali (ribociclib) continues to grow in-market with overall survival (OS) data in aBC from the MONALEESA-2 trial anticipated in the second half of 2021.
- Alpelisib (BYL719) is on track for a US submission in PIK3CA-Related Overgrowth Spectrum (PROS) in 2021.
- Beovu (brolucizumab) is progressing in Phase III development for diabetic macular edema (DME) with a potential submission planned in 2021.
From the many assets in the Pharmaceuticals business unit, Novartis is also highlighting multiple mid- to late-stage assets with key milestones expected in 2021 and 2022:
- Iptacopan (LNP023), a potential first-in-class oral factor B inhibitor in development for several rare renal diseases and a hematological disorder, is expected to begin Phase III development for IgA Nephropathy (IgAN) in the first half of 2021. The European Medicines Agency (EMA) has granted orphan drug designation to iptacopan for the treatment of IgAN and PRIME designation in C3G.
- Iscalimab (CFZ533) is an anti-CD40 antibody in development across multiple indications including Sjögren’s syndrome, kidney and liver transplantation; with first results expected in 2022.
- The Phase III clinical trials for the next-generation anti-IgE/FcεRI antibody ligelizumab (QGE031) in chronic spontaneous urticaria (CSU) are fully enrolled, with results expected in the second half of 2021 and regulatory submission in 2022.
- In December 2019, Novartis initiated a Phase III outcomes study for pelacarsen (TQJ230), a potential first-in-class antisense oligonucleotide for secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a). Results are expected in 2024.
- Inclisiran (Leqvio®) has received positive CHMP opinion for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, marking an important milestone towards it becoming potentially available in the EU. Currently under regulatory review with the FDA with an action date of December 2020.
- The FDA granted orphan drug designation for the company’s orally administered, small molecule RNA splicing modulator branaplam (LMI070) for the treatment of Huntington’s disease (HD). A Phase IIb study in HD patients is planned to begin in the first half of 2021.
From its broad portfolio in the Oncology business unit, Novartis is also highlighting five mid- to late-stage assets with key milestones expected in 2021:
- The Phase III program for canakinumab (ACZ885) in non-small cell lung cancer (NSCLC) is progressing with final results expected from the CANOPY-1 and CANOPY-2 trials in the second and first half of 2021 respectively.
- Results from the Phase III VISION trial for 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer (mCRPC 3L) are expected in the first half of 2021.
- Sabatolimab (MBG453), an anti-TIM-3 monoclonal antibody, makes progress in a Phase III trial in high risk myelodysplastic syndrome (HR-MDS), and a potential first submission is anticipated in the second half of 2021.
- TNO155, a SHP2 inhibitor, is advancing in early clinical trials with a broad combination strategy for KRAS G12C mutant NSCLC and other solid tumors.
- LXH254, a selective B/C RAF inhibitor, is making progress in multiple combination studies in NRAS and BRAF mutant melanomas and in certain forms of lung cancers.