- 26 potential blockbusters in confirmatory development. 13 projects in clinical development across Cell, Gene & Radioligand therapies. 60 major submissions planned from 2019 to 2021
- AVXS101 in SMA type 1 on track for launch in H1 2019, and clinical development underway in all other SMA subtypes
- Progressing late-stage pipeline of medicines with potential to change the standard of care in high burden disease areas; MS (Mayzent /BAF312 & OMB157), nAMD (RTH258), moderate to severe asthma (QAW039), sickle cell (SEG101) and lung cancer (ACZ885)
- Maximizing key in-line brands Cosentyx, Entresto and Gilenya with potential new indications and data
London, November 5, 2018 Throughout 2018, Novartis took strong action to focus the company and its capital towards the Innovative Medicines Division, resulting in an industry leading pipeline. Today Novartis holds an R&D and investor update in London which will provide deeper insights into the pipeline including the below.
Progressing cell, gene and radioligand therapy platforms with 13 therapies in clinical development, and 9 more expected to enter the clinic in 2019. The potentially foundational gene therapy AVXS101 delivers rapid, transformational and durable benefit in SMA Type 1, with regulatory approvals expected in US, EU and Japan in H1 2019. In Radioligand therapy, Novartis acquired AAA and successfully launched Lutathera in NET and has projects in development for indications beyond NET. Novartis announced the planned acquisition of Endocyte , which would expand the radioligand platform. Novartis also highlights one of the most comprehensive CAR-T development programs across multiple indications.
Novartis is advancing a pipeline of medicines with potential to change the standard of care in high burden disease areas. In multiple sclerosis, Mayzent (siponimod, formerly BAF312) is expected to launch in Q1 2019 as the first and only drug proven to delay progression for typical patients living with SPMS. Also in MS, OMB157 (ofatumumab) is a next generation B-cell depletor with a potentially favorable safety profile from faster b-cell repletion and preserved immunity, and with a convenient monthly sub-cutaneous dosing. In moderate to severe asthma, QAW039 (fevipiprant) is targeting a unique profile of biologic efficacy with oral simplicity. In nAMD, RTH258 (brolucizumab) has the potential to reduce treatment burden by drying the retina better with fewer injections. In sickle cell disease, SEG101 (crizanlizumab) is a promising treatment with data from a pivotal trial showing patients have more Vaso-occlusive Crisis-free days and regulatory filings are expected in 2019. In lung cancer, ACZ885 (canikinumab) has three phase lll trials in adjuvant NSCLC, 1st line NSCLC, and 2nd line NSCLC with an opportunity to become the standard of care in these settings.
Maximizing the potential of in-line brands with new data is a key development priority. Novartis is pursuing new indications and building out the data profile for Cosentyx, Entresto and Gilenya. Cosentyx is expected to be Novartis’ largest drug next year, with robust growth in all three approved indications, PSO, PSA and AS. Confidence in Cosentyx comes from 100 studies and an extensive phase III clinical trial program, including PREVENT in non-radiographic axial spondyloarthropathy, a potential fourth indication. Entresto’s position in HFrEF is being strengthened by new data that could increase initiation of therapy in hospitals. Entresto also has the potential to be the first approved treatment for HFpEF with the PARAGON-HF trial, with results expected in 2019. Gilenya continues to benefit from a wealth of data flow, including the recent approval for pediatric use as well as the ASSESS trial which showed superiority to Copaxone .
For background slides and webcast (audio only) please refer to the following link: www.novartis.com/investors/event-calendar
The background slide decks will be available on Monday November 5th, 2018.
Post-Proof of Concept clinical development
Submissions in US, Europe and Japan.
The brand name Mayzent has been provisionally approved by the FDA and EMA for the investigational product siponimod (BAF312), but the product itself has not been approved for sale in any country.
Closing of the transaction is subject to customary closing conditions, including receipt of regulatory approvals and Endocyte stockholders approval. Until closing, Endocyte will continue to operate as a separate and independent company.