Oct 07, 2021
  • Novartis will present 41 abstracts from a wide-ranging multiple sclerosis (MS) portfolio, including new data on Kesimpta® (ofatumumab) and Mayzent® (siponimod)

  • Novartis will be commencing Phase III pivotal trials investigating remibrutinib in RMS. Remibrutinib is a highly selective, potent oral BTK inhibitor with a potential best-in-class profile1
  • Late-breaking safety data will be presented, including outcomes of COVID-19 in relapsing forms of multiple sclerosis (RMS) patients treated with Kesimpta2, and effects of Kesimpta on immunoglobulin levels and risk of infection based on ~ 3.5 years of exposure3
  • Design of a new open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in MS-patients treated with Kesimpta4, and new findings from open-label study assessing immune response to SARS-CoV-2 mRNA vaccines in secondary progressive MS (SPMS) patients treated with Mayzent will be presented5

Basel, October 7, 2021 — Novartis announced today it will present 41 abstracts at the upcoming 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place digitally on October 13-15, 2021. The data being presented spans a comprehensive MS portfolio, emphasizing the company’s commitment to improving the quality of life for people living with MS at all stages of the disease.

“These data strengthen the role of Kesimpta as a first-choice treatment for relapsing forms of MS, highlighting its long-term safety and efficacy for patients and physicians,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise Head, Novartis Pharmaceuticals. “With new data across our MS portfolio, Novartis is committed to reimagining medicine by leading on new treatment options, challenging ourselves to focus on unmet needs when managing the disease, and ultimately improving the lives of people living with MS.”

In addition to the data presented at ECTRIMS, Novartis will initiate Phase III pivotal trials to investigate remibrutinib in RMS patients. Remibrutinib (LOU064) is a highly selective and potent covalent BTK inhibitor with a potential best-in-class profile and has shown favorable safety based on clinical data established to date.1

BTK inhibitors are a novel class of therapies that target B-cells and other innate immune cells and prevent inflammation and potentially disease progression in MS.

Novartis key highlights at the 37th ECTRIMS Congress include:

New efficacy and safety data on Kesimpta, the first and only self-administered, targeted B-cell therapy for patients with relapsing forms of MS (RMS), show that Kesimpta is a well-tolerated, high-efficacy therapy in adults, including newly diagnosed patients, with RMS. The study results will provide a robust picture of safety data for Kesimpta after extended exposure (~ 3.5 years):

  • New findings from the ALITHIOS Phase IIIb open-label extension study look at immunoglobulin M (IgM) and immunoglobulin G (IgG) levels in people treated with Kesimpta over ~ 3.5 years to better understand the potential effect of ofatumumab on these antibody levels as well as any association with risk of serious infection during continuing observation.3
  • Safety and efficacy data on Kesimpta from the ALITHIOS Phase III study look at RMS-patients treated with Kesimpta and their risk of a COVID-19 infection as well as its severity.2
  • Interim results from a single-center study in the US show the effect of Kesimpta on microglial activation.6
  • An open-label multicenter single-arm pilot study in the US will assess the immune response to SARS CoV-2 mRNA vaccine in MS-patients treated with Kesimpta.4

New data on Mayzent, the first and only oral treatment studied and proven to slow disability progression as demonstrated in the EXPAND study that included a broad range of secondary progressive MS (SPMS) patients, add to the growing body of evidence that patients treated with Mayzent show delays in disability progression and experience benefits in cognitive performance:

  • An open-label, three-cohort, prospective study based in Germany will present interim data on the immune response after SARS CoV-2 mRNA vaccination in SPMS-patients treated with Mayzent.5
  • Findings from the ongoing EXPAND extension study on the long-term outcomes with Mayzent, showing continuing sustained efficacy of the treatment in patients receiving Mayzent.7
  • Real world and phase III study data combined to characterize the extent and patterns of activity in ‘active’ and ‘non-active’ SPMS demonstrates that such definitions can be unreliable and may lead to suboptimal management of people living with SPMS.8
  • A retrospective real-world study will review patient self-reported and physician-reported information on cognitive symptoms, thus examining the discordance between physician and patient perception of cognition impairment.9

Novartis in Neuroscience
At Novartis Neuroscience, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide. We continue to collaborate on industry-leading treatments in multiple sclerosis, pediatric neurology, neurodegeneration and neuropsychiatry because we know through innovation, partnership and community engagement early on, we can improve the standard of care.

To ensure patients everywhere can benefit from these life-changing therapies, we work closely with key stakeholders across the world to ensure rapid and sustainable access to our medicines, with the aim of providing the widest choice of treatments for each person’s unique journey.

Disclaimer
This media update 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,” “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 media update, 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 media update 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update 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.com.

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References

  1. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (Remibrutinib), a Potent and Highly Selective Covalent Inhibitor of Bruton's Tyrosine Kinase: 37th Congress of ECTRIMS, October 13-15, 2021.
  2. Cross AH, Delgado S, Habek M, et al. Outcomes of COVID-19 in Patients With Relapsing Multiple Sclerosis Receiving Ofatumumab: Data From the ALITHIOS Study and Post Marketing Surveillance: 37th Congress of ECTRIMS, October 13-15, 2021.
  3. Wiendl H, de Seze J, Correale J, et al. Effect of Ofatumumab on Serum Immunoglobulin Levels and Infection Risk in Patients With Relapsing Multiple Sclerosis Over 3.5 Years: 37th Congress of ECTRIMS, October 13-15, 2021.
  4. Chitnis T, Hendin B, Rammohan K, et al. Design and Rationale for an Open-label Multicenter Phase 4 Study Assessing Immune Response to COVID-19 Vaccine in Patients With Relapsing Multiple Sclerosis Treated With Ofatumumab: 37th Congress of ECTRIMS, October 13-15, 2021.
  5. Ziemssen T, Bopp T, Rauser B, et al. Assessing the immune response to SARS-CoV-2 mRNA vaccines in patients with secondary progressive multiple sclerosis treated with siponimod (AMA-VACC clinical trial): 37th Congress of ECTRIMS, October 13-15, 2021.
  6. Singhal T, Carter K, Ficke HJ, et al. Early Efficacy of Ofatumumab on Microglial Activity in Patients With Relapsing Forms of Multiple Sclerosis: Interim Analysis of a 9-Month Study: 37th Congress of ECTRIMS, October 13-15, 2021.
  7. Cree BAC, Rouyrre N, Fox RJ, et al. Long-term efficacy of siponimod on physical and cognitive disability progression versus virtual placebo arm in EXPAND core and extension study: 37th Congress of ECTRIMS, October 13-15, 2021.
  8. Giovannoni G, Houchen E, Sobisek L, et al. Characterisation of Disease Activity in Secondary Progressive Multiple Sclerosis: Insights from the Real World and Phase 3 Pivotal Studies: 37th Congress of ECTRIMS, October 13-15, 2021.
  9. Penner I-K, De Las Heras V, Jones E, et al. Discordance between neurologists and people with multiple sclerosis on the perception of the presence and burden of cognitive impairment: 37th Congress of ECTRIMS, October 13-15, 2021.

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