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Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS)

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  • Post hoc EXPAND analysis showed improvements in cognitive processing speed in patients with active and non-active SPMS treated with Mayzent1
  • Subgroup analyses of the EXPAND trial showed the value of early treatment initiation with Mayzent in patients with active SPMS as positive effects on disability, cognitive processing speed and relapse outcomes were sustained for up to five years2
  • Results from EXCHANGE interim analysis presented at ACTRIMS-ECTRIMS reinforced its safety and tolerability profile when patients switched from an oral or injectable disease-modifying therapy (DMT) to Mayzent3

The digital press release with multimedia content can be accessed here:

Basel, September 11, 2020 — Novartis announced today that Mayzent® (siponimod) analyses from the Phase IIIb EXCHANGE and EXPAND trials showed Mayzent to be a safe treatment option that has benefits in cognitive performance and reduces the risk of disability progression in patients with progressing MS1-3. The data were presented at the MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting that is taking place September 11–13, 2020.

“One of the biggest goals for people living with MS is to be able to live their lives independently for as long as possible," said Norman Putzki, MD, Global Head of Development, Neuroscience. “The data presented today reinforces that through its beneficial effects on cognitive performance and delaying disability progression, and as an appropriate option for patients to safely switch to/from other treatments, Mayzent offers hope for people looking to achieve this important goal.”

The EXCHANGE study is a Phase IIIb prospective, six-month open-label study evaluating the safety and tolerability of conversion to Mayzent from other disease-modifying therapies (DMTs) in patients with relapsing multiple sclerosis (RMS), including active secondary progressive multiple sclerosis (SPMS). The interim analysis included 112 patients from 42 centers in the US who were eligible for the safety analysis3. The EXPAND study is a randomized, double-blind, placebo-controlled Phase III study, comparing the efficacy and safety of Mayzent versus placebo in patients with SPMS with varying levels of disability. The post hoc EXPAND analysis found that in patients with active disease, an increased chance for clinically relevant improvement was observed and patients with active SPMS early and continuously treated with Mayzent experienced lower risk of disability progression and cognitive decline than patients who delayed Mayzent treatment1,2.

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,” “seek,” “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.    Penner IK, Giovannoni G, Cree B, et al. Effect of siponimod on cognitive processing speed in SPMS patients with active and non-active disease. ePoster presentation at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 2020
2.    Giovannoni G, Kappos L, Fox RJ, et al. Sustained reduction of disability and cognitive decline with long-term siponimod treatments in patients with active SPMS: EXPAND data up to 5 years. ePoster presentation at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 2020
3.    Bar-Or A, Weinstock-Guttman B, Mao-Draayer Y, et al. Safety and tolerability of conversion to siponimod in patients with relapsing multiple sclerosis: interim results of the EXCHANGE study. ePoster presentation at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting; September 2020

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

Antonio Ligi
Novartis External Communications
+41 79 723 3681 (mobile)
antonio.ligi@novartis.com



Eric Althoff
Novartis US External Communications
+1 862 778 3243
+1 646 438 4335
eric.althoff@novartis.com
Michael Amos
Novartis Global Pharma Communications
+41 61 324 2705 (direct)
+41 79 123 7806 (mobile)
michael.amos@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

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Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052
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+41 61 324 8425
+41 61 324 7188

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