Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis

• There are more than 1 million people living with multiple sclerosis (MS) in Europe¹, Kesimpta^® (ofatumumab) addresses the current unmet need for a high-efficacy disease-modifying therapy (DMT) that combines powerful efficacy and favorable safety profile with the flexibility of self-administration at home via the Sensoready^® autoinjector pen^2,3

• Approval based on two Phase III ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction of annual relapses by over 50% versus teriflunomide, a first-line treatment in MS, and achieved more than 30% relative risk reduction of 3-month confirmed disability progression²

• Kesimpta may halt new disease activity in relapsing forms of MS (RMS) patients, as shown in post hoc analysis, where nearly nine out of 10 patients treated with Kesimpta achieved no evidence of disease activity (NEDA-3) in their second year of treatment⁴

• EU approval follows recent approvals for Kesimpta including the US, Canada, Switzerland, Singapore, Australia and Japan

Basel, March 30, 2021 — Novartis announced today that the European Commission has approved Kesimpta^® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide, a first-line treatment in MS². Kesimpta is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready^® autoinjector pen and can be a first-choice treatment option for patients with RMS³.

“With more than 1 million people living with MS – an incurable condition so far - in Europe, it is encouraging to see that research continues to develop more treatments.  We welcome the approval from the European Medicines Agency that gives another treatment option for people living with RMS”, said Pedro Carrascal, President of the European Multiple Sclerosis Platform (EMSP).

“Slowing the worsening of disability is one of the main goals when managing RMS and evidence shows that early initiation of a high-efficacy treatment can improve long-term outcomes. Additionally, as RMS progresses, it can substantially increase overall healthcare costs as a result of increased disability,” said Haseeb Ahmad, Global Head of Value & Access, Novartis Pharmaceuticals. “Kesimpta’s powerful efficacy and favorable safety profile has the potential to become a first-choice treatment to help improve the quality of life of people living with MS, as well as having broader value in potentially reducing medical costs associated with infusion therapies. Kesimpta is a testament to our commitment to reimagine medicine and we remain dedicated to helping to improve the lives of people living with this disease.”

About Kesimpta^® (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously^2,3. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion⁵. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen⁶. Once-monthly dosing of Kesimpta differs from other anti-CD20 therapies as it allows faster repletion of B-cells, offering more flexibility in MS management⁷. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015⁸.

Novartis is working closely with all stakeholders to ensure that eligible European patients can start benefitting from this treatment as quickly as possible. In August 2020, the US Food and Drug Administration approved Kesimpta as an injection for subcutaneous use for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in adults. Additionally, Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in Canada, Switzerland, Singapore, Australia, Japan, Argentina, United Arab Emirates, Albania, and India.

Novartis in Neuroscience
Novartis has a long heritage and strong ongoing commitment to neuroscience and to bringing innovative treatments to patients suffering from neurological and neuropsychiatric conditions where there is a high unmet need. We are committed to supporting patients and physicians with our ambition to pioneer, develop and deliver treatments across four pillars: multiple sclerosis, pediatric neurology, neurodegeneration and neuropsychiatry.

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 110,000 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. Multiple Sclerosis International Federation. Atlas of MS 2020-Mapping multiple sclerosis around the world. Available from: https://www.msif.org/wp-content/uploads/2020/10/Atlas-3rd-Edition-Epidemiology-report-EN-updated-30-9-20.pdf [Last accessed: March 2021].
2. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2020;383(6):546-557.
3. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; February 27-29, 2020; West Palm Beach, FL.
4. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(S1):85-86.
5. Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presentation at: ECTRIMS; September 2016; London, UK.
6. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: ECTRIMS; September 2016; London, UK.
7. Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-cell recovery time following discontinuation of anti-CD20 therapies. ePoster presentation at: ECTRIMS; October 2017; Paris, FR.
8. Genmab Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Accessed March 9, 2021. https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d.

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