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09.11.2023 16:59:47

Press Release: Novartis data show potential of -2-

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; 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 press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn https://www.linkedin.com/company/novartis, Facebook https://www.facebook.com/novartis/, X/Twitter https://twitter.com/Novartis and Instagram https://www.instagram.com/novartis/?hl=de.

References

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and Favorable Safety Profile With Remibrutinib in Chronic Spontaneous

Urticaria: REMIX-1/-2 Studies. Presented as a late-breaking abstract at

ACAAI 2023.

2. Guillen-Aguinaga S, Jauregui Presa I, Aguinaga-Ontoso E, et al. Updosing

nonsedating antihistamines in patients with chronic spontaneous

urticaria: a systematic review and meta-analysis. Br J Dermatol.

2016;175:1153--1165.

3. Weller K, Church M, Kalogeromitros D, et al. Chronic spontaneous

urticaria: how to assess quality of life in patients receiving treatment.

Available from:

https://jamanetwork.com/journals/jamadermatology/fullarticle/1105319

[Last accessed: November 2023].

4. Novartis Data on File.

5. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in

chronic spontaneous urticaria. A GA2LEN task force report. Allergy.

2011;66:317--330.

6. Powell RJ, Leech SC, Till S, et al. BSACI guideline for the management of

chronic urticaria and angioedema. Clin Exp Allergy. 2015;45:547--565.

7. Maurer M, Berger W, Gimenez-Arnau A, et al. Remibrutinib, a novel BTK

inhibitor, demonstrates promising efficacy and safety in chronic

spontaneous urticaria. J Allergy Clin Immunol. 2022;150:1498--1506.

8. Angst D, Gessier F, Janser P, et al. Discovery of LOU064 (Remibrutinib),

a Potent and Highly Selective Covalent Inhibitor of Bruton's Tyrosine

Kinase. J Med Chem. 2020;63:5102--5118.

9. ClinicalTrials.gov. NCT05156281. Efficacy and Safety of Remibrutinib

Compared to Teriflunomide in Participants With Relapsing Multiple

Sclerosis (RMS). Available from:

https://clinicaltrials.gov/study/NCT05156281 [Last accessed: November

2023].

10. ClinicalTrials.gov. NCT05147220. Efficacy and Safety of Remibrutinib

Compared to Teriflunomide in Participants With Relapsing Multiple

Sclerosis. Available from: https://clinicaltrials.gov/study/NCT05147220

[Last accessed: November 2023].

11. ClinicalTrials.gov. NCT03827798. Study of Efficacy and Safety of

Investigational Treatments in Patients With Moderate to Severe

Hidradenitis Suppurativa. Available from:

https://clinicaltrials.gov/study/NCT03827798 [Last accessed: November

2023].

12. ClinicalTrials.gov. NCT05432388. Study of Efficacy, Safety and

Tolerability of Remibrutinib in Adult Participants With an Allergy to

Peanuts. Available from: https://clinicaltrials.gov/study/NCT05432388

[Last accessed: November 2023].

13. ClinicalTrials.gov. NCT04035668. A Phase 2 Study to Evaluate the Safety

and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's

Syndrome (LOUiSSe). Available from:

https://clinicaltrials.gov/study/NCT04035668 [Last accessed: November

2023].

14. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. Xolair

Omalizumab. Chronic Spontaneous Urticaria (CSU). Available at:

https://www.xolair.com/chronic-spontaneous-urticaria.html [Last accessed:

November 2023].

15. Clinical Trials.gov. A Phase 3 Study of Efficacy and Safety of

Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by

H1 Antihistamines (REMIX-1). NCT05030311. Available from:

https://clinicaltrials.gov/ct2/show/NCT05030311 [Last accessed: November

2023].

16. Clinical Trials.gov. A Phase 3 Study of Efficacy and Safety of

Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by

H1 Antihistamines (REMIX-2). NCT05032157. Available from:

https://clinicaltrials.gov/ct2/show/NCT05032157 [Last accessed: November

2023].

17. The World Bank. Population, total. Available from:

https://data.worldbank.org/indicator/SP.POP.TOTL [Last accessed: November

2023].

18. AAAAI. Hives (Urticaria) and Angioedema Overview. Available at:

https://www.aaaai.org/tools-for-the-public/conditions-library/allergies/hives-(urticaria)-and-angioedema-overview

[Last accessed: November 2023].

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Central North America

Richard Jarvis +41 79 584 2326 Julie Masow +1 862 579 8456

Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414

Anna Schäfers +41 79 801 7267 Marlena Abdinoor +1 617 335 9525

Switzerland

Satoshi Sugimoto +41 79 619 2035

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central North America

Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440

Nicole Zinsli-Somm +41 61 324 3809 Parag Mahanti +1 973 876 4912

Isabella Zinck +41 61 324 7188 Jonathan Graham +1 201 602 9921

Imke Kappes +41 61 324 82 69

Zain Iqbal +41 61 324 03 90

(END) Dow Jones Newswires

November 09, 2023 11:00 ET (16:00 GMT)

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