Novartis Pharma AG: Novartis highlights depth of immunology pipeline with novel data at key upcoming international congresses

• Pivotal results for efficacy and safety of Cosentyx (secukinumab) in hidradenitis suppurativa from Phase III SUNSHINE and SUNRISE trials to be debuted as late-breaker at European Academy of Dermatology and Venereology (EADV) Congress

• Phase IIb data on remibrutinib (LOU064), an oral Bruton's tyrosine kinase inhibitor, for people living with chronic spontaneous urticaria to be highlighted at EADV

• Results of analysis at Week 52 from Phase IIb trial of ianalumab (VAY736), a dual mode of action B-cell activating factor receptor inhibitor in Sjögren's syndrome, to be unveiled at International Symposium on Sjögren's Syndrome

• Total of 37 abstracts across both meetings will be presented, reflecting Novartis ambition to improve the lives of those affected by a range of immunological diseases

Basel, September 2, 2022 - Novartis today announced it will showcase data from its leading immunology portfolio and emerging pipeline at the upcoming 31st European Academy of Dermatology and Venereology (EADV) Congress and the 15th International Symposium on Sjögren's Syndrome (ISSS), both occurring September 7-10, 2022. A total of 37 abstracts will be shared across both meetings, spanning hidradenitis suppurativa (HS), chronic spontaneous urticaria (CSU), Sjögren's syndrome, axial spondyloarthritis, and psoriasis.

"These data - including late-breaking results from our pivotal trials for Cosentyx in hidradenitis suppurativa - demonstrate both the strength of our portfolio, and our commitment to pioneering the medicines of tomorrow in immunology," said Angelika Jahreis M.D., Ph.D., FAAD, Global Head Development Unit Immunology and Clinical Development Excellence, Novartis. "We are focusing our development efforts on immunological diseases with significant unmet need, and hope that we will soon be able to provide more treatment options to patients to manage their conditions."

The Novartis ambition is to reduce the suffering from immunological conditions, which affect up to 4.5% of the world's population and can have a significant impact on quality of life¹. In addition to its comprehensive portfolio of innovative therapy options, Novartis is exploring potential biologic and oral treatments with various mechanisms of action in HS, developing medicines that could help those living with CSU achieve complete symptom control, and advancing research in Sjögren's syndrome, for which there are currently no disease-modifying treatments available^2,3.

To assess and elevate the patient perspective at every stage of its clinical research, Novartis will also share the latest findings from a number of patient-based initiatives at EADV, including the global Psoriasis and Beyond study exploring the impact of psoriatic disease on mental health. Results from a comprehensive social media monitoring program to help illuminate the significant unmet needs of people living with HS will also be presented.

Highlights at ISSS

Medicine	Disease area	Abstract title	Abstract number/ presentation details
Ianalumab (VAY736)	Sjögren's syndrome	Ianalumab (VAY736) Safety and Efficacy in Patients with Sjögren's Syndrome: 52 Week Results from a Randomized, Placebo-controlled, Phase 2b Dose-ranging Trial	Abstract ID119/ oral presentation/ September 9, 17:44-17:51

Highlights at EADV

Medicine	Disease area	Abstract title	Abstract number/ presentation details
Cosentyx	Hidradenitis suppurativa	Secukinumab in Moderate to Severe Hidradenitis Suppurativa: Primary Endpoint Analysis from the SUNSHINE and SUNRISE Phase 3 Trials	Abstract LB3549/ oral presentation/ September 10, 2022, 08:30-08:45 Late-breaking presentation
Cosentyx	Hidradenitis suppurativa	Baseline Characteristics and Subtype Clusters in Hidradenitis Suppurativa: Exploratory Analysis of SUNSHINE and SUNRISE Studies	Abstract P0040/ poster presentation/ September 7, 2022, 07:00
Cosentyx	Psoriasis	Secukinumab Demonstrates Superiority over Narrow-Band Ultraviolet B Phototherapy in New-Onset Moderate to Severe Plaque Psoriasis Patients: Week 52 Results from the STEPIn Study	Abstract P1518/ poster presentation/ September 7, 2022, 07:00
Cosentyx	Psoriasis	Secukinumab Treatment Interruption Does Not Impact Effectiveness in Patients with Moderate to Severe Plaque Psoriasis: Results from an Interim Analysis of the SERENA Study	Abstract P1520/ poster presentation/ September 7, 2022, 07:00
Cosentyx	Spondyloarthritis	Humoral Immunogenicity to Second and Third Doses of COVID-19 Vaccine BNT162b2 in Patients with Spondyloarthritis Receiving Secukinumab: A Prospective Study	Abstract P0584/ poster presentation/ September 7, 2022, 07:00
Remibrutinib (LOU064)	Chronic spontaneous urticaria	Remibrutinib Demonstrates Faster Time to Complete Urticaria Control in Patients with Chronic Spontaneous Urticaria Compared with Placebo	Abstract P1726/ poster presentation/ September 7, 2022, 07:00
Remibrutinib (LOU064)	Chronic spontaneous urticaria	Long-Term Safety and Tolerability of Remibrutinib (LOU064) in Phase 2b Study in Chronic Spontaneous Urticaria Patients	Abstract P1722/ poster presentation/ September 7, 2022, 07:00
Patient study	Chronic urticaria	Urticaria Voices: Design of a Real-World Study on the Burden of Chronic Urticaria from Patients' and Physicians' Perspectives	Abstract P1739/ poster presentation/ September 7, 2022, 07:00
Patient study	Psoriatic disease	Impact of Psoriatic Disease on Mental Health: Results from the Global Psoriasis and Beyond Study	Abstract FC06.08/ oral presentation/ September 10, 15:25-15:35
Patient study	Hidradenitis suppurativa	Understanding the Real-World Patient Journey and Unmet Needs of Patients with Hidradenitis Suppurativa through Social Media Monitoring	Abstract FC08.02/ oral presentation/ September 10, 16:10-16:20

Disclaimer
This press release 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 press release, 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 press release 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 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 in Immunology
Novartis aims to improve outcomes and enhance the lives of those affected by painful and debilitating immunological conditions. As a result, we have already helped transform the standard of care for children and adults suffering from conditions such as psoriatic disease and axial spondyloarthritis with Cosentyx, chronic urticaria with Xolair, and a number of rare autoinflammatory diseases with Ilaris. We continue to focus on discovering and delivering innovative medicines for complex, less-explored immunological diseases where there is significant unmet need, such as hidradenitis suppurativa and Sjögren's syndrome, lupus and osteoarthritis.

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 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com (https://www.novartis.com).

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References

1. Scientific American. The Terrible Toll of 76 Autoimmune Diseases [online]. Available from: https://www.scientificamerican.com/article/the-terrible-toll-of-76-autoimmune-diseases/ (https://www.scientificamerican.com/article/the-terrible-toll-of-76-autoimmune-diseases/) [Last accessed: August 2022].
2. Sjögren's Foundation. Understanding Sjögren's - Symptoms [online]. Available from: https://www.sjogrens.org/understanding-sjogrens/symptoms (https://www.sjogrens.org/understanding-sjogrens/symptoms) [Last accessed: August 2022].
3. NHS. Treatment - Sjögren's syndrome [online]. Available from: https://www.nhs.uk/conditions/sjogrens-syndrome/treatment/ (https://www.nhs.uk/conditions/sjogrens-syndrome/treatment/) [Last accessed: August 2022].

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