Press Release: Novartis highlights depth of immunology pipeline with novel data at key upcoming international congresses

-- Pivotal results for efficacy and safety of Cosentyx(R) (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(R) 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 life(1). 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 Sjögren's Ianalumab (VAY736) Safety and Efficacy in Patients Abstract ID119/

(VAY736) syndrome with Sjögren's Syndrome: 52 Week Results from oral presentation/ September 9,

a Randomized, Placebo-controlled, Phase 2b Dose-ranging 17:44--17:51

Trial

----------- -------------- ---------------------------------------------------------- ----------------------------------

Highlights at EADV

Medicine Disease area Abstract title Abstract number/ presentation details

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Cosentyx Hidradenitis Secukinumab in Moderate to Severe Hidradenitis Suppurativa: Abstract LB3549/

suppurativa Primary Endpoint Analysis from the SUNSHINE and SUNRISE oral presentation/ September 10, 2022, 08:30--08:45

Phase 3 Trials Late-breaking presentation

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Cosentyx Hidradenitis Baseline Characteristics and Subtype Clusters in Hidradenitis Abstract P0040/

suppurativa Suppurativa: Exploratory Analysis of SUNSHINE and poster presentation/ September 7, 2022, 07:00

SUNRISE Studies

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Cosentyx Psoriasis Secukinumab Demonstrates Superiority over Narrow-Band Abstract P1518/

Ultraviolet B Phototherapy in New-Onset Moderate to poster presentation/ September 7, 2022, 07:00

Severe Plaque Psoriasis Patients: Week 52 Results

from the STEPIn Study

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Cosentyx Psoriasis Secukinumab Treatment Interruption Does Not Impact Abstract P1520/

Effectiveness in Patients with Moderate to Severe poster presentation/ September 7, 2022, 07:00

Plaque Psoriasis: Results from an Interim Analysis

of the SERENA Study

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Cosentyx Spondyloarthritis Humoral Immunogenicity to Second and Third Doses of Abstract P0584/

COVID-19 Vaccine BNT162b2 in Patients with Spondyloarthritis poster presentation/ September 7, 2022, 07:00

Receiving Secukinumab: A Prospective Study

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Chronic Remibrutinib Demonstrates Faster Time to Complete Abstract P1726/

Remibrutinib (LOU064) spontaneous Urticaria Control in Patients with Chronic Spontaneous poster presentation/ September 7, 2022, 07:00

urticaria Urticaria Compared with Placebo

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Chronic Long-Term Safety and Tolerability of Remibrutinib Abstract P1722/

Remibrutinib (LOU064) spontaneous (LOU064) in Phase 2b Study in Chronic Spontaneous poster presentation/ September 7, 2022, 07:00

urticaria Urticaria Patients

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Chronic urticaria Urticaria Voices: Design of a Real-World Study on Abstract P1739/

Patient study the Burden of Chronic Urticaria from Patients' and poster presentation/ September 7, 2022, 07:00

Physicians' Perspectives

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Patient study Psoriatic disease Impact of Psoriatic Disease on Mental Health: Results Abstract FC06.08/

from the Global Psoriasis and Beyond Study oral presentation/ September 10,

15:25--15:35

------------------------- ----------------- --------------------------------------------------------------- ------------------------------------------------------

Patient study Hidradenitis Understanding the Real-World Patient Journey and Unmet Abstract FC08.02/

suppurativa Needs of Patients with Hidradenitis Suppurativa through oral presentation/ September 10,

Social Media Monitoring 16:10--16:20

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September 02, 2022 01:15 ET (05:15 GMT)