Cosentyx® provides long-lasting inhibition of radiographic progression in psoriatic arthritis, new Novartis data show

• Almost 90% of patients had no radiographic progression of psoriatic arthritis (PsA) at 2 years with Cosentyx (secukinumab) 300mg[1]
   
• Data at 2 years demonstrate over 50% of adults with active PsA achieved ACR50, and almost 50% achieved PASI 100 response with Cosentyx 300mg[1] 
   
• Results strengthen unique position of Cosentyx as a rapid and long-lasting comprehensive treatment of spondyloarthritis and psoriatic disease, with over 200,000 patients treated worldwide

Basel, June 12, 2019 - Novartis, a global leader in rheumatology and immuno-dermatology, announced today new data from the FUTURE 5 trial showing no radiographic progression (mTSS <0.5) in almost 90% of psoriatic arthritis (PsA) patients treated with Cosentyx^® (secukinumab) 300mg over 2 years.

"Half of patients with psoriatic arthritis experience bone erosion within approximately two years. Left untreated, this can lead to irreversible joint damage and disability, having a substantial impact on quality of life," said Dr. Philip J. Mease, Director of Rheumatology Research, Swedish Medical Center/Providence St Joseph Health and Clinical Professor, University of Washington School of Medicine, Seattle, WA. "The availability of a treatment that is proven to inhibit progression of psoriatic arthritis through two years gives physicians and patients more choice in the management of this debilitating condition."

The trial investigated the effect of Cosentyx on the signs and symptoms of PsA, in addition to inhibition of radiographic progression of PsA. These data demonstrate that 89.5% (300mg), 82.3% (150mg) and 81.1% (150mg no loading dose [LD]) of PsA patients treated with Cosentyx found no radiographic progression at 2 years. Clinical responses, such as American College of Rheumatology criteria (ACR20/50) and Psoriasis Area and Severity Index (PASI 90/100) were also maintained through 2 years, with 77% of Cosentyx 300mg patients achieving ACR20, 51.9% ACR50, 70.1% PASI 90 and 49.5% PASI 100. Results were also achieved at the lowest dose of Cosentyx 150mg (79.4% ACR20, 52.6% ACR50, 59.2% PASI 90 and 44.2% PASI 100)[1]. These data are being presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.

"We are continuing to reimagine psoriatic arthritis therapy to improve patients' lives and provide a treatment option that addresses multiple manifestations and inhibits disease progression," said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. "These data further reinforce Cosentyx as a comprehensive treatment that's backed by over 100 studies, including five-year data across psoriasis, psoriatic arthritis and ankylosing spondylitis."

PsA is a complex disease with multiple manifestations driving patient symptoms[2],[3]. It is estimated to affect up to 50 million people worldwide[4]^-[7] and is part of a family of long-term inflammatory diseases (spondyloarthritis) that target the joints. If left untreated, PsA patients can go on to develop irreversible radiographic structural damage[8]. Radiographic damage is defined by joint inflammation, erosion and joint space narrowing, particularly in the hands and feet[9]. PsA with radiographic progression is reported in more than half of patients[8].

About FUTURE 5
FUTURE 5 is a Phase III, randomized, double-blind, placebo-controlled study reporting on the effect of Cosentyx on radiographic progression across 2 years in PsA patients. In the study, 996 adults with active PsA were randomized to receive subcutaneous Cosentyx 300 mg (with LD of 300 mg), 150 mg (LD 150 mg), 150 mg with no LD or placebo at baseline at Weeks 1, 2, 3, 4 and every 4 weeks thereafter. Patients could have the Cosentyx dose escalated from 150 to 300 mg, starting from Week 52, based on physicians' judgement. The primary endpoint was ACR20 at Week 16. Radiographic progression as measured by mean change at Week 24 in van der Heijde-modified total Sharp score and its components erosion and joint space narrowing measured by hand/foot/wrist X-rays was a key secondary endpoint. Other endpoints included ACR50, PASI75/90/100 and resolution of dactylitis and enthesitis[1].

About Cosentyx (secukinumab)
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of PsA, psoriasis (PsO), and ankylosing spondylitis (AS)[10].

Cosentyx is backed by robust clinical evidence, including dedicated studies in the persistent manifestations of psoriasis, namely nails, scalp, palms and soles, as well as PsA and AS[11]-[13]. Cosentyx has shown long-lasting efficacy and a favorable safety profile while addressing psoriatic disease, therefore offering a complete treatment[13]. It has shown sustained safety and long-lasting efficacy in three 5-year Phase III extension studies in PsO, PsA and AS[12]-[14]. Today, more than 200,000 patients worldwide have been treated with Cosentyx since launch[15].

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," "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 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 healthcare 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 and economic conditions; safety, quality 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 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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 105,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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References
           [1]     Mease P, et al. Subcutaneous secukinumab 300mg and 150mg provides sustained inhibition of radiographic progression in psoriatic arthritis over 2 years: Results from the Phase 3 FUTURE-5 trial. Presented at the Annual European Congress of Rheumatology (EULAR); June 12-15, 2019; Madrid, Spain. 
           [2]     Ritchin CT, et al. N Engl J Med 2017;376:957-970.
           [3]     Kavanaugh A, et al. Rheumotol Ther 2016;3;91-102.
           [4]     Statistics. National Psoriasis Foundation. Available from: https://www.psoriasis.org/content/statistics [Last accessed: June 2019].
           [5]     Mease PJ, et al. Drugs 2014;74:423-441.
           [6]     Liu JT, et al. World JOrthop 2014;5:537-543.
           [7]     Scotti L, et al. Science Direct 2018;48:28-34.
           [8]     Gladman D, et al. Arthritis Res Ther 2010;12:R113.
           [9]     Landewe R, et al. Radiographic progression in rheumatoid. Available from: arthritishttps://www.clinexprheumatol.org/article.asp?a=2688 [Last accessed: June 2019].
           [10]   Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124 [Last accessed: June 2019].
           [11]   Reich, K et al. Secukinumab Shows Sustained Efficacy in Difficult-to-Treat Palmoplantar, Nail, and Scalp Psoriasis: Long-term Results From 3 Phase III Placebo-Controlled Randomized Trials. Presented as a Late Breaking Poster #6 at the 3rd Inflammatory Skin Disease Summit (ISDS), Vienna. December 2018.
           [12]   Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.
           [13]   Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.
           [14]   Bissonnette, R et al. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32: 1507-1514
           [15]   Novartis, data on file. June 2019.

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