Novartis data confirm rapid response and high efficacy of Cosentyx® in psoriasis patients for first time in China

• Phase III study shows close to 9/10 patients who received Cosentyx® 300mg achieved clear or almost clear skin during the first 16 weeks of treatment (87%), with rapid onset of relief seen as early as week 3[1]
   
• Results strengthen unique position of Cosentyx as a rapid and long-lasting complete treatment of psoriatic disease, with over 200,000 patients treated worldwide[2]
   
• Data is being presented at the 2019 American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C.

Basel, March 4, 2019 - Novartis announced today new data in 441 Chinese patients with moderate to severe plaque psoriasis from a Phase III study investigating the efficacy and safety of Cosentyx (secukinumab). The data, part of a broader ongoing 52 week Phase III study in 543 patients, show 97.7% of patients treated with Cosentyx 300mg achieved PASI 75 and 80.9% achieved PASI 90 by week 12, with 87% of patients reaching PASI 90 by week 16. In patients treated with Cosentyx 150mg, 87.8% achieved PASI 75 and 66.4% achieved PASI 90 at week 12[1].

"Cosentyx continues to deliver what psoriasis patients need - reimagining care to provide clear skin and a complete treatment," said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology, and China Region Development Head. "We're excited to report for the first time data for a Chinese population, and to see strong support from the data for Cosentyx."

Cosentyx is backed by a wealth of research with 100 studies and has been proven to offer clear or almost clear skin in 8 out of 10 patients within 16 weeks of treatment[3]. Nearly 100% of response rates are maintained up to 5 years[4]. It is a fully human monoclonal antibody neutralizing IL-17A and has demonstrated rapid, long-lasting efficacy and safety in the treatment of moderate to severe psoriasis, psoriatic arthritis, and the more persistent manifestations of psoriasis, namely scalp, palms, soles and nails[5,6].

About Cosentyx
Cosentyx is a targeted biologic and the first and only fully-human treatment that specifically inhibits IL-17A, a cornerstone cytokine involved in the inflammation and development of psoriatic disease, including psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)[7-10]. IL-17A is produced by both IL-23 dependent and IL-23 independent pathways, by various cells from both the innate immune system (which can be triggered by mechanical stress) and the adaptive immune system[11]. By acting directly on IL-17A, Cosentyx inhibits this cornerstone cytokine irrespective of where the IL-17A comes from[8].

Cosentyx is an established brand, supported by 5-year sustained efficacy and safety data across three indications (PsO, PsA and AS) and more than 200,000 patients treated[2,6,12,13]. Cosentyx has shown fast and sustained long-term efficacy, as well as a consistently favorable safety profile, with almost zero injection site reactions and pain[6,12,14-17]. It is approved in more than 80 countries, which includes the European Union countries and the US, and is supported by 100 studies in the real world and clinical setting[2,18].

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 health care cost containment, including government, payor and general public pricing and reimbursement pressures; 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 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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References
[1]         Jianzhong, J et al. Secukinumab 300 mg showed faster and higher efficacy in Chinese moderate to severe plaque psoriasis patients. Presented as poster 10499 at the American Academy of Dermatology (AAD) Annual Meeting. March 2019.
[2]         Novartis, data on file. February 2019.
[3]         Blauvelt, A et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. JAAD 2017;76(1):60-69.
[4]         Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th September 2017
[5]         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.
[6]         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.
[7]         EU Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/
003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed September 2018.
[8]         Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol. 2014;66:231-41.
[9]         Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496-509.
[10]       Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
[11]       Schett G et al. Enthesitis: from pathophysiology to treatment. Nat Rev Rheumatol. 2017 Nov 21;3(12):731-741.
[12]       Bissonnette R et al. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile Through 5 years of Treatment in Moderate to Severe Psoriasis. Presented as a Late Breaking Poster #7 at the 3^rd Inflammatory Skin Disease Summit (ISDS), Vienna. December 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]       Braun J et al. Secukinumab demonstrates low radiographic progression and sustained efficacy through 4 years in patients with active ankylosing spondylitis. Late breaking abstract presented at the 2017 ACR/ARHP Annual Meeting, San Diego, USA. 7th November 2017.
[15]       Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015; 373:2534-48.
[16]       McInnes IB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386(9999):1137-1146.
[17]       Reich K et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis. Br. J. Dermatol. 2017;176:752-58.
[18]       Clinicaltrials.gov. Active trials include all those that are listed as recruiting, active but not recruiting, enrolling by invitation and not yet recruiting and completed. This list excludes all trials listed as suspended, terminated and withdrawn

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