New analysis of Novartis data confirms that Cosentyx® demonstrates durable comprehensive treatment across psoriatic disease

• For the first time efficacy and safety data from dedicated phase III trials are analyzed together in one abstract, backing Cosentyx^® as comprehensive treatment across multiple manifestations of psoriatic disease and ankylosing spondylitis[1]
   
• The abstract presented at the World Congress of Dermatology in Milan shows the long-term efficacy and safety of Cosentyx^® in multiple manifestations of psoriatic disease including moderate-to-severe plaque-type, nail and palmoplantar psoriasis, psoriatic arthritis and ankylosing spondylitis[1]
   
• Proven efficacy of treatments in persistent manifestations of nails, scalp and palmoplantar psoriasis is a specific concern for patients as these are significantly reducing the quality of life and are impacting up to 9 out of 10 psoriasis patients[2],[3]
   
• Additional new 5 year data with Cosentyx^® confirmed low immunogenicity with rates year-over-year consistently below 1% in patients with moderate to severe plaque psoriasis[4]
   
• Cosentyx^® is reimagining patient care with a wealth of research from 100 studies and has been proven to offer clear or almost clear skin in 8 out of 10 patients within 16 weeks of treatment.[5]  Data presented in 2017 showed that PASI 90 and PASI 100 response rates were nearly 100% maintained with Cosentyx^® from Year 1 to Year 5 in patients with moderate-to-severe plaque psoriasis[6] 

Basel, June 17, 2019 - "Today, patients and doctors are concerned about the manifestations of psoriatic disease beyond skin plaques which are painful and often lead to irreversible damage", said Richard Langley, Professor of Dermatology, Dalhousie University, Halifax, Nova Scotia, Canada. "These data across multiple manifestations of psoriatic disease including persistent manifestations, psoriatic arthritis as well as ankylosing spondylitis provide much needed, additional guidance for prescribing dermatologists who want to treat their patient in a comprehensive way." 

The abstract "Secukinumab provides comprehensive long-term treatment across multiple manifestations of psoriatic disease" (World Congress of Dermatology in Milan, 10-15 June 2019) is presenting the long-term efficacy and safety of secukinumab in multiple manifestations of psoriatic disease including, moderate-to-severe plaque-type, nail and palmoplantar psoriasis; psoriatic arthritis and ankylosing spondylitis. Data are derived from key Phase 3, randomised, double-blind trials of secukinumab (SCULPTURE, ERASURE/FIXTURE, TRANSFIGURE, GESTURE, FUTURE 2 and MEASURE 2) in a total of 1,872 patients.

The abstract "Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients over 5 years" (World Congress of Dermatology in Milan, 10-15 June 2019) investigated the immunogenicity of secukinumab treatment up to 5 years in two phase III extension studies (CAIN457A2304 and CAIN457A2307) in patients with moderate to severe plaque psoriasis. In total, 1821 patients entered the extension studies.

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 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. About 105 000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact [email protected]

References

      [1]   Langley R et al. Secukinumab provides comprehensive long-term treatment across multiple manifestations of psoriatic disease. Presented at the 24th World Congress of Dermatology; June 10-15 2019; Milan, Italy.
      [2]   Baran R. The burden of nail psoriasis: an introduction. Dermatol. 2010:221 Suppl 1:1-5.
      [3]   Kumar B et al. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Dermatol Venereol. 2002;82:192-5.
      [4]   Reich K et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients over 5 years. Presented at the 24th World Congress of Dermatology; June 10-15 2019; Milan, Italy.
      [5]   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.
      [6]   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.

# # #

Novartis External Communications
E-mail: [email protected]