Novartis to present new late-breaking Cosentyx data at AAD 2015 showing significant patient benefit in achieving clear skin

• Detailed results from the CLEAR study will be revealed showing Cosentyx superiority to Stelara^® in clearing skin (PASI 90 and PASI 100)¹
• New data from the long-term Phase III program to be presented demonstrating Cosentyx efficacy and safety over two years in psoriasis patients¹
• Cosentyx is the first and only IL-17A inhibitor approved in Europe, the US, Japan Canada and Switzerland for moderate-to-severe plaque psoriasis^2-4

Novartis announced today that new results for Cosentyx(TM) (secukinumab) in moderate-to-severe plaque psoriasis, including detailed findings from the head-to-head CLEAR study and long-term data from the Phase III program, will be presented as late breaking research at the 73^rd Annual Meeting of American Academy of Dermatology (AAD), from 20 – 24 March in San Francisco, California, USA. In total, 25 posters from the Novartis Dermatology portfolio will be highlighted at this leading congress.

New data from the CLEAR study will include results that demonstrate Cosentyx is superior to Stelara^®* (ustekinumab) in clearing skin (PASI 90 and PASI 100) at Week 16¹. CLEAR is the first Phase III psoriasis study designed with a PASI 90 objective, which is considered an important measure of treatment success by the European Medicines Agency⁵ and an optimal treatment goal for patients⁶.

In addition, new long-term results for Cosentyx up to two years from the Phase III program will be highlighted for the first time at the congress. The data comes from an extension of the pivotal FIXTURE and ERASURE studies. In the FIXTURE study, Cosentyx cleared the skin of 72% psoriasis patients compared to 31% for Enbrel^®** (etanercept) at Week 16⁷.

“We are excited to present new late-breaking research at AAD, following the back-to-back regulatory approvals received earlier this year,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “Our commitment is to keep demonstrating more evidence on the ability of Cosentyx to clear psoriasis skin, to inform physicians and give hope to people living with this life-long disease who need treatments that provide long-term relief.”

In January 2015, Cosentyx (at a dose of 300 mg) became the first and only interleukin-17A (IL-17A) inhibitor approved in Europe as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients, and in the US as a treatment for moderate-to-severe plaque psoriasis in adult psoriasis patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy)⁷. In addition to the EU and the US, Cosentyx has been approved in Switzerland, Chile, Australia and Canada for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

Novartis dermatology highlights at AAD 2015

Cosentyx presentations

A total of 18 Cosentyx abstracts will be presented for the first time at AAD 2015, including:

• Late-breaking oral presentations:
  • Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 16-week results from the CLEAR study (Friday 20 March, 10:00 PST / 18:00 CET)
  • Secukinumab treatment maintains efficacy in moderate-to-severe plaque psoriasis through second year of treatment: a randomized extension of the ERASURE and FIXTURE studies (Friday 20 March, 11:00 PST / 19:00 CET)
• Highlights of electronic posters available throughout the congress:
  • Secukinumab demonstrates sustained efficacy in moderate-to-severe plaque psoriasis across disease severity subgroups
  • Secukinumab shows efficacy in subjects regardless of previous exposure to biologic therapy: a pooled subanalysis from four Phase 3 clinical trials in psoriasis
  • Pooled analysis of phase 3 ERASURE and FIXTURE trials: Secukinumab 300 mg shows superior efficacy in moderate to severe plaque psoriasis vs. placebo in ERASURE vs. etanercept 50 mg and placebo in FIXTURE across subjects’ body weight groups
  • Secukinumab long-term self-administration by prefilled syringe or auto-injector/pen is highly acceptable to subjects with moderate-to-severe plaque psoriasis
  • Secukinumab, a novel anti-IL-17A antibody, exhibits low immunogenicity in clinical trials and human in vitro Assays

Other Cosentyx Phase III analyses at AAD 2015 include the efficacy and safety of Cosentyx in Asian patients and North American patients, efficacy on the head and neck, scalp psoriasis and a Phase III safety analysis.

References

1. Novartis, Data on file.
2. Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. Brit J Dermatol. 2013; 168(2): 412-421.
3. Rich PA, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Brit J Dermatol. 2013; 168(2): 402-411.
4. Ohtsuki, M., Morita, A., Abe, M., et al. Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: Subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study. The Journal of Dermatology, 41: 1039-1046. doi: 10.1111/1346-8138.12668
5. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Guidelines on clinical investigation of medicinal products indicated for the treatment of psoriasis. 2004. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/
   Scientific_guideline/2009/09/WC500003329.pdf Accessed February 9, 2015.
6. Mrowietz, U. Implementing treatment goals for successful long-term management of psoriasis. Journal of the European Academy of Dermatology and Venereology, 26: 12-20. doi: 10.1111/j.1468-3083.2011.04411.x
7. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med 2014;371:326-338.