New Novartis 3 year data demonstrated Cosentyx™ long-term safety in patients with moderate-to-severe plaque psoriasis

• The extension study is the longest Cosentyx^TM Phase III trial conducted to-date
• In this study, Cosentyx^TM had a favourable safety profile consistent with that observed in previous Phase III studies^1,2-7.
• In Canada, the prevalence of psoriasis is estimated at approximately 2%. According to a recent Canadian database study, 85% of patients have chronic plaque psoriasis, 28% of which are considered moderate to severe⁸.

DORVAL, QC, Oct. 28, 2015 /CNW/ - Novartis presented new data demonstrating that first in class Cosentyx^TM (secukinumab) maintained a favourable safety profile while providing sustained skin clearance in patients with moderate-to-severe plaque psoriasis over three years¹. The results of this study were presented at the 24^th Annual Congress of the European Academy of Dermatology and Venereology (EADV) in Copenhagen, Denmark in early October. Cosentyx^TM is the first fully human interleukin-17A (IL-17A) inhibitor approved to treat adult moderate-to-severe plaque psoriasis⁹.

"Long-term safety is an important aspect of treatment when dealing with a chronic life-long disease like psoriasis. Canadians managing psoriasis will likely be on treatment for the rest of their lives and they need to know that this part of their disease management is safe" said Dr. Sheetal Sapra, Ontario Dermatologist and SCULPTURE and STATURE Study investigator. "As an investigator in this study, I'm glad to see the primary objective to assess the long-term safety was met, making Cosentyx^TM a safe treatment option for Canadians."

About the A2304E1 Extension Study (Cosentyx^TM Extension Study to SCULPTURE and STATURE studies)
A2304E1 is a multicenter, double-blind and open-label, four-year extension to the Phase III studies SCULPTURE² and STATURE³. In SCULPTURE 642 patients who completed 52 weeks of treatment continued into the extension. During the core study, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of subcutaneous secukinumab 300 mg or 150 mg, administered either at a four-week fixed-interval (FI) regimen (320 patients) or in a retreatment-as-needed (RAN) regimen (322 patients). Patients that achieved PASI 50 but not PASI 75 (43 patients) were transferred into the STATURE study in which patients were up dosed to intravenous regimen (22 patients) or 300 mg regimen (21 patients) every four weeks. At entry into the extension, patients continued with the same blinded maintenance treatment regimen and dose that they had received in the SCULPTURE core study¹.

The primary objective of the extension study was to assess the long-term safety and tolerability of Cosentyx^TM in patients with moderate-to-severe chronic plaque psoriasis. The secondary objective was to evaluate long-term efficacy of 300 mg and 150 mg Cosentyx^TM administered in retreatment-as-needed versus fixed-interval regimens in patients who were PASI 75 responders at Week 12. Efficacy measures included proportion of patients achieving PASI 75, PASI 90 and PASI 100 as well as IGA mod 2011 0/1 responses¹.

About psoriasis
Affecting as many as one million Canadians and more than 125 million people worldwide¹⁰, psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain.¹¹ People living with psoriasis reported that these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult.^10-12

Additionally, people with psoriasis are at increased risk for other chronic illnesses^13-14 such as psoriatic arthritis, a type of inflammatory arthritis, which about 30% of people who have psoriasis get.¹⁵ Psoriasis symptoms can begin at any age, including in childhood, but the disease mainly affects adults.¹⁶ Symptoms start when a combination of environmental triggers and genetic factors disrupt the lifecycle of skin cells.¹⁶

In Canada, the prevalence of psoriasis is estimated at approximately 2%. According to a recent Canadian database study, 85% have chronic plaque psoriasis, 28% of which are considered moderate to severe⁸.

About Cosentyx^TM (secukinumab) and interleukin-17A (IL-17A)
Cosentyx^TM is a human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A) ⁹.  Cosentyx^TM works by inhibiting the action of IL-17A, a protein found in high concentrations in skin affected by the disease.^17-19 In the Phase III program, Cosentyx^TM demonstrated a favorable safety profile, with similar incidence and severity of adverse events between Cosentyx^TM treatment arms (300 mg and 150 mg)⁴. It is approved by Health Canada for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.⁹

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2014, the company invested $76 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs approximately 700 people in Canada. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

Cosentyx is a trademark 

References

1.	Bissonnette R., et al. Secukinumab maintains high levels of efficacy through 3 years of treatments: results from an extension to a phase 3 study (SCULPTURE). Presented as a late breaking abstract at the European Academy of Dermatology and Venereology 2015. October 10 2015
2.	Mrowietz U, Leonardi CL,Girolomoni G et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, double-blind, noninferiority trial (SCULPTURE). Am Acad Dermatol. 2015 Jul;73(1):27-36.
3.	Thaçi D, Humeniuk J, Frambach Y, et al. Secukinumab in Psoriasis: Randomized, Controlled Phase 3 Trial Results Assessing the Potential to Improve Treatment Response in Partial Responders (STATURE). Br J Dermatol. 2015 2015 Sep;173(3):777-87.
4.	Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in Plaque Psoriasis – Results of Two Phase Three Trials. N Engl J Med. 2014; 371(4):326-338.
5.	Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014 Sep 22 [E-pub ahead of print].
6.	Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015 Sep;73(3):400-9
7.	Blauvelt A, Prinz JC, Gottlieb AB et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015 Feb;172(2):484-93.
8.	Petrella RJ, Gregory V, Luciani L, Barbeau M . Characteristics of chronic plaque psoriasis in Canada: a retrospective database study. (PSS7) Poster presented at ISPOR 19th Annual International Meeting, Montréal, QC, Canada, May 2014.
9.	Cosentyx^TM Product Monograph, Novartis Pharmaceuticals Canada Inc., February 27, 2015.
10	Canadian Dermatology Association "Living with Psoriasis". http://www.dermatology.ca/skin-hair-nails/skin/psoriasis/living-with-psoriasis/ (Accessed October 23^rd 2015).
11.	National Psoriasis Foundation. Facts about psoriasis. Accessed February 16 2015.
12.	Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.
13.	Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146 (1):9-15.
14.	National Psoriasis Foundation website. "Health conditions associated with psoriasis". Accessed February 16, 2015
15.	Wilson FC, Icen M, Crowson CS et al. Incidence and clinical predictors of psoriatic arthritis in patients with psoriasis: a population-based study. Arthritis Rheum. 2009 15;61(2):233-9.
16.	Nestle FO, Kaplan DH, Barker J. Psoriasis. New Engl J Med. 2009; 361: 496-509
17.	Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.
18.	Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.
19.	Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-21.

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Elizabeth Tanguay, Manager, Communications, Novartis Pharmaceuticals Canada Inc., [phone], [email protected]; Rob McEwan, Vice President, Argyle Public Relationships, + 1 416 968-7311 ext. 242, [email protected]