Cosentyx™: First IL-17A Antagonist for Moderate-to-Severe Plaque Psoriasis Now Approved in Canada

• Cosentyx^TM is an approved psoriasis medication to selectively bind to IL-17A and inhibit interaction with the IL-17 receptor^1,2
• Phase III data demonstrated Cosentyx^TM resulted in clear or almost clear skin in the majority of patients with moderate-to-severe plaque psoriasis³
• Efficacy and safety was demonstrated in 10 Phase II and III studies which included over 3,430 adults with moderate-to-severe plaque psoriasis³, of which 12 sites were in Canada with 116 Canadians, providing a good clinical experience representation of the Canadian population living with psoriasis⁴
• Affecting 1 million Canadians⁵, psoriasis can negatively impact daily life and is associated with increased risk for other chronic illnesses^6,7

DORVAL, QC, March 2, 2015 /CNW/ - Novartis announced today that Health Canada has approved Cosentyx^TM (secukinumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy³. Offering a new treatment option for Canadians living with plaque psoriasis, Cosentyx^TM is the first approved human monoclonal antibody (mAb) that selectively binds to interleukin IL-17A^1,2.

"An unmet need exists in the treatment of moderate-to-severe plaque psoriasis in achieving clear to almost clear skin and not all treatments are effective in all patients." said Dr. Richard Langley, Professor in Dermatology of Medicine, and Director of Dermatology Research at Dalhousie University in Halifax, Nova Scotia. "Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies. The approval of Cosentyx^TM, a therapy targeting IL-17A for moderate-to-severe plaque psoriasis, offers a new treatment option for physicians in treating this condition."

"About 2% of Canadians are estimated to be diagnosed with psoriasis, and nearly half of them are dissatisfied with their current therapies, including biologic treatments, demonstrating a high unmet need for patients," said Tim Maloney, President of Novartis Pharmaceuticals Canada Inc. "We are excited about the Health Canada approval of Cosentyx^TM and the potential opportunity to offer a new treatment option to these people."

"Our goal at the Canadian Association of Psoriasis Patients is to get this challenging and misunderstood skin condition out into the open, and to help us all as we manage our lives with psoriasis. We also want to make sure that anyone, anywhere in Canada can get access to the treatment they need," said Christine Janus, Executive Director of both the Canadian Association of Psoriasis Patients and the Canadian Skin Patient Alliance. "And so we always welcome news of a new treatment option for Canadians with psoriasis."

About Cosentyx^TM
Cosentyx^TM is a human monoclonal antibody (mAb) that selectively binds to interleukin-17A (IL-17A) and inhibits its interaction with the IL-17 receptor^14-19. 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 phototherapy³.

About PASI
PASI measures the redness, scaling and thickness of psoriatic plaques and the extent of involvement in each region of the body.

About interleukin-17A (IL-17A)
IL-17A is a naturally occurring cytokine (messenger protein) involved in normal inflammatory and immune responses^19,21. IL-17A is highly upregulated in lesional skin in contrast to non-lesional skin of plaque psoriasis patients.

About Psoriasis
Affecting as many as one million Canadians⁵ and more than 125 million people worldwide⁶, psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain²¹. People living with psoriasis reported that these symptoms can negatively impact their quality of life, both psychosocially and physically, which makes daily functioning difficult^22,23,24.

Additionally, people with psoriasis are at increased risk for other chronic illnesses²³ such a psoriatic arthritis, a type of inflammatory arthritis, which about 30% of people who have psoriasis get²⁴.

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 severe²⁵.

Psoriasis symptoms can begin at any age, including in childhood, but the disease mainly affects adults²⁶. Symptoms start when a combination of environmental triggers and genetic factors disrupt the lifecycle of skin cells²¹.

About Novartis in specialty dermatology
Novartis is committed to developing specialty dermatology therapies, where there are remaining high unmet medical needs.

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 2012, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 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, cost-saving generic pharmaceuticals, preventive vaccines and over-the-counter products. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58 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 130,000 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.

Cosentyx is a trademark.

References

1.	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.
2.	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.
3.	Cosentyx^TM Product Monograph, Novartis Pharmaceuticals Canada Inc., March 2, 2015
4.	Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. New Engl J Med. 2014 [published online ahead of print 9 July 2014].
5.	Canadian Assocation of Psoriasis Patients "What is Psoriasis". Accessed February 16 2015.
6.	National Psoriasis Foundation. Facts about psoriasis. Accessed February 16 2015.
7.	Guenther L, Gulliver W. Psoriasis Comorbidities. J Cutan Med Surg. 2009; 13(suppl 2):S77-87.
8.	Blauvelt A, Prinz J, 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. 2014; [published online ahead of print August 16, 2014].
9.	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; [published online ahead of print September 22, 2014].
10.	Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp. 2004;9(2):136-9.
11.	Christophers E, Griffiths CEM, Gaitanis G, et al. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol. 2006;20:921-925.
12.	Krueger JG, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: Results for a 1998 National Psoriasis Foundation patient membership survey. Arch Derm. 2001;137:280-284.
13.	Sterry W, Barker J, Boehncke WH, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol. 2004;151 Suppl 69:3-17.
14.	Gaffen SL. "Structure and signaling in the IL-17 receptor family." Nat Rev Immunol. 2009;9(8):556-67.
15.	Ivanov S, Linden A. "Interleukin-17 as a drug target in human disease." Trends Pharmacol Sci. 2009;30(2):95-103
16.	Kopf M, Bachmann MF, Marsland BJ. "Averting inflammation by targeting the cytokine environment" Nat Rev Drug Discov. 2010; 9(9):703-18.
17.	Onishi RM, Gaffen SL. "Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease." Immunology. 2010;129(3):311-21.
18.	Krueger J, Fretzin S, Suárez-Fariñas M, et al. "IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis." J Allergy Clin Immunol. 2012;130(1):145-154.
19.	Johansen C, Usher PA, Kjellerup RB, et al. "Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin." Brit J Dermatol. 2009;160(2):319-24.
20.	Arican O, Aral M, Sasmaz S, et al. Serum levels of TNF-alpha, IFN-gamma, IL-6, IL-8, IL-12, IL-17, and IL-18 in patients with active psoriasis and correlation with disease severity. Mediat Inflamm. 2005; 5: 273-9.
21.	Nestle FO, Kaplan DH, Barker J. Psoriasis. New Engl J Med. 2009; 361: 496-509.
22.	Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM. Psoriasis causes as much disability as other major medical disease. J. Am. Acad.Dermatol. 1999 Sept; 41 (3 Pt 1): 401-7.
23.	Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.
24.	National Psoriasis Foundation website. "Health conditions associated with psoriasis". Accessed February 16 2015.
25.	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
26.	Raval K, Lofland JH, Waters HC, Tak Piech C. Disease and treatment burden of psoriasis: Examining the impact of biologics. J Drugs Dermatol 2011; 10(2):189-96

SOURCE Novartis Pharmaceuticals Canada Inc.

Image with caption: "Psoriasis: An incurable chronic skin disease (CNW Group/Novartis Pharmaceuticals Canada Inc.)". Image available at: http://photos.newswire.ca/images/download/20150302_C8498_PHOTO_EN_12706.jpg

Image with caption: "About Interleukin 17-A (IL-17A) (CNW Group/Novartis Pharmaceuticals Canada Inc.)". Image available at: http://photos.newswire.ca/images/download/20150302_C8498_PHOTO_EN_12707.jpg

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