Novartis announces NEJM publication of two phase III studies demonstrating high efficacy of investigational new drug secukinumab (AIN457) in psoriasis patients

• Results of two phase III psoriasis studies consistently show rapid, very high skin clearance, sustained efficacy and an acceptable safety profile with investigational secukinumab¹

• Investigational secukinumab is the first IL-17A inhibitor with phase III data presented in psoriasis and regulatory submissions filed with international health authorities¹

• International investigators led by Canadian Dr. Richard Langley, published data in the NEJM involving 35 countries totaling 2044 patients, of which 12 sites were in Canada and 116 patients were Canadians, providing a good representation of the Canadian population living with psoriasis¹

DORVAL, QC, Aug. 5, 2014 /CNW/ - Novartis recently announced that detailed results from two pivotal phase III studies evaluating the interleukin-17A (IL-17A) inhibitor investigational secukinumab (AIN457) were published online in the New England Journal of Medicine (NEJM). Investigational secukinumab met all primary and key secondary endpoints at Week 12. Superiority over placebo in both ERASURE and FIXTURE studies was demonstrated, while FIXTURE study also demonstrated superiority to Enbrel* (etanercept) in improving moderate-to-severe plaque psoriasis symptoms¹.

"The publication of the two pivotal phase III studies in NEJM showed consistently high efficacy of investigational secukinumab validates IL-17A as a new therapeutic target in moderate-to-severe psoriasis, said main author Dr. Richard Langley, Dermatology Professor of Medicine, and Director of Dermatology Research at Dalhousie University in Halifax, Nova Scotia. Dr. Langley headed an international team of researchers in FIXTURE: "Data published in NEJM also showed that investigational secukinumab-treated patients had their symptoms reduced faster than those treated with Enbrel^®* in the FIXTURE study¹. Clinically relevant differences were observed as early as Week 2, and on average investigational secukinumab patients had their symptoms reduced by half by Week 3, compared to Week 7 for Enbrel^®* patients¹."

"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, CEO and Executive Director of both the Canadian Association of Psoriasis Patients and the Canadian Skin Patient Alliance. "And so we always welcome news of research advancement offering the possibility of new treatment options for Canadians living with psoriasis."

"Psoriasis has been shown to impact psychological well-being and social functioning, similarly to that of cancer, arthritis, heart disease or depression²." said Tim Maloney, President of Novartis Pharmaceuticals Canada Inc. "Over 850,000 Canadians are estimated to be diagnosed with psoriasis, and up to 50% of patients are dissatisfied with their current therapies. We are excited about this new data and the potential opportunity to bring new options to these patients^3-5."

Over half of investigational secukinumab 300 mg patients experienced clear (PASI 100) or almost clear (PASI 90) skin, described as Psoriasis Area and Severity Index 90 or 100 (PASI 90/PASI 100) by Week 12 (59.2% for ERASURE and 54.2% for FIXTURE, p<0.001)¹. In comparison, only 20.7% of Enbrel^®*-treated patients experienced PASI 90 or 100 in FIXTURE¹. Investigational secukinumab 300 mg patients' response continued to improve from Week 12, with more than 70% experiencing clear or almost clear skin by Week 16 (72.4% and 36.8% for PASI 90 and 100, respectively) in the FIXTURE study, which was maintained in the majority of patients up to Week 52 (with continued treatment)¹.

About PASI
PASI measures the redness, scaling and thickness of psoriatic plaques and the extent of involvement in each region of the body. Treatment efficacy is assessed by the reduction of the score from baseline (i.e. a 75% reduction is known as PASI 75, a 90% reduction is known as PASI 90, and PASI 100 is completely clear skin). PASI 90 and 100 are more robust measures of the extent of skin clearance compared to standard measures⁶, such as PASI 75, that have been used in most psoriasis clinical studies.

About interleukin-17A (IL-17A)
Investigational secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A (IL-17A)^7-9. IL-17A is a central cytokine (messenger protein) involved in the development of psoriasis and is found in high concentration in skin affected by the disease^10-11. Research shows that IL-17A plays a key role in driving the body's autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies^7-9,12,13.

About Psoriasis
Psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain¹⁴ that is associated with significant impairment of physical and psychological quality of life^15,16.

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 severe³.

About Novartis in specialty dermatology
Novartis is committed to developing innovative 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 Pharmaceuticals Canada Inc. is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis Group of Companies offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 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 135,000 full-time equivalent associates and sell products in more than 150 countries around the world. For more information, please visit www.novartis.com.

*Enbrel is a registered trademark of Amgen Inc.

References

1. 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].
2. 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.
3. 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
4. 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 Invest Derm Symp P. 2004; 9: 136-9.
5. 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: 921-25.
6. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. European Medicines Agency Web site. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf Published  November 2004. Accessed April 2014.
7. Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009; 9: 556-67.
8. Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009; 30:95-103.
9. Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9: 703-18.
10. 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: 319-24.
11. 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.
12. Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010; 129: 311-21.
13. 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 Immun. 2012; 130: 145-54.
14. Nestle FO, Kaplan DH, Barker J. Psoriasis. New Engl J Med. 2009; 361: 496-509.
15. Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet. 2007; 370: 263-71.
16. de Korte J, Sprangers MA, Mombers FM, Bos JD. Quality of life in patients with psoriasis: a systematic literature review. J Invest Derm Symp P. 2004; 9:140-7.

SOURCE: Novartis Pharmaceuticals Canada Inc.

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