Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx® reinforcing sustained efficacy and safety profile in psoriasis

• 5 year data from long-term Phase III extension study demonstrate sustained efficacy and safety of Cosentyx in patients with moderate-to-severe plaque psoriasis[1]
   
• Data planned to be presented at a key medical congress in the second half of 2017. 5 year Phase III data is a recognized milestone for assessing long-term efficacy and safety of innovative treatments
   
• Recently announced EU approval for Cosentyx label update underlined long-term superiority versus Stelara^®* in psoriasis, and efficacy in moderate-to-severe scalp psoriasis[2],[3]

Basel, July 14, 2017 - Novartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis[1]. Data will be presented at a key medical congress in the second half of 2017. 5 year Phase III data are a recognized milestone for assessing long-term efficacy and safety of innovative treatments.

"Cosentyx has consistently demonstrated sustained efficacy and safety providing psoriasis patients a new standard of long-term care," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "With the first data from a pivotal trial with 5 years of follow up, Cosentyx continues to demonstrate it can provide what psoriasis patients want, a life with clear skin."

4 year Phase III data presented at EADV 2016 showed Cosentyx delivered almost clear or completely clear skin in a majority of patients (PASI 90 - 66%, PASI 100 - 44%) after 4 years of treatment[13]. The data showed that with Cosentyx, 97% of PASI 90 and 99% of PASI 100 response rates were maintained from Year 1 to Year 4[13].

Recently, new label updates announced for Cosentyx in Europe demonstrated long-term superiority of Cosentyx versus Stelara^®* (ustekinumab) in moderate-to-severe plaque psoriasis on the basis of 52 week data from the CLEAR study, and expanded the use of Cosentyx for the treatment of moderate-to-severe scalp psoriasis[2],[3]. Cosentyx was launched in 2015 as the first and only fully-human IL-17A inhibitor to treat psoriasis and is now licenced for the treatment of psoriatic arthritis and ankylosing spondylitis as well. Novartis remains committed to investigating important scientific questions with Cosentyx that address unmet needs and could significantly enhance patients' quality of life.

About the study
The long-term extension study for Cosentyx in patients with moderate-to-severe psoriasis is designed to analyze efficacy and safety over the period of 5 years (Week 260)[1]. The current data analysis for Cosentyx includes all patients who reached a PASI 75 response at Week 12 and subsequently received continuous treatment with 300mg secukinumab until the end of Year 5[1].  The study includes analysis of the PASI 75/90/100 response rates over the extended treatment period from Year 1 (Week 52) to the end of Year 5 (Week 260), analyses of body surface area (BSA) and absolute PASI (i.e. assessments of increasing relevance to the dermatologists), showing how many patients still on study drug had no more than 1% of their BSA covered by psoriasis, mean PASI and BSA improvement, as well as the safety profile of Cosentyx[1].

About psoriasis
Psoriasis is a common, non-contagious, auto-immune disease that affects more than 125 million people worldwide[4]. Plaque psoriasis is the most common form of the disease and appears as raised, red patches covered with a silvery white buildup of dead skin cells. Scalp psoriasis is a form of psoriasis that is reported to affect approximately half of all patients with psoriasis[5]. The disease has a significant impact on patients' quality of life, which is an aspect of the disease underestimated by most physicians[6].

Psoriasis is not simply a cosmetic problem, but a persistent, chronic (long-lasting), and sometimes distressing disease, which can affect even the smallest aspects of people's lives on a daily basis. Up to 30% of patients with psoriasis have, or will develop, PsA[7]. PsA is a condition in which the joints are also affected, causing debilitating symptoms including pain, stiffness and irreversible joint damage[7],[8]. Psoriasis is also associated with other serious health conditions, such as diabetes, heart disease and depression[7].

About Cosentyx and interleukin-17A (IL-17A)
Launched in January 2015, Cosentyx is a targeted treatment that specifically inhibits the IL-17A cytokine. Research suggests that IL-17A may play an important role in driving auto-inflammatory conditions in enthesis and ultimately the body's immune response in psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS)[9],[10].

Cosentyx is approved in more than 75 countries for the treatment of moderate-to-severe plaque psoriasis, which includes the US, Canada, the European Union countries, Japan, Switzerland and Australia. In Europe, Cosentyx is approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients.[2] In the US, Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).[11]

Cosentyx is the first IL-17A inhibitor approved in more than 70 countries for the treatment of active PsA and AS, which includes the US and the European Union countries. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.[12]

Disclaimer
This press release contains forward-looking statements, including "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; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, 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 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, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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*Stelara® is a registered trademark of Janssen Biotech, Inc.

References
[1] Novartis, data on file
[2] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR-Product_Information/human/003729/WC500183129.pdf. Last accessed July 2017.
[3] 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. Journal of the American Academy of Dermatology. 2017;76:60-69.
[4] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." Available at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed June 2017.
[5] Farber EM, Nall L. Natural history and treatment of scalp psoriasis. Cutis. 1992;49:396-400.
[6] Wozel G. Psoriasis treatment in difficult locations: scalp, nails, and intertriginous areas. Clinics in Dermatology. 2008;26:448-459.
[7] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed June 2017.
[8] Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423-441.
[9] Kirkham BW et al. Interleukin-17A: a unique pathway in immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid arthritis. Immunology. 2014; 141:133-142.
[10] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends in Pharmacological Sciences. 2009; 30(2):95-103.
[11] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
[12] Novartis, data on file
[13] Bissonnette R et al. Secukinumab maintains high levels of efficacy through 4 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 2016. 1^st October 2016.

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