Novartis receives FDA approval for Cosentyx® label update to include moderate-to-severe scalp psoriasis

• US label updated to include Cosentyx^® (secukinumab) data in moderate-to-severe scalp psoriasis[1] - one of the difficult-to-treat types of psoriasis[2]
   
• Approximately half of all 125 million patients with psoriasis suffer from scalp psoriasis, which can have an impact on patients' quality of life[3]-[6]
   
• This follows a similar European label update in June 2017[7]

Basel, February 8, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx^® (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis[1]. The updated label includes Cosentyx data in moderate-to-severe scalp psoriasis - one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients[1]-[3].The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial[8].

The updated label for Cosentyx in scalp psoriasis addresses an important unmet need. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors[2]. Approximately half of all 125 million patients with psoriasis suffer from scalp psoriasis[2],[4].

Kristian Reich, M.D., Ph.D., Georg-August-University Göttingen and Dermatologikum Hamburg, Germany, said: "Scalp psoriasis is on a very sensitive, and a very visible area of the body. For patients this could translate into physical pain, frustration and social isolation. Patients and doctors are in need of effective treatment options in this and other difficult-to-treat forms of psoriasis."

"This is an important label update for Cosentyx, the first IL-17A inhibitor approved for moderate-to-severe plaque psoriasis. It confirms the additional value Cosentyx offers to patients who seek a treatment effective in various areas of the body," said Eric Hughes, Global Development Unit Head, Immunology & Dermatology. "We're proud to expand treatment possibilities of Cosentyx for an even greater number of patients."

Cosentyx is currently the only fully human IL-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase III study of scalp psoriasis[8]. The label update is based on 12-week primary endpoint results from the SCALP study of moderate-to-severe scalp psoriasis where Cosentyx demonstrated superior efficacy compared to placebo[1],[8].

Cosentyx has demonstrated sustained long-term efficacy, as well as a consistently favorable safety profile, including injection site pain at rates similar to placebo[9]-[14]. To date, more than 125,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications since launch[15]. 

About psoriasis
Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide[6]. It is a debilitating condition associated with a significant emotional and physical daily burden. In the long-term, psoriasis can also lead to other conditions, such as diabetes, heart disease, depression and psoriatic arthritis - which up to 30% of patients with psoriasis will develop[16].

Plaque psoriasis is the most common form of the disease and appears as raised, red skin patches covered with a silvery white build-up of dead cells. Most patients with psoriasis will also develop hard-to-treat forms of the disease which appear on the scalp, nails, palms of the hands or soles of the feet and are associated with further pain, decreased mobility and functional impairment[3]-[6],[17]-[19].

About Cosentyx (secukinumab) and IL-17A
Cosentyx is the first and only fully human IL-17A inhibitor approved to treat psoriasis, PsA and ankylosing spondylitis (AS)[1],[7]. Cosentyx is a targeted treatment that specifically inhibits IL-17A, cornerstone cytokine involved in the pathogenesis of psoriasis, and the inflammation of the entheses in PsA and AS[7],[20]-[22].

Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years[10]. Cosentyx is also approved for the most hard-to-treat forms of plaque psoriasis - palmoplantar psoriasis (psoriasis of the palms of the hands and soles of the feet), nail psoriasis and scalp psoriasis[1],[7].

About the SCALP study[8]
This study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Cosentyx in 102 patients with moderate-to-severe scalp psoriasis. Eligible patients were equally randomized to either subcutaneous Cosentyx 300 mg or placebo at Weeks 0, 1, 2, 3 and 4, then every four weeks for 12 weeks. At Week 12, patients in the placebo group who did not achieve at least a 90% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score were re-randomized to Cosentyx 300 mg until study completion. The primary endpoint was the proportion of patients who achieved PSSI 90 response rate at Week 12. The proportion of patients achieving an IGA scalp only score of 0 or 1 (clear or almost clear) were 56.9% and 5.9% for Cosentyx and the placebo groups, respectively.

About Novartis Immunology & Dermatology
Novartis is a global leader in Immunology & Dermatology. We are dedicated to transforming the lives of people living with immunologic diseases, focusing on immunodermatology, rheumatology and specialty liver diseases. Our I&D pipeline includes multiple compounds in liver disease and other immunological areas where high unmet medical needs exist.

Disclaimer
This press release contains 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; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

References
[1]   Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018.
[2]   Crowley JJ. Nail, Scalp, and Palmoplantar Psoriasis. Biologic and Systemic Agents in Dermatology. 2018; 160-174.
[3]   National Psoriasis Foundation. Scalp Psoriasis. psoriasis.org. https://www.psoriasis.org/about-psoriasis/specific-locations/scalp. Last accessed January 2018.
[4]   International Federation of Psoriasis Associations. Profile of Psoriasis. http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed January 2018.
[5]   Zampieron A et al. Quality of life in patients with scalp psoriasis. G Ital Dermatol Venereol. 2015 Jun;150(3):309-16
[6]   American Academy of Dermatology. Scalp Psoriasis. Available at: https://www.aad.org/public/diseases/hair-and-scalp-problems/scalp-psoriasis#symptoms. Last accessed January 2018.
[7]   European Medicines Agency. Cosentyx Summary of Product Characteristics. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Updated July 17, 2017. Last accessed January 2018.
[8]   Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77:667-674.
[9]   Braun J et al. Secukinumab demonstrates low radiographic progression and sustained efficacy through 4 years in patients with active ankylosing spondylitis. Late breaking abstract presented at the 2017 ACR/ARHP Annual Meeting, San Diego, USA. 7^th November 2017.
[10] Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th September 2017.
[11] Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and Safety Results from a Phase 3 Trial. AnnRheum Dis. 2017;76:952-953.
[12] Baeten D et al. Secukinumab, an interleukin-17A inhibitor in ankylosing spondylitis. N Engl J Med. 2015; 373:2534-48.
[13] McInnes IB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386(9999):1137-1146.
[14] Reich K et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis. Br. J. Dermatol. 2017;176:752-58.
[15] Novartis Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; Nov. 2017.
[16] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed June 2017.
[17] Baran R. The burden of nail psoriasis: an introduction. Dermatol. 2010:221 Suppl 1:1-5.
[18] Kumar B et al. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Dermatol Venereol. 2002;82:192-5.
[19] Chung J et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2014;71(4):623-32.
[20] Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol. 2014;66:231-41.
[21] Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496-509.
[22] Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.

# # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com