Novartis AG Posts Stunning 5-Year Sustained Late-Stage Psoriasis Data

• Cosentyx^® (secukinumab) is the first and only fully human IL-17A inhibitor to show sustained skin clearance rates at 5 years in phase III in psoriasis[1]
  
• Landmark data show that PASI 90 and PASI 100 response rates were nearly 100% maintained with Cosentyx from Year 1 to Year 5 in patients with moderate-to-severe plaque psoriasis[1]
  
• 5-year data from a Phase III study reinforce Cosentyx long term skin clearance and safety[1]

The digital press release with multimedia content can be accessed here:

Basel, September 13, 2017 - Novartis announced today, first of its kind Phase III data showing Cosentyx^® (secukinumab) delivered high and long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis at 5 years[1]. These data were presented for the first time at the 26th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland.

By specifically targeting interleukin-17A (IL-17A), Cosentyx addresses the key cytokine involved in the development of psoriasis[2]. IL-17A plays a significant role in the pathogenesis of plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS)[3]-[5]. Inhibiting IL-17A is important as up to 30% of patients with psoriasis may have PsA[6],[7].

"These final data are meaningful for dermatologists as they show that the high efficacy and safety of secukinumab was sustained over the 5-year treatment period.", said Dr. Robert Bissonnette, Innovaderm Research, Montreal, Canada.

"The 5-year data reinforce Cosentyx as an important treatment option for those people living with psoriasis who aspire for skin clearance that can last," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Cosentyx is the first and only IL-17A inhibitor approved for psoriasis, psoriatic arthritis and ankylosing spondylitis and has been prescribed to more than 100,000 patients since launch."

Clear skin is the aim of psoriasis treatment, and a Psoriasis Area and Severity Index (PASI) 75, 90 or 100 response is considered an important measure of treatment success[8]-[11]. Over the extended treatment period from Year 1 (Week 52) to the end of Year 5 (Week 260), PASI 75/90/100 response rates remained consistent[1]. PASI 75 and PASI 90 response rates were achieved by 89% and 69% of psoriasis patients, respectively, at Year 1 ('as observed' analysis) and this high rate was maintained to Year 5 (89% and 66%, respectively). In addition, 44% of psoriasis patients achieved completely clear skin (PASI 100) at Year 1 and this rate was maintained to Year 5 (41%). Cosentyx continued to have a favorable and consistent safety profile, and low immunogenicity[1],[3].

To date, more than 100,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications[12]. In addition, 2017 marks 10 years since the first patient, first visit in a clinical trial with Cosentyx.

About Cosentyx and IL-17A
Cosentyx, launched in 2015, is the first and only fully-human IL-17A inhibitor approved to treat psoriasis, PsA and AS[3]. Cosentyx is a targeted treatment that specifically inhibits the IL-17A cytokine which plays a significant role in the pathogenesis of plaque psoriasis, PsA and AS[3]-[5].

Cosentyx delivers long-lasting skin clearance, with proven sustainability, safety out to 5 years and convenient once-monthly dosing in a patient-friendly auto injector[13]. Cosentyx is also approved for the most difficult-to-treat types of plaque psoriasis - palmoplantar psoriasis (psoriasis of the hands and feet), scalp psoriasis, and nail psoriasis[3].

Cosentyx is approved in 79 countries for the treatment of moderate-to-severe plaque psoriasis, which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for the first-line systemic treatment of moderate-to-severe plaque psoriasis in adult patients[3]. 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)[14].

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

About the 5-year Cosentyx extension study (A2304E1)[1]
A2304E1 is a multicenter, double-blind and open-label, 5-year extension to the pivotal Phase III SCULPTURE study. The primary objective of this extension study was to assess the long-term safety and tolerability of Cosentyx in patients with moderate-to-severe plaque psoriasis. Efficacy measures included the proportion of patients achieving PASI 75, PASI 90 and PASI 100. This long-term extension study demonstrated the sustained efficacy and safety of Cosentyx. In 162 psoriasis patients at Year 1, PASI 75 and PASI 90 response rates were achieved by 89% and 69% of patients respectively. This high rate was maintained at Year 5 with 122 patients observed (89% and 66%, respectively). In SCULPTURE, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of Cosentyx 300 mg or 150 mg, given either at a 4-week fixed-interval regimen or in a retreatment-as-needed regimen. Patients who completed 52 weeks of the SCULPTURE study were eligible to continue the same dose and regimen in the extension study (N=642).

About psoriasis
Psoriasis is a common, non-contagious, auto-immune disease that affects more than 125 million people worldwide[15]. 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.

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 may develop PsA[6]. PsA is a condition in which the joints are also affected, causing debilitating symptoms including pain, stiffness and for some people, irreversible joint damage[6],[16]. Psoriasis is also associated with other serious health conditions, such as diabetes, heart disease and depression[6].

About Novartis Immunology & Dermatology
Novartis is a global leader in Immunology & Dermatology. We are transforming the lives of people living with immunologic diseases, focusing on specialty dermatology, rheumatology, auto-inflammatory, transplant and specialty liver diseases where high unmet medical needs exist. Our leading brand Cosentyx^® (secukinumab) is an innovative biologic approved in more than 70 markets for the treatment of moderate-to-severe psoriasis (PsO), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Other key brands include Xolair^® (omalizumab)* in chronic spontaneous urticaria (CSU), Zortress^®/Certican^® and Myfortic^® in transplant and Ilaris^® (canakinumab), approved to treat several rare diseases including some Periodic Fever Syndromes. Our I&D pipeline includes multiple compounds in liver disease.

* Novartis co-promotes Xolair with Genentech in the US and shares a portion of the operating income, but does not book US sales.

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 Cosentyx and the other investigational and 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 Cosentyx or the other 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 119,000 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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References
[1] 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..
[2] Zeichner JA and Armstrong A. The role of IL-17 in the pathogenesis and treatment of psoriasis. The Journal of Clinical and Aesthetic Dermatology. 2016;9:S3-S6.
[3] Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/
medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed September 2017.
[4] Nestle FO et al. Mechanisms of disease psoriasis. New England Journal of Medicine. 2009;361:496-509
[5] Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. British Journal of Dermatology. 2012;167:717-24.
[6] National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed September 2017.
[7] Mease PJ et al.. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. Journal of the American Academy of Dermatology. 2013;69:729-35.
[8] European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/
Scientific_guideline/2009/09/WC500003329.pdf. Last accessed September 2017.
[9] ACTAS Dermo-Sifiliográficas. Spanish Evidence-Based Guidelines on the Treatment of Psoriasis With Biologic Agents. Available at: http://www.actasdermo.org/en/spanish-evidence-based-guidelines-on-treatment/articulo/S1578219013001789/. Last accessed September 2017.
[10] Canadian Dermatology Association. Canadian Guidelines for the Management of Plaque Psoriasis. Available at: http://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf. Last accessed September 2017.
[11] Langley RG et al. The 5-point Investigator's Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. Journal of Dermatology Treatment. 2015;26:23-31.
[12] Novartis. Data on file. September 2017.
[13] Lacour JP et al. Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial. Journal of the European Academy of Dermatology and Venereology. 2017;31:847-56.
[14] Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
[15] 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 September 2017.
[16] Mease PJ and Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423-41.

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