NVS Novartis AG

TIDMNOVN 
 
 
   -- Cosentyx narrowly missed statistical significance for superiority in ACR 
      20, the primary endpoint of the EXCEED trial, while showing numerically 
      higher results versus Humira(R)*[1] 
 
   -- Statistically significant advantages of Cosentyx versus Humira(R)* in 
      psoriatic arthritis (PsA)-specific endpoints were observed in a 
      pre-specified sensitivity analysis[1] 
 
   -- EXCEED underscores Novartis commitment in rheumatology as first 
      double-blinded monotherapy head-to-head trial with a primary endpoint 
      specific to joints in PsA[1] 
 
 
   Basel, November 1, 2019 -- Novartis, a leader in rheumatology and 
immuno-dermatology, today announced results from the EXCEED head-to-head 
trial comparing Cosentyx(R) (secukinumab) to Humira(R) * (adalimumab) in 
patients with active psoriatic arthritis (PsA)[1]. While Cosentyx 
narrowly missed statistical significance for superiority in ACR 20, the 
primary endpoint of the EXCEED trial, it showed numerically higher 
results versus Humira(R) *[1]. Statistically significant advantages of 
Cosentyx versus Humira(R) * in PsA-specific endpoints were observed in a 
pre-specified sensitivity analysis. The trial demonstrated a consistent 
and favorable safety profile for Cosentyx in line with previous clinical 
trials[1],[2]-[7]. No new safety signals were detected[1]. 
 
   "These data will be welcomed by patients and clinicians to guide 
clinical decision making and highlight secukinumab as a viable option as 
a first-line biologic for the treatment of psoriatic arthritis," said 
Iain McInnes, Professor of Rheumatology, University of Glasgow and an 
investigator in the secukinumab clinical trial program. 
 
   "EXCEED is the first ever monotherapy head-to-head trial with a primary 
endpoint in psoriatic arthritis specific to joints." said Eric Hughes, 
Global Development Unit Head, Immunology, Hepatology & Dermatology. 
"Novartis continues to reimagine care for patients and advance science 
in rheumatology. We will assess the EXCEED data in their totality and we 
view the results as confirming our vision of Cosentyx becoming standard 
of care in psoriatic arthritis." 
 
   Detailed data is planned to be presented at a future scientific 
congress. 
 
   Cosentyx is the only biologic with proven efficacy in all key 
manifestations of psoriatic arthritis[8] and is backed by 5-year 
sustained efficacy and consistent safety data across psoriatic arthritis, 
ankylosing spondylitis and psoriasis[2]-[7]. To date, over 250,000 
patients have been treated worldwide[9]. 
 
   About Psoriatic Arthritis 
 
   Psoriatic arthritis (PsA) is a complex disease with multiple 
manifestations driving patient symptoms[10],[11]. It is estimated to 
affect up to 50 million people worldwide[12],[13]. 
 
   PsA is part of a family of life-long inflammatory diseases 
(spondyloarthritis) that target the joints and is closely associated 
with psoriasis[13]. Approximately 40% of patients with psoriasis have 
PsA[13] and as many as one in four people with psoriasis may have 
undiagnosed PsA[14]. Symptoms of PsA include joint pain and stiffness, 
skin and nail psoriasis, swollen toes and fingers, persistent painful 
swelling of the tendons, and irreversible joint damage[13]. 
 
   About EXCEED 
 
   EXCEED is the first double-blinded head-to-head clinical trial 
evaluating Cosentyx (secukinumab) 300 mg versus Humira(R) * (adalimumab) 
40 mg. EXCEED is a 52-week, multi-center, randomized, double-blind, 
active control, Phase IIIb trial evaluating the efficacy of Cosentyx 
compared with Humira(R) * in patients with active PsA who are naïve 
to biologic therapy. The trial involves over 800 biologic-naïve 
patients with PsA[1]. 
 
   The primary endpoint assessed statistical superiority of Cosentyx 
monotherapy against Humira(R) * monotherapy for ACR20 response rates at 
Week 52. The ACR20 is a composite measure defined as both improvement of 
20% in the number of tender and number of swollen joints, and a 20% 
improvement in three of the following five criteria: patient global 
assessment, physician global assessment, Health Assessment Questionnaire 
(HAQ), visual analog pain scale, and erythrocyte sedimentation rate or 
C-reactive protein (CRP). Key secondary endpoints, tested for 
superiority at Week 52, are PASI90, ACR50, physical function (HAQ-DI 
(disability index) score relative to baseline), and resolution of 
enthesitis. PASI stands for Psoriasis Area and Severity Index[1]. 
 
   Cosentyx 300 mg was administered at baseline, weeks 1-4, and then every 
4 weeks until Week 48. Humira(R) * 40 mg was administered at baseline, 
and then every 2 weeks until Week 50. 
 
   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 "encouraging," "vision," "to date," "potential," "can," "will," 
"expectations," "commitment," "planned," "to be presented," or similar 
terms, or by express or implied discussions regarding potential new 
indications or labeling for Cosentyx, or regarding potential future 
revenues from Cosentyx. 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 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 Cosentyx will be 
commercially successful in the future. In particular, our expectations 
regarding Cosentyx 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 and requirements 
for increased pricing transparency; 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 is reimagining medicine to improve and extend people's lives. 
As a leading global medicines company, we use innovative science and 
digital technologies to create transformative treatments in areas of 
great medical need. In our quest to find new medicines, we consistently 
rank among the world's top companies investing in research and 
development. Novartis products reach more than 750 million people 
globally and we are finding innovative ways to expand access to our 
latest treatments. About 108,000 people of more than 140 nationalities 
work at Novartis around the world. Find out more at www.novartis.com. 
 
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   References 
 
   [1]   Novartis data on file. October 2019. 
 
   [2]   Data on file. CAIN457F2310 (MEASURE 2): 5 Year Report. Novartis 
Pharmaceuticals Corp; September 15, 2015. 
 
   [3]   Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis 
Pharmaceuticals Corp; November 30, 2015. 
 
   [4]   Data on file. CAIN457F2310 and CAIN457F2305 Summary of 5-Year 
Clinical Safety in (Ankylosing Spondylitis). Novartis Pharmaceuticals 
Corp; May 2019. 
 
   [5]   Data on file. CAIN457F2312 (FUTURE 2): 5 Year- Interim Report. 
Novartis Pharmaceuticals Corp; May 2019. 
 
   [6]   Data on file. CAIN457F2312 Data Analysis Report. Novartis 
Pharmaceuticals Corp; November 2008. 
 
   [7]   Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. 
Novartis Pharmaceuticals Corp; July 23, 2018. 
 
   [8] 
https://www.novartis.com/news/media-releases/novartis-cosentyx-first-show-efficacy-all-key-manifestations-psoriatic-arthritis 
 
 
   [9]   Novartis data on file. September 2019. 
 
   [10] Ritchin CT et al. Psoriatic Arthritis. N Engl J Med. 2017; 376(10): 
957-970. 
 
   [11] Kavanaugh A et al. Psoriatic Arthritis and Burden of Disease: 
Patient Perspectives from the Population-Based Multinational Assessment 
of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Rheumotol Ther. 
2016; 3(1); 91-102. 
 
   [12] National Psoriasis Foundation. Statistics. Available at: 
https://www.psoriasis.org/content/statistics. Last accessed: October 
2019. 
 
   [13] Mease PJ et al. Managing patients with psoriatic disease: the 
diagnosis and pharmacologic treatment of psoriatic arthritis in patients 
with psoriasis. Drugs 2014;74:423-41 
 
   [14] Zachariae H. Prevalence of joint disease in patients with 
psoriasis: implications for therapy. Am J Clin Dermatol. 2003; 4:441-7. 
 
   *Humira is a registered trademark of AbbVie Inc. 
 
 
 
   # # # 
 
   Novartis Global External Communications 
 

   E-mail: media.relations@novartis.com 
 
 
 
 
Antonio Ligi                              Friedrich von Heyl 
 Novartis Global External Communications   Novartis Pharma Communications 
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 antonio.ligi@novartis.com                 +41 79 749 0286 (mobile) 
 Eric Althoff                              friedrich.vonheyl@novartis.com 
 Novartis US External Communications 
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 eric.althoff@novartis.com 
 
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