0K9E Novartis Ag

 
TIDMNOVN 
 
 
   -- Phase III PREVENT study met 52-week primary endpoint of ASAS40, showing a 
      sustained response in patients with non-radiographic axial 
      spondyloarthritis (nr-axSpA)[1] 
 
   -- Novartis plans FDA submission for nr-axSpA, having submitted to EMA 
      previously[1]. This would be the fourth indication for Cosentyx[2],[3] 
 
   -- PREVENT underlines Cosentyx leadership and is a step forward in providing 
      patients with a treatment that addresses the complete axSpA disease 
      spectrum 
 
   -- There are approximately 1.7 million patients with nr-axSpA in the US and 
      EU[4] 
 
 
   Basel, October 02, 2019 -- Novartis, a leader in rheumatology and 
immuno-dermatology, today announced additional positive data from the 
PREVENT trial, evaluating the efficacy and safety of Cosentyx(R) 
(secukinumab) in patients with non-radiographic axial spondyloarthritis 
(nr-axSpA). The ongoing Phase III trial met its primary endpoint of 
ASAS40 at Week 52, showing a significant and clinically meaningful 
reduction in disease activity for patients treated with Cosentyx versus 
placebo. The trial demonstrated a sustained response and a safety 
profile consistent with previous clinical trials. No new safety signals 
were detected[1],[5-10]. 
 
   Positive 16-week PREVENT data were announced mid-September and submitted 
to EMA for approval in nr-axSpA[11]. These data add to the five-years of 
clinical data supporting the long-term efficacy and safety of Cosentyx 
across ankylosing spondylitis, psoriatic arthritis and psoriasis[5-10]. 
 
   "Non-radiographic axial spondyloarthritis is a chronic debilitating 
disease, which left untreated can have a significant impact on patients' 
quality of life," said Atul Deodhar, MD, professor of medicine and 
medical director of Rheumatology Clinics at Oregon Health & Science 
University, and an investigator in the secukinumab clinical trial 
program. "These positive results indicate a potential new treatment 
option to help patients experience relief from the signs and symptoms of 
their disease." 
 
   "These data are encouraging for people living with nr-axSpA, where there 
are only limited treatment options available," said John Tsai, M.D., 
Head of Global Drug Development and Chief Medical Officer for Novartis. 
"It's a great example of how we're working to reimagine medicine to help 
patients realize early relief from this disease." 
 
   Detailed data is planned to be presented at a future scientific 
congress. 
 
   About axSpA 
 
   Axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory 
disease characterized by chronic inflammatory back pain[12]. The axSpA 
disease spectrum includes ankylosing spondylitis (AS), in which joint 
damage is generally visible on x-ray, and non-radiographic axial 
spondyloarthritis (nr-axSpA), in which joint damage is not visible on 
x-ray[12],[13]. Both parts of the disease spectrum have a similar 
symptom burden, including nocturnal pain, fatigue, morning stiffness and 
functional disability[14]. If left untreated, axSpA could impair 
activity, lead to lost work time and have a significant impact on 
quality of life[14]. 
 
   About PREVENT 
 
   PREVENT is an ongoing two-year randomized, double-blind, 
placebo-controlled Phase III study (with a two-year extension phase) to 
investigate the efficacy and safety of Cosentyx, in patients with active 
nr-axSpA. The study enrolled 555 male and female adult patients with 
active nr-axSpA (with onset before 45 years of age, spinal pain rated as 
>=40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis 
Disease Activity Index (BASDAI) >=4) and who had been taking at least 
two different non-steroidal anti-inflammatory drugs (NSAIDs) at the 
highest dose up to 4 weeks prior to study start. Patients may have 
previously taken an TNF inhibitor (not more than one) but had had an 
inadequate response. Of the 555 patients enrolled in the study, 501 
(90%) were biologic naive. Patients were allocated to one of three 
treatment groups: Cosentyx 150 mg subcutaneously with loading dose 
(Induction: 150 mg Secukinumab subcutaneously weekly for 4 weeks, then 
maintenance with 150 mg Secukinumab monthly); Cosentyx 150 mg no loading 
dose (150 mg Secukinumab subcutaneously monthly), or placebo (induction 
of subcutaneously weekly for 4 weeks, followed by maintenance of 
once-monthly)[1]. 
 
   The primary endpoints are the proportion of patients achieving an ASAS40 
response with Cosentyx 150 mg at weeks 16 and 52. Secondary endpoints 
include change in BASDAI over time and change in the Ankylosing 
Spondylitis Disease Activity Score with CRP (ASDAS-CRP)[1]. 
 
   ASAS40 is achieved when there is a measure of an improvement of at least 
40% and an improvement of at least 10 units on a 0--100 scale in at 
least three of the following domains: Patient global assessment, Pain 
assessment, Function (Bath Ankylosing Spondylitis Functional Index 
(BASFI)), and Inflammation (morning stiffness severity and duration) and 
no worsening in the remaining domains[15]. BASDAI assesses a patient's 
disease activity on six measures: fatigue, spinal pain, joint 
pain/swelling, enthesitis, morning stiffness duration and morning 
stiffness severity[15]. 
 
   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 "plans," "submitted," "would," "step forward," "ongoing," 
"supporting," "potential," "encouraging," "planned," "could," "to 
investigate," "expectations," 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 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. September 2019. 
 
   [2]    Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis 
Pharmaceuticals Corp; 2018. 
 
   [3]     Novartis Europharm Limited. Cosentyx (secukinumab): Summary of 
Product Characteristics. Available from: 
https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf. 
Last accessed: September 2019. 
 
   [4]     DRG Epidemiology Database - Axial Spondyloarthritis: Disease 
Landscape & Forecast. August 2019. Available from: 
https://decisionresourcesgroup.com/report/716950-biopharma-axial-spondyloarthritis-landscape-forecast/. 
Last accessed: September 2019. 
 
   [5]     Data on file. CAIN457F2310 (MEASURE 2): 5 Year Report. Novartis 
Pharmaceuticals Corp; September 15, 2015. 
 
   [6]     Data on file. Data Analysis Report: Study CAIN457A2302E1. 
Novartis Pharmaceuticals Corp; November 30, 2015. 
 
   [7]     Data on file. CAIN457F2310 and CAIN457F2305 Summary of 5-Year 
Clinical Safety in (Ankylosing Spondylitis). Novartis Pharmaceuticals 
Corp; May 2019. 
 
   [8]     Data on file. CAIN457F2312 (FUTURE 2): 5 Year- Interim Report. 
Novartis Pharmaceuticals Corp; May 2019. 
 
   [9]     Data on file. CAIN457F2312 Data Analysis Report. Novartis 
Pharmaceuticals Corp; November 2008. 
 

   [10]   Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. 
Novartis Pharmaceuticals Corp; July 23, 2018. 
 
   [11]   Novartis press release. Novartis Cosentyx(R) positive 16-week 
PREVENT results advance potential new indication for patients with axial 
spondyloarthritis. Available from: 
https://www.novartis.com/news/media-releases/novartis-cosentyx-positive-16-week-prevent-results-advance-potential-new-indication-patients-axial-spondyloarthritis. 
Last accessed: September 2019. 
 
   [12]   Strand V, et al. Patient Burden of Axial Spondyloarthritis. J 
Clin Rheumatol. 2017 Oct;23(7):383--391. 
 
   [13]   Rudwaleit M, van der Heijde D, Landewé R, et al. The 
development of Assessment of SpondyloArthritis International Society 
classification criteria for axial spondyloarthritis (part II): 
validation and final selection. Ann Rheum Dis. 2009;68(6):777-783. 
 
   [14]   Mease PJ, van der Heijde D, Karki C, et al. Characterization of 
patients with ankylosing spondylitis and nonradiographic axial 
spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res 
(Hoboken). 2018;70(11):1661-1670. 
 
   [15]   Landewe R, et al. Clinical Tools to Assess and Monitor 
Spondyloarthritis. Curr Rheumatol Rep. 2015;17(7):47. 
 
   # # # 
 
   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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