0K9E Novartis Ag

 
TIDMNOVN 
 
 
   -- Phase III PREVENT study met 16-week primary endpoint of ASAS40 in 
      patients with active non-radiographic axial spondyloarthritis (nr-axSpA). 
      All secondary endpoints were also met [1] 
 
   -- Novartis has submitted to EMA for approval in nr-axSpA, which would be 
      the fourth indication for Cosentyx [2]. 52-week data from the PREVENT 
      study, to support FDA submission, are expected later in the year 
 
   -- There are approximately 1.7 million patients with nr-axSpA in the EU and 
      US [3]. nr-axSpA forms part of the axial spondyloarthritis (axSpA) 
      spectrum and is characterized by chronic inflammatory back pain and 
      symptoms such as nocturnal pain, morning stiffness and impaired quality 
      of life [4,5] 
 
   -- The PREVENT study underlines Cosentyx leadership and is a step forward in 
      providing patients with a treatment that addresses the complete axSpA 
      disease spectrum 
 
 
   Basel, September 17, 2019 -- Novartis, a leader reimagining rheumatology 
and immuno-dermatology, today announced positive new data from the 
PREVENT trial evaluating the efficacy and safety of Cosentyx(R) 
(secukinumab) in patients with nr-axSpA (non-radiographic axial 
spondyloarthritis). The ongoing Phase III trial met its primary endpoint 
of ASAS40 at Week 16, showing a significant and clinically meaningful 
reduction in disease activity for patients treated with Cosentyx versus 
placebo. The trial demonstrated a favorable safety profile consistent 
with previous clinical trials [1,6,7,8]. 
 
   "These study results for Cosentyx build on our long-standing experience 
in ankylosing spondylitis and are a step toward a new treatment option 
that could allow patients to realize relief much earlier in axial 
spondyloarthritis," said John Tsai, M.D., Head of Global Drug 
Development and Chief Medical Officer for Novartis. "If approved, this 
would be the fourth indication for Cosentyx." 
 
   Detailed data is planned to be presented at a future scientific 
congress. These data add to the existing evidence supporting Cosentyx as 
a rapid and long-lasting comprehensive treatment, backed by evidence 
from over 100 studies, across axial spondyloarthritis, psoriatic 
arthritis and psoriatic disease, with over 250,000 patients treated 
worldwide [9,10]. 
 
   About axSpA 
 
   Axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory 
disease characterized by chronic inflammatory back pain [4]. The axSpA 
disease spectrum includes ankylosing spondylitis (AS), in which joint 
damage is visible on x-ray, and non-radiographic axial spondyloarthritis 
(nr-axSpA), in which joint damage is not visible on x-ray [4]. Both 
parts of the disease spectrum have a similar symptom burden, including 
nocturnal pain, fatigue, morning stiffness and functional disability 
[5]. If left untreated, axSpA could impair activity, lead to lost work 
time and have a significant impact on quality of life [5]. 
 
   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). 
BASDAI assesses a patient's disease activity on six measures: fatigue, 
spinal pain, joint pain/swelling, enthesitis, morning stiffness duration 
and morning stiffness severity [11]. 
 
   About Cosentyx (secukinumab) 
 
   Cosentyx is the first and only fully-human biologic that directly 
inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in 
the inflammation and development of psoriatic arthritis (PsA), psoriasis 
(PsO), and ankylosing spondylitis (AS) [2,12]. 
 
   Cosentyx is backed by robust clinical evidence, including 5-year data 
across three indications of psoriasis, PsA and AS as well as data from 
real world evidence [6,7,8,13-22]. These data strengthen the unique 
position of Cosentyx as a rapid and long-lasting comprehensive treatment 
across axial spondyloarthritis, psoriatic arthritis and psoriatic 
disease, with more than 250,000 patients treated worldwide with Cosentyx 
since launch [10]. 
 
   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 "advance," "potential," "submitted," "would," "to support," 
"expected," "later in the year," "ongoing," "builds on," "step toward," 
"could," "planned," "supporting," "launch," 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]    Novartis Europharm Limited. Cosentyx (secukinumab): Summary of 
Product Characteristics. Available from: 
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124 
[Last accessed: August 2019]. 
 
   [3]    DRG Epidemiology Database -- Axial Spondyloarthritis: Disease 
Landscape & Forecast. August 2019. 
 
   [4]    Strand V, et al. Patient Burden of Axial Spondyloarthritis. J 
Clin Rheumatol. 2017 Oct; 23(7): 383--391. 
 
   [5]    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 
 

   [6]    Mease PJ, et al. Secukinumab Provides Sustained Improvements in 
the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and 
Safety Results from a Phase 3 Trial. Abstract presented at the American 
College of Rheumatology Annual Meeting, 2018. 
 
   [7]    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. 
 
   [8]    Baraliakos X et al. Long-term Evaluation of Secukinumab in 
Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 
3 Trial. Presented as a late-breaking abstract at the American College 
of Rheumatology Annual Meeting, 2018. 
 
   [9]    ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet 
recruiting, active, not recruiting, completed, enrolling by invitation 
studies. Listed results on ClinicalTrials.gov [online]. Available from: 
https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= 
[Last accessed: September 2019]. 
 
   [10]  Novartis data on file. September 2019. 
 
   [11]  Landewe R. et al. Clinical Tools to Assess and Monitor 
Spondyloarthritis. Curr Rheumatol Rep. 2015; 17(7): 47. 
 
   [12]  Girolomoni G, et al. Psoriasis: rationale for targeting 
interleukin-17. Br J Dermatol 2012;167:717--724. 
 
   [13]  ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet 
recruiting, active, not recruiting, completed, enrolling by invitation 
studies. Listed results on ClinicalTrials.gov [online]. Available from: 
https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= 
[Last accessed: August 2019]. 
 
   [14]  ClinicalTrials.gov. Comparison of Secukinumab Versus Guselkumab in 
Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW). 
NCT03553823. Available from: 
https://clinicaltrials.gov/ct2/show/NCT03553823 [Last accessed: August 
2019]. 
 
   [15]  Langley RG, et al. Secukinumab in plaque psoriasis--results of two 
phase 3 trials. N Engl J Med 2014;371:326--338. 
 
   [16]  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. J Am Acad Dermatol 2017;76:60--69. 
 
   [17]  Bagel J, et al. Secukinumab is Superior to Ustekinumab in Clearing 
Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week 
CLARITY Results). Dermatol Ther 2018;8:571--579. 
 
   [18]  ClinicalTrials.gov. Effect of Secukinumab on Radiographic 
Progression in Ankylosing Spondylitis as compared to GP2017 (Adalimumab 
Biosimilar) (SURPASS). NCT03259074. Available from: 
https://www.clinicaltrials.gov/ct2/show/NCT03259074 [Last accessed: 
August 2019]. 
 
   [19]  MEASURE 2. Novartis data on file. 
 
   [20]  Holdsworth E. et al. Real world physician satisfaction with 
secukinumab in Psoriatic Arthritis and Ankylosing Spondylitis in Europe. 
Presented at EULAR 2019. 
 
   [21]  Michelsen B et al. Remission and drug retention rates of 
secukinumab in 1549 patients with psoriatic arthritis treated in routine 
care -- pooled data from the observational EuroSpA Research 
Collaboration Network. Presented at EULAR 2019. 
 
   [22]  Michelsen B et al. Pooled 6-month treatment outcomes and drug 
retention rates in 1556 patients with axial spondyloarthritis treated 
with secukinumab in routine clinical practice in 12 European Countries 
in the EuroSpA Research Collaboration. Presented at EULAR 2019. 
 
   # # # 
 
   Novartis Global External Communications 
 
   E-mail: media.relations@novartis.com 
 
 
 
 
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 Novartis Global External Communications   Novartis Pharma Communications 
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