NVS Novartis AG

TIDMNOVN 
 
 
   -- Pooled analyses of LUSTER 1 and 2 did not support further development of 
      Fevipiprant in asthma as a primary indication 
 
   -- Fevipiprant was well tolerated with adverse events balanced across 
      treatment groups 
 
 
   Basel, Switzerland, December 16, 2019 -- Novartis today announced 
topline results from its pivotal global Phase III LUSTER-1(1) and 
LUSTER-2(2) studies exploring the efficacy and safety of the 
investigational oral, once-daily, DP(2) receptor antagonist fevipiprant 
(QAW039). The pooled analyses of the LUSTER trials did not meet(3) the 
clinically relevant threshold for reduction in rate of moderate 
-to-severe exacerbation compared to placebo over a 52-week treatment 
period for either of the doses (150mg / 450 mg). The studies included 
patients who had inadequately controlled moderate-to-severe asthma (GINA 
Steps 4 and 5) despite receiving inhaled mid-to-high dose 
corticosteroids (ICS) and at least one additional controller. The 
totality of these results do not support further development of 
fevipiprant in asthma. 
 
   Fevipiprant was generally well tolerated, with treatment-emergent 
adverse events generally balanced across groups and comparable to 
placebo(3) . Detailed efficacy and safety data from the LUSTER-1 and 
LUSTER-2 studies are being analyzed and will be submitted for 
presentation at an upcoming medical congress. 
 
   "While the results of the LUSTER studies with fevipiprant are 
disappointing, they meaningfully contribute to our understanding of the 
DP(2) pathway in asthma. We are incredibly grateful to all the patients, 
their families and the investigators who participated in the studies and 
contributed greatly to this research," said John Tsai, Head Global Drug 
Development and Chief Medical Officer, Novartis. 
 
   The pivotal replicate LUSTER-1(1) and LUSTER-2(2) studies are part of 
the VIBRANT Phase III program, which also includes the SPIRIT(4) safety 
study and the supplemental replicate ZEAL-1(5) and ZEAL-2(6) studies. 
Topline results from ZEAL-1 and ZEAL-2 were announced in October 2019. 
 
 
 
   Novartis continues to invest into respiratory medicines with in-market 
products Xolair(R)7 (severe allergic asthma [SAA] and chronic 
spontaneous urticaria [CSU]), Ultibro(R) Breezhaler(R) (8) (COPD), Phase 
III investigational products QVM149(9) (moderate-to-severe asthma), and 
QMF149(10) (moderate-to-severe asthma), as well as active research 
programs covering asthma, COPD and other areas of high unmet need, such 
as idiopathic pulmonary fibrosis and sarcoidosis. 
 
   About Fevipiprant 
 
   Fevipiprant is an investigational, novel, steroid-free once-daily pill. 
It blocks the DP(2) pathway(11) , a potentially important regulator of 
the asthma inflammatory cascade(12) . 
 
   About LUSTER-1 and LUSTER-2(1,2) 
 
   LUSTER-1 and LUSTER-2 (CQAW039A2307, NCT02555683 and CQAW039A2314, 
NCT02563067) were 52-week, randomized, multi-center, double-blind, 
placebo-controlled, replicate Phase III studies in patients with 
moderate-severe asthma. The patient population included 894 (LUSTER-1) 
and 877 (LUSTER-2) patients aged >=12 years, all of whom suffer from 
inadequately controlled moderate-severe asthma, receiving Global 
Initiative for Asthma(13) (GINA) Steps 4 and 5 standard-of-care (SoC) 
asthma therapy: inhaled mid-to-high dose corticosteroids (ICS) and at 
least one additional controller. Recruitment was stratified based on 
blood eosinophil counts at Visit 1, so that approximately two-thirds of 
randomized patients had a blood eosinophil count >=250 cells/<MU>l and 
one-third had a blood eosinophil count <250 cells/<MU>L, to determine 
the effect of fevipiprant across patients with varying eosinophil 
levels. Patients were randomized (1:1:1) to receive either fevipiprant 
150 mg, fevipiprant 450 mg or placebo once daily. 
 
   The aim of these studies was to determine the efficacy, safety and 
tolerability of fevipiprant in addition to the current standard-of-care 
for severe asthma patients. 
 
   The primary endpoint for the replicate LUSTER-1 and LUSTER-2 studies was 
the reduction of the annual rate of moderate--to--severe exacerbations 
over a 52--week treatment period in patients with moderate-to-severe 
uncontrolled asthma and high levels (>= 250 cells/uL) of a type of white 
blood cell called eosinophils. The rate of reduction in all patients 
independent of blood eosinophil level was also studied as part of the 
primary endpoint. 
 
   Secondary endpoints included change in asthma quality of life (as 
measured by the Asthma Quality of Life Questionnaire [AQLQ] for people 
12 years and older), asthma control (measured via Asthma Control 
Questionnaire--5), and lung function (measured via FEV1) over the 
52--week treatment period in patients with high blood eosinophil counts 
(>=250 cells/<MU>l)  and in all patients independent of blood eosinophil 
level. 
 
   Safety of fevipiprant in terms of adverse events, electrocardiograms, 
vital signs and laboratory tests was also assessed. 
 
   About Moderate-to-Severe Asthma 
 
   The severity of asthma ranges between mild, moderate and severe, with 
more severe asthma requiring more treatment (higher dose or stronger 
medication) to control symptoms and exacerbations. According to the the 
Global Initiative for Asthma (GINA) stepwise approach to asthma 
treatment, patients between Step 3 and Step 5 are considered 
moderate-to-severe(13) . 
 
   Despite the availability of standard-of-care asthma treatments for the 
moderate-to-severe asthma patients, over 45% at GINA Step 4 and 5 remain 
uncontrolled(14) . These uncontrolled asthma patients often downplay or 
underestimate the severity of their asthma by tolerating their symptoms 
and accepting the severe impact of their disease on their quality of 
life(15) . These patients are at an increased risk of experiencing a 
severe exacerbation, hospitalization, or death(15,16,17) . 
 
   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 "investigational," "being analyzed," "will," "upcoming," 
"committed," "potentially," "aim," "potential," "ambition," or similar 
terms, or by express or implied discussions regarding potential 
marketing approvals, new indications or labeling for fevipiprant, Xolair, 
Ultibro Breezhaler, QVM149 or QMF149, 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 
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, data integrity 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 in Respiratory 
 
   Over the last 60 years, there have been two breakthroughs in asthma care, 
inhalers in the 1960s and more recently biologics. They have helped 
patients with asthma cope with their condition, but a majority are still 
suffering from exacerbations and symptoms, severely affecting their 
quality of life. The Novartis ambition is to reimagine asthma care. 
Novartis is a leading respiratory company that drives novel advances to 
improve the lives of those living with lung conditions around the world. 
Through courageous innovation and close partnership with patients and 
medical experts, Novartis is committed to solving the unmet needs in 
asthma management, improving treatment outcomes for chronic obstructive 
pulmonary disease (COPD) and other respiratory diseases. 
 
   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 109,000 people of more than 140 nationalities 
work at Novartis around the world. Find out more at 
 
   www.novartis.com. 
 
   Novartis is on Twitter. Sign up to follow @Novartis at 
http://twitter.com/novartis 
 

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   References 
 
   1.    Clinicaltrials.gov. 
https://clinicaltrials.gov/ct2/show/NCT02555683. Last accessed: Dec 
2019. 
 
   2.    Clinicaltrials.gov. 
https://clinicaltrials.gov/ct2/show/NCT02563067.  Last accessed: Dec 
2019. 
 
   3.    Novartis Data on file. 
 
   4.    Clinicaltrials.gov. 
https://clinicaltrials.gov/ct2/show/NCT03052517. Last accessed Dec 2019. 
 
   5.    Clinicaltrials.gov. 
https://clinicaltrials.gov/ct2/show/NCT03215758. Last accessed: Dec 
2019. 
 
   6.    Clinicaltrials.gov. 
https://clinicaltrials.gov/ct2/show/NCT03226392. Last accessed: Dec 
2019. 
 
   7.    In the US, Novartis and Genentech, Inc. work together to develop 
and co-promote Xolair. Outside the US, Novartis markets Xolair and 
records all sales and related costs. 
 
   8.    Glycopyrronium bromide and certain use and formulation 
intellectual property were exclusively licensed to Novartis in April 
2005 by Sosei Heptares and Vectura. 
 
   9.    Glycopyrronium bromide and certain use and formulation 
intellectual property were exclusively licensed to Novartis in April 
2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively 
licensed to Novartis from a subsidiary of Merck & Co., Inc., Kenilworth, 
NJ, USA, for use in QVM149 (Worldwide excluding US). 
 
   10.  Mometasone furoate is exclusively licensed to Novartis from a 
subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, for use in QMF149. 
 
   11.  Gonem S, et al. Fevipiprant, a prostaglandin D2 receptor 2 
antagonist, in patients with persistent eosinophilic asthma: a 
single-centre, randomised, double-blind, parallel-group, 
placebo-controlled trial. Lancet Respir Med 2016;4(9):699-707. 
 
   12.  Domingo C, et al. The prostaglandin D2 receptor 2 pathway in 
asthma: a key player in airway inflammation. Respir Res 
2018;19(1):189-196. 
 
   13.  Global Initiative for Asthma -- GINA 2019. 
https://ginasthma.org/wp-content/uploads/2019/01/GINA-Implementation-Toolbox-2019.pdf 
Last accessed: Dec 2019 
 
   14.  Fang J, et al. Demographic, Clinical Characteristics and Control 
Status of Pediatric, Adolescent and Adult Asthma Patients by GINA Step 
in a US Longitudinal Cohort. Am J Resp Crit Care Med 2018;197:A53. 
 
   15.  Katsaounou P, et al. Still Fighting for Breath: a patient survey of 
the challenges and impact of severe asthma. ERJ Open Res 
2018;4(4):00076. 
 
   16.  Peters SP, et al. Uncontrolled asthma: a review of the prevalence, 
disease burden and options for treatment. Respir Med 
2006;100(7):1139-1151. 
 
   17.  Price D, et al. Asthma control and management in 8,000 European 
patients: the REcognise Asthma and LInk to Symptoms and Experience 
(REALISE) survey. NPJ Prim Care Respir Med 2014(24):14009. 
 
   # # # 
 
   Novartis Media Relations 
 
   Central media line: +41 61 324 2200 
 
   E-mail: media.relations@novartis.com 
 
 
 
 
Peter Züst                           Phil McNamara 
 Novartis Global External Communications   Global Head, Respiratory Communications 
 +41 79 899 9812 (mobile)                  +1 862 274 5255 (mobile) 
 peter.zuest@novartis.com                  philip.mcnamara@novartis.com 
 Eric Althoff 
 Novartis US External Communications 
 +1 646 438 4335 
 eric.althoff@novartis.com 
 
   Novartis Investor Relations 
 
   Central investor relations line: +41 61 324 7944 
 
   E-mail: investor.relations@novartis.com 
 
 
 
 
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