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05.06.2020 07:14:57

Press Release: Novartis Phase IIIb ARGON study -2-

All patients were symptomatic at screening despite treatment with

medium- or high- stable doses of LABA/ICS as defined by Asthma Control

Questionnaire (ACQ-7) score >=1.5.

Approximately 1,251 male and female patients with uncontrolled asthma

(aged 18 and above) were randomized 1:1:1 (approximately 417 patients in

each of the treatment groups) to receive either:

-- IND/GLY/MF 150/50/80 g (once-daily)

-- IND/GLY/MF 150/50/160 g (once-daily)

-- Open label Sal/Flu 50/500 g (twice-daily) delivered via Diskus(R)

plus Tio delivered via Respimat(R)

The primary objective of this study was to demonstrate non-inferiority

of both high-dose IND/GLY/MF and medium-dose IND/GLY/MF to comparator

Sal/Flu plus Tio after 24 weeks of treatment based on Asthma Quality of

Life Questionnaire (AQLQ).

Secondary objectives included:

-- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF

compared with Sal/Flu plus Tio based on trough FEV1 after 24 weeks of

treatment.

-- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF

compared with Sal/Flu plus Tio based on Asthma Quality of Life

Questionnaire (AQLQ) over 24 weeks of treatment.

-- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF

compared with Sal/Flu plus Tio based on ACQ-7 over 24 weeks of treatment.

-- To evaluate efficacy of high-dose IND/GLY/MF and medium-dose IND/GLY/MF

compared with Sal/Flu plus Tio based on lung function over 24 weeks of

treatment.

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," "may," "could," "would,"

"expect," "anticipate," "seek," "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 the investigational or 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 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, economic and

business conditions, including the effects of and efforts to mitigate

pandemic diseases such as COVID-19; 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

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 nearly 800 million people globally

and we are finding innovative ways to expand access to our latest

treatments. About 109,000 people of more than 145 nationalities work at

Novartis around the world. Find out more at https://www.novartis.com.

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References

1. Gessner C et al. Fixed-dose combination of

indacaterol/glycopyrronium/mometasone furoate once-daily versus

salmeterol/fluticasone twice-daily plus tiotropium once-daily in

patients with uncontrolled asthma: A randomised, Phase IIIb,

non-inferiority study (ARGON). Resp Med 2020;106021. DOI:

https://doi.org/10.1016/j.rmed.2020.106021.

2. CHMP Opinion -- Enerzair Meeting highlights from the Committee

for Medicinal Products for Human Use (CHMP) 28-30 April 2020. Available

at:

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-28-30-april-2020.

Last accessed June 2020.

3. GBD Chronic Respiratory Disease Collaborators. Global, regional,

and national deaths, prevalence, disability-adjusted life years, and

years lived with disability for chronic obstructive pulmonary disease

and asthma. 2017. Available at:

https://doi.org/10.1016/S2213-2600(17)30293-X. Last accessed June 2020.

4. AAFA. My Life With Asthma Survey Findings Report. Available at:

https://www.aafa.org/media/1684/my-life-with-asthma-in-2017-survey-findings-report.pdf

Last accessed June 2020.

5. Chung KF et al. International ERS/ATS guidelines on definition,

evaluation and treatment of severe asthma. Eur Respir J

2014;43(2):343-73.

6. 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:A1903

7. Peters SP et al. Uncontrolled asthma: a review of the prevalence,

disease burden and options for treatment. Respir Med

2006;100(7):1139-1151.

8. 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):00076-2018.

9. 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.

10. Price D, et al. Adverse outcomes from initiation of systemic

corticosteroids for asthma: long-term observational study. J Asthma

Allergy 2018;11:193-204.

11. Albers FC et al. Biologic treatment eligibility for real-world

patients with severe asthma: The IDEAL study. J Asthma

2018;55(2):152-160.

12. EMA. Enerzair Breezhaler. Available at:

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/enerzair-breezhaler.

Last accessed June 2020.

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Peter Zuest Phil McNamara

Novartis Global External Communications Global Head, Respiratory Communications

+41 79 899 9812 (mobile) +41 79 510 8756 (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

Central North America

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Samir Shah 7944 Sloan Simpson +1 862 778 5052

+41 61 324

Thomas Hungerbuehler 8425 Cory Twining +1 862 778 3258

Isabella Zinck +41 61 324

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(END) Dow Jones Newswires

June 05, 2020 01:15 ET (05:15 GMT)