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2014-04-25

Novartis International AG: Novartis' INSTEAD study for Onbrez® Breezhaler® in patients with moderate COPD meets primary objective

Novartis International AG / Novartis' INSTEAD study for Onbrez® Breezhaler® in
patients with moderate COPDmeets primary objective . Processed and
transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* Results confirm non-inferiority of Onbrez®Breezhaler®(indacaterol) in lung
function compared to Seretide®* (salmeterol/fluticasone) in the studied
population
* In INSTEAD study, patients with moderate COPD and no exacerbations in the
past year were switched from salmeterol/fluticasone to Onbrez Breezhaler
* Study showed similar symptomatic benefits in terms of shortness of breath
and health status in patients treated with Onbrez Breezhaler compared to
those on salmeterol/fluticasone

Basel, April 25, 2014
- Novartis announced today top-line results from the Phase IV INSTEAD switch
study in patients with chronic obstructive pulmonary disease (COPD), which
met its primary objective. Once-daily Onbrez®
Breezhaler®
(indacaterol) 150 mcg demonstrated non-inferiority in lung function at week 12
to twice-daily Seretide®

*
(salmeterol/fluticasone propionate (SFC)) 50/500 mcg in patients with moderate
COPD and no exacerbations in the previous year.

The INSTEAD switch study also showed similar symptomatic benefits in terms of
shortness of breath and health status after 12 and 26 weeks in patients
treated with Onbrez Breezhaler compared to those on SFC. The safety profile
of Onbrez Breezhalerobserved in this study was consistent with previously
reported results from Phase III studies.

"These positive results help inform the switch from salmeterol/fluticasone to
Onbrez Breezhaler in patients with moderate COPD and who are at low risk of
exacerbations. This confirms that Onbrez Breezhalerprovides an effective
maintenance treatment option for these patients," said Tim Wright, Global
Head of Development, Novartis Pharmaceuticals. "In addition, these results
support international guidelines, which advise against the use of inhaled
corticosteroids due to long-term risks in COPD patients at low risk of
exacerbations[1]".

COPD affects an estimated 210 million people worldwide[2] and is projected to
be the third leading cause of death by 2020[1]. Treatments that effectively
control the symptoms of COPD and allow patients to continue with their daily
activities are very important in helping address the unmet needs in the
management of COPD[3],[4].

INSTEAD was a global, randomized, double-blind, parallel-group, 26-week study.
This study randomized 581 patients with moderate COPD who had been taking
SFC* for at least three months to either continue on SFC* or switch to
indacaterol. The primary objective of this study was to demonstrate the
non-inferiority of indacaterolversus SFC* in lung function (trough FEV1)
after 12 weeks of treatment in patients with moderate COPD who had
experienced no exacerbations in the previous year. Data from this study are
expected to be presented at major medical congresses later this year.

About Onbrez Breezhaler
Onbrez Breezhaler (indacaterol) is a once-daily inhaled long-acting
beta2-adrenergic agonist (LABA) that offers clinically relevant 24 hour
bronchodilation combined with a rapid onset of action within five minutes at
first dose, as demonstrated in the INERGIZE Phase III trial program[5]-[18].
Onbrez Breezhaler 150 mcg provided greater clinical benefit in terms of
reduced shortness of breath, lower use of rescue medication and improved
health status, compared with blinded tiotropium 18 mcg[16]. Onbrez
Breezhalerwas first approved and launched in the EU (150 mcg and 300 mcg
once-daily doses) for maintenance bronchodilator treatment of airflow
obstruction in adult patients with COPD[19]. It has now received approvals in
more than 100 countries around the world and is available in Japan (as
OnbrezInhalation Capsules 150 mcg once-daily) and in the USA (as
ArcaptaTMNeohalerTM75 mcg once-daily).

About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients
and improving their quality of life by providing innovative medicines and
devices. The Novartis COPD portfolio includes Onbrez®Breezhaler®/
Arcapta®Neohaler®(indacaterol), Seebri®Breezhaler®(glycopyrronium bromide)
and Ultibro®Breezhaler®(indacaterol / glycopyrronium bromide), which are all
indicated as maintenance treatments for COPD patients. Glycopyrronium bromide
was exclusively licensed to Novartis in April 2005 by Vectura and its
co-development partner Sosei.

Novartis continues development of respiratory products for delivery via the
low resistance Breezhaler®inhalation device, which makes it suitable for
patients with different severities of airflow limitation[20]. The Breezhaler
device allows patients to hear, feel and see that they have taken the full
dose correctly[19],[20].

About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe,
with symptoms that have a destructive impact on patients' function and
quality of life[1],[21]. COPD is often considered to be a disease of later
years, but estimates suggest that 50% of those with COPD are now less than 65
years old, resulting in increases in absenteeism, premature retirement and
reductions in workforce participation[3],[4].

*In some countries, Seretide®
(salmeterol/fluticasone) 50/500 mcg is indicated for the symptomatic treatment
of patients with COPD, with a FEV1<60% predicted normal (prebronchodilator)
and a history of repeated exacerbations, who have significant symptoms
despite regular bronchodilator therapy. The patient population in the INSTEAD
study who received salmeterol/fluticasone were moderate COPD patients who had
not exacerbated twelve months prior to entry. The INSTEAD study used the
Accuhaler
®

dry powder inhaler, also known as Diskus
®

. Seretide
®

, Diskus
®

and Accuhaler
®

are registered trademarks of the GlaxoSmithKline group of companies.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "projected," "expected," "later this year,"
"committed," "continues," or similar terms, or by express or implied
discussions regarding potential new indications or labeling for Onbrez
Breezhaler, or regarding potential future revenues from any or all of the
products in the Novartis COPD portfolio, including Onbrez Breezhaler. You
should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
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 Onbrez Breezhaler 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 any of the products in
the Novartis COPD portfolio will receive additional regulatory approvals or
be commercially successful in the future. In particular, management's
expectations regarding these products could be affected by, among other
things, the uncertainties inherent in research and development, including
unexpected clinical trial results and additional analysis of existing
clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues, 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 provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, eye care, cost-saving generic pharmaceuticals, preventive
vaccines, over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2013, the Group
achieved net sales of USD 57.9 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 135,000 full-time-equivalent associates and sell products in
more than 150 countries around the world. For more information, please
visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

References
[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated
2014.http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf.
[Accessed 14 April 2014].

[2] Global Alliance Against Chronic Respiratory Diseases (GARD). Global
surveillance, prevention and control of chronic respiratory diseases: a
comprehensive approach. Available
at:http://www.who.int/gard/publications/GARD_Manual/en/. [Accessed 14 April
2014].

[3] Fletcher MJet al
. COPD Uncovered: An International survey on the impact of chronic obstructive
pulmonary disease (COPD) on a working age population. BMC Public Health
2011;11:612.

[4] daCosta Met al.
The burden of chronic obstructive pulmonary disease among employed adults.Int
J Chron Obstruct Pulmon Dis
2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280.
[Accessed 14 April 2014].

[5] Vogelmeier Cet al
. Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled
blinded comparison with tiotropium.Respir Res
2010;11:135.

[6] Balint Bet al
. Onset of action of indacaterol in patients with COPD: comparison with
salbutamol and salmeterol- fluticasone.Int J Chron Obstruct Pulmon Dis
2010;5:311-318.

[7] La Force Cet al
. Sustained 24-hour efficacy of once-daily indacaterol (300 µg) in patients
with chronic obstructive pulmonary disease: a randomized, crossover
study.Pulm Pharmacol Ther
2011;24:162-168.

[8] Beeh KM, Wagner F, Khindri S, Drollmann AF. Effect of indacaterol on
dynamic lung hyperinflation and breathlessness in hyperinflated pati...

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