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2014-04-30

Novartis International AG: Novartis once-daily Ultibro® Breezhaler® showed superior efficacy versus Seretide®* for COPD patients in second head-to-head stud

Novartis International AG / Novartis once-daily Ultibro® Breezhaler® showed
superior efficacy versusSeretide®* for COPD patients in second head-to-head
study . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* Ultibro® Breezhaler® demonstrated superiority in lung function compared to
Seretide® Accuhaler®* in chronic obstructive pulmonary disease ( COPD)
patients with or without exacerbations in the previous year

* Primary and key secondary objectives met in pivotal Phase III LANTERN study

* Positive results to be part of the regulatory submission for Ultibro
Breezhaler in China later this year

Basel, April 30, 2014
- Novartis today announced positive first results from the Phase III
head-to-head LANTERN study, which showed the superiority of once-daily
Ultibro®Breezhaler®(indacaterol/glycopyrronium) 110/50 mcg in improving lung
function compared to twice-daily Seretide®
Accuhaler®*
(salmeterol/fluticasone (SFC)) 50/500 mcg in COPD patients with or without a
history of moderate-to-severe exacerbations in the previous year. Ultibro
Breezhaler met both the primary and key secondary objectives.

The primary objective of the LANTERN study was to demonstrate the
non-inferiority of Ultibro Breezhaler to SFC in terms of lung function
(trough FEV1) after 26 weeks of treatment in patients with moderate-to-severe
COPD, with or without a history of moderate-to-severe exacerbations in the
previous year. Ultibro Breezhaler demonstrated non-inferiority and
additionally showed superior efficacy versus SFC for the primary objective.
These results will be part of the regulatory submission of Ultibro Breezhaler
in China later this year.

"This is the second time Ultibro Breezhaler has shown superiority in improving
lung function to Seretide®* in a head-to-head study and confirms benefits
beyond this current standard of care," said Tim Wright, Global Head of
Development, Novartis Pharmaceuticals. "Such promising data will be part of a
regulatory submission in China later this year and is exciting news for the
COPD community and ultimately patients."

The LANTERN study also showed superiority of Ultibro Breezhaler compared to
SFC for the key secondary objective of lung function (FEV1AUC0-4h) over the
first four hours post dose at week 26. The safety and tolerability profile of
Ultibro Breezhaler was comparable to SFC.

COPD is a major public health concern in China, ranking first in terms of the
country's disease burden[1]. Recent estimates suggest that in China over 40
million people have COPD[2]and the overall prevalence in people aged 40 years
or older is 8%[1].

COPD symptoms can have a major, negative impact on a patient's ability to
breathe and function and they reduce their quality of life[3]. Essential
daily activities such as climbing stairs can become very difficult as the
condition gradually worsens[4]. There is a need for new treatment options in
COPD because many patients remain symptomatic despite medical therapy[5].

About LANTERN
LANTERN was a randomized, double-blind, parallel-group, 26-week study
conducted at 56 sites across China, Argentina, Chile and Taiwan[6]. The study
randomized 741 patients to assess the efficacy and safety of Ultibro
Breezhaler (indacaterol/glycopyrronium) 110/50 mcg compared to SFC 50/500 mcg
in patients with moderate-to-severe COPD[6], with or without exacerbations in
the previous year.

ILLUMINATE was the first study to demonstrate that Ultibro Breezhaler achieved
superior lung function in patients with moderate-to-severe COPD and no
history of exacerbations in the previous year, compared with twice-daily
salmeterol/fluticasone 50/500 mcg[7] administered with the Accuhaler®* dry
powder inhaler.

About Ultibro
®Breezhaler
®

Ultibro Breezhaler (indacaterol/glycopyrronium bromide) is a novel, once-daily
dual bronchodilator approved in the EU as a maintenance bronchodilator
treatment to relieve symptoms in adult patients with COPD[8]. Clinical trials
have shown that Ultibro Breezhaler offers statistically significant
improvements in bronchodilation compared to treatments widely used as current
standards of care, including SFC 50/500 mcg, in patients with no history of
moderate or severe exacerbations over the last year[9]-[11] and open-label
tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over
30 countries, including the EU, Japan, Canada and Australia.

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®/ArcaptaTMNeohalerTM(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[12]. The
Breezhaler®device allows patients to hear, feel and see that they have taken
the full dose correctly[12],[13].

About COPD
COPD is a progressive life-threatening disease that makes it difficult to
breathe, with symptoms that have a destructive impact on patients' function
(i.e. activity limitation, decreased mobility) and quality of life[3],[14].
It affects an estimated 210 million people worldwide[15]and is projected to
be the third leading cause of death by 2020[14]. 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[16],[17].

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "to be," "later this year," "will," "can,"
"committed," "continues," "projected," or similar terms, or by express or
implied discussions regarding potential new indications or labeling for
Ultibro Breezhaler, or regarding potential future revenues from any or all of
the products in the Novartis COPD portfolio, including Ultibro 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 Ultibro 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.

*The LANTERN study used Seretide®
(salmeterol/fluticasone) 50/500 mcg, which is indicated in the UK 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[18]. The patient
population in the LANTERN study who received salmeterol/fluticasone
administered via the Accuhaler
®

dry powder inhaler, were moderate-to-severe COPD patients with or without
exacerbations in the previous year. Seretide®is also known as Advair®and
Accuhaler
®

is also known as Diskus
®

. Seretide
®

, Advair®, Diskus
®

and Accuhaler
®

are registered trademarks of the GlaxoSmithKline group of companies.

References

[1] Zhong Net al.
Prevalence of Chronic Obstructive Pulmonary Disease in China. A Large,
Population-based Survey.Am J Respir Crit Care Med.
2007;176
:753-760 (4).

[2] Zhanget al.
Impact of risk factors, activities and psychological disorders on the health
of patients with chronic obstructive pulmonary disease in China: a
cross-sectional study.BMC Public Health.
2013;13
:627.

[3] Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive
pulmonary disease and cancer.Curr Opin Pulm Med
2012;18
:97-103.

[4] World Health Organization. Chronic Obstructive Pulmonary Disease Factsheet
No. 315, Available at:http://www.who.int/mediacentre/factsheets/fs315/en/.
[Accessed 17 April 2014].

[5] Hersh CP. Pharmacogenetics of chronic obstructive pulmonary disease:
challenges and opportunities.Pharmacogenomics<...

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