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2014-05-21

Novartis International AG: Novartis announces positive results at ATS for once-daily Ultibro® Breezhaler® versus combination therapy (tiotropium plus formote

Novartis International AG / Novartis announces positive results at ATS for
once-daily Ultibro® Breezhaler®versus combination therapy (tiotropium plus
formoterol) . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* QUANTIFY study met primary endpoint demonstrating non-inferiority of
Ultibro® Breezhaler® vs tiotropium 18 mcg plus formoterol 12 mcg in
improving health-related quality of life outcomes[1],[2]

* QUANTIFY study met secondary endpoint demonstrating superiority of Ultibro
Breezhaler vs tiotropium plus formoterol by improving lung function[1],[2]

* Ultibro Breezhaler provides the convenience of a once-daily fixed-dose
combination in a single inhalation device for the treatment of COPD

* Novartis showcases 16 respiratory abstracts at the 2014 American Thoracic
Society (ATS) International Conference

The digital press release with multimedia content can be accessed here:

Basel, May 21, 2014
- Novartis announced today new data from the QUANTIFY study, which
demonstrated the non-inferiority of
Ultibro®Breezhaler®(indacaterol/glycopyrronium) 110/50 mcg compared to
tiotropium 18 mcg plus formoterol 12 mcg in terms of health-related quality
of life (HRQoL) outcomes in moderate-to-severe chronic obstructive pulmonary
disease (COPD) patients at week 26[1],[2]. Positive results from QUANTIFY are
part of 16 Novartis respiratory abstracts being presented at the American
Thoracic Society (ATS) International Conference, May 16-21, 2014 in San
Diego, CA, USA.

In the QUANTIFY study, which included over 900 COPD patients, once-daily
Ultibro Breezhaler showed superior improvements in lung function (trough
FEV1) at 26 weeks compared to once-daily tiotropium plus twice-daily
formoterol in moderate-to-severe COPD patients. Additionally, patients taking
Ultibro Breezhaler were more likely to demonstrate a clinically meaningful
improvement in shortness of breath and health-related quality of life (per
protocol set) at 26 weeks compared to tiotropium plus formoterol. The safety
and tolerability of Ultibro Breezhaler was comparable to the other treatment
arm in the study[1],[2].

"These positive results from QUANTIFY demonstrate that once-daily Ultibro
Breezhaler can provide better symptom control versus a combination of two
individual treatments, tiotropium plus formoterol," said Tim Wright, Global
Head of Development, Novartis Pharmaceuticals. "More patients on Ultibro
Breezhaler had a meaningful improvement in health-related quality of life
demonstrating superiority of our LABA/LAMA vs tiotropium plus formoterol."

COPD affects an estimated 210 million people worldwide[3] and is projected to
be the third leading cause of death by 2020[4]. Symptoms can impose a
significant burden on patients and reduce quality of life[5],[6], but they
are often inadequately managed. Treatments that are easy for patients to take
and have reliable dose control whilst effectively managing the symptoms of
COPD are important to improve patient outcomes[7]-[9].

QUANTIFY was a 26-week treatment, multicenter, randomized, parallel group,
blinded study to assess the efficacy and safety of once-daily Ultibro
Breezhaler in 934 patients with moderate-to-severe COPD, versus the
free-combination of tiotropium 18 mcg plus formoterol 12 mcg. The primary
objective was to demonstrate non-inferiority of Ultibro Breezhaler in HRQoL
as assessed by the St. George's Respiratory Questionnaire-COPD (SGRQ-C)
versus tiotropium plus formoterol after 26 weeks of treatment. Secondary
endpoints included transition dyspnea index (TDI) score, trough FEV1, forced
vital capacity (FVC) and safety and tolerability[1],[2].

About Ultibro Breezhaler
Ultibro Breezhaler (indacaterol/glycopyrronium bromide) is a novel, once-daily
dual bronchodilator approved as a maintenance bronchodilator treatment to
relieve symptoms in adult patients with COPD[10]. Ultibro Breezhaler is a
fixed-dose combination of two bronchodilators, indacaterol 110 mcg, a
long-acting beta2-adrenergic agonist (LABA) and glycopyrronium 50 mcg, a
long-acting muscarinic antagonist (LAMA). Ultibro Breezhaler was developed
and previously known as QVA149. Clinical trials have shown that Ultibro
Breezhaler offers statistically significant improvements in bronchodilation
compared to treatments widely used as current standards of care, including
salmeterol/fluticasone 500/50 mcg, in patients with no history of moderate or
severe exacerbations over the last year[11]-[13]and open-label tiotropium 18
mcg. Ultibro Breezhaler is currently approved for use in over 30 countries,
including the EU, Japan, Canada, Mexico 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[9]. The Breezhaler
device allows patients to hear, feel and see that they have taken the full
dose correctly[9],[10].

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[4],[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[5],[6].

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "can," "projected," "to be," "committed,"
"continues," 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.

References
[1] Geßner Cet al
. Once-Daily QVA149 Demonstrates Superior Improvements in Lung Function
Compared to Tiotropium plus Formoterol: The QUANTIFY Study. [ATS abstract #
50961; Thematic Poster Session D44; Date: May 21, 2014 Time: 8:15 AM-4:30
PM].

[2] Korn Set al
. Once-Daily QVA149 Improves Dyspnea, Quality of Life and Reduces the Rate of
Exacerbations Compared to Tiotropium Plus Formoterol in COPD Patients: The
QUANTIFY Study. [ATS abstract # 50965; Thematic Poster Session D44; Date: May
21, 2014 Time: 8:15 AM-4:30 PM].

[3] 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 13 May
2014].

[4] 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 13 May 2014].

[5] 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.

[6] 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
13 May 2014].

[7] Bryantet al
. Improving medication adherence in chronic obstructive pulmonary disease: a
systematic review.Respiratory Research
2013;14
:109. Available
at:http://...

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