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Novartis : announces positive results at ATS for once-daily Ultibro« Breezhaler« versus combination therapy (tiotropium plus formoterol)

05/21/2014 | 01:17am US/Eastern
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
  * 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 FEV(1)) 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 FEV(1), 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
beta(2)-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(® )/ Arcapta(TM
)Neohaler(TM) (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

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].

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 NovartisNovartis 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 visit

Novartis is on Twitter. Sign up to follow @Novartis at

[1] Geßner C et 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 S et 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: [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. [Accessed
13 May 2014].
[5] Fletcher MJ et 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 M et 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] Bryant et al. Improving medication adherence in chronic obstructive
pulmonary disease: a systematic review. Respiratory Research 2013;14:109.
Available at:
[Accessed 13 May 2014].
[8] Chrystyn H et al. Impact of patients' satisfaction with their inhalers on
treatment compliance and health status in COPD. Respir Med 2014;108(2):358-65.
[9] Pavkov et al. Characteristics of a capsule based dry powder inhaler for the
delivery of indacaterol. CMRO 2010;26; 11:2527-2533.
doi:10.1185/03007995.2010.518916. [Accessed 13 May 2014].
[10] EMA. 2012. Ultibro Breezhaler EU Summary of Product Characteristics.
[Online] 3 October 2013. Available at:
_Product_Information/human/002679/WC500151255.pdf [Accessed 13 May 2014].
[11] Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful
improvements in lung function and clinical outcomes versus placebo, indacaterol,
glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD.
[ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].
[12] Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful
improvements in lung function and clinical outcomes. [ERS abstract 851178;
Session 82; Date: September 8, 2013 Time: 12:50-14:40].
[13] Banerji D et al. Dual bronchodilation with once-daily QVA149 improves
dyspnea and health status and reduces symptoms and rescue medication use in
patients with COPD: the IGNITE trials. [ERS abstract 851388; Session 346; Date:
September 10 2013 Time: 8:30-10:30].
[14] Joshi A et al. Symptom burden in chronic obstructive pulmonary disease and
cancer. Curr Opin Pulm Med 2012;18:97-103.
                                     # # #

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Media release (PDF):

This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
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(ii) they are solely responsible for the content, accuracy and
     originality of the information contained therein.

Source: Novartis International AG via GlobeNewswire

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