Novartis Pharmaceuticals Canada Inc. Announces Results At 2014 American Thoracic Society International Conference For Once Daily Dual Bronchodilator Ultibro® Breezhaler® Versus Combination Therapy For COPD

• 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 that Ultibro^® Breezhaler^® significantly increased the pre-dose FEV₁ lung function vs tiotropium plus formoterol by 68ml by the end of the study ^1,2
• Novartis showcases 16 respiratory abstracts at the 2014 American Thoracic Society (ATS) International Conference

DORVAL, QC, May 21, 2014 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) announced today new data from the QUANTIFY study, which demonstrated 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. 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 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, in the study, 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.

"We know that dual bronchodilation can provide symptom control in patients with COPD. The QUANTIFY results add to the evidence that Ultibro^® Breezhaler^® is an effective treatment option for some patients," says Dr. Francois Maltais, Professor, Laval University Faculty of Medicine and, Director of the Research Group in Respiratory Health, Institut universitaire de cardiologie et de pneumologie de Québec, Laval University. "The dual bronchodilation offered by Ultibro^® may also make it easier for patients to adhere to their treatment over the long-term."

About QUANTIFY

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.^1,2

Secondary endpoints included transition dyspnea index (TDI) score, trough FEV₁, forced vital capacity (FVC) and safety and tolerability.^1,2 The QUANTIFY study demonstrated that Ultibro^® Breezhaler^® significantly increased the pre-dose FEV₁ vs tiotropium plus formoterol by 68ml at 26 weeks and the percentage of patients achieving >1 point improvement in the Breathlessness score (TDI) was significantly higher in the Ultibro^® Breezhaler^® arm.^1,2

"The 16 respiratory abstracts presented at the ATS by Novartis and the results from QUANTIFY are good news in terms of treatment advancement for Canadians living with COPD," said Tim Maloney, Country Head and President of Novartis Pharmaceuticals Canada Inc.

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^3,4. It affects an estimated 210 million people worldwide⁵ and is projected to be the third leading cause of death by 2020³. COPD is often considered to be a disease of later years, but estimates suggest that 50 per cent of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation⁶.

COPD symptoms can impose a significant burden on patients and reduce quality of life^6,7, but they can also be inadequately managed.

In Canada, 2009-2010 estimates show that 4 per cent of Canadians aged 35 and older are affected. Cigarette smoking is the principal cause, accounting for 80 per cent of COPD deaths.⁸

About Ultibro^® Breezhaler^®

Ultibro^® Breezhaler^® (indacaterol/glycopyrronium bromide) is a fixed-dose combination (FDC) of two bronchodilators, Onbrez^® Breezhaler^® (indacaterol maleate), a long-acting beta2-adrenergic agonist (LABA)⁹ and Seebri^® Breezhaler^® (glycopyrronium bromide), a long-acting anticholinergic (LAAC)¹⁰. Both are currently used by healthcare professionals as individual therapies to treat COPD in Canada.

Ultibro^® Breezhaler^® (indacaterol/glycopyrronium bromide) is approved as a maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.¹¹ Ultibro^® Breezhaler^® is currently approved for use in over 30 countries, including the EU, Japan and Australia.

About the Novartis COPD portfolio

Novartis is committed to addressing the unmet medical needs of patients with respiratory diseases and improving their quality of life by providing innovative medicines and devices.

Please refer to www.novartis.ca for more information about the Novartis Canada respiratory portfolio.

About Novartis Pharmaceuticals Canada Inc.

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2012, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

About Novartis

Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis Group of Companies 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 www.novartis.com.

® Ultibro, Onbrez, Seebri and Breezhaler are registered trademarks.

References

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 Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. [Accessed 3 September 2013].
4. Joshi M et al. Symptom burden in chronic obstructive pulmonary disease and cancer. Obstructive, occupational and environmental diseases. 2012;18 (2).
5. 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 2 May 2014].
6. 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.
7. 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].
8. PHAC. Fast facts about Chronic Obstructive Pulmonary Disease (COPD) 2011. Available from: www.phac-aspc.gc.ca/cd-mc/publications/copd-mpoc/ff-rr-2011-eng.php. Accessed September 3, 2013.
9. Onbrez^® Breezhaler^® Product Monograph, December 3, 2013.
10. Seebri^® Breezhaler^® Product Monograph, December 3, 2013.
11. Ultibro® Breezhaler® Product Monograph, April 8, 2014.

SOURCE Novartis Pharmaceuticals Canada Inc.