Novartis continues to build its COPD pipeline and presents new data on investigational once-daily QVA149 at ERS

DORVAL, QC, Sept. 9, 2013 /CNW/ - Novartis announced new analyses of data for investigational QVA149 (indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), which showed clinically significant improvements in lung function, shortness of breath and health-related quality of life for chronic obstructive pulmonary disease (COPD) patients versus those comparators evaluated in the study^1,2. These data were part of 39 respiratory abstracts presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain.

First results from a pooled analysis of 4,891 COPD patients in the IGNITE clinical trial program (SHINE, ILLUMINATE and SPARK studies) showed that investigational QVA149 provided rapid and sustained improvements in lung function, and significantly reduced shortness of breath, evaluated against comparator treatments widely used as current standards of care evaluated in the study^1,2. These improvements were maintained throughout the duration of the trials^1,2.

"These new trial results for investigational QVA149 are good news for my COPD patients who struggle each day with a disease that causes disabling breathlessness as they attempt simple everyday tasks," says Dr. Kenneth Chapman, Director, Asthma & Airway Centre of the University Health Network. "A new treatment option improving lung function and relieving breathlessness around the clock with just one inhalation will be a welcome advance."

"COPD is known to affect an estimated 210 million people worldwide³ and is projected to be the third leading cause of death by 2020⁴. Many patients find COPD symptoms really tough to cope with - even if they're already taking treatment," said Tim Wright, Global Head of Development, Novartis. "Novartis is pleased that these new analyses further support the efficacy of dual therapy, which has the potential to make a real difference to peoples' lives."

Currently being assessed in a clinical trial program involving over 10,000 patients^5-15, investigational QVA149 is a fixed-dose combination (FDC) of two bronchodilators, ONBREZ* BREEZHALER* (indacaterol maleate), a long-acting beta₂-adrenergic agonist (LABA) and SEEBRI* BREEZHALER* (glycopyrronium bromide), a long-acting anticholinergic (LAAC). Both are currently used by healthcare professionals as individual therapies to treat COPD.

About the IGNITE clinical trial program
In the Phase III IGNITE clinical trial program, investigational QVA149 is being investigated for the treatment of COPD patients as an inhaled FDC of indacaterol maleate and glycopyrronium bromide. IGNITE is one of the largest international clinical trial programs in COPD comprising 11 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000* patients across 52 countries^5-17. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012. The studies are designed to investigate the efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life in patients treated with investigational QVA149.

Results from the Phase III IGNITE trials^5-15 demonstrated statistically significant improvements in bronchodilation with investigational QVA149 versus comparator treatments widely used as current standards of care¹⁸. Data showed that investigational QVA149 significantly improved bronchodilation providing a rapid onset within five minutes, and sustained bronchodilation during a 24-hour period which was maintained for up to 26 weeks¹⁹. In the IGNITE Phase III trial program, investigational QVA149 also showed symptomatic improvements versus placebo in COPD patients^5,6,8,18. These symptomatic improvements included shortness of breath, exercise tolerance, rescue medication use and health-related quality of life^5,6,8,18.

In clinical studies, investigational QVA149 demonstrated an acceptable safety profile with no meaningful differences between the treatment groups in the incidence of adverse and serious adverse events^5,6,7,8,19.

*Total refers to all 11 IGNITE studies.

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.

Available in Canada, ONBREZ* BREEZHALER* (indacaterol maleate) 75 mcg is a long-acting β₂-agonist (LABA) indicated for long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. Also approved for use in Canada, once-daily SEEBRI* BREEZHALER* (glycopyrronium bromide) is a novel inhaled long-acting anticholinergic (LAAC; also referred to as a long-acting muscarinic antagonist) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD²⁰.

About COPD
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 participation²².

In Canada, 2009-2010 estimates show that 4% of Canadians aged 35 and older are affected. Cigarette smoking is the principal cause, accounting for 80% of COPD deaths²³.

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.

*SEEBRI, ONBREZ and BREEZHALER are registered trademark.

References

1. 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].
2. 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].
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%20Book%202007.pdf. [Accessed 3 September 2013].
4. 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].
5. Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respir Med 2013 http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70052-3/abstract [Accessed 3 September 2013].
6. Beeh et al. QVA149 once daily improves exercise tolerance and lung function in patients with COPD: the BRIGHT study. [BTS Winter Meeting 2012, Poster presentation P191; Date: 6 December; Time: 16:00-17:30].
7. Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone in patients with COPD (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1): 51-60.
8. Bateman ED et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. European Respiratory Journal http://erj.ersjournals.com/content/early/2013/05/30/09031936.00200212.full.pdf. [Accessed 3 September 2013].
9. Dahl et al. 2012. QVA administered once daily provides significant improvements in lung function over 1 year in patients with COPD: The ENLIGHTEN study. Volume abstract 853405.
10. Mahler D et al. Superior lung function with once-daily QVA149 translates into improvements in patient reported breathlessness compared with placebo and tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308; Session C20; Date: May 21, 2013 Time: 8:15-10:45].
11. ClinicalTrials.gov, n.d. Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD) (ARISE). [Online] Available at: http://www.clinicaltrials.gov/ct2/show/NCT01285492?term=%28ARISE%29&rank=4 . [Accessed 3 September 2013].
12. ClinicalTrials.gov, n.d. Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BEACON). [Online] Available at: www.clinicaltrials.gov/ct2/show/NCT01529632?term=BEACON&rank=6. [Accessed 3 September 2013].
13. ClinicalTrials.gov, n.d. Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation (RADIATE). [Online] Available at: www.clinicaltrials.gov/ct2/show/NCT01610037?term=GLISTEN&rank=1 .[Accessed 3 September 2013].
14. ClinicalTrials.gov, n.d. A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. [Online]. Available at: www.clinicaltrials.gov/ct2/show/NCT01709903?id=01709903&rank=1. [Accessed 3 September 2013].
15. ClinicalTrial.gov, n.d. A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Futicasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD (FLAME). [Online] Available at: http://clinicaltrials.gov/ct2/show/NCT01782326?term=COPD+novartis+52&rank=2 .[Accessed 3 September 2013].
16. FDA Access Data, n.d.Spiriva Medical Review Part 2. [Online] Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm. [Accessed 3 September 2013].
17. FDA Access Data, 2003.Advair Medical Review. [Online] Available at: www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf. [Accessed 3 September 2013].
18. 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].
19. Welte T et al. QVA149 once daily is safe and well tolerated in patients with COPD: the SHINE study. [ATS abstract 41616; Session A43; Date: May 19, 2013, 8:15-16.30].
20. EMA. 2012. aler EU Summary of Product Characteristics. [Online] 17 October 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002430/WC500133769.pdf. [Accessed 3 September 2013].
21. Joshi  M et al. Symptom burden in chronic obstructive pulmonary disease and cancer. Obstructive, occupational and environmental diseases. 2012;18(2).
22. 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.
23. 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.

SOURCE: Novartis Pharmaceuticals Canada Inc.

Novartis - Media Relations
Andrea Gilpin
Director, Corporate Communications
Novartis Pharmaceuticals Canada Inc.
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