Novartis Pharmaceuticals Canada Inc. receives Health Canada approval for Ultibro™ Breezhaler®, a once-daily dual bronchodilator for COPD

• Ultibro™ Breezhaler®¹ (QVA149), a long-term once-daily dual bronchodilator, received Health Canada approval on December 23^rd 2013 for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
• Pivotal Phase III IGNITE data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standards of care^2,3,4

DORVAL, QC, Jan. 13, 2014 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Health Canada has approved the use of long-term once-daily dual bronchodilator Ultibro™ Breezhaler^® (indacaterol 110 mcg / glycopyrronium 50 mcg) as a maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

"The availability of Ultibro™ Breezhaler^® is good news for my patients with COPD who struggle with disabling breathlessness as they attempt simple everyday tasks." says Dr. Kenneth Chapman, Director, Asthma & Airway Centre of the University Health Network, located in Toronto. "A new treatment option that improves lung function and relieves breathlessness around the clock following just one inhalation is a welcome advance."

Health Canada approved Ultibro™ Breezhaler^® based on five studies from the IGNITE clinical program (SHINE², ILLUMINATE³, SPARK⁴, BRIGHT⁵ and ENLIGHTEN⁶ studies). These studies showed that QVA149 provided rapid and sustained improvements in lung function, and significantly reduced shortness of breath. These improvements were maintained throughout the duration of the trials^13,14. The IGNITE clinical program is one of the largest international phase III clinical trial programs in COPD, with 11 trials in total and more than 10 000 patients involved. ^2-12

Ultibro™ Breezhaler^® is a fixed-dose combination (FDC) of two bronchodilators, Onbrez^® Breezhaler^®15 (indacaterol maleate), a long-acting beta₂-adrenergic agonist (LABA) and Seebri^® Breezhaler^®16 (glycopyrronium bromide), a long-acting anticholinergic (LAAC). Both are currently used by healthcare professionals as individual therapies to treat COPD in Canada.

"COPD is known to affect an estimated 210 million people worldwide¹⁷ and is projected to be the third leading cause of death by 2020¹⁸. Several patients find COPD symptoms really tough to cope with - even if they're already taking treatment," said Dr. Riad Sherif, President of Novartis. "With the approval of Ultibro™ Breezhaler^®, Novartis is pleased that Health Canada recognizes the efficacy of dual therapy, which has the potential to make a real difference for those with COPD."

About the IGNITE clinical trial program
In the Phase III IGNITE clinical trial program, Ultibro™ Breezhaler^® (QVA149) was 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^2-12,19,20. 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 QVA149.

Results from the Phase III IGNITE trials^2-12 demonstrated statistically significant improvements in bronchodilation with Ultibro™ Breezhaler^® versus placebo. Data showed that Ultibro™ Breezhaler^® significantly improved bronchodilation providing a rapid onset and sustained bronchodilation during a 24-hour period which was maintained for up to 26 weeks²¹. In the IGNITE Phase III trial program, Ultibro™ Breezhaler^® also showed symptomatic improvements versus placebo in COPD patients^2,4,5,13. These symptomatic improvements included shortness of breath, exercise tolerance, rescue medication use and health-related quality of life^2,4,5,13.

In clinical studies, Ultibro™ Breezhaler^® demonstrated an acceptable safety profile with no meaningful differences between the treatment groups in the incidence of adverse and serious adverse events^2,3,4,5,21. The most common adverse drug reactions related to Ultibro™ Breezhaler^® were cough and oropharyngeal pain¹.

*Total refers to all 11 IGNITE studies.

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.

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 emphysema¹⁵.

Also approved for use in Canada, once-daily Seebri^® Breezhaler^® (glycopyrronium bromide) 50 mcg is a novel inhaled long-acting anticholinergic (LAAC; also referred to as a long-acting muscarinic antagonist) indicated as a maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and emphysema¹⁶.

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^18,22. It affects an estimated 210 million people worldwide¹⁷ and is projected to be the third leading cause of death by 2020¹⁸.

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 participation²³.

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 deaths²⁴.

About Novartis
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.

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 offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time equivalent associates and operate in more than 140 countries around the world. For more information, please visit www.novartis.com.

™Ultibro is a trademark of Novartis Pharmaceuticals Canada Inc.

®Onbrez, Seebri and Breezhaler are registered trademarks of Novartis Pharmaceuticals Canada Inc.

References

1. Ultibro™ Breezhaler^® Product Monograph, Novartis Pharmaceuticals Inc.
2. 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].
3. 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.
4. 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 Respiratory Medicine 2013;1(3): 199-209.
5. 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].
6. 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.
7. 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].
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SOURCE: Novartis Pharmaceuticals Canada Inc.