New Data presented at European Respiratory Society (ERS) comparing the once-daily dual bronchodilator Ultibro® Breezhaler® to Advair* Diskus* further supports the efficacy of Ultibro® Breezhaler® in moderate to severe COPD patients

• LANTERN study met primary endpoint demonstrating non-inferiority of Ultibro^® Breezhaler^® 110/50 mcg vs Advair* Diskus* (SFC) 50/500 mcg followed by statistically significant superiority in post dose trough FEV₁ after 26 weeks of treatment in patients with moderate-to-severe COPD¹
  
  
• In addition, LANTERN study met an endpoint demonstrating that Ultibro^® Breezhaler^® reduced exacerbations by 31 per cent vs twice-daily Advair* Diskus* in moderate-to-severe COPD patients¹
  
  
• First presentation of LANTERN trial at European Respiratory Society (ERS) International Congress involving over 700 COPD patients¹

DORVAL, QC, Sept. 8, 2014 /CNW/ - Novartis, announces today new data from the LANTERN study that demonstrated Ultibro^® Breezhaler^® (indacaterol/glycopyrronium bromide, QVA149) was superior in bronchodilation and rate of exacerbations vs Advair* Diskus* (salmeterol/fluticasone, (SFC)).¹ The head-to-head LANTERN study results were presented for the first time at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany.

"Until now, we've regarded inhaled steroids as a necessary component in the treatment of severe COPD," says Dr. Kenneth Chapman, Director, Asthma & Airway Centre of the University Health Network, located in Toronto. "The findings from LANTERN will encourage us to consider a steroid-free dual bronchodilator regimen in COPD patients with moderate to severe disease, a strategy consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 recommendations.  Certainly, Ultibro^® improved several health outcomes, including exacerbation reduction, more effectively than a widely used inhaled steroid containing combination regimen, SFC."

About LANTERN
LANTERN was a randomized, double blind, parallel group, 26-week study involving 744 patients and was conducted at 56 sites across China, Argentina, Chile and Taiwan.⁴ The results of the LANTERN study demonstrated the efficacy of once-daily Ultibro^® Breezhaler^® was superior and clinically meaningful compared to twice-daily SFC in terms of lung function (trough FEV₁; AUC_0-4h), in patients with moderate-to-severe COPD after 26 weeks of treatment. These findings further demonstrated the use of a LABA/LAAC combination over LABA/inhaled corticosteroid in moderate-to-severe COPD patients with or without exacerbation and are consistent with the current GOLD 2014 strategy.^1,3

The primary objective of the study was to demonstrate the non-inferiority of Ultibro^® Breezhaler^® 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough FEV₁) after 26 weeks of treatment in patients with moderate-to-severe COPD, with no more than one exacerbation in the previous year.¹ Ultibro^® Breezhaler^® met its primary objective of non-inferiority. Additionally, the LANTERN study showed Ultibro^® Breezhaler^® significantly reduced the rate of moderate-to-severe exacerbations by 31 per cent compared to SFC, in moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year.¹

The safety profile of Ultibro^® Breezhaler^® was comparable to SFC.¹ Adverse events were lower for Ultibro^® Breezhaler^® (40.17%) vs SFC (47.4%) and incidence of pneumonia were also lower with Ultibro^® Breezhaler^® (0.8%) vs SFC (2.7%). The safety profile in this study is similar to the overall safety profile for this product.

About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients' lung function and quality of life.^3,5 Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens.⁶ It affects an estimated 210 million people worldwide⁷ and is projected to be the third leading cause of death by 2020.³ 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

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.⁹ COPD symptoms can impose a significant burden on patients and reduce quality of life.^9,10 There is a need for newer treatment options in COPD because many patients remain symptomatic despite medical therapy.¹¹

About Ultibro^® Breezhaler^®
Ultibro^® Breezhaler^® (indacaterol/glycopyrronium bromide, QVA149) is a fixed-dose combination (FDC) of the active ingredients of two bronchodilators, Onbrez^® Breezhaler^® (indacaterol maleate), a long-acting beta₂-adrenergic agonist (LABA)¹² and Seebri^® Breezhaler^® (glycopyrronium bromide), a long-acting anticholinergic (LAAC).¹³ Both are currently used by healthcare professionals as individual therapies to treat COPD in Canada.

Ultibro^® Breezhaler^® is approved as a maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema but not for COPD exacerbation reduction.² Ultibro^® Breezhaler^® is currently approved for use in over 40 countries, including the EU, Japan, Australia and other countries in Latin America.

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

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

* All trademarks and registered trademarks are the property of their respective owners.

References

1. Zhong N et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study. [ERS abstract 700090; Session 281; Date: September 8 2014 Time: 12:50-14:40].
2. Ultibro® Breezhaler® Product Monograph, August 18, 2014.
3. 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 21 August 2014].
4. Clinicaltrials.gov. A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149 (LANTERN). NCT01709903. http://clinicaltrials.gov/ct2/show/NCT01709903 [Accessed 23 July 2014].
5. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.
6. World Health Organization. Chronic Obstructive Pulmonary Disease Factsheet No. 315, Available at: http://www.who.int/mediacentre/factsheets/fs315/en/. [Accessed 5 August 2014].
7. 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 21 August 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 21 August 2014].
9. 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.
10. 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 21 August 2014].
11. Hersh CP. Pharmacogenetics of chronic obstructive pulmonary disease: challenges and opportunities. Pharmacogenomics 2010;11(2):237-247.
12. Onbrez® Breezhaler® Product Monograph, December 3, 2013.
13. Seebri® Breezhaler® Product Monograph, August 7, 2014.

SOURCE: Novartis Pharmaceuticals Canada Inc.

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