TONADO™ study finds significant improvement in lung function and quality of life with tiotropium + olodaterol Respimat®*± Soft Mist Inhaler FDC in Chronic Obstructive Pulmonary Disease

·First presentation of pivotal Phase III TONADO™ results for the only fixed-dose combination (FDC) containing tiotropium1,+

·Well-tolerated, with a favourable safety profile similar to either treatment alone2

·Data support recent regulatory submissions for tiotropium + olodaterol Respimat®*±

Burlington, Ontario, September 15, 2014 – Data presented recently at the European Respiratory Society (ERS) International Congress 2014 from the pivotal Phase III TONADO™ studies† for tiotropium + olodaterol Respimat®*± found that tiotropium + olodaterol Respimat®*± brought further lung function and quality of life benefits to patients than either compound alone.1 The 52-week studies involved more than 5,000 patients with COPD and have been part of the recent regulatory submissions for tiotropium + olodaterol Respimat®*± as a COPD maintenance therapy. TONADO™ is part of the Phase III TOviTO™ clinical trial program. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programs conducted in COPD.3

COPD is a chronic disease that affects more than 800,000 Canadians.4 It is believed that 1.6 million Canadians may have COPD but remain undiagnosed.5 It is a significant burden on patients and the fourth leading cause of death in Canada, and is expected to be the third leading cause of death worldwide by the year 2020.6,7

Results from TONADO™ showed tiotropium + olodaterol Respimat®*± provided a significant improvement in lung function and health-related quality of life over the mono-components.1

"Tiotropium alone has been shown to reduce both trips to the hospital and the risk of COPD exacerbations,” said Dr. Denis O’Donnell, professor, Medicine, Rehabilitation Medicine, Biomedical & Molecular Sciences, Kinesiology & Health Studies, Queen’s University. “This new data shows that the combination treatment may be more effective than either molecule alone for lung function – an important development for the treatment of this challenging disease.”

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Footnotes

*The fixed-dose combination of tiotropium + olodaterol is an investigational compound. Its safety and efficacy has not yet been fully established and it is currently not authorized for sale in Canada.
+TONADO™ consists of two replicate studies: TONADO™ 1&2. In the studies two doses of tiotropium + olodaterol Respimat®*± FDC were investigated: 2.5µg/5µg and 5µg/5µg. The data included in this press release are for the tiotropium 5µg/olodaterol 5µg dose, which is the FDC* dose submitted to the regulatory authorities for marketing authorization.

±Tiotropium + olodaterol is a Fixed-Dose Combination medication delivered via Respimat™ Soft Mist Inhaler Fixed-Dose Combination

References

1.Buhl, R. et al. Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® improves outcomes vs mono-components in COPD in two 1-year studies. ERS 2014 abstract No. OP1895.
2. Buhl, R. et al. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat® in chronic obstructive pulmonary disease in two 1-year studies. ERS 2014 abstract No. P922.
3. TOviTO™ clinical trial programme backgrounder. http://www.newshome.com/education_hub1/respiratory/backgrounders/TOviTO_clinical_trial_programme_backgrounder.html Accessed September 2, 2014.
4. Statistics Canada. Fast Facts about Chronic Obstructive Pulmonary Disease http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health104a-eng.htm. Accessed at August 12, 2014.
5.The Lung Association. Chronic Obstructive Pulmonary Disease (COPD) in Canada. http://www.lung.ca/pdf/copd/COPD_in_Canada.pdf Accessed September 4, 2014
6. O’Donnell, DE. et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2008 update –highlights for primary care. Can Respir J. 2008. 15(Suppl A):1A-8A.
7. Camp PG. Levy RD. A snapshot of chronic obstructive pulmonary disease in British Columbia and Canada. BCMJ. 2008. 50(2): 80.