Sosei Group Corporation confirms that the New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) was submitted to the US Food and Drug Administration (FDA) by Novartis in Q4 2014. Sosei is eligible to receive milestone payments upon the acceptance of applications by FDA.

In addition, the positive top-line results were announced recently by Novartis from the pivotal phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support the application. The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM (including GEM 1, 2 and 3 studies) clinical trial programmes met their primary and secondary endpoints.

The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients. Improvements in overall health status, a secondary endpoint based on the St George’s Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 121. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies.

In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo, meeting its primary objective. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies.

Data from the EXPEDITION and GEM programmes are expected to be presented at major medical congresses later this year.

COPD symptoms can have a major negative impact on a patient’s ability to breathe and perform essential daily activities, thereby reducing their quality of life. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy.

The EXPEDITION Programme consisted of studies, including FLIGHT 1 and 2, which were identical 12-week, multi-centre, randomised, double blind, parallel-group, placebo and active controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare twice-daily QVA149 27.5/12.5 mcg to its monotherapy components in terms of lung function (FEV1 AUC0-12h) at Week.

FLIGHT 3 was a 52-week randomised, double blind, parallel-group study to assess the safety and tolerability of twice-daily QVA149 27.5/12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study.

GEM 1 and 2 were 12-week multi-centre, randomised, double-blind, placebo controlled studies to assess the efficacy and safety of twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg in moderate to severe COPD patients. The primary objective was to compare twice-daily NVA237 to placebo in terms of lung function (FEV1 AUC0-12h) after 12 weeks of treatment. The objective of GEM 3 was to determine safety and tolerability of twice-daily NVA237 12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.

Twice-daily QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, as used in the EXPEDITION program, is being submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro Breezhaler 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD10. Once-daily Ultibro Breezhaler is currently approved for use in over 50 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia.

Twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg, as used in the GEM trials, is being submitted for US registration only. Outside of the US, NVA237 has been developed/marketed as Seebri Breezhaler 50 mcg, which is a once daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD and is approved for use in over 70 countries, including countries within the EU, Japan, Latin America, Canada, Switzerland and Australia.

Glycopyrronium bromide was exclusively licenced to Novartis in April 2005 by Sosei and its co-development partner Vectura.

COPD is associated with chronic morbidity and mortality and The World Health Organization (WHO) estimates that 210 million people worldwide have COPD. Deaths from COPD are projected to increase over the next 10 years by more than 30 per cent unless underlying risk factors are addressed. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 2010-14 and is now also the third leading cause of death worldwide.

COPD is progressive (usually gets worse over time), and can be a life-threatening disease. It makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life. It 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 participation.