Phase 3 Study Update of QVA149 for COPD

Sosei confirmed the information released by Novartis that results from the fifth QVA149 (indacaterol maleate/glycopyrronium bromide) Phase 3 study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide.

SPARK was a 64-week, multi-center, randomized, double-blind, parallel-group, active controlled study designed to evaluate the effect of QVA149 (indacaterol maleate 110mcg / glycopyrronium 50mcg) QD vs. glycopyrronium 50mcg and QD OL tiotropium 18mcg on moderate-to-severe COPD exacerbations in 2,224 patients with severe to very severe COPD.

SPARK met its primary endpoint by demonstrating that patients treated with once-daily (QD) investigational QVA149 for 64 weeks demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations compared to patients treated with QD glycopyrronium 50mcg (P=0.038). The study also showed that the rate of moderate-to-severe exacerbations was numerically lower (P=0.096) in patients on QVA149 compared to open-label (OL) tiotropium 18mcg.

A further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium 50mcg (P=0.001) and OL tiotropium 18mcg (P=0.002).

To date, the first five studies of the IGNITE QVA149 Phase 3 clinical trials program have all met their primary endpoints of efficacy, safety, exercise endurance, and reduction of exacerbations. IGNITE is comprised of 10 studies in total with more than 7,000 patients. The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year. The studies are designed to investigate efficacy, safety and tolerability, exercise endurance, exacerbations, breathlessness and quality of life.

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of the long-acting beta2-adrenergic agonist (LABA) indacaterol maleate, and the investigational long-acting muscarinic antagonist (LAMA) glycopyrronium bromide.

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