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Sosei Group Corporation QVA149 Phase III Study Meets Primary Endpoint in Reducing Exacerbations in COPD Patients and Filings in EU and Japan by End of Year
Date:8/29/2012

TOKYO, August 30, 2012 /PRNewswire/ --

  • SPARK demonstrated QVA149 statistically significantly reduced rate of moderate-to-severe exacerbations compared to glycopyrronium 50 mcg[1]
  • Study showed QVA149 statistically significantly reduced overall exacerbation rates compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg[1]
  • SPARK is the final study of the IGNITE Phase III clinical trial program intended for initial regulatory filings

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis that results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared to glycopyrronium bromide (Seebri® Breezhaler®)[1]. SPARK is the final study intended for initial regulatory filings of QVA149 in Europe and Japan, which are expected in Q4 2012. US filing of QVA149 is expected at the end of 2014. To date, the first five studies of the IGNITE QVA149 Phase III clinical trials program have all met their primary endpoints of efficacy, safety, exercise endurance, and reduction of exacerbations[1-5].

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 50 mcg (p=0.038)[1]. The study also showed that the rate of moderate-to-severe exacerbations was numerically lower (p=0.096) in patients on QVA149 com
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