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NVA237 Phase III GLOW2 Data at American Thoracic Society (ATS) International Conference and Phase II Clinical Trial Update
Date:5/16/2012

TOKYO, May 17, 2012 /PRNewswire/ --

  • GLOW2 study showed NVA237 superior to placebo and similar to OL tiotropium in increasing lung function, improving COPD symptoms and reducing exacerbations
  • Results demonstrated that once-daily NVA237 had rapid onset of action at first dose, sustained 24-hour bronchodilation, and was well tolerated over 52 weeks
  • NVA237 submitted forEU approval under proposed brand name Seebri® Breezhaler®. CHMP decision anticipated in 2012. In Japan, NDA submitted in November 2011. US filing expected in 2014

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis that results from the pivotal Phase III GLOW2 study demonstrated that once-daily (QD) 50 mcg NVA237 (glycopyrronium bromide) was superior to placebo in improving lung function, symptom relief and quality of life, and reducing exacerbations over a one-year period. The data will be presented at the 2012 American Thoracic Society (ATS) International Conference May 18-23, 2012 in San Francisco, CA, USA.

GLOW2 met its primary endpoint by demonstrating NVA237 provided superior 24-hour bronchodilation compared to placebo at 12 weeks measured by mean trough FEV1 (97 mL; p<0.001). At this same time point, trough FEV1 for open-label (OL) tiotropium was 83 mL versus placebo (p<0.001). In addition, NVA237 showed similar efficacy to OL tiotropium (Spiriva® HandiHaler®* Spiriva® HandiHaler® is a registered trademark by Boehringer Ingelheim Pharma Gmbh & Co. KG.
/18 mcg) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). NVA237 also demonstrated rapid onset of action (within five minutes at first dose) and su
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SOURCE Sosei Group Corporation
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