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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

stained 24-hour bronchodilation over 52 weeks.

At Day 1, Week 26 and Week 52 of the GLOW2 study, NVA237 significantly improved lung function (measured by mean trough FEV1) compared to placebo (all p<0.001) and results were similar to those seen with OL tiotropium. At Day 1 and Week 12, 26 and 52, the FEV1 area under the curve (AUC) for 0-4 hr, 0-12 hr, 12-24 hr and 0-24 hr for NVA237 was superior to placebo (p<0.05) and numerically greater than OL tiotropium.

Shinichi Tamura, CEO of Sosei:

"GLOW2 data further illustrate the potential benefits of once daily NVA237 for patients with COPD. NVA237 has been submitted for approval in Europe and Japan and we look forward to a decision from EU regulators that is expected in 2012."

The study also demonstrated that NVA237 improved COPD symptoms, quality of life and reduced exacerbations compared to placebo. NVA237 significantly reduced breathlessness (measured by the transition dyspnea index or TDI, p=0.002), improved health-related quality of life (measured by the St George's Respiratory Questionnaire or SGRQ, p<0.001), reduced use of rescue medication (p=0.039), and increased the percentage of days with no daytime symptoms (p<0.05)compared to placebo over 52 weeks.

For these symptomatic and quality of life indicators, results were numerically similar to those observed with OL tiotropium over the same time period. NVA237 also significantly prolonged the time to first exacerbation and significantly reduced the rate of moderate/severe exacerbations versus placebo over 52 weeks (p=0.001); these effects were similar to OL tiotropium (p=0.001).

Throughout the GLOW2 study, NVA237 was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium. Serious adverse events were reported less frequently with NVA237 (12.6%) than with either placebo (15.4%) or OL tiotropium (15.0%).


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SOURCE Sosei Group Corporation
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