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NVA237 Filed in Europe and Positive Phase III Data at European Respiratory Society Congress
Date:9/26/2011

TOKYO, September 27, 2011 /PRNewswire/ --

NVA237 has been filed for marketing authorisation by Novartis with the European Medicines Agency (EMA) under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei

Studies show investigational once-daily NVA237 provides superior 24-hour bronchodilation and increases exercise endurance relative to placebo

Additional data show NVA237 significantly prolonged time to first moderate/ severe COPD exacerbation and reduced associated hospitalizations compared to placebo

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), today announces that NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA) being investigated as a once-daily treatment for chronic obstructive pulmonary disease (COPD), has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei.

In addition, Novartis has presented new NVA237 Phase III data at the European Respiratory Society (ERS) congress.  The GLOW1 and GLOW3 studies in chronic obstructive pulmonary disease (COPD) patients show that NVA237 (glycopyrronium bromide) significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance.  NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class.

The GLOW1 study met its primary endpoint by showing that NVA237 50 mcg once-daily produced a significant improvement in lung function of 108 mL in trough FEV1 (forced expiratory volume of breath in one second) after 12 weeks in patients with moderate-to-severe COPD compared to placebo (p<0.001). Moreover, NVA237 had a rapid onset of action, with a 93 mL improvement in FEV1 compared to placebo at five minutes post-dose fo
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SOURCE Sosei Group Corporation
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