Press release
Apr 19, 2011

Phase III data show NVA237 significantly improves lung function with good safety profile in COPD patients


• Data from the Novartis Pivotal GLOW1 study show once-daily NVA237 met its primary endpoint, demonstrating superior bronchodilation (trough FEV1) relative to placebo (p<0.001) at 12 weeks

• NVA237 significantly improved lung function while demonstrating a good safety profile in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)

• Detailed results to be presented at a scientific congress in H2 2011

Tokyo, Japan – 19 April 2011: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announces that NVA237, a long-acting muscarinic antagonist (LAMA) being investigated as a once daily treatment for chronic obstructive pulmonary disease (COPD), achieved its primary end point in a Phase III study. As part of its first quarter earnings release today, Novartis confirmed results from the first Phase III clinical trial with once-daily NVA237 (glycopyrronium bromide) show that it significantly improved lung function while demonstrating a good safety profile in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

The pivotal double-blind 26-week GLOW1 study met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function (p<0.001).

The incidence of adverse events was similar in the NVA237 treated patients and in those receiving placebo. Detailed data will be presented at a scientific congress in H2 2011.


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