Novartis NVA23 Phase III trial in COPD achieves primary end point

Sosei Group CorporationApr 19 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.

Mr Shinichi Tamura, CEO of Sosei, said:

"We are very encouraged that results from the initial pivotal GLOW1 trial, showing significantly increased lung function with a positive safety profile, have provided further confirmation of the clinical potential of NVA237 as a novel once-daily LAMA therapy for COPD patients."

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD. The first launch for QVA149; the combination of NVA237 with Novartis' once-daily, long-acting beta2-agonist (LABA), indacaterol, is planned for 2013. Indacaterol is now approved in more than 50 countries and available in more than 20, with US approval dependent on an FDA decision expected in July 2011.