Press release
Oct 25, 2011

Update on US NDA timelines for NVA237 and QVA149

Tokyo, Japan – 25 October 2011: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), notes that Novartis has provided an update on NVA237 and QVA149 in its Q3 results today.

In the US, NVA237 will require additional clinical data to support submission and will consequently be delayed. The changes to the US NVA237 program will similarly impact approval timing for QVA149 in the US, where additional clinical studies will be required. The QVA149 submission remains on track for 2012 in EU and rest of world.

NVA237 (glycopyrronium bromide) has been submitted for approval in the EU under the brand name Seebri® Breezhaler®, as a once-daily maintenance treatment for chronic obstructive pulmonary disease (COPD). Results from the Phase III GLOW3 study presented at the European Respiratory Society Congress in September, showed that NVA237 50 mcg once-daily produced a 21% improvement in exercise endurance compared to placebo in moderate-to-severe COPD patients. NVA237 was well tolerated, with a similar incidence of adverse events for patients treated with NVA237 and with placebo.