Novartis reports NVA237 Phase III trial results against COPD

SOSEI GROUP CORPORATIONJun 30 2011

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), announces that results reported today by Novartis from the pivotal Phase III GLOW2 clinical trial show that once-daily NVA237 (glycopyrronium bromide) 50 mcg significantly improved lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) relative to placebo (p<0.001), with similar efficacy to open-label tiotropium.

Further efficacy and safety results from GLOW2 will be presented at a scientific congress in 2012, and the data will be used to support an application for regulatory approval to be filed before the end of 2011.

Mr Shinichi Tamura, CEO of Sosei, said: "GLOW2 is the second NVA237 Phase III study to meet its primary end point and further endorses the benefit of NVA237 in COPD patients. We look forward to Novartis filing the product in 2011, followed by the filing of QVA149, the fixed-dose combination of NVA237 and indacaterol, expected to occur in 2012 ."

In an exploratory arm of the study, NVA237 was compared with open-label tiotropium (Spiriva(R) HandiHaler[(R) Spiriva(R) and HandiHaler(R) are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG.]) 18 mcg, another once-daily long-acting muscarinic antagonist (LAMA) indicated for the treatment of COPD. Results show that NVA237 produced similar improvements in lung function to tiotropium.

The study met its primary endpoint by demonstrating superior 24-hour bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function[1]. NVA237 was delivered using the Concept1(R) device, a single-dose dry-powder inhaler.

Key secondary endpoints were improvement in breathlessness assessed using the Transition Dyspnea Index (TDI) at 26 weeks, and improved quality of life as measured by the St George's Respiratory Questionnaire (SGRQ) at 52 weeks. Important secondary endpoints were time to first COPD exacerbation and use of rescue medication during 52 weeks of treatment. The study met all of these endpoints.

The GLOW2 study also showed that NVA237 was well-tolerated with a similar incidence of adverse events for patients treated with NVA237, placebo and open-label tiotropium.

GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety and tolerability of NVA237 in patients with COPD. Patients were randomized into three treatment arms receiving either once-daily NVA237 50 mcg, placebo, or once-daily open-label tiotropium 18 mcg. They were also permitted to use COPD background therapy and rescue medication.

In April 2011 Novartis announced results from the first Phase III clinical trial with NVA237. 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 (p<0.001). The incidence of adverse events was similar in NVA237-treated patients and in those receiving placebo. Further data from GLOW1 will be presented at the European Respiratory Society congress in Amsterdam in September 2011.