Press release
Apr 2, 2012

QVA149 phase III COPD studies met primary endpoints

Tokyo, Japan – 2 April 2012: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), confirms the information released today by Novartis that the first three QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are part of the IGNITE program demonstrate the potential of QVA149 in the treatment of COPD.

The results of SHINE, with an enrollment of more than 2,100 patients, met the primary endpoint by demonstrating the superiority in trough FEV1 (p<0.001) of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD. In addition, QVA149 showed superiority in trough FEV1 (p<0.001) compared to placebo and open-label tiotropium (18 mcg).

The results of BRIGHT demonstrated that patients experienced significantly better exercise endurance versus placebo (p=0.006). ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo.

Mr. Shinichi Tamura, CEO of Sosei, commented: “Achieving the primary endpoints in all three of the Phase III studies, gives us confidence that QVA149 could be the first LAMA/LABA combination product to provide benefit to patients with COPD in a multi-billion dollar market that is still growing.”

QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237). Data from the IGNITE clinical trial program will be submitted for presentation to a major medical congress later this year.

IGNITE is one of the largest international patient registration programs in COPD comprising 10 studies in total. The first seven studies (ENLIGHTEN, BRIGHT, SHINE, ILLUMINATE, SPARK, BLAZE, ARISE) are expected to complete in 2012 and include more than 5,700 patients across 42 countries and support planned filings in the EU and Japan. Included in a program is a head-to-head trial vs Seretide®1 (ILLUMINATE), which is also expected to complete during the second quarter of 2012 and will be incorporated into the regulatory filings. These studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, dyspnea and quality of life.

SHINE is a 26-week, multicenter, randomized, double-blind, parallel-group, placebo and active controlled pivotal trial of 2,144 patients with moderate to severe COPD to assess efficacy in terms of trough FEV1.

BRIGHT is a three-week, randomized, blinded, double-dummy, multi-center, placebo controlled, three-period crossover pivotal trial of 85 patients with moderate or severe COPD to assess the effect on exercise tolerance of QVA149. 

ENLIGHTEN is a 52-week, multicenter, randomized, double-blind, parallel-group, placebo controlled pivotal trial of 339 patients with moderate or severe COPD to assess the safety and tolerability of QVA149.