Novartis achieves primary endpoints in all three of QVA149 Phase III studies on COPD

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."