Tokyo, Japan – 25 October 2012: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released today by Novartis that QVA149, (indacaterol maleate/glycopyrronium bromide) an investigational drug for chronic obstructive pulmonary disease (COPD) has been filed for marketing authorisation with the European Medicines Agency (EMA), triggering a $5 million milestone payment to Sosei.
The first five studies in the Phase III IGNITE clinical trial program for QVA149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 area under the curve (AUC) for 0-12 hours at 26 weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data from ENLIGHTEN demonstrated that QVA149 has a similar overall adverse event profile to placebo.
CEO of Sosei, Shinichi Tamura commented:
“We are delighted with the EU filing for QVA149.
The IGNITE program is among the largest COPD clinical trials performed, the results from which provide strong support as to the effectiveness and safety of QVA149 and its potential to treat patients suffering from this progressive disease. Today’s news follows the recent approval of Seebri® Breezhaler® in Europe and Canada, and Seebri® Inhalation Capsules in Japan.”