Novartis presents Phase II results of the QVA149 bronchodilator for the treatment of COPD

Promising Efficacy and Tolerability for Novel Combination COPD Therapy

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) announce that Novartis have presented the results of their two Phase II studies evaluating the efficacy, safety and tolerability of QVA149 at the annual congress of the European Respiratory Society (ERS) in Vienna. QVA149 is a novel once-daily, dry powder fixed dose bronchodilator combination of the once-daily beta2-agonist QAB149 (indacaterol) and the LAMA, NVA237 (glycopyrronium bromide) for the treatment of chronic obstructive pulmonary disease (COPD).

NVA237 was licensed to Novartis by Sosei and Vectura in 2005 in a deal in which the two companies could receive up to US$375 million in milestones as well as royalties on product sales.

One of the randomised, cross-over double-blind, placebo-controlled studies compared inhaled administration of QVA149 300/50 (QAB149 300 micrograms + NVA237 50 micrograms) with two doses of QAB149 (300 micrograms, 600 micrograms) to evaluate bronchodilatory effect in terms of trough FEV1 (forced expiratory volume in one second) after 7 days of therapy. One hundred and thirty-five patients with moderate to severe COPD completed the study with an observed clinically relevant mean improvement in trough FEV1 between QVA149 and placebo on Day 7 of 226 mL. Similarly, the estimated mean treatment differences between QVA149 and QAB149 300 micrograms and 600micrograms were 123 mL and 117 mL, respectively. Similar results were observed on Day 1 of the study and both QVA149 and QAB149 were well tolerated.

The other placebo-controlled trial evaluated the safety and tolerability of 3 doses of QVA149 (600/100, 300/100 and 150/100) and QAB149 (300 micrograms) in 255 patients during 14 days of treatment. In this study, QVA149 had no significant effect on change in 24 hour mean heart rate from baseline to Day 14, there was no clinically relevant effect on QTc interval at 1, 7, or 14 Days and QVA149 was well tolerated with overall adverse event rates similar to placebo.

Mr Shinichi Tamura, President & CEO of Sosei, said: "These results support the perceived benefit of combining two potent bronchodilators in a convenient once-daily therapy with an attractive efficacy and safety profile. QVA149 has the potential to be the first such product to come to market and provide an important addition to the available options to treat COPD."