Tokyo, Japan and Chippenham, UK – 15 November 2007: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) and Vectura Group plc (“Vectura”; LSE: VEC) announce the start, by Novartis, of a Phase II safety study of QVA149 for the treatment of chronic obstructive pulmonary disease (COPD). QVA149 is a combination of NVA237, a once-daily long-acting muscarinic antagonist (LAMA) and indacaterol, a once-daily long-acting beta-2 agonist (LABA).
The randomised, double-blind, placebo-controlled, multi-centre study will determine the effect of QVA149 and indacaterol on mean 24-hour heart rate in patients with moderate to severe 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. Indacaterol was discovered by Novartis and is currently in Phase III trials for COPD. NDA submissions have been projected for 2010.
Mr Shinichi Tamura, President & CEO of Sosei, said: “I am delighted that QVA149 has now entered Phase II clinical development. This once-daily LAMA/LABA combination has the potential to be a best in class treatment.”
Dr Chris Blackwell, Chief Executive of Vectura added: “Chronic respiratory diseases like COPD are often sub-optimally treated, and patients don’t always receive effective therapies. The market for COPD therapy is predicted to double in size to $11 billion by 2011. The progress Novartis is making with both NVA237 and QVA149 is therefore of interest to many.”