Chippenham, UK and Tokyo, Japan – July 18 2007: Vectura Group plc (“Vectura”; LSE: VEC) and Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), announce the publication by Novartis on the ClinicalTrials.gov website of a second dose ranging study of NVA237; a once daily long acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease (COPD), against an active comparator. NVA237 was licensed to Novartis by Vectura and Sosei in 2005 in a deal in which the two Companies could receive up to USD 375 million in milestones as well as royalties on product sales.
The trial, a randomised, double-blind, placebo-controlled, multiple dose, 4 period cross-over study is being undertaken to assess the efficacy and safety of 4 doses of NVA237 in patients with stable COPD, compared to an active control, tiotropium, using Novartis’ proprietary Single Dose Dry Powder Inhaler (SDDPI). The study will define, in this new device, the optimal dose range of NVA237 to be used in the Phase III clinical trials.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am delighted that development of NVA237 continues to progress on schedule and that NDA submissions are expected to be filed for both NVA237 and QVA149 in 2010.”
Dr Chris Blackwell, Chief Executive of Vectura added: "The dose-ranging study in this new device is necessary to support the Phase III clinical trials. Good progress therefore continues to be made on the development of NVA237.”