Tokyo, Japan and Chippenham, UK – 6 August 2007: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) and Vectura Group plc (“Vectura”; LSE: VEC) announce the commencement of a Phase II clinical study in the USA, by Novartis, with NVA237, a once daily long acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease (COPD). This follows the publication on the ClinicalTrials.gov website of a study being undertaken under a US IND regulatory authorisation to support the safety of NVA237 in a Novartis proprietary Single Dose Dry Powder Inhaler (SDDPI).
The trial, a randomised, double-blind, placebo-controlled, parallel group, multicentre study will assess the safety of 28 days treatment of NVA237 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. NDA submissions are expected to be filed in 2010 for both NVA237 and the combination product with indacaterol known as QVA149.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am pleased that clinical development of NVA237 has now commenced in the USA and that work in support of Phase III studies is progressing to plan.”
Dr Chris Blackwell, Chief Executive of Vectura added: “Continued good progress on NVA237 with a study under a US IND provides additional confidence that the development of both NVA237 and QVA149 by Novartis is on track.”