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Sosei and Vectura Announce Start of Phase II Clinical Study with NVA237 in the USA

08 Aug 2007 - Sosei Group Corporation and Vectura Group plc announced 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, multi-centre 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.