Worldwide, exclusive rights to NVA237 have been granted to Novartis who is responsible for the development and commercialisation of this product going forward. The product concept of using the compound as a long acting bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD) was developed by Sosei R&D Ltd. and then partnered with Vectura Group plc in a 50/50 joint development. NVA237 has been developed using Vectura's proprietary PowderHale® inhalation technology to optimise delivering of product to the lung and utilising a commercially available dry-powder inhaler device. NVA237 has kinetic selectivity for M3 receptors in the lung and is effective over 24 hours. The active ingredient in NVA237, an antimuscarinic, is currently approved and marketed for a completely different non-respiratory indication. COPD is an irreversible and chronic obstruction of the airways which in the developed world is primarily caused by smoking. It is estimated that the disease is prevalent in approximately 4% of the population in the key markets of the USA, Europe and Japan, but currently remains under diagnosed. COPD is considered to be the fourth leading cause of morbidity and mortality in the USA with an annual cost in excess of $30 billion. Two exploratory studies in patients with COPD and asthma, confirmed that NVA237 produced significant bronchodilatation and demonstrated duration of action appropriate for once daily dosing. A phase I study of NVA237 in healthy volunteers demonstrated that bioavailability of NVA237 is low and that the drug which is absorbed, is rapidly cleared. To improve the product performance, an optimized formulation was developed for subsequent studies using Vectura's proprietary PowderHale® technology. PowderHale® increases the efficiency and reproducibility of delivery of drug to the lungs. A Phase IIa study in patients with COPD demonstrated statistically significant clinical improvements in bronchodilatation over a 32 hour time period, supporting once daily administration. In addition, the treatment was well tolerated. NVA237 completed a Phase IIb multiple dose-ranging clinical trial in June 2006 which delivered positive safety and efficacy data. Novartis expects to file an NDA submission for NVA237 in 2011.