QVA149 is an inhaled fixed dose combination product for the treatment of COPD, an irreversible and chronic obstruction of the airways. The product combines NVA237, the long acting anti-muscarinic antagonist (LAMA) licensed to Novartis by Sosei in 2005, together with Novartis' long acting beta agonist (LABA), indacaterol, which is about to enter Phase III. Both NVA237 and indacaterol are once-daily bronchodilators but act on different receptors in the lung thereby offering the potential in combination to provide additional patient benefit. COPD is primarily caused in the developed world 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. Under the terms of the Licence Agreement, Novartis is responsible for the global development and commercialisation of both NVA237 and QVA149. A Phase II safety study commenced in November 2007. Novartis expects to file an NDA submission for QVA149 in 2011.