NVA237 was licensed to Novartis by Sosei and its co-development partner Vectura Group in a 2005 deal in which the two companies could receive up to $375m in milestones as well as royalties on product sales. The start of Phase III triggers a $7.5m milestone payment to Sosei.
The programme commences with two 52 week studies. The first trial is a randomised, double-blind, parallel-group design, will assess as its primary outcome measure the superiority of QVA149 over NVA237 alone in the rate of exacerbations in 1,998 patients with severe or very severe COPD (GOLD stages III or IV) from study centres across the US, Europe and other territories. Secondary endpoints include time to first exacerbation together with safety and tolerability.
Additionally, the second trial has a randomised, double-blind, parallel-group, placebo controlled design and will assess the long term safety and tolerability of QVA149 in 339 patients with moderate to severe COPD. FEV1 (forced expiratory volume in one second) is a secondary outcome measure.
In both trials patients are expected to be randomised to receive a once-daily dose of either the combination product or the comparator from a single dose dry powder inhaler for a 52-week period.
Phase III trials on NVA237 commenced in June 2009 and Novartis has stated that it expects to file for approval in 2011.
Shinichi Tamura, president & CEO of Sosei, said: “The data from the two Phase II QVA149 studies presented at the annual congress of the European Respiratory Society (ERS) in Vienna in September 2009 were encouraging and demonstrated the benefit of combining two potent bronchodilators in a convenient once-daily therapy with an attractive efficacy and safety profile.
“This is the first once daily LAMA/LABA combination product to enter Phase III trials and, with an anticipated filing date of 2012, could provide an important future addition to the available treatment options for COPD.”