Sosei Group Corporation announced commencement of phase-III clinical programme by Novartis, with QVA149, a once-daily, dry powder bronchodilator for inhalation combining a fixed dose of the once-daily beta2–agonist QAB149 (indacaterol) and the long-acting muscarinic antagonist NVA237 (glycopyrronium bromide) for the treatment of chronic obstructive pulmonary disease (COPD). The start of phase-III triggers a US$ 7.5 million milestone payment to Sosei.
The programme commences with two 52 week studies. The first trial, 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 USA, Europe and other territories. Secondary endpoints include time to first exacerbation together with safety and tolerability. 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 will 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. NVA237 was licensed to Novartis by Sosei and its co-development partner Vectura Group plc in a 2005 deal in which the two companies could receive up to US$ 375 million in milestones as well as royalties on product sales.
Phase-III trials on NVA237 commenced in June 2009 and Novartis has stated that it expects to file for approval in 2011. Novartis received European regulatory approval for indacaterol (Onbrez Breezhaler - indacaterol maleate) in November 2009 and launched the product in Germany in December 2009 and in Ireland and Denmark in March 2010 and have confirmed that they are on track to file the additional data requested by the Food and Drug Administration (FDA) in the second half of 2010.
Shinichi Tamura, president & CEO of Sosei, commented, "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 very 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.”
Sosei and Vectura concluded a global development and commercialisation agreement with Novartis in April 2005 for their collaborative product NVA237.
Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.