Tokyo, Japan – 22 October 2009: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), announces that the Phase III trials with NVA237, which commenced in June 2009, are proceeding to plan. Initiation of Phase III studies with QVA149 is now expected to occur during 2010. Receipt of the associated milestone payment of $7.5m is therefore expected during the financial year to 31 March 2011.
QVA149 is a novel once-daily, dry powder, fixed dose, bronchodilator combination of the once-daily beta2-agonist indacaterol and the long-acting muscarinic antagonist NVA237 (glycopyrronium bromide), in development for the treatment of chronic obstructive pulmonary disease (COPD). Novartis announced on 25 September 2009 that indacaterol was recommended for approval in European Union to treat patients with COPD following its regulatory submission in late 2008. Furthermore, Novartis received a Complete Response letter from the FDA on 16th October requesting additional information on the dosing proposed for indacaterol.
Mr Shinichi Tamura, President and CEO of Sosei said: “Progress with Phase III studies evaluating NVA237, and the rapid review and recommendation for approval of indacaterol in Europe, are both encouraging with regard to the development of QVA149. We were impressed with the positive data at the European Respiratory Society meeting, and it continues to be our belief that QVA149 has the potential to be the first once-daily LAMA/LABA combination available to patients.”