Sosei Provides Update On NVA237, QVA149 Studies

Sosei Group (Sosei) has provided updates on NVA237 and QVA149 trials. The company is planning to proceed the phase III trials with NVA237, which commenced in June 2009. The company is expecting the initiation of phase III studies with QVA149 in 2010. Receipt of the associated milestone payment of $7.5m is therefore expected during the financial year to 31 March 2011.

Reportedly, 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 has announced on 25 September 2009 that indacaterol was recommended for approval in EU to treat patients with COPD following its regulatory submission in late 2008. Furthermore, Novartis has received a Complete Response letter from the FDA on 16th October requesting additional information on the dosing proposed for indacaterol.

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.”