Novartis Initiates Phase-III Clinical Study Of NVA237

Novartis has initiated phase-III clinical study with NVA237, a once-daily, muscarinic antagonist (Lama), for the treatment of chronic obstructive pulmonary disease (COPD). NVA237 is a dry powder formulation for oral inhalation of glycopyrronium bromide, a LAMA with a rapid onset of activity.

The trial is a randomised, double-blind, placebo-controlled, parallel-group design, including an open-label tiotropium bromide arm, and will assess efficacy, safety and tolerability of NVA237 in patients with COPD.

The study would include approximately 1000 patients with moderate to severe COPD from study centres across the US, Europe and other territories. Each patient will be randomised to receive a once-daily dose of placebo, tiotropium bromide or 50µg of NVA237 for a 52-week period.

The enrollment of first patient will trigger a $7.5 million milestone payment to both Sosei and Vectura.

Shinichi Tamura, President and CEO of Sosei, said: “This represents an important milestone in the clinical development of NVA237 and we look forward also to the anticipated commencement of the Phase III study for QVA149 towards the end of this year.

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis plans to launch NVA237 as a once-daily monotherapy for COPD and also in combination with Novartis’ investigational once-daily, beta2-agonist (Laba) indacaterol (QAB149).

NDA submissions are expected to be filed by Novartis for both NVA237 and QVA149 in 2011.