Singapore, Jun 29, 2009: Pharmaceutical companies Sosei and Vectura have announced the commencement of a phase III clinical study by Novartis, with NVA237, a once-daily, long-acting 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 study will be recruiting in the next few weeks when the first patient first visit will trigger a $7.5 million milestone payment to both Sosei and Vectura.

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis intends to launch NVA237 as a once-daily monotherapy for COPD and also in combination with Novartis' investigational once-daily, long-acting beta2-agonist (LABA) indacaterol (QAB149), which was filed for approval with the regulatory authorities as a monotherapy treatment for COPD at the end of 2008. The combination of NVA237 and indacaterol is known as QVA149. NDA submissions are expected to be filed by Novartis for both NVA237 and QVA149 in 2011.

Mr Shinichi Tamura, President, 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.”

The trial is a randomized, 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. It will include approximately 1000 patients with moderate to severe COPD from study centres across the USA, Europe and other territories.

Also, under the terms of the agreement, Sosei and Vectura to date have each received $15 million and will each receive up to $172.5 million for achieving pre-agreed clinical, regulatory and commercialization targets for both the monotherapy and combination product. These potential milestones total up to $375 million. In addition, royalties on product sales will be paid for the monotherapy and the combination product. If additional combination products are developed by Novartis, using NVA237, further milestones and royalties will be payable.