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Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237
Date:6/28/2009

CHIPPENHAM, England and TOKYO, June 29 /PRNewswire/ --

- Study Triggers $7.5m Milestones for Both Companies

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE: VEC) announce 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 has now appeared on clinicaltrials.gov and 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.

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. It will include approximately 1000 patients with moderate to severe COPD from study centres across the USA, Europe and other territories. Each patient will be randomised to receive a once-daily dose of placebo, tiotropium bromide or 50microg of NVA237 for a 52-week period. The primary endpoint of the study will be the change from baseline in FEV1 (forced expiratory volume in one second) over 12 weeks of treatment. A number of secondary endpoints will also be evaluated.

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
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SOURCE Sosei Group
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