Study triggers $7.5m milestones for both companies
Tokyo, Japan and Chippenham, UK – 29 June 2009: 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 50µg 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 are expected to be filed by Novartis for both NVA237 and QVA149 in 2011.
Mr Shinichi Tamura, President & CEO of Sosei, commented:
“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.”
Dr Chris Blackwell, Chief Executive of Vectura, added: “The Phase II studies demonstrated that NVA237 provides sustained 24-hour bronchodilation in patients with moderate to severe COPD. As it now enters the final stage of clinical development before market, confidence in the product is at a new high as we anticipate confirmation of such benefit in a large target patient population.”