Chippenham, UK – 21 May 2010: Vectura Group plc (LSE: VEC) (“Vectura”), the specialty pharmaceutical company, announces results from two Phase II studies of NVA237 (glycopyrronium bromide), a novel inhaled long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD), presented by Novartis at the American Thoracic Society (ATS) annual meeting in New Orleans. These studies provide useful corroboration of data presented previously.
One presentation showed the results of a post-hoc analysis of a 7-day Phase IIb trial reported at the annual congress of the European Respiratory Society (ERS) in Berlin in September 2008. Using trough FEV1 (forced expiratory volume in one second) as the primary end-point and including a responder analysis the data provide further evidence for the efficacy of NVA237 in patients with COPD.
A second presentation demonstrated the benefit on FEV1 of 50µg NVA237 given once-daily to 33 mild/moderate COPD patients in a double-blind, placebo-controlled crossover study over a 14-day period. The FEV1 over 24-hours increased by 163mL when compared with placebo (165mL over the first 12 hours and 161mL over the second 12 hours). Peak FEV1 increased by 208mL and trough FEV1 by 154mL. No anti-muscarinic side effects, such as dry mouth, were reported.
The data at ERS in 2008 also demonstrated NVA237 provides sustained 24-hour bronchodilation in patients with moderate-to-severe COPD and showed similar efficacy and duration of action to tiotropium. In addition, in studies lasting up to 28 days NVA237 was well tolerated with no clinically relevant cardiovascular findings.
NVA237 was licensed to Novartis by Vectura and its co-development partner Sosei Group Corporation in a 2005 deal in which the two companies could receive up to US$375 million in milestones as well as royalties on product sales.
Dr Chris Blackwell, Chief Executive of Vectura commented: “The results of the latest analyses are consistent with previous clinical studies with NVA237 and our confidence grows as each new data set is released. Novartis has committed to an extensive clinical development programme for NVA237, stating that regulatory filings are anticipated in 2011 for NVA237, and 2012 for the combination product, QVA149.”
