Tokyo, Japan and Chippenham, UK – 7 October 2008: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) and Vectura Group plc (“Vectura”; LSE: VEC), announce results of two Phase II studies evaluating the efficacy, safety and tolerability of NVA237 presented at the annual congress of the European Respiratory Society (ERS) in Berlin, Germany. The new data show that NVA237 (glycopyrronium bromide), a novel inhaled long-acting muscarinic antagonist (LAMA), provides sustained 24-hour bronchodilation in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
NVA237 showed similar efficacy and duration of action to tiotropium with potentially a more rapid onset of action. In addition, studies lasting up to 28 days showed that NVA237 was safe and well tolerated with no clinically relevant cardiovascular findings.
NVA237 was licensed to Novartis by Sosei and Vectura in 2005 in a deal in which the two companies could receive up to US$ 375 million in milestones as well as royalties on product sales.
COPD affects 210 million people worldwide and is projected to be the third leading cause of death by 2030. It is a progressive lung disease with symptoms including chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. While there is no cure, bronchodilators such as LAMAs make breathing easier by enlarging the patient’s airways, and are recognized in international guidelines as first-line treatment for COPD.
One of the randomized, double-blind, placebo-controlled studies compared NVA237 (12.5, 25, 50 and 100µg once-daily) with placebo and open-label tiotropium. In the study involving 83 patients, all doses of NVA237 showed rapid onset of action and sustained 24-hour bronchodilation over the seven-day treatment period.
Clinically relevant improvements (i.e. >120mL more than placebo) in forced expiratory volume in one second (FEV1), a standard measure of lung function, were observed with both the 50 and 100µg doses of NVA237. Early post-dose spirometry data suggested a more rapid onset of action than tiotropium. During the study, NVA237 was well tolerated with a good overall safety profile.
The other study evaluated the safety and tolerability of NVA237 (100 and 200µg once-daily) in 250 patients during 28 days of treatment. In this study, both doses were safe and well tolerated, with no clinically significant changes seen in vital signs or on other cardiac monitoring. NVA237 provided sustained 24-hour bronchodilation over the study period. The authors concluded that NVA237 should be further evaluated for the treatment of COPD.
The results of the latest studies are consistent with previous clinical studies with NVA237 which demonstrated a potentially faster onset of action than tiotropium (five minutes versus 20-30 minutes) and a good overall safety and tolerability profile.
Mr Shinichi Tamura, President & CEO of Sosei, said: "I am pleased that these two trials have further confirmed the clinical profile of NVA237 in terms of low side effects and fast onset of action and that the drug has been deemed worthy of further study.”
Dr Chris Blackwell, Chief Executive of Vectura commented: “On the back of these encouraging results, we now look forward to the continued progress of NVA237, and the combination therapy, QVA149.”