Sosei Co. Ltd and Vectura Group plc announced that their collaborative product, NVA237, a novel inhaled once daily treatment for chronic obstructive pulmonary disease (COPD), had successfully completed a phase IIb multiple dose-ranging clinical trial. NVA237 is being developed and commercialised by Novartis both as a monotherapy and in combination with their once daily bronchodilator indacaterol, under the terms of a global licence agreement signed in April 2005.
The outcome of the study supports the progression of NVA237 and Novartis are proceeding as planned with the development programme.
The trial randomised 335 subjects in 35 European sites into a multi-centre double-blind, parallel group, placebo controlled study, including an additional open label tiotropium group, to assess the efficacy, safety and tolerability of four doses of NVA237 inhaled once daily for 28 days in subjects with COPD.
VA237 demonstrated bronchodilatory efficacy, as determined by a range of pulmonary function measures. NVA237 achieved statistical significance over placebo in terms of the primary efficacy variable, trough FEV1 and was comparable to tiotropium. These data support the use of NVA237 as a once daily bronchodilator.
Preliminary data indicate that the majority of adverse events were mild and there were no marked differences in incidence or severity compared to placebo or tiotropium.
COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. COPD is currently the fourth most common cause of death and by 2020 is predicted to become the third most common cause of death and the fourth most important disability causing illness. The total financial burden of lung disease in Europe amounts to nearly €102 billion with COPD contributing almost one half of this figure. Around three-quarters of patients with advanced COPD are unable to perform normal everyday activities. The current market for COPD drug therapy is estimated to be worth around $5.5 billion per annum and is predicted to double to over $11 billion by 2011 as a result of increasing diagnosis and treatment and the growth of high value new products.
Shinichi Tamura, president & CEO of Sosei, said: "These results further validate the clinical profile of NVA237 and support the potential of the product to provide an important addition to the available therapeutic options to treat COPD, a common and costly disease with high unmet patient need."
Dr Chris Blackwell, chief executive of Vectura, added: "We are proud to have delivered pharmaceutical and clinical data to Novartis in a timely manner allowing the development of NVA237 to continue on track. This positive efficacy data, taken together with the human pharmacokinetic data published at the recent ATS congress, show great promise for NVA237."