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NVA237 Phase II Results Presented at the European Respiratory Society Annual Meeting Show Promising Efficacy and Tolerability With Potentially Faster Onset Than Tiotropium
Date:10/6/2008

TOKYO and CHIPPENHAM, England, October 7 /PRNewswire-FirstCall/ -- 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 100microg 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 seco
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SOURCE Sosei Group Corporation
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