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Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD
Date:6/30/2011

primary endpoint by demonstrating superior 24-hour bronchodilation to placeboat 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function[1]. NVA237 was delivered using the Concept1® device, a single-dose dry-powder inhaler.

Key secondary endpoints were improvement in breathlessness assessed using the Transition Dyspnea Index (TDI) at 26 weeks, and improved quality of life as measured by the St George's Respiratory Questionnaire (SGRQ) at 52 weeks. Important secondary endpoints were time to first COPD exacerbation and use of rescue medication during 52 weeks of treatment. The study met all of these endpoints.

The GLOW2 study also showed that NVA237 was well-tolerated with a similar incidence of adverse events for patients treated with NVA237, placebo and open-label tiotropium.

GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study involving 1,066 patients to assess the efficacy, safety and tolerability of NVA237 in patients with COPD. Patients were randomized into three treatment arms receiving either once-daily NVA237 50 mcg, placebo, or once-daily open-label tiotropium 18 mcg. They were also permitted to use COPD background therapy and rescue medication.

In April 2011 Novartis announced results from the first Phase III clinical trial with NVA237. The pivotal double-blind 26-week GLOW1 study met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (p<0.001). The incidence of adverse events was similar in NVA237-treated patients and in those receiving placebo. Further data from GLOW1 will be presented at the European Respiratory Society congress in Amsterdam in September 2011.

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura.  Novartis intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD.  The first launch for Q
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SOURCE Sosei Group Corporation
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