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NVA237 Phase III GLOW2 Data at American Thoracic Society (ATS) International Conference and Phase II Clinical Trial Update
Date:5/16/2012

ver a 24-hour period compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. It was submitted for regulatory approval in Europe in Q3 2011 and Japan in Q4 2011, and expected US filing is in the beginning of 2014. NVA237 was licensed to Novartis in April 2005 by Sosei and our co-development partner Vectura.

Indacaterol (Onbrez® Breezhaler®) is Novartis' once daily long acting beta2-agonist (LABA). Novartis received European regulatory approval for 150 mcg and 300 mcg once-daily doses, under the brand name Onbrez® Breezhaler® in November 2009. In July 2011, Novartis announced approval of the 75 mcg once-daily dose in the US under the brand name Arcapta™ Neohaler™, and of the 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.

QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237). The first four QVA149 Phase III studies in the treatment of COPD all met their primary endpoints. The results of the SHINE, BRIGHT, ENLIGHTEN and ILLUMINATE studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD. Filing for QVA149 in Europe is expected in Q4 2012.

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide[1]and is predicted to be the third leading cause of death by 2020[2]. Although COPD is often thought of as a disea
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