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Sosei Group Corporation QVA149 Phase III Study Meets Primary Endpoint in Reducing Exacerbations in COPD Patients and Filings in EU and Japan by End of Year
Date:8/29/2012

ternational clinical trial programs in COPD comprising 10 studies in total with more than 7,000 patients across 42 countries[1-5,13-20]. The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year. The studies are designed to investigate efficacy, safety and tolerability, exercise endurance, exacerbations, breathlessness and quality of life[1-5,13-17].

CEO of Sosei, Shinichi Tamura commented:

"The SPARK study demonstrated a meaningful reduction in exacerbations in COPD patients; something that is of major benefit for patients and doctors and eases the burden of healthcare costs. We look forward to more detailed data from both glycopyrronium bromide (NVA237) and QVA149 at the upcoming European Respiratory Society meeting in Vienna in early September with the first filings for QVA149 expected in Europe and Japan by the end of this year."

Notes for editors

About NVA237/QVA149

NVA237 (glycopyrronium bromide - Seebri® Breezhaler®) was licensed to Novartis in April 2005 by Sosei and its co-development partner, Vectura. It is an investigational LAMA developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW1, 2 and 3 studies demonstrated that glycopyrronium bromide increased patients' lung function over a 24-hour period compared to placebo with a fast onset of action at first dose, and improved exercise endurance versus placebo[21-23].

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of NVA237 and the LABA, indacaterol maleate, for which Novartis received European regulatory approval as Onbrez® B
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