Tokyo, Japan – 24 April 2013: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released today by Novartis on the positive outcome of the Phase III GLOW 5 and GLOW 6 studies of Seebri® Breezhaler® (glycopyrronium bromide). Novartis also reported that data from the QVA149 Phase III SPARK study have been published in Lancet Respiratory Medicine.
GLOW 5 met its primary endpoint and demonstrated the non-inferiority of Seebri® Breezhaler® 50 mcg once-daily compared to tiotropium 18 mcg once-daily as measured by trough FEV1 at 12 weeks. This Phase IIIb study was a 12-week blinded, double dummy study and included moderate-to-severe COPD patients.
The Phase IIIb study GLOW 6 met its primary endpoint and demonstrated the superiority of treating moderate-to-severe COPD patients with both Seebri® Breezhaler® 50 mcg and Onbrez® Breezhaler® (indacaterol) 150 mcg administered once-daily, versus treating patients with indacaterol 150 mcg alone as measured by trough FEV1 at week 12. The results of the study demonstrated that combining once-daily bronchodilators of two different classes resulted in a statistically significant improvement in FEV1 and a statistically significant reduction in dyspnea, or shortness of breath. The full results of GLOW 5 and GLOW 6 studies will be presented at an upcoming medical congress.
It was also confirmed that data from the 64-week Phase III SPARK study have been published in the Lancet Respiratory Medicine. The results showed that investigational once-daily dual bronchodilator QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) reduced the overall rate of exacerbations, improved lung function and health related quality of life (SGRQ) compared to once-daily glycopyrronium 50 mcg and once daily open-label tiotropium 18 mcg in patients with severe and very severe COPD.
Seebri® Breezhaler® received regulatory approval in the EU and Japan in September 2012. The product has since been launched in a number of countries including Germany, UK, Japan, Denmark, and approvals have also been granted in nine other countries including Canada and Australia. In the US, filing is expected in Q1 2014.
The EU and Japan marketing authorization application for QVA149 were filed in October and November 2012, respectively, and the US application is expected to be submitted by the end of 2014.
Notes for editors
About Seebri® Breezhaler®:
Seebri® Breezhaler® (glycopyrronium bromide) is an effective and generally well-tolerated once-daily long-acting muscarinic antagonist (LAMA) indicated as maintenance therapy for the treatment of the symptoms of adult patients with chronic obstructive pulmonary disease (COPD). Glycopyrronium bromide was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura.
Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium 50 mcg delivered rapid and significant sustained improvements in lung function (measured by mean FEV1) from the morning on Day 1 compared with placebo and sustained this for 24 hours over 52 weeks, and significantly improved shortness of breath, heath related quality of life, exacerbations and exercise endurance versus placebo and was generally safe and well tolerated.
QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the maintenance treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest international clinical trial programs in COPD comprising 10 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN) with more than 7,000 patients across 42 countries. The first eight studies have already completed in 2012. The studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life.
All Novartis inhaled COPD portfolio products are being developed for delivery via the Breezhaler® device, a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it suitable for patients with airflow limitation. The Breezhaler® device allows patients to hear, feel and see that they have taken the drug correctly1.
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 worldwide2 and is predicted to be the third leading cause of death by 20203. Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of 50 and 65, which means that half of the COPD population are likely to be impacted at the peak of their earning power and family responsibilities4.
1. Onbrez® Breezhaler® (indacaterol) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001114/hu man_med_001219.jsp&mid=WC0b01ac058001d124. Last Accessed 12 September 2012.
2. Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 12 September 2012.
3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011.
4. Fletcher MJ et al., COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.