TOKYO, Oct. 25, 2012 /CNW/ - Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis that QVA149, (indacaterol maleate / glycopyrronium bromide) an investigational drug for chronic obstructive pulmonary disease (COPD) has been filed for marketing authorisation with the European Medicines Agency (EMA), triggering a $5 million milestone payment to Sosei.
The first five studies in the Phase III IGNITE clinical trial program for QVA149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 area under the curve (AUC) for 0-12 hours at 26 weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data from ENLIGHTEN demonstrated that QVA149 has a similar overall adverse event profile to placebo.
CEO of Sosei, Shinichi Tamura commented:
"We are delighted with the EU filing for QVA149. The IGNITE program is among the largest COPD clinical trials performed, the results from which provide strong support as to the effectiveness and safety of QVA149 and its potential to treat patients suffering from this progressive disease. Today's news follows the recent approval of Seebri® Breezhaler®in Europeand Canada, and Seebri® Inhalation Capsulesin Japan."
Notes for editors
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 with more than 7,000 patients across 42 countries-. 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, lung function, exercise endurance, exacerbations, breathlessness and quality of life. Further filings for regulatory approval are expected in Q4 2012 for Japan and at the end of 2014 for the US.
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, such as COPD patients. The Breezhaler® device allows patients to hear, feel and see that they have taken the drug correctly.
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 and is predicted to be the third leading cause of death by 2020. 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 responsibilities.
Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.
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- Onbrez® Breezhaler® (indacaterol) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001114/human_med_001219.jsp&mid=WC0b01ac058001d124. Last Accessed 12 September 2012.
- ClinicalTrials.gov. A Study to Assess the Efficacy, Safety and Tolerability of Once-daily QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (SHINE). NCT01202188. http://www.clinicaltrials.gov/ct2/show/NCT01202188?term=NCT01202188&rank=1. Last accessed 12 September 2012.
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SOURCE: Sosei Group Corporation
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