Sosei Group Corporation, an international biopharmaceutical company, has confirmed that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved once-daily Ultibro Inhalation capsules (glycopyrronium 50 mcg / indacaterol 110 mcg), delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD). Ultibro Inhalation Capsules were developed by Novartis under the name of QVA149 and will be available to the 5.3 million Japanese patients who may be living with COPD Four.

The approval triggers a $2.5m milestone payment to Sosei.

Dual bronchodilation with QVA149 is expected to set a new standard of care in COPD by combining the proven efficacy and safety benefits of two established Novartis COPD treatments, the LABA, Onbrez Inhalation Capsules (indacaterol), and the LAMA, Seebri Inhalation Capsules (glycopyrronium bromide). Both these components are delivered through the Breezhaler device, as is QVA149, and are widely available in many countries around the world including Japan.

The efficacy and safety of QVA149 is supported by the comprehensive IGNITE phase III clinical trial programme, one of the largest international trial programmes in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries.

From the eight IGNITE studies which completed in 2012, data showed that QVA149 significantly improved lung function versus several current standard treatments and showed significant symptomatic improvements versus placebo in breathlessness, exercise tolerance, rescue medication use and health-related quality of life. QVA149 also demonstrated statistically significant symptomatic improvements in breathlessness, rescue medication use and health-related quality of life compared to open-label (OL) tiotropium 18 mcg One. The rate of all COPD exacerbations (mild, moderate and severe) was significantly improved with QVA149 compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg.

In clinical studies, QVA149 demonstrated an acceptable safety profile with no meaningful differences between the treatment groups (placebo, indacaterol 150 mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, salmeterol/ fluticasone (SFC) 50 mcg / 500 mcg) in the incidence of adverse and serious adverse events. The safety profile was characterized by typical anticholinergic and beta-adrenergic effects related to the individual components of the combination.

In July, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for approval of QVA149. US submission is anticipated at the end of 2014.

QVA149 is an inhaled, once-daily, fixed-dose combination of glycopyrronium bromide and indacaterol maleate. QVA149 was investigated for the treatment of COPD in the phase III IGNITE clinical trial programme. IGNITE is one of the largest international clinical trial programs in COPD comprising 11 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000 patients across 52 countries. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012. The studies are designed to investigate the efficacy (lung function, exercise endurance, exacerbations, shortness of breath and quality of life), safety and tolerability, in patients treated with QVA149.

Results from the phase III IGNITE trials demonstrated statistically significant improvements in bronchodilation with QVA149 versus comparator treatments widely used as current standards of care. Data showed that QVA149 significantly improved bronchodilation compared to OL tiotropium 18 mcg, fixed dose combination SFC 50 mcg/500 mcg, indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo providing a rapid onset within five minutes, and sustained bronchodilation during a 24 hour period which was maintained for up to 26 weeks. In the IGNITE phase III trial programme, QVA149 also showed symptomatic improvements versus placebo in COPD patients. These symptomatic improvements included shortness of breath, exercise tolerance, rescue medication use and health-related quality of life. QVA149 aslo significantly improved the rate of all COPD exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg.

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.