Approval of once-daily dual bronchodilator Ultibro® Inhalation Capsules in Japan (QVA149) for the treatment of COPD

Vectura Group plc (LSE: VEC) (“Vectura”), confirms that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Novartis’ 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 under the name of QVA149 and will be available to the 5.3 million Japanese patients who may be living with COPD[4].

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 program, one of the largest international trial programs in COPD comprising 11 studies in total with more than 10,000 patients from 52 countries[1-3],[5-14].

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.

 Dr Chris Blackwell, Chief Executive of Vectura, commented:

“The approval in Japan of QVA149, delivered through the Breezhaler® device is an important first step towards making new treatment options available globally for patients with COPD. This innovative, once-daily therapy has the potential to reduce breathlessness and exacerbations, improve lung function and help improve overall quality of life. The approval of QVA149 in Japan further de-risks Vectura’s business strategy and brings a new royalty stream from a first in class asset, as well as triggering a $2.5 million milestone to Vectura.”

About QVA149

QVA149 is an inhaled, once-daily, fixed-dose combination of glycopyrronium bromide and indacaterol maleate being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE was 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[1-3],[5-14]. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012[1-3],[5-9]. The studies were designed to investigate efficacy (lung function, exercise endurance, exacerbations, shortness of breath and quality of life), safety and tolerability of patients treated with QVA149,[1-3],[5-12].

Results from the Phase III IGNITE trials have demonstrated statistically significant improvements in bronchodilation with QVA149 versus several treatments[1-3],[5] widely used as current standards of care.

Data showed that QVA149 significantly improved lung function 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 of action within five minutes, and sustained bronchodilation during a 24 hour period which was maintained for up to 26 weeks1. In the IGNITE phase III trial program, QVA149 also showed symptomatic improvements versus placebo in COPD patients[1,5,7].

These symptomatic improvements included breathlessness, exercise tolerance, rescue medication use and health-related quality of life[1,2,5]. QVA149 also significantly improved the rate of all COPD exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg[1-3],[5-9].

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[1-3],[5]. The safety profile was characterized by typical anticholinergic and beta- adrenergic effects related to the individual components of the combination Ultibro®, Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG.