Ultibro®* (QVA149) (glycopyrronium bromide/indacaterol maleate; Ultibro® Breezhaler® (EU), Ultibro® Inhalation Capsules (Japan)) is an inhaled, fixed-dose combination of the LAMA, Seebri®* (NVA237) that was licensed to Novartis in 2005 and the LABA, Onbrez®*, Novartis’ own product.
Ultibro® was 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. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012. 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 Ultibro.
Ultibro® is approved as first-in-class once-daily dual bronchodilator in over 40 countries outside the US (including EU, Japan, Canada, Mexico, Australia and Switzerland) and launched in Germany, Japan, Canada etc. Ultibro® has also recently been filed for approval in China. New drug application for Ultibro® was submitted to US FDA in Q4 2014.
Under the terms of the agreement with Novarits, Sosei is eligible to receive development milestones, as well as royalties on product sales.
COPD is a chronic obstruction of the airways which in the developed world is caused primarily by smoking. Symptoms include chronic bronchitis and/or emphysema which slowly progress and eventually lead to a largely irreversible loss of lung function. Worldwide, COPD is estimated to affect a total of 210 million people and is projected to become the third leading cause of death by 2020.
COPD is a large and fast expanding market which is estimated to be worth around $11 billion (2011) and is expected to reach $14.8 billion by 2016 as a result of better recognition of the disease and improved treatment options.
* Seebri® Breezhaler®, Onbrez® Breezhaler® and Ultibro® Breezhaler® are registered trademarks of Novartis AG in areas outside Japan. Seebri® Inhalation Capsules 50mcg, Onbrez® Inhalation Capsules 150mcg and Ultibro® Inhalation Capsules are registered trademarks of Novartis AG in Japan.