Ultibro®/QVA149

About Ultibro®/QVA149

Once-daily 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 is licensed to Novartis, and the LABA Onbrez®, Novartis' own product. It has already been approved in the EU and Japan as a maintenance bronchodilator treatment for COPD.
In the US, QVA149 was approved in October 2015 as a twice-daily inhaled, fixed-dose combination of indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg, for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and under the brand name Utibron™ Neohaler®.

Development

Milestones and Royalty Revenue

Under the terms of the agreement with Novartis, Sosei is eligible to receive Ultibro® development milestones, as well as royalties on product sales.

Related material

Progress

About COPD (chronic obstructive pulmonary disease)

COPD is a chronic obstruction of the airways caused by emphysema or chronic bronchitis induced primarily by smoking or air pollution.
According to a WHO survey, there were 210 million COPD patients worldwide in 2009, and in 2012, COPD became the third leading cause of death.

COPD market

In 2013, the COPD market was estimated at around $13 billion. It is expected to increase still further in future, reaching $19 billion by 2019 as a result of better recognition of the disease and improved treatment options.

Notes

*Seebri® Breezhaler®/Seebri® Inhalation Capsules 50mcg, Onbrez® Breezhaler® /Onbrez® Inhalation Capsules 150mcg, Ultibro® Breezhaler®/Ultibro® Inhalation Capsules are registered trademarks of Novartis AG.