Sosei Group and Vectura have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Ultibro glycopyrronium/indacaterol inhalation capsules, which are delivered using the Breezhaler DPI, for treatment of COPD. Ultibro, also known as QVA149, was developed by Novartis, which filed the Japanese marketing application in November 2012. Inhalation capsules of the individual components are already available in Japan and elsewhere; glycopyrronium bromide is marketed as Seebri and indacaterol as Onbrez.
Vectura Chief Executive Chris Blackwell 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.”
The approval also triggers a $2.5 million milestone payment to Sosei.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of the Ultibro Breezhaler in July 2013. The companies anticipate submission of an NDA in the US by the end of 2014.
Read the Sosei press release.
