Posted by Michael Wonder on 25 May 2019
Sosei Heptares notes that a valid marketing authorisation application for QVM149, a potential new inhaled combination therapy for asthma, has been filed with the European Medicines Agency
24 May 2019 - Sosei Group Corporation announces it has been notified today by its strategic alliance partner Novartis that it has submitted a valid marketing authorisation application to the EMA for QVM149, a potential new inhaled combination therapy for asthma.
The filing, which was previously planned for Q4 2019, has triggered a US$2.5 million payment to Sosei Heptares from Novartis.
QVM149 is an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate, delivered with the dose-confirming Breezhaler inhalation device. Glycopyrronium bromide and certain intellectual property relating to its use and formulation were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura Group. Novartis is responsible for the development and commercialisation of QVM149.
QVM149 is currently being investigated in Phase III/IIIb studies (IRIDIUM and ARGON), which are expected to complete in Q3 2019.
