Policy & Regulation
Sosei Heptares reports submission of European MAA for new asthma therapy
24 May 2019 -

Biopharmaceutical company Sosei Group Corporation (TSE:4565) reported on Thursday that its strategic alliance partner Novartis (SWX: NOVN) has filed a valid Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for the potential new inhaled combination asthma therapy QVM149.

Following the MAA filing, Sosei Heptares will now receive a USD2.5m payment from Novartis.

According to the company, QVM149 is an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF), delivered with the dose-confirming Breezhaler inhalation device.

In 2005, glycopyrronium bromide and certain intellectual property relating to its use and formulation were exclusively licensed to Novartis by Sosei Heptares and Vectura Group PLC (LSE:VEC). Novartis is responsible for the development and commercialization of QVM149.

Currently, QVM149 is being investigated in Phase III/IIIb studies (IRIDIUM1 and ARGON2), which are expected to be completed in Q3 2019.