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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial