Sosei Heptares Notes That a Valid Marketing Authorization Application For QVM149, a Potential New Inhaled Combination Therapy For Asthma, Has Been Filed With the European Medicines Agency

 - Sosei Heptares to receive US$2.5 million milestone payment

 - MAA filing ahead of expectations

TOKYO and LONDON, May 24, 2019 /PRNewswire/ -- Sosei Group Corporation ("the Company"; TSE: 4565) announces it has been notified today by its strategic alliance partner Novartis (SWX: NOVN) that it has submitted a valid Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for QVM149,  a potential new inhaled combination therapy for asthma. The MAA 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 (IND/GLY/MF), 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 PLC (LSE: VEC). Novartis is responsible for the development and commercialization of QVM149.

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

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, said: "The acceptance of the MAA submission for QVM149 is an important milestone in the development of this novel, once daily, inhaled combination therapy for asthma patients. More than one-third of asthma patients have uncontrolled disease despite the availability of multiple therapies. With the filing of the MAA for approval in Europe, we are greatly looking forward to see QVM149 become available to patients and improve the lives of those with uncontrolled asthma." 

¹Phase III CQVM149B2302 study (ClinicalTrials.gov Identifier: NCT02571777)

²Phase III CQVM149B2306 study (ClinicalTrials.gov Identifier: NCT03158311)

* Breezhaler is a registered trademark of Novartis AG.

About QVM149 (IND/GLY/MF)

Indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF) is currently in development. This formulation combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists]) with mometasone furoate (high- or medium-dose ICS [inhaled corticosteroid]) in a precise once-daily formulation, delivered with the dose-confirming Breezhaler inhalation device.