QVM149 submission means early $2.5m payment for Vectura

24th May 2019

Vectura announced today that it will receive a $2.5million milestone payment under an exclusive licence agreement with Novartis AG. The payment was triggered following the acceptance of Novartis' valid Marketing Authorisation Application (MAA) by the EU Regulatory Authorities for the regulatory approval of QVM149. QVM149 is a potential new inhaled combination therapy for inadequately controlled asthma.

Vectura's Chief Executive Officer, James Ward-Lilley, said: "We are pleased to see the progression of the QVM149 program and the acceptance of the EU registration dossier ahead of its original timeline. Based on the strong Phase II study results for QVM149 presented at ATS this week, we believe this new asthma treatment has the potential to have a competitive profile and provide an important and compelling additional option for physicians and patients."

QVM149 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 (an inhaled corticosteroid) in a precise once-daily formulation delivered in a dry-powder inhaler device. Vectura and Sosei Heptares exclusively licensed glycopyrronium bromide and certain intellectual property relating to its use and formulation to Novartis in April 2005. Novartis is responsible for the development and commercialisation of QVM149.

Vectura is due to receive a further milestone payment of $5.0 million on European regulatory approval of the product and thereafter royalties on net sales from launch.