Vectura Group plc's partner, Sandoz, has received Belgian marketing authorisation for AirFluSal Forspiro (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the Belgian marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.
The product was first approved (and now launched) in Denmark on December 18, 2013 with subsequent market authorisations received in 2014 in Germany, Sweden, Hungary, Romania, Bulgaria and Norway. The new product offers the proven combination of salmeterol (a long-acting inhaled ß2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device. The product has now been launched in Denmark and Germany.
Belgium has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials.
Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal Forspiro by Aeropharm GmbH in Rudolstadt, Germany, Sandoz' global respiratory Center of Excellence. The innovative and intuitive to use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.
Vectura Group plc and its subsidiaries is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway-related diseases.