German/Swedish Authorities Approve AirFluSal Forspiro
Sandoz ( Novartis) has received German and Swedish marketing authorisations for AirFluSal Forspiro (fluticasone+salmeterol, formerly known as VR315), an inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the German marketing authorisation by Sandoz triggers a milestone payment to the company's partner, Vectura, of EUR 1.5mn.
AirFluSal Forspiro was first approved in Denmark on December 18 2013 and Germany on January 13 2014. The product offers the combination of salmeterol (a long-acting inhaled beta2-agonist) and fluticasone (an inhaled corticosteroid) in an inhalation device.
The German authority has approved a 50-500mcg dosage form and the Swedish authority has approved 50-500mcg and 50-250mcg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The product's safety, efficacy and equivalence have been proven in a number of clinical trials.
Chris Blackwell, CEO of Vectura, stated that this approval further de-risks the company's respiratory generic portfolio in Europe and the rest of the world and, provides a significant cash milestone to Vectura. Once launched, the royalty stream from AirFluSal Forspiro will contribute to Vectura's differentiated top-line growth.
The receipt of the marketing authorisations in Sweden, Germany and Denmark follows the completion of EU decentralised procedures that also include Norway for 50-500mcg and 50-250mcg dosage forms and for the 50-500mcg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania.
Vectura initially developed VR315 and created the design of the inhaler before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal Forspiro by Aeropharm in Rudolstadt, Germany, Sandoz' global respiratory 'centre of excellence'.