NorthWest Biotherapeutics Inc (NWBO)

[bbking2003]

Can you guys say this looks familiar once you get into Germany it could happen to us hit the link and see what happens after you get exclusive rights in Germany Germany 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 in the same patient group. The product’s safety, efficacy and equivalence have been proven in multiple clinical trials1,2.
"This approval further de-risks our high value respiratory generic portfolio in Europe and the Rest of the World and, provides a significant cash milestone to Vectura." said Chris Blackwell, CEO of 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 Germany and Denmark follows the successful completion of EU decentralised procedures which also include Belgium, Bulgaria, Hungary, Luxembourg, Romania, Sweden and Norway. We will communicate as and when further market approvals are received.
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.
[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric asthma. Submitted ERS – Reference September 2013 http://www.vectura.com/media/press-releases/2014/13-jan-2014.aspx