Clinical development of Insulin Spray

Offentlig prosjektsammendrag

Insulife AS is a Norwegian company with an exclusive licence to commercialize Levellor, a spray-on insulin being absorbed through the skin. The license implies that Insulife is responsible for clinical documentation needed to be granted Marketing Authorization from the European Medicines Agency. Levellor is developed by HSP Pharma in the US. As Insulin is a well known molecule which have been used to treat diabetes for more than 100 years, safety and efficacy of the active ingredient is well documented. What needs to be documented, is that Levellor sprayed on the skin gives the same biological effect on blood sugar as injected insulin. Insulife will intiate a formal Scientific Advice procedure with the European Medicines Agency (EMA) to secure that the studies we perform are aligned with the view from EMA. We will source Levellor for clinical studes from HSP in the US and perform the studies in cooperation with Smerud Medical Research International and the National Hospital (Rikshospitalet). Type 2-diabetes patients will be recruited for the clinical studies. This is based on less safety concern and a higher number of patients that can benefit from Levellor. Results from the clinical studies will be published in peer-reviewed medical journals. The end goal of the project is to file a an application for marketing authorization with the European Medicines Agency. This Marketing Authorization is a pre-requisite for commercializing Levellor in Europe.