Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genimmune, a biopharmaceutical subsidiary of Innogenetics, has announced that its candidate hepatitis C monoclonal antibody has been granted orphan medicinal product designation by the European Commission.
Subscribe to our email newsletter
The product is under development for the prevention of hepatitis C virus (HCV) re-infection after liver transplantation.
As an outcome of its E1 research program, Genimmune has identified a series of HCV monoclonal antibodies that show potent neutralizing properties by blocking the infection of liver cells in vitro. Orphan medicinal products benefit from various advantages, including a 10-year market exclusivity period following marketing authorization in the European Community.
Guy Buyens, CEO of Genimmune, said: “The orphan medicinal product designation for our neutralizing human monoclonal antibody is an important milestone for Genimmune. It is a clear confirmation that this product offers an innovative solution to meet an urgent medical need. Furthermore, it fully valorizes our previous investment in the HCV E1 program. The decision by the European Medicines Agency (EMEA) provides Genimmune with either an exciting opportunity for streamlined development of this product by ourselves, or as a means to work on this program with an interested partner. In either case, this antibody now becomes an important asset of our expanding pipeline of innovative products that will make us a key player in the field of immune therapeutics.”