Idogen AB (“Idogen”) today announces that the European Commission formally has granted Idogen’s orphan drug designation for the treatment of patients with hemophilia A in Europe. An orphan drug designation provides several important advantages for Idogen – the product receives market exclusivity in the EU for ten years following marketing authorization and Idogen will benefit from free scientific advice and lower costs for regulatory applications for market introduction.
In December 2016 the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) reached a positive opinion regarding Idogen’s application for orphan drug status in Europe. Thus, COMP recommended that the European Commission grant Idogen an orphan drug designation. The European Commission has now formally approved Idogen’s application for orphan drug status in Europe for the treatment of patients with hemophilia A.
“That we have now received formal orphan drug status in Europe for our first product is extremely gratifying and important to us. This means that we now have free consultations with the European Medicines Agency and market exclusivity for the product ten years after approval, which is very valuable for our first product.” CEO Lars Hedbys commented.
For additional information about Idogen, please contact:
Lars Hedbys, CEO
Tel: +46 (0)46-275 63 30
This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 16th of January 2017.
Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com