Corline Biomedical AB has received notification from the US FDA , the company’s heparin ingredient granted orphan drug status in the US for the prevention of ischemia / reperfusion injury associated with organ transplantation.
Orphan drug designation provides US regulatory and financial support during the development and seven years of market exclusivity after approval.
Based on the company’s heparin substance develops Corline product Renaparin® to improve kidney transplant, by preventing the ischemia / reperfusion injury that occurs in up to 40 percent of kidney transplants, which can lead to reduced renal function and in the worst case, re-transplantation. The company estimates that the market potential amounts to 4 billion annually to treat the approximately 35,000 kidneys transplanted in the EU and the US. The Phase 1 trial is 100 percent funded by the European Commission through the Horizon 2020 funding of around 23 million.
FDA grants orphan drug status to the company’s heparin substance for the prevention of ischemia / reperfusion injuries that can occur with all types of helorgantransplantation. Renaparin® is Corlines first product in the field of organ transplantation. The company has already received orphan drug status by the European Medicines Agency for the same indication.
Henrik Nittmar, president of Corline Biomedical, commented,
“To our substance obtained orphan drug designation by the FDA is a very important and good news. We have previously noted that the US is an important future market for Renaparin® and that we want a common development strategy for both the US and European markets. Orphan drug designation for both of these key markets provides a strong common platform to build on. We can also note that both FDA and the European counterpart EMA accepts that orphan drug designation shall apply to all types of helorgantransplantationer, which means that renal transplantation can be complemented by other products in the field of organ transplantation. “.
For questions, please contact
Henrik Nittmar, CEO
Phone: 018-71 30 90
E-mail: henrik.nittmar@corline.se
Corline Biomedical AB works with the body’s own substance heparin and has developed a portfolio of drug candidates for use in connection with organ and cell transplantation. The company is planning clinical trials in type 1 diabetes and kidney transplantation, for which Corline also has received orphan drug designation ( “Orphan Drug”). Within the framework of the wholly-owned subsidiary Corline Pharma AB evaluated in vivo administration of Corlines heparin substance.
