August 26th, 2014

Corline receives EU orphan drug designation for CHC™ in prevention of ischemia reperfusion injury associated with kidney transplantation

The EU commission has decided to grant Swedish company Corline Systems AB’s CHC™ compound designation as orphan drug (EU/3/14/1332/ and EMA/OD/090/14). CHC™ is being developed for the prevention of ischemia/reperfusion injury (IRI) associated with kidney transplantation.

“Being granted an orphan designation offers incentives for both our development and marketing efforts which of course will be of great utility for us going forward in realizing our ambitious plans in the transplantation area. Adding to that, it also represents a quality milestone for Corline moving the company further towards first-in-man clinical trials with the CHC™ compound. We are very excited”, comments CEO Henrik Nittmar. IRI affects a large share of patients undergoing kidney transplantation and in 25-40 % of cases it leads to delayed graft function and increased risk of re-transplantation. Both conditions involve serious health risks for patients and represent significant costs to the health care system due to increased need for dialysis and prolonged hospitalization. According to WHO, each year more than 60,000 kidneys are transplanted world-wide, of which some 35,000 in the EU and US, and the number of patients on the waiting list to receive an organ exceeds 200,000. As each transplanted kidney potentially saves both lives and health care cost it is paramount to improve transplantation outcome in every possible way. There are currently no effective pharmaceutical treatment for IRI approved in the EU and US or any other major market. “Kidney transplantation is an excellent application for our unique CHC™ platform. Here we are able to combine a well-known pharmaceutical entity such as heparin and its safety profile, with the possibility to administer and present it locally, exactly where it is needed. By doing this ex vivo to the kidney rather than the patient we avoid systemic distribution and its potential negative side-effect. This is a truly unique and therapeutically very strong approach”, concludes CEO Henrik Nittmar. About Orphan Drug Designation Orphan drug designation is a status assigned to a medicine intended for use in rare diseases. The medicine must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of up to five in 10,000, and the intended medicine must aim to provide significant benefit to those affected by the condition. Orphan status provides sponsors with development and commercial incentives for designated compounds and medicines.

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