Clinigen gains rights to GC Pharma's Hunterase for Japan

The Japanese subsidiary of London-listed Clinigen Group (AIM: CLIN) today announced an exclusive licensing agreement in Japan with South Korea’s GC Pharma ((KRX: 006280; formerly known as Green Cross Corp) to commercialize Hunterase (idursulfase-beta) ICV, a human recombinant iduronate-2-sulfatase (IDS) used in enzyme replacement therapy for the treatment of Hunter syndrome.

Used as one of the methods for Hunter syndrome treatment, intravenous injection does not penetrate the blood brain barrier in clinically adequate amounts. Hunterase ICV developed by GC Pharma is delivered directly to cerebral ventricles by intracerebroventricular (ICV) administration, in order to reach the cells of the brain and central nervous system.

Hunterase ICV is expected to meet the unmet needs of severe patients in improving their quality of life, as a method that can achieve what previous intravenous injection could not. The Phase I/II clinical trial conducted as an investigator-initiated trial by Prof Torayuki Okuyama in National Center for Child Health and Development in Japan showed a significant decrease in Heparan sulfate which causes mental retardation.