GC said Thursday that it has signed an exclusive licensing agreement to commercialize Hunterase, a Hunter syndrome therapy, with Clinigen K.K., a Japanese-based drug company.
|GC President Huh Eun-chul (left) and Clinigen K.K. Representative Director Yoshikazu Nakamura hold up their licensing agreement at GC headquarters in Yongin, Gyeonggi Province., Wednesday|
Developed by GC, Hunterase is a human recombinant iduronate-2-sulfatase (IDS) enzyme replacement therapy for treating Hunter syndrome. The company is marketing the product in more than 10 countries.
The intracerebroventricular (ICV) injection method developed by GC delivers the drug directly to cerebral ventricles, which in turn, reaches the cells of the brain and central nervous system.
Hunter syndrome (Mucopolysaccharidosis type II) is an inherited lysosomal storage disease that occurs primarily in boys. It causes an enzyme deficiency that interferes with the body’s ability to break down certain complex sugars, resulting in serious skeletal, tissue, neurological and multi-organ complications and, ultimately, death.
The company expects Hunterase ICV will 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.
Phase 1 and 2 clinical trials, led by Professor Torayuki Okuyama at the National Center for Child Health and Development in Japan, showed a significant decrease in Heparan sulfate which causes mental retardation.
“We are proud to bring this innovative treatment to Japanese patients through the partnership with GC, said Yoshikazu Nakamura, a representative director at Clinigen K.K. “Hunter Syndrome is a complex disease with unmet medical needs. We earnestly hope that this product provides significant benefit to patients in Japan.”
GC President Huh Eun-chul also said, “We are delighted to enhance the value of Hunterase through this partnership further. The company plans to continue its efforts to make substantial differences in the lives of those with Hunter syndrome by providing new treatment environments and opportunities.”