GC Green Cross Signs Exclusive Domestic Contract for Pediatric Rare Epilepsy Drug 'Maralixibat'
[Asia Economy Reporter Lee Chun-hee] GC Green Cross announced on the 27th that it has signed an exclusive license agreement with the U.S. company Mirum Pharmaceuticals for the development and commercialization of the pediatric rare liver disease drug ‘Maralixibat’.
Mirum is currently conducting approval procedures and clinical trials in the U.S. and Europe for Maralixibat’s indications including Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC), and Biliary Atresia (BA). Maralixibat was designated as a ‘breakthrough therapy’ by the U.S. Food and Drug Administration (FDA) in 2019 for pruritus in ALGS patients aged one year and older, and the approval application was submitted last January. For the PFIC type 2 indication, approval procedures are underway in Europe, and global Phase 2 clinical trials are ongoing for the BA indication. Currently, there are no approved treatments worldwide for ALGS and BA indications other than liver transplantation, which has drawn significant attention.
Through this agreement, GC Green Cross has secured exclusive domestic development and commercialization rights for Maralixibat. The company expects sequential domestic approvals for the three indications, starting with ALGS next year.
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Chris Fitz, CEO of Mirum, said, “We are pleased to share the vision of providing innovative therapies with GC Green Cross,” and added, “We look forward to quickly supplying the treatment in Korea through collaboration with GC Green Cross, which already has experience in commercializing rare disease treatments.” Heo Eun-cheol, CEO of GC Green Cross, also stated, “This collaboration will be another important milestone in overcoming pediatric rare diseases,” and emphasized, “We will do our best to expedite the commercialization of the treatment to improve the quality of life for rare disease patients in Korea.”
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