Research & Development
Mirum licenses its maralixibat to GC Pharma for the treatment of rare liver diseases in South Korea
27 July 2021 -

Biopharmaceutical company Mirum Pharmaceuticals Inc (Nasdaq:MIRM) on Monday announced an exclusive licensing agreement to develop and commercialise its maralixibat in South Korea to GC Pharma (KRX:006280) for the treatment of rare liver diseases.

Maralixibat is an investigational, orally administered medication being evaluated in Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA). Maralixibat targets the apical sodium dependent bile acid transporter (ASBT) ultimately resulting in lower levels of bile acids systemically, added Mirum.

The licensing agreement provides GC Pharma with the exclusive right to develop and commercialise maralixibat within South Korea for ALGS, PFIC and BA.

In conjunction with the license agreement, Mirum is entitled to receive an upfront payment of USD5.0m as well payments for the achievement of future regulatory and commercial milestones, with tiered double-digit royalties based on product net sales in the region.

In addition, the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for maralixibat for the treatment of cholestatic pruritus in patients with ALGS under priority review. The European Medicines Agency is reviewing maralixibat for the treatment of PFIC. Mirum has commenced a global Phase 2b maralixibat study (EMBARK) for the treatment of BA.

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