FOSTER CITY, Calif. & YONGIN, South Korea– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) and GC Pharma (KRX:006280) today announced that they have entered into an exclusive licensing agreement, pursuant to which GC Pharma has agreed to develop and commercialize maralixibat in South Korea. 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. The U.S. 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 PFIC2. Mirum has commenced a global Phase 2b maralixibat study (EMBARK) for the treatment of BA.
Under the terms of the licensing agreement, GC Pharma has obtained the exclusive right to develop and commercialize maralixibat within South Korea for ALGS, PFIC, and BA. In exchange, Mirum is entitled to receive an upfront payment of $5.0 million 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.
“GC Pharma shares a vision for creating and delivering transformative treatments,” said Chris Peetz, president and chief executive officer at Mirum. “We are excited about GC Pharma’s proven track record commercializing treatments for rare diseases and the potential to pursue an expedited approval pathway for maralixibat for Alagille syndrome in South Korea.”
“This collaboration is another significant milestone in delivering our vision for rare disorders,” said EC Huh, Ph.D., president of GC Pharma. “We look forward to leveraging our capabilities to explore the development and commercialization of maralixibat.”
