The British pharmaceutical giant has agreed to transfer global development and commercialization rights for its experimental drug, linerixibat, to the Italian firm Alfasigma, sharpening its focus on high-priority innovation.
Deal structure and regulatory milestones
Under the agreement announced on March 9, Alfasigma will pay GSK $300 million upfront. The total deal value could reach $690 million, contingent on regulatory approvals and market performance. Notably, an additional $100 million is tied to U.S. FDA approval, with a targeted PDUFA decision date set for March 24, 2026.
Linerixibat is an oral targeted therapy developed for cholestatic pruritus in patients with primary biliary cholangitis (PBC). This condition involves disrupted bile flow, leading to an internal itch that standard scratching cannot relieve, affecting up to 90% of patients at some stage of the disease.
Strategic portfolio realignment
This divestment allows GSK to concentrate resources on its next wave of liver disease treatments, including candidates for chronic hepatitis B, MASH, and alcohol-related liver disease (ALD), which collectively impact millions globally.
For Alfasigma, the acquisition strengthens its PBC portfolio following its $794 million buyout of Intercept Pharmaceuticals in 2023. Despite previous regulatory setbacks with other products, Alfasigma is optimistic about linerixibat’s potential. Phase III clinical data demonstrated that the drug significantly improved itch scores and reduced sleep interference compared to a placebo over a 24-week period.