Alfasigma licenses liver drug from GSK in $590m deal
GSK has signed an eleventh-hour agreement to give Alfasigma rights to its primary biliary cholangitis (PBC) therapy linerixibat, which is under regulatory review in most major pharma markets worldwide.
Alfasigma is paying $300 million upfront for rights to linerixibat, an IBAT inhibitor filed for the treatment of cholestatic pruritus in liver disorder PBC, a chronic, progressive autoimmune liver disease that can cause relentless, debilitating itching. GSK stands to receive $100 million on US approval, $20 million on EU and UK approvals, and up to $270 million in sales performance milestone payments.
The FDA is due to deliver its verdict on linerixibat this month, and the drug has been filed for approval in the EU, UK, China, and Canada.
The deal gives GSK a near-term cash injection and will allow it to focus on its candidate therapies for more widespread liver conditions, such as chronic hepatitis B therapy bepirovirsen and efimosfermin alfa for metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease (ALD).
"We're proud of the role GSK has played discovering and developing linerixibat to advance treatment in this rare disease with high unmet need," said Tony Wood, the pharma group's chief scientific officer. "We believe Alfasigma, given their expertise in PBC, is the right partner to take this medicine forward for patients."
Italy's Alfasigma built a position in PBC when it acquired Intercept Pharma in 2023 for $800 million, giving it ownership of the latter's Ocaliva (obeticholic acid) therapy for the disease. However, that strategy suffered a setback when Ocaliva was taken off the market last year after failing a confirmatory study and a review that suggested its benefits no longer outweighed its risks.
Buying linerixibat gives the Italian company's hepatology salesforce a new liver disease therapy to concentrate on, along with older drugs like Normix/Xifaxan (rifaximin), which is used to reduce the risk of recurrence of overt hepatic encephalopathy (OHE) in adults with chronic liver disease.
"With our deep hepatology expertise and strong global footprint, we are uniquely positioned to lead the worldwide commercialisation of linerixibat," said Alfasigma's chief executive, Francesco Balestrieri.
Analysts have suggested that linerixibat has the potential to make peak sales in the region of $500 million a year, which would be a relatively modest product for GSK, but quite a big product for Alfasigma, whose sales were €1.87 billion in 2024.
Competition could also be coming soon from Mirum Pharma, whose rival oral IBAT inhibitor volixibat is in late-stage clinical testing. Analysts at Morgan Stanley have previously said that they think Mirum's drug may have an efficacy edge over linerixibat, based on phase 2b data on itch reduction.
Meanwhile, treatment options for PBC have been growing, with FDA approvals in 2024 for Ipsen/Genfit's dual PPAR alpha/delta agonist Iqirvo (elafibranor) and Gilead Sciences' Livdelzi (seladelpar).
This is the second licensing deal for Alfasigma so far this year, coming after it bought rights to Innovative Molecules' parenteral formulation of adibelivir for the treatment of HSV encephalitis, an ultra-rare and life-threatening condition, for up to €125 million.
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