The British pharma giant will hand off its experimental itch treatment to Italian company Alfasigma as it focuses on broader liver disease pipeline
GSK PLC (LSE:GSK, NYSE:GSK), the British pharmaceutical giant, has agreed to license worldwide rights to its experimental liver disease drug linerixibat to Italian pharma company Alfasigma in a deal worth up to $690 million.
Under the terms of the agreement, GSK will receive an upfront payment of $300 million, a further $100 million upon US Food and Drug Administration (FDA) approval, $20 million on EU and UK approval, and up to $270 million in sales-based milestone payments, as well as tiered double-digit royalties on net sales.
FDA approval is expected before the deal closes, with a target approval date of 24 March 2026.
Linerixibat is an investigational oral drug designed to treat cholestatic pruritus, a chronic and often debilitating internal itch caused by a build-up of bile acids in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease.
The drug works by inhibiting the ileal bile acid transporter (IBAT), a protein that controls the reabsorption of bile acids in the gut, thereby reducing the circulation of itch-causing compounds.
Linerixibat has not yet been approved anywhere in the world, but marketing applications are currently under regulatory review in the US, EU, UK, China and Canada, based on positive results from the phase III GLISTEN trial.
The drug has been granted orphan drug designation, a regulatory status designed to encourage development of treatments for rare conditions, in the US, EU and Japan.
Alfasigma, which has products in more than 100 markets worldwide, said it had significant existing experience in developing and commercialising therapies for serious liver diseases, including PBC.
Tony Wood, chief scientific officer at GSK, said the deal would allow the company to sharpen its focus on its next wave of liver disease treatments, including potential therapies for chronic hepatitis B, metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease (ALD), conditions that he said account for two million deaths annually.
The transaction is subject to customary regulatory clearances.