GSK and Alfasigma Form Global Partnership for Linerixibat Rights
The collaboration aims to advance the development of linerixibat, a promising treatment for cholestatic pruritus associated with primary biliary cholangitis.
GSK PLC has entered into a global licensing agreement with Alfasigma Spa, granting the Italian pharmaceutical company exclusive rights to develop, manufacture, and commercialize linerixibat, an investigational treatment for cholestatic pruritus in primary biliary cholangitis. This strategic partnership is designed to enhance the reach and potential of linerixibat in the global market.
As part of the agreement, GSK will receive an upfront payment of USD 300 million from Alfasigma. Additionally, GSK stands to gain USD 100 million upon receiving approval from the U.S. Food and Drug Administration (FDA) for linerixibat, which is anticipated before the targeted closing date of March 24. GSK is also eligible for further financial incentives, including USD 20 million upon approval in the EU and UK, as well as up to USD 270 million in sales-based milestones and tiered royalties on global net sales.
Linerixibat has received orphan drug designation in the United States, European Union, and Japan, and is currently undergoing regulatory review in several markets following positive results from the Phase III Glisten trial. While the drug has not yet received approval, its promising trial outcomes suggest significant potential for addressing unmet medical needs in patients suffering from this condition.
This collaboration reflects GSK's commitment to advancing innovative treatments and expanding its portfolio in the biopharmaceutical sector. The partnership with Alfasigma is expected to accelerate the development timeline for linerixibat, ultimately benefiting patients who require effective therapies for cholestatic pruritus.