Licence agreement with the Italy-based pharma company to advance GSK’s ambitions in rare disease.
GSK is licencing its investigational ileal bile acid transporter (IBAT) inhibitor to the pharmaceutical company Alfasigma for up to $690 million.
The treatment is indicated for cholestatic pruritus associated with the primary biliary cholangitis. With PBC being a rare autoimmune liver disease, the deal enables GSK to “sharpen” its focus to deliver its next wave of liver disease innovation, according to GSK’s Chief Scientific Officer, Tony Wood.
He explained this includes “potential treatments for chronic hepatitis B, MASH and ALD, which account for two million deaths annually and have a major impact on healthcare utilisation.”
Under the agreement, GSK will receive $300 million upfront. The company is also eligible for $100 million upon approval in the US and $20 million contingent to EU and UK approval. A further $270 million is available upon achievement of key milestones, alongside royalty payments.
We’re proud of the role GSK has played discovering and developing linerixibat to advance treatment in this rare disease with high unmet need. We believe Alfasigma, given their expertise in PBC, is the right partner to take this medicine forward for patients"
GSK’s CSO said: “We’re proud of the role GSK has played discovering and developing linerixibat to advance treatment in this rare disease with high unmet need. We believe Alfasigma, given their expertise in PBC, is the right partner to take this medicine forward for patients.”
Linerixibat is under regulatory review for approval in the US, EU, UK, China and Canada. The IBAT inhibitor enabled rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference, according to data from the GLISTEN phase III trial.
Francesco Balestrieri, Chief Executive Officer, Alfasigma, said: “With our deep hepatology expertise and strong global footprint, we are uniquely positioned to lead the worldwide commercialisation of linerixibat. This agreement underscores our strategic focus on bringing meaningful new treatments to patients and improving outcomes for communities around the world.”
This transaction is subject to customary closing conditions.
While the current deal involves GSK granting rights to one of its oral therapy, in February the firm itself gained access to a potential best-in-class cardiopulmonary treatment, as part of a $950 million acquisition of the Canadian biopharmaceutical firm 35Pharma.
