GSK and Alfasigma announce new agreement on linerixibat

GSK and Alfasigma S.p.A. has recently announced their new licence agreement under which Alfasigma will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational ileal bile acid transporter inhibitor being developed for cholestatic pruritus in primary biliary cholangitis.

Note that Alfasigma is a global pharmaceutical company with established capabilities in specialty care and rare diseases. The company has significant experience in developing and commercialising therapies for serious liver diseases, including PBC, and has products in more than 100 markets worldwide.

Tony Wood, Chief Scientific Officer, GSK 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. This agreement sharpens GSK’s focus to deliver our next wave of liver disease innovation, including potential treatments for chronic hepatitis B, MASH and ALD, which account for two million deaths annually and have a major impact on healthcare utilisation.”

In addition, Linerixibat has officially been granted Orphan Drug Designation in the US, EU and Japan, and priority review in China, for the treatment of cholestatic pruritus in patients with PBC. Marketing applications for linerixibat are currently under regulatory review in the US, EU, UK, China and Canada, based on positive data from the GLISTEN phase III trial.

Francesco Balestrieri, Chief Executive Officer, Alfasigma, said: “Alfasigma is committed to advancing rare and specialty care by developing and delivering innovative solutions that address some of the most complex healthcare challenges. With our deep hepatology expertise and strong global footprint, we are uniquely positioned to lead the worldwide commercialization of linerixibat. This agreement underscores our strategic focus on bringing meaningful new treatments to patients and improving outcomes for communities around the world.”

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Related Topics and Keywords

Alfasigma, GSK, linerixibat