Italian pharma Alfasigma is handing $300 million to GSK for an itching treatment the FDA could approve in a couple of weeks.
The British Big Pharma unveiled phase 3 data last year that showed the ileal bile acid transporter (IBAT) inhibitor, called linerixibat, hit its primary endpoint of reducing itching among patients with a liver disease called primary biliary cholangitis (PBC).
GSK has since taken those data to regulators in the U.S., the EU, the U.K., China and Canada as part of its approval application package and is waiting for a response on all fronts.
In return for the worldwide rights for the drug, Alfasigma is paying $300 million to GSK in upfront cash. The FDA is expected to make an approval decision March 24. If the regulator gives linerixibat the nod, Alfasigma will pay out a further $100 million, followed by $20 million if the drug also gets the green light in the EU and the U.K.
Assuming linerixibat makes it to market, GSK could receive sales-based milestones reaching up to $270 million as well as tiered double-digit royalties on net sales worldwide.
Bile flow is disrupted in people with PBC, increasing the level of bile acids in circulation. The excess bile acids cause itches that cannot be relieved by scratching. Linerixibat is designed to block the resorption of bile acids in the small intestine, decreasing levels of itch-driving bile acids in circulation.
Alfasigma’s main therapeutic focus is split between gastroenterology, vascular and rheumatology. Back in 2023, the Bologna, Italy-based company bought Intercept Pharmaceuticals and its approved PBC medicine Ocaliva.
Alfasigma CEO Francesco Balestrieri said the company’s “deep hepatology expertise and strong global footprint” meant the business was “uniquely positioned to lead the worldwide commercialization of linerixibat.”
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GSK Chief Scientific Officer Tony Wood, Ph.D., said the licensing deal “sharpens GSK’s focus to deliver our next wave of liver disease innovation.”
“Given their expertise in PBC,” Alfasigma is “the right partner to take this medicine forward for patients,” Wood added.
GSK’s hepatic pipeline already includes the likes of bepirovirsen, an Ionis Pharmaceuticals-partnered antisense oligonucleotide that recently showed its potential as a “functional cure” for hepatitis B in a pair of phase 3 studies. Meanwhile, GSK paid $1.2 billion upfront last year for Boston Pharmaceuticals’ late-stage liver disease candidate.
Mirum Pharmaceuticals has its own oral IBAT inhibitor in development for PBC. But a phase 2 study of the drug, called volixibat, isn’t expected to read out until 2027, giving Alfasigma a chance to dominate the market with the first treatment for reducing itch specifically for PBC patients.
