Intercept Offloads Ex-US Business To Advanz, May Be Doubling Down On NASH In US
Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.
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The French biotech was firmly on the ropes last year after elafibranor joined the long list of failures for NASH but the promise it has shown in primary biliary cholangitis has persuaded Ipsen to part with a hefty upfront fee.
Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.