Intercept Offloads Ex-US Business To Advanz, May Be Doubling Down On NASH In US

Intercept Pharmaceuticals, Inc. divested its ex-US business, including commercial and development rights to Ocaliva (obeticholic acid), on 5 May to privately held ADVANZ PHARMA Corp. for $405m up front, along with a $45m contingent payment as well as potential royalties should Advanz bring the drug to market for non-alcoholic steatohepatitis (NASH) outside the US. The move clears overhead costs and increases the cash runway for Intercept as it awaits a pair of Phase III readouts that it hopes will lead to refiling OCA with the US Food and Drug Administration for NASH fibrosis.

The payment from Advanz mainly reflects the commercial value of Ocaliva for primary biliary cholangitis, a cholestatic liver disease for which the drug obtained FDA and EU approval in 2016. (Also see "Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC" - Scrip, 16 November, 2016.) The FXR agonist brought in $363.5m worldwide in 2021, up 16% year-over-year, with US sales of $260