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

 
• By Joseph Haas

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.

International deal
Intercept dealt ex-US rights to Ocaliva to Advanz Pharma • Source: Alamy

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...

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