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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.

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