With crucial readouts looming, Intercept reaches for a lifeline

Considering Ocaliva's tarnished history it is pretty remarkable that Intercept has managed to drum up commercial interest in the drug. Sales in its globally approved indication of primary biliary cholangitis are flatlining thanks to tightened label warnings, while Intercept is clinging to hope that regulators’ minds can be changed in Nash, after an FDA rejection two years ago. The company is also heavily indebted, so the sale of overseas rights, announced today, offers some breathing space before some important readouts. The buyer is Advanz, a private European speciality pharma group, which as part of a fairly complex deal is paying $405m for Intercept’s various foreign operations and ex-US commercialisation rights to Ocaliva. Intercept will continue to supply the drug in bulk tablet form but will only receive royalties if Ocaliva is approved in Nash. The chances of that happening should soon become clear, with Intercept due in the coming months to unveil a re-analysis of the controversial Regenerate trial, as well as topline data from Reverse, a new study in more advanced patients. Ahead of these results it is hard to tell whether this sale represents a lifeline or a last gasp. 

Crunch time for Intercept: the crucial read outs
Timing Event Details
H1 2022 Reanalysis of ph3 Regenerate trial Trial in advanced fibrotic Nash; company hopes to resubmit application this year based on new analyses
Q3 2022 Ph3 Reverse trial readout Ocaliva in compensated cirrhotic Nash, delayed from YE 2021 owing to complexities gathering data
Source: company communications.

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