After an FDA-mandated three-month delay, Intercept Pharmaceuticals ($ICPT) is set for a meeting with agency advisers to discuss obeticholic acid, an in-development liver drug tabbed by analysts as a potential blockbuster.
Intercept will make its case before the FDA's committee on gastrointestinal drugs on April 7, arguing in favor of approving obeticholic acid in primary biliary cirrhosis, or PBC. The disease is a rare affliction that results in serious liver damage, and Intercept believes obeticholic acid, when added to standard therapy, can make a difference in PBC. In three clinical trials, Intercept's drug met its primary endpoints of improving symptoms of the disease, the company said.
The panel will issue a nonbinding recommendation at the end of the meeting, and the FDA has promised to hand down final word on obeticholic acid's PBC application by May 29.
The biggest potential for obeticholic acid, however, lies in NASH, a much more common liver disease with no approved treatments. Short for nonalcoholic steatohepatitis, NASH is a fatty liver disease estimated to affect as many as 5% of Americans and is on pace to become the leading cause of liver transplants by 2020, according to Intercept. The company is working through a Phase III trial in NASH with hopes of submitting its lead drug for approval in 2017.
If approved for NASH, obeticholic acid could eventually bring in peak sales of around $2.6 billion, according to Thomson Reuters. And that potential has made Intercept a common subject of buyout speculation. On Thursday, rumors surfaced suggesting AstraZeneca ($AZN) may be taking a look at the company--which commands a market cap of around $2.2 billion--but the idea never rose above market chatter.
Intercept remains in first place among companies working to develop drugs for NASH. Behind it, French biotech Genfit has begun enrollment in a Phase III trial for a similar treatment, while Gilead Sciences ($GILD), Enanta Pharmaceuticals ($ENTA) and a host of other companies advance NASH therapies of their own.
- read the FDA notice (PDF)