Italian pharma company Alfasigma has agreed to acquire liver disease specialist Intercept Pharmaceuticals in a cash deal worth roughly $794 million.
Alfasigma says the transaction, which values NJ-based Intercept at $19 per share, will expand Alfasigma’s gastrointestinal and hepatology portfolio — and its presence in the U.S. market.
With the deal, Alfasigma will pick up Intercept’s lead drug, Ocaliva, the only FDA approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disease affecting the liver. The farnesoid X receptor agonist, first approved in 2016, generated revenue of $152 million in the first half of 2023.
Although the transaction price represents an 82% premium to Intercept’s September 25 closing price, trouble has been looming for the biotech. Back in June, the FDA handed the company its second CRL for its NASH treatment, obeticholic acid. Intercept had originally filed the NDA in 2019, only to have the regulator reject it the following June.
The second submission was not a charm, however, because the FDA wanted a successful completion of the long-term outcomes phase of Intercept's REGENERATE study. Intercept decided to discontinue all NASH-related investment, resulting in a workforce reduction of approximately one third of the company.
Moving forward, Alfasigma and Intercept expect that the transaction will close by the end of 2023.
