Italian company Alfasigma has signed a definitive agreement for the acquisition of all issued and outstanding shares of Intercept Pharmaceuticals in a cash deal valued at $794m.

Alfasigma will pay $19 for each share of Intercept.

The purchase is part of Alfasigma’s strategy to bolster its gastrointestinal and hepatology portfolio and increase its footprint in the US market.

Alfasigma will gain access to Intercept’s Ocaliva (obeticholic acid), strengthening its pipeline.

Ocaliva is approved by the US Food and Drug Administration (FDA) as a second-line therapy for treating primary biliary cholangitis (PBC).

It is indicated for use along with ursodeoxycholic acid (UDCA) in adults with an insufficient response to UDCA.

Patients who are intolerant to UDCA can use Ocaliva as a monotherapy.

A fixed-dose combination of obeticholic acid with bezafibrate is currently being analysed by Intercept in Phase II trials for PBC treatment.

Alfasigma CEO Francesco Balestrieri stated: “The acquisition of Intercept marks another important milestone in Alfasigma’s growth path, particularly with regard to the US market in which we have significant development objectives. 

“Intercept represents a compelling fit with Alfasigma’s core business areas of gastroenterology and hepatology, and we believe that the transaction represents a transformational opportunity for both companies.” 

Alfasigma plans to fund the acquisition with both cash and corporate credit facilities.

The Intercept board has granted unanimous approval for the proposed merger, which will conclude by the end of 2023.

In June 2023, the FDA rejected Intercept’s Ocaliva to treat pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis following a negative Advisory Committee (AdCom) decision.