Failing to gain a potentially lucrative FDA approval to treat nonalcoholic steatohepatitis (NASH) was a blow to Intercept Pharmaceuticals.
The new Jersey-based company still is working to get Ocaliva blessed in the indication, but in the meantime, it's embarking on a transformation.
On Thursday, the company revealed it has licensed the rights to Ocaliva outside of the United States to Advanz Pharma of the U.K., for $405 million. Advanz will pay Intercept an additional $45 million if it can obtain an extension of pediatric orphan exclusivity for the drug in Europe.
Intercept said “a majority” of its employees based outside the U.S. will transfer to Advanz Pharma, while its remaining international employees "will continue to work for Intercept."
The company will also maintain its office in the U.K. to "manage its global supply chain, supply its quality organization and support its global clinical trials."
Intercept, a company focused on non-viral liver diseases, had high hopes for Ocaliva, which reached the market in 2016 for primary biliary cholangitis (PBC). A market-first endorsement in the NASH arena would have been a game changer for the 20-yer-old company, which reported $363.5 million in revenue in 2021, all of it from Ocaliva.
But in June of 2020, the FDA rejected Intercept’s bid for accelerated approval in NASH patients with liver fibrosis, forcing the company to reassess.
Intercept’s efforts to advance Ocaliva in NASH are ongoing, with results from two extensive phase 3 studies due in the third quarter of this year and a pre-submission meeting with the FDA expected in the next few months.
Advanz revealed that Intercept will continue to manufacture Ocaliva for use outside the U.S. and that Advanz will take over the responsibilities for its packaging, distribution and commercialization.
Intercept's shares were up about 19% after the news midday Thursday.