After NASH Hopes Are Dashed, Intercept Pharma Agrees to $794M Buyout

Intercept Prescribed drugs, whose NASH drug candidate went from frontrunner to also-ran, is being acquired for $794 million by an Italian firm that sees the biotech’s remaining property as a technique to broaden its portfolio and increase its U.S. presence.

Alfasigma has agreed to pay $19 money for every Intercept share, which is an 82% premium to the New York firm’s closing inventory value on Monday. Shares of Intercept rose greater than 78% after the deal was introduced Tuesday. The businesses anticipate the transaction to shut by the tip of this 12 months.

Intercept’s most important asset is obeticholic acid, an analog of a bile acid present in people. The drug binds to a receptor within the liver and intestines that performs a task in irritation, fibrosis, and metabolism. The FDA authorized obeticholic acid in 2016 as a second-line therapy for treating main biliary cholangitis. It’s marketed below the model title Ocaliva for this uncommon bile duct dysfunction. However Intercept believed the molecule’s mechanism of motion may additionally tackle NASH, a extra prevalent dysfunction that, thus far, has no FDA-approved medicine.

Medical exams of obeticholic acid in NASH yielded encouraging scientific information, and Intercept was broadly anticipated to turn out to be the primary firm to win an FDA approval for a NASH drug. However in 2020, the FDA turned down Intercept’s software in search of accelerated approval, saying it’s unclear the drug’s advantages outweigh its dangers. The regulator requested for extra scientific information from an ongoing Part 3 research. Intercept produced extra security and efficacy information, after which proceeded with a resubmission. This previous June, the FDA rejected that software, once more asking for extra Part 3 information. However Intercept opted to cease work in NASH and return its focus to uncommon liver illnesses.

Ocaliva is Intercept’s solely commercialized product. The drug accounted for $151.6 million in gross sales within the first half of this 12 months, a 15.8% improve in comparison with the identical interval in 2022. A hard and fast-dose mixture of obeticholic acid and bezafibrate is in Part 2 testing for main biliary cholangitis. The Intercept pipeline additionally contains INT-787, which is in mid-stage scientific improvement as a possible therapy for extreme alcohol-associated hepatitis. These applications will increase Alfasigma’s presence in key therapeutic areas.

“The acquisition of Intercept marks one other essential milestone in Alfasigma’s development path, notably with regard to the U.S. market by which we now have important improvement aims,” Alfasigma CEO Francesco Balestrieri stated in a ready assertion. “Intercept represents a compelling match with Alfasigma’s core enterprise areas of gastroenterology and hepatology, and we imagine that the transaction represents a transformational alternative for each firms.”

Alfasigma, based mostly in Bologna, is certainly one of Italy’s largest pharmaceutical firms. The privately held agency says its 2021 income topped €1 billion from gross sales of merchandise in gastroenterology, vascular illnesses, and metabolic issues in addition to nutraceuticals and medical meals. The corporate additionally supplies contract manufacturing companies. Alfasigma employs about 2,900 folks worldwide. The corporate maintains U.S. websites in Louisiana and New Jersey.

Intercept’s acquisition by Alfasigma represents a homecoming of types. The biotech was based mostly on the analysis of Roberto Pellicciari, a College of Perugia professor and a co-founder of the corporate. Pellicciari’s analysis on the Italian college targeted on the rational design of compounds that selectively bind to bile acid receptors. Intercept’s regulatory filings credit score Pellicciari because the inventor of obeticholic acid.

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