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Intercept Pharma Accepts Alfasigma’s $800 million Buyout Offer After FDA Rejections for NASH Therapy

Following two FDA rejections for its non-alcoholic steatohepatitis (NASH) therapy, obeticholic acid (OCA), Intercept Pharma has accepted a takeover offer from Italian pharmaceutical company Alfasigma. This deal places Intercept’s valuation at approximately $800 million, reflecting its diminished worth due to OCA’s inability to secure approval for NASH. However, Intercept continues to market another formulation with the same active ingredient, known as Ocaliva, which serves as the only second-line treatment for primary biliary cholangitis (PBC), a liver disease.

Intercept expects sales of Ocaliva to reach between $320 million and $340 million this year for its use in PBC. Approval for NASH would have unlocked a significantly larger market, given that the disease affects approximately 5% of the US population, according to the American Liver Foundation.

The acquisition by Alfasigma is a strategic move to expand its presence in the US market, particularly in the field of gastroenterology, and to bolster its portfolio in liver diseases and digestive system disorders. The addition of Ocaliva will substantially contribute to Alfasigma’s turnover, which was reported to be just under €1 billion in 2020.

Alfasigma’s offer represents an 82% premium on Intercept’s closing price of $10.44, not far from its 52-week high of nearly $22. The transaction is expected to be finalized by the end of the year.

Stefano Golinelli, Alfasigma’s board chairman, stated, “Today’s proposed acquisition is aligned with our strategy to build presence in the US market, with a focus in our core gastroenterological area, while adding another important asset to our innovation pipeline.”

While Intercept has abandoned its NASH pursuits, it is still actively developing an extension of the Ocaliva line for PBC, which includes a fixed-dose combination of the drug with bezafibrate. This combination is currently in phase 2 testing and has yielded positive results.

Intercept’s CEO, Jerry Durso, noted that Alfasigma’s offer “delivers significant value to shareholders” and recognizes the value of Intercept’s portfolio, research and development efforts, commercial capabilities, and its dedicated workforce.

Intercept, which had previously been a frontrunner in NASH development, faced setbacks due to OCA’s disappointing results in clinical trials. Now, competitors such as Madrigal Pharma, with its resmetirom candidate under FDA review, as well as Gilead Sciences, Viking Therapeutics, and Terns Pharma, are vying to bring the first drug for NASH to market.

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