Intercept Pharmaceuticals, After 2 FDA Setbacks and Restructuring Efforts, Finds a Buyer in Italy’s Alfasigma

Intercept Pharmaceuticals, After 2 FDA Setbacks and Restructuring Efforts, Finds a Buyer in Italy's Alfasigma

Intercept Pharmaceuticals has faced substantial challenges over the past three years, particularly after the FDA rejected its attempts to bring Ocaliva to nonalcoholic steatohepatitis (NASH)-related liver fibrosis patients. However, the company’s fortunes are changing as Italy’s Alfasigma steps in to acquire the struggling biopharmaceutical firm along with its sole commercial product.

Alfasigma has entered into a cash merger agreement with Intercept at a rate of $19 per share, marking an impressive 82% premium over Intercept’s closing stock price on September 25. This deal carries an overall value of approximately $800 million, as reported by Reuters. Intercept’s stock had once traded at over $100 before FDA setbacks in 2020 significantly impacted its share price, leading to restructuring efforts and workforce reductions. Despite a subsequent attempt this year, Intercept was unable to secure FDA approval for NASH-related treatments, prompting the discontinuation of all NASH-related investments.

Also Read: Inventiva And Kezar Partner With Asian Biotechs To Advance NASH And Lupus Drugs

“Today’s proposed acquisition is aligned with our strategy to build presence in the U.S. market, with a focus in our core gastroenterological area while adding another important asset to our innovation pipeline. This acquisition will contribute to the ambitious growth strategy designed for our company.”

– Mr. Stefano Golinelli, Chairman of Alfasigma Board 

With this merger, Intercept’s remaining staff will have the opportunity to join Alfasigma’s team, as stated by Alfasigma CEO Francesco Balestrieri. This strategic move aligns Intercept’s focus on liver health with Alfasigma’s core expertise in gastroenterology and hepatology. While Ocaliva did not receive FDA approval as the first NASH treatment, it did successfully enter the market in 2016 for specific patients with primary biliary cholangitis (PBC).

“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. We are excited to welcome Intercept employees and look forward to working together as we invest in the company to realize the full potential, to the benefit of patients.”

– Mr. Francesco Balestrieri, Chief Executive Officer of Alfasigma

Also Read: Madrigal’s NASH Drug Gets Fast-Track Review From FDA, No Panel Needed

In 2022, Ocaliva contributed to Intercept’s revenue of $285.7 million. The second quarter of this year saw the company achieve sales of $83.7 million, reflecting a notable 17% growth compared to the same quarter in the previous year.

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