Intercept Sells Rights to Ocaliva for PBC Outside the United States to Advanz Pharma for $450 Million

Intercept Pharmaceuticals said it closed a deal to sell its international business to French specialty pharmaceutical Advanz Pharma, including all commercialization rights outside the United States to Ocaliva for the treatment of primary biliary cholangitis, a rare autoimmune disease targeting the liver.

Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist, approved under accelerated approval in the Unites States for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.

PBC is caused by the dysregulated immune response towards proteins of liver bile duct cells that leads to immune-mediated destruction of bile ducts. As a result, bile acids build up progressively in the liver leading to irreversible damage and scarring of the liver tissue ultimately requiring liver transplant. Currently there is no cure for PBC. Medical care is focused only on the management of symptoms and does not address the underlying dysregulated immune system responsible for disease progression or recovery of the damaged tissue.

Intercept received $405 million at closing, subject to working capital, closing costs, France reimbursement liability, and other adjustments. An additional $45 million from Advanz is contingent upon receipt of extensions of orphan drug exclusivity from the EMA and MHRA. Intercept will also receive royalties on future ex-U.S. net sales of obeticholic acid for nonalcoholic steatohepatitis (NASH).

Author: Rare Daily Staff