ADVANZ PHARMA, a UK-headquartered pharmaceutical company with a strategic focus on specialty and hospital pharmaceuticals in Europe, has signed an agreement with Intercept Pharmaceuticals, to acquire the majority of Intercept’s subsidiaries and operations in Europe, Canada, and all other markets outside of the U.S.
This includes the ex-U.S. rights to commercialise Ocaliva® (obeticholic acid) for primary biliary cholangitis (PBC), a progressive autoimmune disease that damages the bile ducts in the liver. Intercept is a U.S.-based biopharmaceutical company focused on the development and commercialisation of novel therapeutics to treat progressive non-viral liver diseases.
“This acquisition is transformational for ADVANZ PHARMA,” said Steffen Wagner, CEO at ADVANZ PHARMA. “Acquiring this high-quality rare disease business outside of the U.S. grows our position as a partner of choice for specialty and hospital pharmaceuticals in Europe, and we are thrilled to welcome Intercept’s dedicated and experienced team, which will bring additional capabilities to us for the benefit of patients. Today’s announcement furthers our purpose of improving the lives of patients by providing and enhancing the critical medicines they depend on.”
Intercept’s European activities complement ADVANZ PHARMA’s footprint across key markets in Western Europe. With the majority of Intercept employees outside of the U.S. transferring to ADVANZ PHARMA, this combination will more than double ADVANZ PHARMA’s commercial and medical team with sizable additions across major EU countries, while creating an effective specialty and hospital commercialisation team in the region.
“We look forward to building on this transaction as we continue to strengthen our platform for future acquisitions and in-licensing agreements to drive growth, especially in the areas of gastroenterology and hepatology as well as more broadly in rare diseases,” said Susanna El-Armale, Chief Corporate Development Officer at ADVANZ PHARMA.
ADVANZ PHARMA will have a sizable presence in the treatment of rare diseases with Ocaliva® as an orphan drug in PBC and expects to further grow in specialty pharmaceuticals going forward. Intercept will continue to be responsible for the manufacturing and supply of obeticholic acid globally and ADVANZ PHARMA will be responsible for packaging, distribution and commercialisation of the therapy in all markets outside of the U.S.
Under the terms of the agreement, Intercept will receive an upfront consideration of $405 million as well as an additional payment of $45 million from ADVANZ PHARMA contingent upon receipt of an extension of paediatric orphan exclusivity in Europe. The agreement also includes the ex-U.S. rights to commercialise obeticholic acid in NASH, in exchange for royalty payments on any future net sales outside of the U.S. Closing of the transaction is expected to take place in two to three months, subject to customary legal and regulatory closing conditions.
The transaction is actively supported by ADVANZ PHARMA’s owner Nordic Capital, a private equity investor which acquired ADVANZ PHARMA in June 2021.