Ipsen and GENFIT enter into exclusive licensing agreement for elafibranor.

The agreement gives Ipsen exclusive worldwide license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor, for people living with Primary Biliary Cholangitis (PBC). The partnership also gives Ipsen access to future clinical programs led by GENFIT and combines GENFIT’s scientific expertise and proprietary technologies in liver disease with Ipsen’s development and commercialization capabilities. To underscore the long-term commitment represented by this partnership, Ipsen will also purchase newly issued GENFIT equity representing 8% post-issuance through a €28 million investment in GENFIT, becoming one of the largest shareholders.

The ongoing, pivotal Phase III global trial, ELATIVE, is evaluating the safety and efficacy of elafibranor in 150 people living with PBC who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Global recruitment is well underway. There is significant unmet medical need for people with PBC and, following positive Phase II data, elafibranor was granted Breakthrough Therapy Designation by the FDA and Orphan Drug Designation by the FDA and European Medicines Agency (EMA).

Results from the Phase II randomized double-blind, placebo controlled trial found that after 12 weeks of dosing with elafibranor, patients with PBC unresponsive to UDCA experienced significantly reduced levels of disease-activity markers including alkaline phosphatase (ALP) and composite endpoints with bilirubin as well as other markers of disease activity when compared to placebo.