Core Viewpoint - GENFIT has announced that Ipsen's Iqirvo® has received pricing and reimbursement approval in Italy for Primary Biliary Cholangitis (PBC), marking a significant milestone for the company [1][2]. Group 1: Financial Impact - The approval in Italy triggers a milestone payment of €26.5 million under the Licensing and Collaboration Agreement with Ipsen, which is due upon pricing and reimbursement in three major European markets [2]. - This payment will support the advancement of GENFIT's pipeline focused on Acute On-Chronic Liver Failure (ACLF) and other serious diseases [2]. Group 2: Company Overview - GENFIT is a biopharmaceutical company dedicated to addressing unmet medical needs in patients with rare and life-threatening liver diseases, with over two decades of research and development experience [3]. - The company has a diversified R&D portfolio, including five assets under development for ACLF and other serious diseases such as cholangiocarcinoma, urea cycle disorder, and organic acidemia [3]. - GENFIT has successfully achieved accelerated approval for Iqirvo® (elafibranor) from major regulatory agencies, including the U.S. FDA and the European Medicines Agency [3]. Group 3: Strategic Partnerships - Ipsen became one of GENFIT's largest shareholders in 2021, acquiring an 8% stake in the company, indicating a strong partnership and commitment to the collaboration [3].
GENFIT to receive a €26.5 million milestone payment following the approval of pricing and reimbursement of Ipsen’s Iqirvo® in Italy