Genfit in $228m deal with Terns Pharmaceuticals

Under the agreement, Terns will develop and commercialise elafibranor in Greater China, namely hina, Hong Kong, Macau and Taiwan, for the treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). Genfit will receive $35m upfront. Milestone payments could amount up to $193m. Upon commercial launch of elafibranor for the treatment of NASH in Greater China, Genfit will be entitled to receive mid-teen percentage sales royalties from Terns.

As part of the deal, Genfit and Terns will also conduct joint R&D projects in liver disease, including the development of elafibranor in combination with Terns’ liver therapeutics. Terns has extensive clinical development capabilities in China and a robust pipeline of early-stage candidates may be combined with elafibranor.  

Elafibranor is currently been tested along with a companion diagnostics test for stratification in an ongoing Phase III study to demonstrate NASH resolution and tclinical utility for patients living with NASH and PBC. Elafibranor is an orally administered agonist both of PPARalpha and PPARdelta. Based on clinical results, Genfit suggests that elafibranor has the potential to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. Phase II clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a severe liver disease. Elafibranor has FDA Breakthrough Therapy Designation in PBC.