GSK, Arrowhead announce deal with Janssen for rights to JNJ-3989

GSK plc (GSK) and Arrowhead Pharmaceuticals (ARWR) announced that they have reached an agreement with Janssen Pharmaceuticals, a Johnson & Johnson (JNJ) company, to transfer exclusive worldwide rights to further develop and commercialise JNJ-3989 to GSK. JNJ-3989, formerly ARO-HBV, was initially in-licensed by Janssen from Arrowhead in 2018. JNJ-3989 is an investigational hepatitis B virus-targeted small interfering ribonucleic acid, or siRNA, therapeutic that GSK intends to evaluate in a sequential regimen with bepirovirsen, GSK’s investigational antisense oligonucleotide, for the treatment of adult non-cirrhotic patients with chronic hepatitis B on nucleos(t)ide analogue therapy. Upon closing of the transaction, GSK will assume rights and obligations of the existing license agreement between Janssen and Arrowhead, including all remaining financial obligations owed to Arrowhead for JNJ-3989 under the original agreement. GSK will be responsible for upfront and potential milestone-based payments to both Janssen and Arrowhead totalling approximately $1B. Janssen will continue to be responsible for the ongoing clinical trials of JNJ-3989 at its expense and GSK will be solely responsible for all future development and commercialization activities. Additionally, Arrowhead will receive tiered royalties on net sales pursuant to the original agreement. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the U.S. Tony Wood, Chief Scientific Officer, GSK, said: “We are excited to build on promising results already demonstrated with bepirovirsen to investigate a novel sequential regimen with JNJ-3989. We believe this approach could redefine the treatment paradigm for chronic hepatitis B by helping even more patients achieve functional cure.”