Johnson & Johnson Offloads Rights For Hepatitis B Candidate To GSK

GSK plc GSK and Arrowhead Pharmaceuticals Inc ARWR have reached an agreement with Janssen Pharmaceuticals Inc, a Johnson & Johnson company JNJ, to transfer exclusive worldwide rights to further develop and commercialize 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 (siRNA) therapeutic that GSK intends to evaluate in a sequential regimen with bepirovirsen, GSK’s investigational antisense oligonucleotide, for non-cirrhotic patients with chronic hepatitis B (CHB) on nucleos(t)ide analog (NA) therapy.

There is a high unmet need in CHB, with an estimated 300 million people living with the disease and a less than 3-7% functional cure rate with current treatment options.

JNJ-3989 has the potential to move immediately into a phase 2 sequential regimen trial with bepirovirsen beginning in 2024, further strengthening GSK’s late-stage pipeline of specialty medicines. 

This transaction builds on GSK’s relationship with Arrowhead, following the exclusive license of GSK4532990 (ARO-HSD), an investigational oligonucleotide therapeutic targeting HSD17B13 as a potential treatment for alcohol-related and nonalcohol-related liver diseases. 

GSK will assume the 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 Janssen and Arrowhead, totaling approximately $1 billion. 

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 under the original agreement.

Price Action: ARWR shares are down 0.17% at $23.18, and GSK stock is up 0.17% at $35.33 on the last check Tuesday.