Arrowhead Pharmaceuticals (NASDAQ:ARWR) and GlaxoSmithKline (NYSE:GSK) have secured exclusive global rights from Janssen Pharmaceuticals to develop and commercialize JNJ-3989, a hepatitis B virus-targeted siRNA therapeutic. The deal involves milestone-based payments from GSK to Janssen and Arrowhead, totaling approximately $1 billion.
JNJ-3989 will be evaluated in conjunction with bepirovirsen, GSK's antisense oligonucleotide, for the treatment of adult non-cirrhotic patients with chronic hepatitis B (CHB) on nucleos(t)ide analogues (NA) therapy. CHB is a global health concern affecting around 300 million people worldwide, with current treatments providing a functional cure rate of less than 3-7%.
Bepirovirsen, currently the only agent in phase III development, has demonstrated significant functional cure response in CHB patients receiving oral NAs, as indicated by the B-Clear and B-Sure clinical trials. These trials also highlighted bepirovirsen's potential as a backbone therapy for future CHB regimens.
GSK is planning a phase II sequential regimen trial with bepirovirsen and JNJ-3989 in 2024, which will strengthen its late-stage pipeline of specialty medicines. This move follows GSK's prior collaboration with Arrowhead in 2021, concerning the exclusive license of GSK4532990 (ARO-HSD), an investigational oligonucleotide therapeutic for liver diseases.
Under the terms of the new agreement, GSK will assume all rights and obligations of the original Janssen-Arrowhead license agreement for JNJ-3989, including all remaining financial obligations. While Janssen will continue to manage ongoing clinical trials of JNJ-3989 at its own expense, GSK will be responsible for future development and commercialization of the therapy. As per the original agreement, Arrowhead is set to receive tiered royalties on net sales.
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