Janssen Collaborates on RNA Therapy

The agreement with Arrowhead Pharmaceuticals focuses on ARO-HBV, a phase 1/2 subcutaneous, RNAi therapy candidate for the treatment of chronic hepatitis B.

Over 250 million people around the world live with chronic hepatitis B viral (HBV) infections. A preventive vaccine for hepatitis B is available, but current treatments for people that have the virus do not cure the disease and must be taken throughout their lifetimes. Recent research has raised hope that a cure may be possible. Ribonucleic acid interference (RNAi) agents have been shown to impact HBV infection replication pathways and the production of viral proteins, providing a potential new approach to treatment.

Arrow Pharmaceuticals has one such candidate –– ARO-HBV –– in early development. It is designed to silence HBV gene products by specifically targeting two regions of the HBV genome. Results to date have attracted the attention of Janssen Pharmaceuticals (the Pharmaceutical Companies of Johnson & Johnson), which recently agreed to collaborate with Arrowhead on the development and commercialization of ARO-HBV.

Financial terms were not disclosed, but Arrowhead will receive an upfront payment and has the potential to earn future royalties. In addition, Johnson & Johnson Innovation will make an equity investment in Arrowhead. As part of the deal, Arrowhead will complete its phase 1/2 clinical trial for ARO-HBV, while Janssen will spearhead its clinical development from phase 2 onward. The two companies will also participate in joint research to develop RNAi therapeutics for other disease targets using Arrowhead's proprietary Targeted RNAi Molecule (TRiM) platform. Arrowhead will receive additional payments for any candidates for which Janssen exercises its options.

The agreement is expected to be approved under the Hart–Scott–Rodino Antitrust Improvements Act and to close in the fourth quarter of 2018.


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