Janssen Pharmaceutical has entered into an agreement with Arrowhead Pharmaceuticals for an exclusive, worldwide license to develop and commercialize ARO-HBV, a Phase 1/2 subcutaneous, ribonucleic acid interference (RNAi) therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.
Under the agreement, Arrowhead will complete the ongoing Phase 1/2 clinical trial for ARO-HBV, a next-generation RNAi therapy candidate which is designed to silence HBV gene products by specifically targeting two regions of the HBV genome. Janssen will lead the clinical development from Phase 2b onwards. Arrowhead will receive an initial upfront payment, potential development and commercial milestone payments and potential future royalties. Separately, Johnson & Johnson Innovation – JJDC, will make an equity investment in Arrowhead.
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Janssen and Arrowhead also agreed to a research collaboration to develop RNAi therapeutics directed against additional targets using Arrowhead's proprietary Targeted RNAi Molecule (TRiM) platform. If Janssen exercises its option for such RNAi therapeutics, Arrowhead will be eligible to receive additional payments.
Hepatitis B viral infection presents a major global health concern and places a significant burden on the 257 million people living with the disease worldwide. While a prophylactic vaccine for hepatitis B exists, many people living with chronic hepatitis B remain uncured by current treatments and endure lifelong therapy.[1] RNAi therapy candidates such as ARO-HBV have been shown to have an effect on hepatitis B viral infection replication pathways and on the production of viral proteins, providing another avenue for investigation into treatments in this area.
"An important objective within Janssen is to develop highly effective combination products that cure people living with chronic hepatitis B infections," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development. "Working with the talented Arrowhead team and their RNAi therapy candidate adds to the strength of our hepatitis B portfolio and substantially increases our confidence that we can achieve our objective."
The transactions are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and expected to close in Q4 2018.