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The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.
On Oct. 4, 2018, J&J’s Janssen Pharmaceuticals and Arrowhead Pharmaceuticals, a Pasadena, CA-based biopharmaceutical company focused on gene therapies, announced an exclusive, worldwide license agreement to develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference (RNAi) therapy candidate being investigated for the treatment of chronic hepatitis B viral (HBV) infection, in a deal worth up to $3.7 billion.
Under the agreement, Arrowhead will complete the ongoing Phase I/II clinical trial for ARO- HBV, a next-generation RNAi therapy candidate designed to silence HBV gene products by specifically targeting two regions of the HBV genome. Janssen will lead the clinical development from Phase II-b onwards. Upon closing, Arrowhead will receive $250 million, consisting of $175 million upfront payment from Janssen and $75 million equity investment from Johnson & Johnson Innovation. Arrowhead is eligible to receive additional $3.5 billion in potential milestone payments, and potential further royalties on commercial sales.
Arrowhead states that ARO-HBV silences all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act; the company believes this will allow the body’s natural immune defenses to clear the virus and lead to a functional cure.
Janssen and Arrowhead also agreed to a research collaboration to develop RNAi therapeutics directed against additional targets using Arrowhead’s proprietary targeted RNAi Molecule (TRiMTM) platform. If Janssen exercises its option for such RNAi therapeutics, Arrowhead will be eligible to receive additional payments, the companies report.
The transactions are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and expected to close in the fourth quarter of 2018.
“An important objective within Janssen is to develop highly effective combination products that cure people living with chronic hepatitis B infections,” said Mathai Mammen, MD, PhD, global head, Janssen Research & Development, in a company press release. “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.”