Janssen Pharmaceuticals, a unit of Johnson & Johnson, entered a deal with Arrowhead Pharmaceuticals potentially worth more than $3.7 billion to develop the latter’s ARO-HBV for patients with chronic hepatitis B virus (HBV) infection, as well as additional RNAi therapeutics. Johnson & Johnson made an upfront payment to Arrowhead of $175 million, with the company also making an equity investment in the company of $75 million at $23 per share, reflecting a 24-percent premium to Arrowhead’s closing share price on October 3.
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.
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.
ARO-HBV is being developed as a potentially curative therapy for patients with chronic HBV infection. Shares in Arrowhead surged as much as 30 percent last month after the drugmaker unveiled positive data for the therapy from the AROHBV1001 trial.
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. 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, LLC. “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.”
- World Health Organization (WHO). Hepatitis B. July 2017. Available at: http://www.who.int/mediacentre/factsheets/fs204/en/ Last accessed September 2018.
- World Health Organization (WHO). Draft global health sector strategy on viral hepatitis, 2016-2021 Sixty-ninth World Health Assembly provisional agenda item 15.1. Document A69/32. April 2016. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_32-en.pdf?ua=1 Last accessed September 2018.
- Yuen MF et. al., RNA interference therapy with ARC-520 Injection results in long term off-therapy antigen reductions in treatment naïve, HBeAg positive and negative patients with chronic HBV. Poster FRI-362 presented at EASL 2018, April 13, 2018 [LINK].