GSK and Arrowhead Pharmaceuticals have signed an agreement for Johnson & Johnson company Janssen Pharmaceuticals’ JNJ-3989.

GSK will obtain exclusive global rights for its further development and commercialisation.

An investigational hepatitis B virus-targeted small interfering ribonucleic acid (siRNA) therapeutic, JNJ-3989 (previously ARO-HBV) was in-licensed by Janssen in 2018 from Arrowhead.

The rights and commitments under the licence will now be assumed by GSK, including the financial commitments to Arrowhead. 

GSK will pay $1bn in upfront and potential milestone-based payments to both Janssen and Arrowhead. 

Janssen will bear the expenditure of continuing clinical trials of JNJ-3989, which are underway. 

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Arrowhead is also entitled to receive tiered royalty payments on net product sales.

Following the licensing, GSK plans to assess JNJ-3989 along with its investigational antisense oligonucleotide bepirovirsen to treat non-cirrhotic patients with chronic hepatitis B who are receiving nucleos(t)ide analogue therapy.

The JNJ-3989 plus bepirovirsen therapy is anticipated to enter a Phase II sequential regimen trial in 2024.

The latest deal is part of GSK’s strategy to bolster its late-stage speciality therapeutics pipeline.

GSK chief scientific officer Tony Wood stated: “We are excited to build on promising results already demonstrated with bepirovirsen to investigate a novel sequential regimen with JNJ-3989.

“We believe this approach could redefine the treatment paradigm for chronic hepatitis B by helping even more patients achieve a functional cure.”

In October 2023, GSK entered a deal with Chongqing Zhifei Biological Products (Zhifei) to jointly promote the shingles vaccine, Shingrix, in China.

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