GSK intends to evaluate JNJ-3989 in a sequential regimen with bepirovirsen, its investigational antisense oligonucleotide designed to identify and destroy the genetic components of the hepatitis B virus, to treat chronic hepatitis B (CHB) in non-cirrhotic adults
GSK House, London, UK. (Credit: GSK plc.)
British pharmaceutical company GSK has agreed to pay $1bn to obtain exclusive global rights to further develop and commercialise Janssen Pharmaceuticals’ hepatitis B therapy JNJ-3989.
California-based biopharmaceutical firm Arrowhead Pharmaceuticals initially developed JNJ-3989 and licenced it to Janssen, a subsidiary of Johnson & Johnson (J&J), in 2018.
JNJ-3989, previously known as ARO-HBV, is an investigational small interfering ribonucleic acid (siRNA) antiviral therapeutic for subcutaneous injection that targets the hepatitis B virus.
GSK, Arrowhead, and Janssen have signed an agreement pursuant to which GSK will assume the rights and obligations of the existing license deal between Janssen and Arrowhead.
Under the terms of the agreement, the British drugmaker will pay a total of around $1bn in upfront and potential milestone-based payments to both Janssen and Arrowhead.
Janssen will continue to fund the ongoing clinical trials of JNJ-3989, and GSK will fund all future development and commercialisation activities.
In addition, Arrowhead is eligible to receive tiered royalties on net sales of the drug, according to its original agreement with Janssen.
The transaction is subject to customary conditions, including regulatory approval under the Hart-Scott-Rodino Act in the US.
GSK chief scientific officer Tony Wood said: “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.”
Arrowhead president and CEO Chris Anzalone said: “GSK has a global reach, a clear commitment to help those living with chronic hepatitis B, and a promising strategy for clinical studies designed to improve functional cure rates.
“We have great confidence in the team at GSK and look forward to seeing this program progress towards the goal of potentially helping the millions of patients with chronic hepatitis B worldwide without adequate treatment options.”
GSK intends to study JNJ-3989 in a sequential regimen with bepirovirsen, its experimental antisense oligonucleotide drug bepirovirsen to treat chronic hepatitis B (CHB) in adults.
US-based biotechnology company Ionis Pharmaceuticals originally discovered bepirovirsen, which was licenced by GSK in August 2019.
Bepirovirsen is a triple-action investigational antisense oligonucleotide, currently being evaluated in the Phase 3 B-Well clinical trial programme for the treatment of CHB.
The drug is designed to identify and destroy the genetic components of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control.
Bepirovirsen inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulates the immune system.
GSK said that JNJ-3989 has the potential to move immediately into a Phase 2 sequential regimen trial with bepirovirsen, starting in 2024.