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In a significant development, GSK has acquired an exclusive license for JNJ-3989, a siRNA therapeutic targeting hepatitis B, in a $1 billion agreement. The deal entails the initiation of a Phase II trial with Bepirovirsen, another promising drug for hepatitis B treatment, in 2024. Following the closure of the deal, GSK will assume sole responsibility for JNJ-3989’s future development and commercialization activities.
The acquisition also transfers the obligations of the existing license agreement between Janssen Pharmaceuticals and Arrowhead Pharmaceuticals (NASDAQ:) to GSK. Both Janssen and Arrowhead are set to receive tiered royalties as per the agreement. However, Janssen will continue to manage ongoing clinical trials.
This move is part of GSK’s collaboration with Arrowhead Pharmaceuticals and Janssen Pharmaceuticals. The company aims to pair JNJ-3989 with bepirovirsen, an antisense oligonucleotide currently under phase III development. The goal is to enhance treatment for non-cirrhotic Chronic Hepatitis B (CHB) patients on Nucleos(t)ide Analogues (NA) therapy.
Approximately 300 million people suffer from CHB worldwide, with existing treatments only offering a 3-7% functional cure rate. A functional cure is achieved when the hepatitis B virus and viral proteins are undetectable in blood and can be controlled by the immune system without medication.
Bepirovirsen has shown considerable promise in achieving a functional cure in CHB patients receiving oral NAs. This is evidenced by positive results from the B-Clear and B-Sure clinical trials. The sequential regimen of JNJ-3989 and bepirovirsen could potentially redefine CHB treatment, enhancing cure rates.
Tony Wood, GSK’s Chief Scientific Officer, views this innovative approach as a potential game-changer for CHB treatment. He believes that the strategic combination of JNJ-3989 and bepirovirsen may pave the way for more effective treatments for CHB in the future.
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