Arrowhead Pharmaceuticals (NSDQ:ARWR) has signed an exclusive license agreement with GlaxoSmithKline (NYSE:GSK) related to Arrowhead’s experimental RNA interference (RNAi) therapeutic ARO-HSD.
The drug is now the subject of a Phase 1/2 study focusing on the drug’s potential as a treatment for nonalcoholic steatohepatitis (NASH), which involves liver inflammation and can cause cirrhosis and liver failure.
ARO-HSD has “the potential to be the first investigational therapeutic to achieve robust reductions in mRNA and protein levels of hepatic HSD17B13, leading to reductions in ALT, a liver enzyme typically elevated in liver diseases such as NASH,” said Christopher Anzalone, Arrowhead’s president and CEO, in a statement.
In exchange for an exclusive license to develop and commercialize the drug throughout the world apart from in China, GSK will make an upfront payment to Arrowhead of $120 million. GSK stands to earn an additional $30 million once the Phase 2 study begins and another $100 million once the Phase 2 trial readout is completed and the first patient is dosed in a Phase 3 study. In addition, GSK will pay $190 million should the drug receive regulatory approval and up to $590 million in sales-based milestone payments. The total of those payments would be $1.03 billion. On top of that, Arrowhead could also receive additional tiered royalty payments.
Arrowhead initiated the Phase 1/2 study of ARO-HSD last year.