Merck & Co. and Hanmi Pharmaceutical, a Seoul, South Korea-based pharmaceutical company, have formed an exclusive licensing agreement, in a deal worth up to $870 million, for the development, manufacture and commercialization of efinopegdutide, Hanmi’s investigational drug for treating nonalcoholic steatohepatitis (NASH), a form of liver inflammation and damage caused by a buildup of fat in the liver.

Under the agreement, Merck will be granted an exclusive license to develop, manufacture, and commercialize efinopegdutide in the US and globally. Hanmi will receive an upfront payment of $10 million and is eligible to receive milestone payments up to $860 million associated with the development, regulatory approval, and commercialization of efinopegdutide as well as double-digit royalties on sales of the approved product. Hanmi retains an option to commercialize efinopegdutide in Korea.

Efinopegdutide is a glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, which activates both the GLP-1 and glucagon receptors. The safety and efficacy of efinopegdutide has previously been evaluated in Phase I and Phase II clinical trials, including for the treatment of severely obese individuals with and without Type 2 diabetes mellitus.

Source: Merck & Co.