Merck and Hanmi Enter into Licensing Agreement to Develop Efinopegdutide

Merck, known as MSD outside the United States and Canada, and Hanmi Pharmaceutical announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A),Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis (NASH).

“Data from phase 2 studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,” said Dr. Sam Engel, associate vice president, Merck clinical research, diabetes and endocrinology, Merck Research Laboratories. “We continue to build on our proud legacy of developing meaningful medicines for the treatment of metabolic diseases and look forward to advancing this candidate.”

Under the agreement, Merck will be granted an exclusive license to develop, manufacture and commercializeefinopegdutidein the United States 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 approved product. Hanmi retains an option to commercialize efinopegdutide in Korea.

“This licensing agreement supports Hanmi’s goals of developing and providing innovative therapies to the patients who need them,” said Dr. Se Chang Kwon, CEO and president, Hanmi Pharmaceutical. “We believe that Merck’s strong scientific expertise in metabolic diseases makes it well positioned to advance this candidate forward and maximize its potential for patients around the world.”