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The companies have entered into an exclusive licensing agreement to develop, manufacture, and commercialize efinopegdutide, an investigational drug for treating nonalcoholic steatohepatitis.
On Aug. 4, 2020, Merck, known as MSD outside the United States and Canada, and Hanmi Pharmaceutical, a Korean pharmaceutical company, announced that they have entered into an exclusive licensing agreement worth up to $870 million 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 treating nonalcoholic steatohepatitis (NASH), a type of liver disease.
Under the agreement, Merck will be granted an exclusive license to develop, manufacture, and commercialize efinopegdutidein 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 the drug. Hanmi is also eligible to receive double-digit royalties on sales of approved product and retains an option to commercialize efinopegdutide in Korea.
“Data from [P]hase [II] 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, in a company press release. “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.”
“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, in the press release. “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.”
Efinopegdutide has previously been evaluated in multiple Phase I and Phase II clinical trials, including for the treatment of severely obese individuals with and without Type 2 diabetes mellitus.