Merck and Hanmi Ink $870 Million NASH Deal

 

Merck entered into an exclusive licensing deal with Hanmi Pharmaceutical for the development, manufacture and commercialization of efinopegdutide for nonalcoholic steatohepatitis (NASH).

NASH is the most severe form of non-alcoholic fatty liver disease (NAFLD). It is related to the epidemic of obesity pre-diabetes and diabetes. It can lead to cirrhosis of the liver but is seen in people who drink little or no alcohol.

Efinopegdutide is a GLP-1/glucagon receptor dual agonist. It activates both the GLP-1 and glucagon receptors. In Phase I and II clinical trials, the drug has shown safety and efficacy for severely obese individuals with and without type 2 diabetes.

“Data from Phase II studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,” said 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 terms of the deal, Merck is paying Hanmi $10 million upfront. Hanmi will be eligible for up to $860 million in various milestone payments as well as double-digit royalties on product sales. Merck will pick up the exclusive licensed to develop, manufacture and commercialize the drug in the U.S. and around the world except in Korea, where Hanmi will hold the rights.

“This licensing agreement supports Hanmi’s goal of developing and providing innovative therapies to the patients who need them,” said Se Chang Kwon, chief executive officer and president of Hanmi. “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.”

Hanmi also has another therapeutic against NASH, HM15211, a ^LAPS-Triple Agonist (Glucagon/GIP/GLP-1). On July 22, the drug received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for NASH. The drug is a first-in-class new drug that the company believes can overcome the limitations of single-target oral treatments. It uses the company’s proprietary LAPSCOVERY technology platform.

Glucacon, one of the components of the therapy, directly decreases fatty liver and inhibits fibrosis (scarring). It also activates GLP-1, which facilitates insulin secretion and helps suppress appetite. GIP also facilitates insulin secretion and has an anti-inflammatory effect.

On June 16, the company presented data on ^LAPSTriple Agonist at the American Diabetes Association (ADA)’s meeting.

In terms of efinopegdutide, Hanmi licensed it from Johnson & Johnson in 2015 for $105 million upfront. J&J evaluated the drug in two Phase II trials in severely obsess patients with or without diabetes. The drug was associated with weight loss, but company didn’t feel the data was strong enough to continue advancing it.

Merck’s interest is based on data from the Phase II trials suggesting effectiveness for NASH. Merck already has another NASH pipeline asset, MK-3655. Merck exercised an option on the drug, an insulin sensitizer, by paying NGM Biopharmaceuticals $20 million in early 2019. Merck had indicated plans to test MK-3655 in a Phase IIb trial to evaluate its effect on liver histology and glucose control in NASH patients with or without diabetes. That trial hasn’t begun yet, although NGM has indicated Merck plans to begin it in the second half of this year.