A Korean drugmaker may receive more than $800 million from U.S. drugmaker Merck under a licensing agreement for a drug developed for nonalcoholic steatohepatitis.
Kenilworth, New Jersey-based Merck said Tuesday that it had entered a licensing agreement with Seoul-based Hanmi Pharmaceutical for the development, manufacturing and commercialization of efinopegdutide, a GLP-1/glucagon receptor dual agonist being developed for NASH.
Under the terms of the deal, Hanmi is receiving $10 million upfront from Merck and will have the opportunity to receive up to $860 million in development, regulatory and commercialization milestones, along with royalties. Hanmi will retain the option to commercialize the drug in Korea.
Shares of Hanmi were up more than 10% on the Korea Exchange when the market closed Tuesday, at 54,600 won ($45.69) per share.
“Data from Phase II studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,” Merck Research Laboratories associate vice president for clinical research, diabetes and endocrinology Sam Engel said in a statement. “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.”
NASH is a severe form of fatty liver disease particularly associated with Type 2 diabetes, pre-diabetes and obesity that is rapidly growing worldwide, representing a market opportunity worth tens of billions of dollars. However, there are currently no approved drugs for the disease, and several companies that have tried to develop them have encountered failure. Most recently, French drugmaker Genfit discontinued the development of elafibranor in NASH after it failed to show a benefit in a Phase III clinical trial. The company that has been in the lead to become the first to win approval for a NASH drug, New York-based Intercept Pharmaceuticals, received a complete response letter from the Food and Drug Administration requesting additional data in response to the application for its drug, obeticholic acid. Gilead Sciences and Germany’s Boehringer Ingelheim have also recently come up short in their NASH drug development efforts.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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