Eli Lilly and Company and Hanmi Pharm. Co., a Seoul, South Korea-based bio/pharmaceutical company, have entered into a license agreement for the development, manufacturing, and commercialization of Hanmi’s drug candidate, sonefpeglutide, in a deal worth up to $1.2 billion ($75 million upfront and $1.18 billion in milestone payments). Sonefpeglutide is a glucagon-like peptide 2 (GLP-2) analog in Phase II development for treating short bowel syndrome (SBS), a chronic intestinal malabsorption disorder. 

A GLP-2 analogue is a synthetic version of glucagon-like peptide-2, an endogenous gut hormone that stimulates intestinal growth and nutrient absorption. Sonefpeglutide incorporates Hanmi’s Lapscovery, a long-acting protein / peptide discovery platform technology that prolongs the half-life and active duration of drugs and makes it possible for once-weekly or monthly drug administration. Hanmi previously received FDA marketing approval for a drug incorporating its Lapscovery platform and is currently conducting additional global clinical trials for five other programs using the same platform. Hanmi has focused on the biological functions of GLP-2, including the promotion of intestinal growth, reduction of inflammation, and protection and regeneration of the intestinal mucosa.

Sonefpeglutide is a GLP-2 analog chemically conjugated with the constant region of human immunoglobulin via a non-peptidyl flexible linker. Under the companies’ deal, Hanmi will continue to conduct the ongoing global Phase II trial of sonefpeglutide in SBS through completion while Lilly will explore additional clinical trials for sonefpeglutide based on its nonclinical and clinical data. Lilly will obtain exclusive rights to develop, manufacture, and commercialize sonefpeglutide worldwide, excluding Korea. 

Under the agreement, Hanmi will receive an upfront payment of $75 million and may receive up to an additional $1.185 billion in clinical development, regulatory approval and commercialization milestone payments. In addition, Hanmi will be eligible to receive royalties following product launch. 

Source: Hanmi Pharm. Co.