Eli Lilly and Company and Hanmi Pharmaceutical Co., Ltd. (Hanmi) have entered into an exclusive license and collaboration agreement for the development and commercialization of Hanmi’s oral Bruton’s tyrosine kinase (BTK) inhibitor, HM71224, for the treatment of autoimmune and other diseases. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the US,and other customary closing conditions.

This small molecule is ready to enter Phase II development, and the parties plan to investigate the molecule for the potential treatment of rheumatoid arthritis, lupus, lupus nephritis, Sjögren’s syndrome, and other related conditions. Under the terms of the agreement, Lilly will receive worldwide rights to the molecule for all indications excluding China, Hong Kong, Taiwan, and Korea. Lilly will take development, regulatory, manufacturing, and commercial leadership for the molecule in the Lilly territories. Hanmi will receive an initial payment of $50 million and is eligible for up to $640 million in potential development, regulatory, and sales milestones. If the BTK inhibitor is successfully commercialized, Hanmi would also be eligible for tiered double-digit royalty payments.

Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products. The company is fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The company invests over 20% of its sales in R&D and has over 20 programs in clinical development in three main areas: (1) long-acting biologics based on the company’s LAPSCOVERY platform,including weekly insulin, weekly to monthl glucagon-like peptide-1 agonists, and their combinations in diabetes and obesity; (2) targeted agents against cancer and autoimmune disorders; and (3) fixed-dose combination programs.

Source: Eli Lilly and Company