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 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.

"Significant unmet medical need exists in many prevalent autoimmune diseases where individual patient needs are not adequately being met with available treatments," said Thomas Bumol,  senior vice president, biotechnology and immunology research at Lilly. "Lilly is committed to changing patient expectations in some of the world's most debilitating disease areas, and we're building a portfolio of potential advances in immunology through our own research and key collaborations such as with Hanmi. We're highly encouraged by the potential of HM71224 to deliver an innovative, first-in-class treatment option."

"HM71224 is a potent and effective BTK inhibitor and has successfully demonstrated proof of mechanism in preclinical studies and a Phase I study in Europe," said Dr. Gwan Sun Lee, CEO/president of Hanmi Pharmaceutical. He continued, "We are very pleased to be collaborating with Lilly on HM71224, and through this agreement and R&D collaborations, we are excited to drive the joint project forward with the ultimate aim to offer new medical treatment options to patients with autoimmune disorders and 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.

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world.

Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products.