INDIANAPOLIS—Eli Lilly and Co. and Hanmi Pharmaceutical Co. Ltd., a global pharmaceutical company based in Seoul, have established an exclusive license and collaboration agreement to develop and commercialize Hanmi's oral Bruton's tyrosine kinase (BTK) inhibitor, HM71224, for the treatment of autoimmune diseases and other diseases.
Per the terms of the agreement, Lilly will be granted worldwide rights to HM71224 for all indications, excluding China, Hong Kong, Taiwan and Korea. Lilly will lead development, regulatory, manufacturing and commercial efforts for the the molecule in its territories. In return, Hanmi will receive an initial payment of $50 million, with the potential for up to $640 million in development, regulatory and sales milestones. Should the compound successfully make it to market, Hanmi will also be eligible for tiered double-digit royalties. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
"HM71224 is a potent and effective BTK inhibitor and has successfully demonstrated proof of mechanism in preclinical studies and a Phase 1 study in Europe," said Dr. Gwan Sun Lee, president and CEO of Hanmi Pharmaceutical, in a press release. "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."
BTK plays a role in B cell development and maturation, and while the exact mechanism of action is unknown, BTK inhibitors have demonstrated anti-inflammatory and anti-tumor effects. Hanmi is currently advancing HM71224 in rheumatoid arthritis, and the compound is ready to enter Phase 2. Among the other diseases in which Lilly and Hanmi plan to explore HM71224's potential are 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," Dr. Thomas Bumol, senior vice president of biotechnology and immunology research at Lilly, commented in a statement. "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."
In other recent news from Hanmi, the company announced on Tuesday that it had received approval for a Phase 2 clinical trial of HM61713, a targeted anti-cancer drug that selectively suppresses EGFR mutation. Previously, Hanmi was able to demonstrate the compound's safety and efficacy in a clinical trial of lung cancer patients who had developed resistance to conventional anticancer drugs. In this Phase 2 trial, Hanmi will evaluate HM61713's safety, speed and anti-cancer effects as a potential primary therapy for treating non-small cell lung cancer.