Global healthcare provider Eli Lilly and Company and the Korean pharmaceutical company Hanmi Pharmaceutical Co., Ltd. signed an exclusive license and collaboration agreement focused on accelerating the development process and commercialization of a potential treatment for autoimmune and other conditions, such as lupus. The oral drug was developed by Hanmi and is expected to be studied in phase II trials soon.
The agreement involves an oral tyrosine kinase (BTK) inhibitor called HM71224, but it is still dependent on the Hart-Scott-Rodino Antitrust Improvements Act clearance, as well as other requirements that regulate the process outside the United States and customary closing conditions, as announced by the companies in a press release.
“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,” explained the president and CEO of Hanmi, Gwan Sun Lee. “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.”
The agreement stipulates that Lilly will be granted rights for all indications all over the world except for China, Hong King, Taiwan and Korea. In addition, Lilly will become responsible for the developing, manufacturing and commercializing the drug, along with its regulations. Hanmi, on the other hand, will be given a $50 million initial payment and has the possibility of receiving up to $640 million in potential development, regulatory, and sales milestones.
The companies are now planning to initiate phase II studies to further understand the role of the molecule in the treatment of autoimmune conditions. “Significant unmet medical need exists in many prevalent autoimmune diseases where individual patient needs are not adequately being met with available treatments,” said senior vice president of biotechnology and immunology research at Lilly, Thomas Bumol, PhD.
“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,” added Bumol about this drug which is expected to become a therapeutic option for the treatment of diseases like lupus, lupus nephritis, rheumatoid arthritis and Sjögren’s syndrome.