Eli Lilly, Hanmi Pharma Forge $690 Million Autoimmune Pact

Published: Mar 19, 2015

Eli Lilly (LLY), Hanmi Pharmaceutical Forge $690 Million Autoimmune Pact
March 19, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Korean drugmaker and Hanmi Pharmaceutical, Co., Ltd will export its autoimmune disease technology to Eli Lilly and Company under a $690 million deal that has the company sharing development and commercialization of its oral Bruton's tyrosine kinase (BTK) inhibitor, HM71224.

The small molecule poised to enter Phase II trials and testing and will be tested as a potential treatment for rheumatoid arthritis, lupus, lupus nephritis, Sjögren's syndrome and other related autoimmune conditions.

Under the terms of the deal, Lilly will now receive worldwide rights to the molecule for all indications excluding China, Hong Kong, Taiwan, and Korea. Hanmi will receive an initial payment of $50 million and is eligible for up to $640 million in potential development, regulator, and sales milestones.

"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.

For its part, Lilly will handle the development, regulatory, manufacturing and commercial leadership for the molecule in the Lilly territories. In addition, if its BTK inhibitor is successfully commercialized, Hanmi would also be eligible for tiered double-digit royalty payments, said the companies 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,” said Bumol. “We're highly encouraged by the potential of HM71224 to deliver an innovative, first-in-class treatment option."

Hanmi has focused on investing over 20 percent of its sales in research and development and said Thursday it has over 20 programs in clinical development in novel long-acting biologics; novel targeted agents against cancer and autoimmune disorders; and fixed-dose combination programs. Hanmi’s biologics include its LAPSCOVERY platform including weekly insulin, weekly to monthly GLP-1, and their Quantum Project in diabetes and obesity. Today’s deal will help fund those efforts, said the company in a statement.

"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 Gwan Sun Lee, chief executive officer and president of Hanmi Pharmaceutical. "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."



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