À̹ÌÁö È®´ë Shares of Hanmi Pharmaceutical opened Wednesday at their daily ceiling on overnight news that it drew in Merck & Co. referred MSD outside North America for an out-licensing deal on its investigational treatment on fatty liver disease.
Under the latest deal, MSD would be granted an exclusive license to develop, manufacture and commercialize efinopegdutide (formerly HM12525A), Hanmi¡¯s investigational once-weekly glucagon-like peptide-1/glucagon receptor dual agonist for the treatment of nonalcoholic steatohepatitis (NASH), a liver disease type related to obesity.
Under the terms of the agreement, MSD will make an upfront payment to Hanmi of $10 million plus pre-launch milestones of up to $860 million and double-digit royalties on sales of approved product, the Korean pharmaceutical company said in a regulatory filing on Tuesday. Hanmi retains an option to commercialize efinopegdutide in Korea.
Shares of Hanmi stayed at their 30 percent daily ceiling of 360,500 won ($303) throughout the day. Shares of its parent Hanmi Science also finished Wednesday 30 percent higher at 70,900 won.
Efinopegdutide was originally developed to control insulin secretion and obesity. In 2015, Hanmi and Janssen Pharmaceutical signed a license deal on the drug, but shortfalls in glycemic control caused the agreement to fall through.
Since then, Hanmi has developed the drug as a potential NASH treatment with its proprietary LAPSCOVERY (Long Acting Protein/Peptide Discovery) technology.
The drug¡¯s safety and efficacy have been evaluated in various Phase I and Phase II clinical studies, including severely obese individuals with and without type 2 diabetes.
¡°Data from Phase II studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,¡± said Dr. Sam Engel, MSD¡¯s clinical research, diabetes and endocrinology associate vice-president. ¡°We continue to build on our proud legacy of developing meaningful medicines for the treatment of metabolic diseases and look forward to advancing this candidate.¡±
¡°This agreement is significant in that a new partnership has been formed in recognition of the drug¡¯s potential as a new treatment of chronic metabolic diseases including NASH,¡± said Hanmi Pharmaceutical¡¯s chief executive Kwon Se-chang said.
By Seo Jin-woo and Minu Kim
[¨Ï Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]