Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Enopegdutide, an Investigational Once-Weekly Therapy for Nonalcoholic Steatohepatitis (NASH)

Aug 5, 2020 | Investor Watch, NASH, News

Clinical Investigation Site Summary: The Institute for Liver Health Treating Nonalcoholic Steatohepatitis (NASH)

Merck,known as MSD outside the United States and Canada, and Hanmi Pharmaceutical today announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of enopegdutide (formerly HM12525A),Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis (NASH).

“Data from phase 2 studies has provided compelling clinical evidence that warrants further evaluation of
enopegdutide for the treatment of NASH,” said Dr. Sam Engel, associate vice president, Merck clinical research,
diabetes and endocrinology, Merck Research Laboratories. “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.”
Under the agreement, Merck will be granted an exclusive license to develop, manufacture and
commercializeenopegdutidein the United States and globally. Hanmi will receive an upfront payment of $10
million and is eligible to receive milestone payments up to $860 million associated with the development,
regulatory approval and commercialization of enopegdutide,as well as double-digit royalties on sales of approved
product. Hanmi retains an option to commercialize enopegdutide in Korea.

“This licensing agreement supports Hanmi’s goals of developing and providing innovative therapies to the patients
who need them,” said Dr. Se Chang Kwon, CEO and president, Hanmi Pharmaceutical. “We believe that Merck’s
strong scientic expertise in metabolic diseases makes it well positioned to advance this candidate forward and
maximize its potential for patients around the world.”

About enopegdutide
Enopegdutide is a GLP-1/glucagon receptor dual agonist, which activates both the GLP-1 and glucagon receptors
The safety and ecacy of enopegdutide has previously been evaluated in multiple Phase 1 and Phase 2 clinical
trials, including for the treatment of severely obese individuals with and without type 2 diabetes mellitus.

About Merck
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for
life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our
mission to save and improve lives. We demonstrate our commitment to patients and population health by
increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues
to be at the forefront of research to prevent and treat diseases that threaten people and animals – including
cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier
research-intensive biopharmaceutical company in the world. For more information, visit and
connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Hanmi Pharmaceutical
Hanmi Pharmaceutical is a Korea-based pharmaceutical company, fully integrated with strong focus in R&D which is
strategically designed in 3 major elds: 1) Biologics: LAPSCOVERY platform applied long-acting pipelines. Key
targeting areas are diabetes and obesity; 2) NCE: Mainly oncology targeted pipelines; and 3) Fixed-dose
combination programs. The company has worked closely with global partners on various co-developments and
collaborations. Hanmi continues to further expand through “Open Innovation Strategy” by nding potential
partners for innovative solutions.

Source: MERCK