Merck & Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigational Once-Weekly Therapy...
August 04 2020 - 5:00AM
Business Wire
Merck (NYSE: MRK), 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 efinopegdutide
(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 efinopegdutide 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 commercialize efinopegdutide in 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 efinopegdutide, as well as double-digit
royalties on sales of approved product. Hanmi retains an option to
commercialize efinopegdutide 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 scientific expertise in metabolic
diseases makes it well positioned to advance this candidate forward
and maximize its potential for patients around the world.”
About efinopegdutide
Efinopegdutide is a GLP-1/glucagon receptor dual agonist, which
activates both the GLP-1 and glucagon receptors. The safety and
efficacy of efinopegdutide 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 www.merck.com 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 fields: 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 finding potential partners for innovative
solutions.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the recent global outbreak of novel coronavirus
disease (COVID-19); the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing
difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of
the company’s patents and other protections for innovative
products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2019
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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