Merck and Samsung Bioepis Enter Biosimilars Development and Commercialization Agreement


February 20, 2013 7:00 am ET

Merck, (NYSE: MRK) known as MSD outside the United States and Canada,
and Samsung Bioepis Co., Ltd., entered into an agreement to develop and
commercialize multiple pre-specified and undisclosed biosimilar

“The combination of Merck’s global commercial presence with Samsung
Bioepis’ biologic development and manufacturing capabilities positions
the two companies well to increase access to biosimilars to improve
human health,” said Rich Murray, Ph.D., senior vice president, biologics
and vaccines research, Merck Research Laboratories. “We look forward to
this collaboration and its potential to complement our expanding
internal biologics portfolio.”

Under the agreement, Samsung Bioepis will be responsible for preclinical
and clinical development, process development and manufacturing,
clinical trials and registration. Merck will be responsible for
commercialization. Samsung Bioepis will receive an upfront payment from
Merck, product supply income and will be eligible for additional
payments associated with pre-specified clinical and regulatory
milestones. Further financial terms were not disclosed.

“Samsung Bioepis has been building the capabilities needed to develop
high-quality biosimilars,” said Christopher Hansung Ko, Ph.D., CEO of
Samsung Bioepis. “With this development and commercialization agreement,
Samsung takes a significant step toward becoming a major player in the
biopharmaceutical industry.”

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside of the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit
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About Samsung Bioepis

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen
Idec, aims to develop affordable and high-quality biopharmaceutical and
biosimilar products. For more information, please visit

Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’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
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; Merck’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 Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2011 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 (

Merck Media Relations:
Ronald Rogers, 908-423-6449
Merck Investor Relations:
Justin Holko, 908-423-5088
Samsung Bioepis:
HongSeok Ji, +82-32-455-6102

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