Merck and Samsung Bioepis Enter Biosimilars Development and Commercialization Agreement
WHITEHOUSE STATION, N.J. & SEOUL, South Korea--(BUSINESS WIRE)--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 candidates.
“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.”
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 www.Merck.com and connect with us on Twitter, Facebook and YouTube.
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 www.samsungbioepis.com.
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 (www.sec.gov).
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HongSeok Ji, +82-32-455-6102
Posted: February 2013
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