Collaboration to develop and commercialize candidate biosimilar form of Enbrel®
WHITEHOUSE STATION, N.J. & SEOUL, South Korea--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Hanwha Chemical Corporation (KOSPI: 09830) today announced that they have entered into an exclusive global agreement to develop and commercialize a candidate biosimilar form of Enbrel® (etanercept).
Under the terms of the agreement, Hanwha Chemical Corporation, through its Bio Business Unit, and Merck, through a subsidiary, will work together to develop and commercialize HD203, a candidate biosimilar form of etanercept developed by Hanwha. Merck will conduct clinical development and be responsible for manufacturing. In addition, upon marketing approval, Merck will commercialize HD203 globally, except for in Korea and Turkey where Hanwha has retained marketing rights. In return, Hanwha receives an upfront payment from Merck and will be eligible for additional payments associated with milestones for technology transfer and regulatory progress as well as tiered royalties on sales. Specific financial terms of the agreement were not disclosed.
"This collaboration to develop and commercialize our lead biosimilar candidate with a leading global health care company such as Merck represents a significant event both strategically and financially for Hanwha and underscores the success of our biopharmaceutical strategy,” said K.J. Hong, chief executive officer Hanwha Chemical Corporation. “We are excited and proud that Hanwha's biobusiness is now well positioned to make a major contribution toward providing access to a biosimilar form of one of the world's leading biologic therapies."
"Hanwha has established outstanding biopharmaceutical development capabilities," said Michael Kamarck, president, Merck BioVentures. "Enbrel is widely considered to be one of the most important biosimilar molecules. This candidate represents a valuable addition to our broad biosimilars portfolio, as we advance our strategy to provide patients with improved access to biologic therapies."
HD203 is currently being evaluated, in Korea, in a randomized double-blind active-controlled parallel group Phase III clinical trial to evaluate the equivalence in efficacy and safety of HD203 and Enbrel in combination with methotrexate in patients with rheumatoid arthritis. Clinical trials have yet to be initiated in the United States.
About Hanwha Chemical Corporation
Hanwha Chemical Corporation has been a pioneer since its establishment in 1965. Hanwha Chemical Corporation has led the development of Korean petrochemical industry by producing basic products, i.e. PVC, LDPE, LLDPE, CA, often compared as “the staple” of industries. Today, Hanwha Chemical Corporation is focused on strengthening core competencies by developing specialty and eco-friendly products and exploring overseas markets, while identifying new growth engines, such as renewable energy resources, biopharmaceuticals, and nano materials. For more focused investment and efficient Bio-business activities, Hanwha Chemical Corporation established a Bio Business Unit focusing on R&D of biopharmaceutical product. For more information, visit www.hanwha.co.kr.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside 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.
Merck 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. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to 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 2010 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).
Enbrel® is a registered trademark of Amgen and Pfizer.
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Ian McConnell, 908-423-3046
Carol Ferguson, 908-423-4465
Hanwha Chemical Corp:
HyukBum Kwon, +82-2-729-3127
JaeHong Jeon, +82-2-729-4016
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