Merck and Hanwha Chemical Corporation establish global strategic collaboration

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.