Pharmaceuticals Merck deal with South Korea’s Hanwha bolsters move into biosimilars

Merck & Co has agreed to pay South Korea’s Hanwha Chemical up to $720 million for access to HD203, a biosimilar form of Amgen’s arthritis and psoriasis treatment Enbrel. The deal buttresses Merck’s ambition to become a leader in the market for biosimilars, which are generic versions of biologic drugs.

Last year, Enbrel logged $3.3 billion in sales in the U.S., where it will lose patent protection in October 2012.

HD203 is in a Phase III study in Korea to confirm its safety and therapeutic equivalence to Enbrel in treating people with rheumatoid arthritis. It has yet to be subject to clinical tests in the U.S.

Merck will run additional clinical trials for and manufacture HD203, and it intends to sell the drug in all countries outside of Korea and Turkey, where Hanwha retains marketing rights. Hanwha will receive an undisclosed up-front payment from Merck, as well as milestone payments. Hanwha could reap up to $720 million over the course of the pact, according to a financial filing from the South Korean firm.

Merck has been working diligently to become a key player in the emerging biosimilars marketplace since launching Merck BioVentures, a unit dedicated to developing generic biologics, in late 2008. The company wants to have five biosimilars in late-stage development in 2012, a goal that it hopes to achieve with the aid of partnerships and ac qui si tions.

The deal-making kicked off in 2006, with the acquisition of GlycoFi, a small biotech firm with technology to make glycosylated proteins in yeast. In 2009, Merck licensed generic versions of Ne upogen and Neulasta, a pair of Amgen chemotherapy adjuncts, from Insmed. And earlier this year, Parexel agreed to provide clinical development services for biosimilar candidates being developed by Merck