THOUSAND OAKS (dpa-AFX) - Healthcare giant Merck & Co. Inc. (MRK) Monday announced an exclusive global agreement with South Korea's Hanwha Chemical Corp. to develop and commercialize HD203 - a biosimilar candidate form of Enbrel (etanercept) - developed by Hanwha. Specific financial terms of the deal were not revealed.
Etanercept is a drug indicated for the treatment of autoimmune diseases like rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.
In North America, etanercept is co-marketed by Amgen, Inc. (AMGN) and Pfizer, Inc. (PFE) under the trade name Enbrel. Outside of North America, Wyeth is the sole marketer of Enbrel, while Takeda Pharmaceuticals (TKPHF.PK, TKPYY.PK) markets the drug in Japan.
In Korea, HD203 is currently being evaluated in a randomized, double-blind active-controlled parallel group phase III clinical trial. This study examines the equivalence in efficacy and safety of HD203 and Enbrel in combination with methotrexate in patients with rheumatoid arthritis. Clinical trials are yet to be initiated in the U.S.
As per the deal terms, Hanwha will receive an upfront payment and will be eligible for additional payments associated with milestones for technology transfer and regulatory progress as well as tiered royalties on sales of HD203.
Merck will be responsible for HD203's clinical development and manufacturing. HD203 will be commercialized globally by Merck except for Korea and Turkey upon marketing approval. Hanwha has retained marketing rights for Korea and Turkey.
Commenting on the deal, Michael Kamarck, president, Merck BioVentures, stated, '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.'
MRK closed Friday's trading at $35.45, down $0.55 or 1.53 percent, on a volume of 11.91 million shares.
Copyright RTT News/dpa-AFX
© 2011 AFX News
