Merck & Co. is teaming up with Korean firm Hanwha Chemical to develop a biosimilar form of Pfizer and Amgen’s TNF-blocker, Enbrel (etanercept), which has a patent expiry date looming in October 2012. The collaboration will focus on Hanwha’s HD203 candidate, which is currently undergoing a Phase III trial in Korea. The study is comparing HD203 with Enbrel as combination therapy with methotrexate in the treatment of rheumatoid arthritis. Clinical trials with HD203 have yet to be initiated in the U.S.
Under terms of the deal Merck will carry out clinical development and manufacturing of HD203, and has rights to commercialize the drug globally, except in Korea and Turkey, where Hanwha has retained marketing rights. Korea-based Hanwha will also receive an up-front payment from Merck, along with technology transfer and regulatory-associated milestones, plus tiered sales royalties.
Enbrel is currently approved in various markets globally for the treatment of rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Originally developed by Immunex, Enbrel is marketed by Amgen in the U.S. and Canada, and by Pfizer in all other approved markets.
For the three months ended March 31 2011 Amgen reported Enbrel sales of $875 million, up 9% on equivalent 2010 sales. The drug is Amgen’s second biggest sales earner, behind Neulasta/Neupogen. Sales of Enbrel by Pfizer in non-U.S./Canadian markets were also up 9% during Q1 2011, at $870 million. The drug is currently Pfizer’s third highest-ranking in terms of global sales, even excluding the U.S. and Canadian markets.