Print“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.”
South Korea’s Hanwha Chemical is teaming up with Merck to bring a generic version of etanercept, better known as Enbrel, to market. The blockbuster biotech drug is used to treat autoimmune conditions such as rheumatoid arthritis and psoriasis.
Enbrel ranked seventh in revenues in 2010 among prescription drugs, according to IMS Health, with close to $6.2 billion in global sales, and U.S. sales of $3.3 billion. It is due to go off patent in 2012 in the United States, where it is marketed by Amgen and Pfizer.
“Enbrel is widely considered to be one of the most important biosimilar molecules,” says Michael Kamarck, president of Merck BioVentures. “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.”
Hanwha’s biobusiness unit and Merck’s Merck Sharp & Dohme Research subsidiary will work together to develop and commercialize HD203, Hanwha’s biosimilar version of etanercept, with Merck conducting clinical development and taking responsibility for manufacturing. Upon marketing approval, Merck will commercialize HD203 globally except 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. Their contract took effect on June 10 and will last through 2024. Specific financial terms of the agreement were not disclosed, but The Wall Street Journal reported the contract is worth about $720 million.
Hanwha CEO K.J. Hong noted that the deal boosts the South Korean chemical company’s biopharmaceutical business in which it has been investing for several years. Development of biosimilars has the backing of the South Korean government, which has set a goal of snaring 22 percent of global market share by 2020.
Hanwha’s HD203 is currently being evaluated in Korea in a late stage 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.
With an estimated $60 billion in biologics expected to lose patent protection through 2017, Merck hopes to be well-positioned to reap the revenue from biosimilars. The company said in its 2010 annual report that it expects to have five biosimilar candidates in late-stage testing by 2011. An estimated $60 billion in biologics are expected to lose patent protection through 2017.
June 17, 2011
http://www.burrillreport.com/article-merck_strikes_biosimilars_deal_with_hanhwa.html
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