Merck to develop biosimilar of Pfizer’s Enbrel
pharmafile | June 15, 2011 | News story | Research and Development, Sales and Marketing | Enbrel, Merck & Co, biosimilar
Merck & Co is to develop its own version of Pfizer’s ageing arthritis drug Enbrel with a South Korean manufacturer.
The company has tied up with Hanwha Chemical Corporation, which has been working on HD203, a candidate biosimilar form of TNF inhibitor Enbrel (etanercept).
Merck will be responsible for its clinical development and manufacture, and will commercialise HD203 everywhere outside Korea and Turkey where Hanwha has retained marketing rights.
Although no details of cash were revealed, Merck is to pay Hanwha an upfront sum and the Seoul-based firm will receive milestone payments and royalties.
“Hanwha has established outstanding biopharmaceutical development capabilities,” said Michael Kamarck, president of Merck BioVentures.
“Enbrel is widely considered to be one of the most important biosimilar molecules,” he continued. “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 and Enbrel, in combination with standard first line treatment methotrexate, are currently being evaluated in Korea in a phase III trial in patients with rheumatoid arthritis.
The randomised double-blind active-controlled parallel group trial aims to establish the equivalence in efficacy and safety between the two treatments.
Hanwha chief executive K.J. Hong said the Merck deal is “a significant event both strategically and financially for Hanwha and underscores the success of our biopharmaceutical strategy”.
“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,” he added.
Merck already has two anti-TNF drugs of its own, Remicade (infliximab) and Simponi (golimumab).
NICE recommended Simponi recently as a second line treatment, in combination with methotrexate, for rheumatoid arthritis.
Adam Hill
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