Daiichi Sankyo files denosumab in Japan for osteoporosis

26 March 2012

Japanese drug major Daiichi Sankyo (TYO: 4568) revealed on Friday that it has filed for approval in Japan to market AMG 162 (denosumab), a gene recombinant drug for osteoporosis.

Denosumab is the world's first fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation, function and survival approved for therapeutic use. Daiichi Sankyo has been working on denosumab since 2007, when it licensed the rights from US biotechnology firm Amgen to develop and market this antibody in Japan for an upfront $20 million plus an undertaking to fund subsequent development of the drug in its home territory, and pay a further $150.0 million towards worldwide R&D costs as well as sales royalties.

Daiichi Sankyo received approval in Japan to market Ranmark A (denosumab), as a treatment for bone complications stemming from multiple myeloma and bone metastases from solid tumors (The Pharma Letter January 18).

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