Amgen and Daiichi-Sankyo have entered a collaboration and license agreement for development and commercialization of Amgen's investigational bone loss therapy denosumab in Japan, the companies announced July 11.

The deal includes milestone payments in two indications, dependent on the approval of denosumab in the European Union or Japan, paid by Amgen to the Japanese drug maker. In return, Amgen will receive "exclusive worldwide rights to certain Daiichi-Sankyo intellectual property to the extent applicable to denosumab."

Daiichi has done extensive work in bone biology and controls a number of patents and patent applications worldwide, Amgen told "The Pink Sheet" DAILY.

Denosumab is a fully human monoclonal antibody that targets RANK Ligand, an essential mediator of cells that break down bone. It is being developed by Amgen for its potential to treat and prevent bone loss conditions, including osteoporosis and bone metastases. The Thousand Oaks, Calif., company is waiting for three-year fracture data from an ongoing Phase III study in postmenopausal osteoporosis before filing a BLA for that indication. The data should be available in late 2008 (¹ Also see "Amgen Denosumab Osteoporosis Submission To Await Three-Year Data" - Pink Sheet, 19 April, 2006.).

Under the agreement, Daiichi will make a $20 million up-front payment to Amgen in exchange for exclusive rights to develop and commercialize the mAb in Japan in post-menopausal osteoporosis and oncology, with the potential to add more indications. In addition, Daiichi will assume all development costs in Japan and will pay approximately $150 million of expected worldwide development costs for denosumab through 2009.

Daiichi will also pay royalties on annual net sales of denosumab in Japan "in amounts commensurate with a major late-stage product for the Japan market," the companies said.

- Shirley Haley (s.haley@elsevier.com)

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Amgen Partners With Daiichi-Sankyo For Denosumab In Japan

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