Amgen, Daiichi Sankyo Enter Denosumab Pact

Amgen and Daiichi Sankyo Co., entered a collaboration and license agreement for the development and commercialization of denosumab in Japan. Denosumab is a fully human monoclonal antibody that targets RANK Ligand (an essential mediator of cells that break down bone) and is being investigated in a broad range of bone loss conditions including osteoporosis and bone metastases.

Daiichi Sankyo will have exclusive rights to develop and commercialize denosumab in Japan in post-menopausal osteoporosis, oncology and potentially additional indications. As part of the agreement, Amgen will receive exclusive worldwide rights to certain Daiichi Sankyo intellectual property as applicable to denosumab.

Amgen will receive an upfront payment of $20 million. Daiichi Sankyo will be responsible for development costs for denosumab in Japan and will pay approximately $150 million of the expected worldwide development costs through 2009. Daiichi Sankyo is eligible to receive milestone payments based on the approval of denosumab in the EU or Japan in two indications. Daiichi Sankyo will pay royalties on annual sales of denosumab in Japan.

“Daiichi Sankyo is an ideal partner for denosumab,” said Kevin Sharer, chairman and chief executive officer of Amgen. “Daiichi Sankyo is uniquely positioned to bring this potential therapy to patients with a wide spectrum of bone-related diseases in Japan.”

“We believe that denosumab has the potential to be a first-in-class, leading product in Japan for multiple indications within Daiichi Sankyo’s therapeutic areas of focus. Denosumab’s potential applicability in oncology makes it an important part of the foundation for our growing oncology business,” said Takashi Shoda, president and chief executive officer of Daiichi Sankyo.