Antibody Drug Licensed from Amgen

Denosumab is a drug being developed by US-based Amgen for the treatment and prophylaxis of various bone diseases such as osteoporosis, metastatic malignant neoplasm to bone, cancer treatment-induced bone loss, and joint destruction in rheumatoid arthritis. It has great potential to grow into a first-in-class product covering multiple fields.
DAIICHI SANKYO concluded a licensing agreement with Amgen under which it has been given the exclusive right to develop and market Denosumab in Japan.

Throughout life, bones go through repeated cycles of bone resorption in which old bones lose elasticity and hardness.Then they are broken down, which results in new bone formation. Bone mass is maintained in an equilibrium between these two processes. Osteoporosis is usually treated with bone formation enhancers or bone resorption inhibitors.
Denosumab is a fully human monoclonal antibody that specifically binds to RANKL, a highly important molecule in normal physiologic bone resorption and bone metabolism in the RANK/RANKL system. It is able to suppress bone resorption through this mechanism.

Under Development in Japan for Treatment of Osteoporosis and Bone Metastasis

In Japan, it has filed for approval in Japan to manufacture and market AMG 162 (Denosumab), a gene recombinant drug for bone disorders stemming from bone metastases in August 2010. In addition, Daiichi Sankyo is conducting a Phase III clinical trial for Denosumab to treat osteoporosis.

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