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Xgeva

Amgen, Inc.

Drug Names(s): AMG 162, recombinant human osteoprotegerin (rhOPG), denosumab 120 mg (dmab), Ranmark (Japan)

Description: BioMedTracker maintains three separate profiles for denosumab:

  • Xgeva is the trade name for 120 mg denosumab currently approved for the treatment of skeletal-related events from bone metastases.
  • Prolia is 60 mg denosumab approved as a treatment to increase bone mass in certain patients.
  • Prolia (Osteoporosis) is 60 mg denosumab approved for osteoporosis treatment and is maintained as a separate drug to reflect the partnership with GSK only for this indication.

Denosumab is a fully-human monoclonal antibody targeting RANKL.

In 1997, Cell published a manuscript describing osteoprotegerin (OPG), a novel, naturally occurring protein that inhibits osteoclast formation as a soluble decoy receptor binding RANK ligand (RANKL). RANKL is a protein that binds to the RANK receptor on osteoclasts and precursors, permitting or mediating the pro-resorptive effects of numerous hormones and cytokines. Osteoclasts are the cells that break down bone mineral after which it is resorbed into the bloodstream. Inhibiting their activity tips cellular bone density regulation in favor of osteoblast activity. Osteoblasts build bone from circulating bone mineral.

OPG is a member of the tumor necrosis factor (TNF) receptor superfamily. Preclinical investigation demonstrates that administration of recombinant OPG into normal mice results in pathologically increased bone mineral density, whereas OPG administration to animals with osteoporosis associated with increased osteoclast activity has a therapeutic effect at the level of bone mineral.

Amgen initially developed a recombinant formulation of osteoprotegerin as a drug for the management of osteoporosis and other disorders of decreased bone mineral density such as metastatic cancer involving bone. However, due to neutralizing antibodies to OPG, as well as the desire for a longer half-life and less frequent administration, denosumab was developed.

Deal Structure: Amgen and Abgenix
Abgenix's collaboration with Amgen began in April 1999 for Abgenix to use its technology to generate fully human monoclonal antibody candidates to undisclosed antigen targets supplied by Amgen during the five-year term of the alliance. Amgen will be responsible for product development, manufacturing and marketing of any products developed through the collaboration. Abgenix will receive upfront research payments and could receive license fees, milestone payments plus royalties on any future product sales by Amgen.

Amgen completed its acquisition of Abgenix in April, 2006. Amgen acquired Abgenix for a total cash consideration of approximately $2.2 billion plus assumed debt. Amgen paid stockholders of Abgenix $22.50 in cash per share of common stock held at the closing.

Daiichi Sankyo and Amgen
In July 2007, Amgen and Daiichi Sankyo Company announced a collaboration and license agreement for the development and commercialization of denosumab...See full deal structure in Biomedtracker

Partners: Daiichi Sankyo Co., Ltd. AstraZeneca PLC Dr. Reddy's Laboratories


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