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Amgen submits denosumab BLA

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Amgen has submitted a BLA for its novel RANK ligand inhibitor denosumab for two indications: treatment and prevention of postmenopausal osteoporosis in women and bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The filing, announced Dec. 18, is supported by two Phase III pivotal studies with fracture endpoints. Analysts have projected the twice-yearly injectable fully human monoclonal antibody could be worth as much as $2.4 billion worldwide by 2016, just in the PMO indication (1"The Pink Sheet" DAILY, July 29, 2008)

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