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Amgen’s Positive Denosumab Pivotal Trial Reduces Overhangs For Firm

This article was originally published in The Pink Sheet Daily

Executive Summary

Big biotech needs the potential $2.4 billion analysts estimate the bone-building drug could bring by 2016.

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Amgen’s Denosumab, GTx’s Toremifene Keep Pace At ASCO On Prevention Of Bone Fractures In Prostate Cancer Patients

Both firms have October user fee dates for prevention of bone fracture risk in prostate cancer patients on androgen deprivation therapy, and both report favorable incremental data.

Amgen’s Denosumab, GTx’s Toremifene Keep Pace At ASCO On Prevention Of Bone Fractures In Prostate Cancer Patients

Both firms have October user fee dates for prevention of bone fracture risk in prostate cancer patients on androgen deprivation therapy, and both report favorable incremental data.

Amgen submits denosumab BLA

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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