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Amgen Cites Osteoporosis Injectable’s Efficacy Over Fosamax In Study

This article was originally published in The Pink Sheet Daily

Executive Summary

Company presents preliminary Phase II results for AMG 162 that show a significantly greater total hip bone mineral density compared to Merck’s Fosamax; changes in lower spine BMD were comparable between the two agents. Amgen has initiated registration for a Phase III study.

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Amgen Osteoporosis Drug Submission Pushed To 2008 To Await Three-Year Data

Submission for Amgen's RANK ligand antibody AMG 162 must wait until 2008 at the earliest, the firm says; FDA guidance calls for three-year data. Pivotal studies are ongoing for four indications, including postmenopausal osteoporosis and reduction in bone marrow density in breast and prostate cancer patients.

Amgen Osteoporosis Drug Submission Pushed To 2008 To Await Three-Year Data

Submission for Amgen's RANK ligand antibody AMG 162 must wait until 2008 at the earliest, the firm says; FDA guidance calls for three-year data. Pivotal studies are ongoing for four indications, including postmenopausal osteoporosis and reduction in bone marrow density in breast and prostate cancer patients.

Amgen's Phase III Osteoporosis Study Is Company's Largest Clinical Program

Clinical trials for Amgen's bone loss therapy AMG 162 will look at the entire spectrum of bone health, VP-R&D Perlmutter says. Phase II studies demonstrated lower incidence of dyspepsia and more rapid absorption than Fosamax, he says.

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