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Amgen investigational therapy, AMG 162, increased bone mineral density with twice yearly injection

SEATTLE (October 03, 2004) Amgen Inc. (NASDAQ: AMGN), the world's largest biotechnology company, today announced that at all doses studied, twice yearly injections of AMG 162, the company's investigational therapy for bone loss, significantly increased bone mineral density (BMD) at the total hip compared with placebo at 12 months. AMG 162, at all doses, also increased total hip BMD, similar to or greater than that resulting from FOSAMAX® (alendronate)* treatment in the same time frame.

The one year results of the ongoing multi-center, Phase 2, dose ranging trial in healthy postmenopausal women with low BMD were presented at the American Society for Bone and Mineral Research (ASBMR) 26th Annual Meeting in Seattle. This double blind trial was designed to evaluate the safety and efficacy of AMG 162 compared with placebo with an open label cohort comparison to FOSAMAX®.

"This study suggests that AMG 162 significantly improves bone mineral density in postmenopausal patients experiencing bone loss," said Michael McClung, MD, FACE, principal investigator of the AMG 162 study and founding director of the Oregon Osteoporosis Center in Portland. "The medical community should be very encouraged by these data that suggest AMG 162, when administered twice a year, may offer a promising alternative for the treatment of osteoporosis."

"With the development of AMG 162, Amgen scientists have validated an entirely new pathway and novel mechanism of action for addressing conditions associated with bone loss," said Beth Seidenberg, MD, chief medical officer and senior vice president of global development, Amgen. "These Phase 2 results with our investigational agent are very compelling and give us great confidence as we actively enroll and initiate our pivotal trial."

The effects of AMG 162 (at 60 mg twice yearly) at the total hip BMD were significantly (p<0.001) greater than FOSAMAX® (at 70 mg once weekly) at 12 months. AMG 162 across
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3-Oct-2004


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