Amgen investigational therapy for bone loss, denosumab, show increased bone mineral density

THOUSAND OAKS, Calif. (November 13, 2005) Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced that twice-yearly subcutaneous injections of denosumab (60 mg), (previously referred to as AMG 162), increased bone mineral density (BMD) in the lumbar spine, total hip, distal 1/3 radius and total body compared to placebo at 24 months. The study also included an open label Fosamax* (alendronate) arm. Investigators reported on a pre-planned exploratory analysis at the American College of Rheumatology Annual Scientific Meeting in San Diego, California.

The ongoing, multi-center, phase 2 dose-ranging trial includes results from 337 healthy postmenopausal women with low BMD who completed two years of study. Researchers reported denosumab 60mg increased BMD of the lumbar spine by 7.4 percent in women administered the therapy twice yearly and 6.2 percent for Fosamax 70mg weekly. Across all doses and dosing intervals, denosumab increased the BMD of the lumbar spine by 4.3 to 9.0 percent over baseline.

"The two-year results showed the continued effect of denosumab in increasing bone mineral density in postmenopausal patients with low bone mass," said Michael Lewiecki, MD, clinical assistant professor of medicine, University of New Mexico School of Medicine, Albuquerque, NM. "These data suggest denosumab, when administered twice a year, may offer a promising alternative for the prevention and treatment of osteoporosis."

Denosumab is designed to target RANK Ligand, a protein that acts as the primary signal to promote bone removal. In many bone loss conditions, RANK Ligand overwhelms the body's natural defense against bone destruction.

Preclinical models have demonstrated that inhibiting RANK Ligand leads to significant improvements in cortical and trabecular bone density, volume and strength.

Denosumab is currently being studied for its potential in a broad range of bone loss conditions inclu

Contact: Christine Cassiano, Amgen
Porter Novelli

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