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Phase 3 Trial of Denosumab Shows Increases in Bone Mineral Density and Reduction in Vertebral Fractures

THOUSAND OAKS, Calif. (July 14, 2008) – Amgen (NASDAQ: AMGN) today announced findings from a three-year pivotal Phase 3 placebo-controlled trial evaluating denosumab in the treatment of bone loss in men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer.

In this study of more than 1,400 men, denosumab treatment produced statistically significantly greater increases in bone mineral density (BMD) at the lumbar spine (primary endpoint) and non-vertebral sites compared with placebo at multiple time points. These improvements in BMD were consistent with those seen in other denosumab studies evaluating BMD in women with breast cancer receiving aromatase inhibitor therapy, and in post-menopausal women with low bone mass.

During the 36-month evaluation period, men receiving denosumab experienced less than half the incidence of new vertebral fractures (a secondary endpoint) compared with those receiving placebo, a statistically significant finding. Furthermore, in the denosumab arm there were fewer non-vertebral fractures over the 36-month period.

The incidence and types of adverse events observed in this study were generally similar between the denosumab and placebo groups. The most common adverse events across both treatment arms were arthralgia, back pain, constipation, and pain in extremity. Serious adverse infectious events occurred in approximately 5 percent of men receiving placebo treatment as compared with approximately 6 percent of those receiving denosumab.

“This pivotal study in men with prostate cancer demonstrated once again that denosumab increases BMD consistently at all sites measured. We are also excited by the reduction in vertebral fractures, which permits the conclusion that the increased BMD seen in patients receiving denosumab is associated with improved bone strength,” said Roger Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “We are encouraged by the potential benefit this may represent to prostate cancer patients undergoing ADT for whom bone loss and fractures are serious and under-recognized complications of cancer treatment.”

About Denosumab and Amgen’s Research in Bone Biology
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). With more than 19,000 patients participating in trials across indications worldwide, the denosumab development program is the largest ever initiated by Amgen. This broad and deep development program demonstrates Amgen’s commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer induced bone disease. Over 11,000 patients are currently enrolled in denosumab oncology clinical trials testing the drug for bone loss associated with cancer treatment-induced bone loss in breast and prostate cancers, for the prevention of skeletal related events due to the spread of cancer to the bone in multiple myeloma and multiple solid tumors, and for its potential to delay bone metastases in prostate cancer. The denosumab oncology program has a specific commitment in prostate cancer, studying more than 4,300 patients to determine the treatment effect of denosumab to treat and prevent bone loss, treat and prevent SREs and delay bone metastases in men with prostate cancer.

Source: Amgen

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