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Amgen Highlights Data to be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
Date:9/10/2009

SU0387 (Sunday, Sept. 13, 2009, 11:30 am MT)

-- Comorbidities, Bone Loss and Concomitant Medication Use in European Postmenopausal Women: POSSIBLE EU

Lead Author: Freemantle N

Abstract No. MO0369 (Monday, Sept. 14, 2009, 12:00pm MT)

-- Assessment of Patient Preference, Satisfaction, and Bother with Two Treatments For Postmenopausal Bone Loss

Lead Author: Gold DT

Abstract No. MO0369 (Monday, Sept. 14, 2009, 12:00pm MT)

About Prolia(TM) (denosumab)

Prolia is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Prolia is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Prolia is being studied in a range of bone loss conditions including postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.

In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA), submitted by Amgen for Prolia for the treatment and prevention of osteoporosis in postmenopausal women and cancer treatment-induced bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer based on these studies and a parallel trial in women with breast cancer. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which denosumab is administered twice yearly subcutaneously at a 60mg dose. The trade name is only for these indications and may not apply for other indications of denosumab.

Amgen has also submitted marketing applications for use of Prolia in the European Union, Canada, Switzerland, and Australia.

Osteoporosis: Impact and Prevalence

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SOURCE Amgen
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