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Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
Date:8/13/2009

cancer therapy results in significant morbidity, and has no currently approved treatments.

Patient safety is Amgen's top priority. Amgen proposed a comprehensive post-marketing surveillance program, including extensions of studies in the osteoporosis and oncology settings in which more than 5,000 patients will be treated with Prolia for up to 10 years, as well as ongoing studies in the advanced cancer setting. In addition, the Company proposed an observational study using healthcare databases that will involve approximately 380,000 women with postmenopausal osteoporosis for up to 5 years.

"Amgen looks forward to collaborating with the FDA to arrive at the best possible approach to make Prolia available to appropriate patients," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.

The FDA has targeted an Agency action within ten months of the application's submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of Oct. 19, 2009.

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 can
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SOURCE Amgen Inc.
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