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Amgen Recognized for Best Pipeline and Best New Drug at Scrip Awards
Date:11/23/2009

ion of existing hematopoietic malignancies or MDS, and effects on red and white blood cells are all potential risks associated with romiplostim treatment. As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein.

About Denosumab

In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologic License Applications (BLA), submitted by Amgen for Prolia(TM) (denosumab) for the treatment and prevention of osteoporosis in postmenopausal women and treatment and prevention of bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer. On October 2009, the FDA issued Complete Response Letters for the BLA application for denosumab requesting additional information needed to complete the review of the applications for approval, including updated safety data. The FDA also requested a new clinical program to support approval of denosumab for the prevention of PMO and additional adequate and well-controlled clinical trials demonstrating the denosumab has no detrimental effects on either time-to disease progression or overall survival for cancer treatment-induced bone loss (in breast cancer and prostate cancer patients).

Denosumab 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). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. It is being studied in a range of other bone loss conditions including rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human
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