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Integrated Analysis Demonstrates That Denosumab Delays the Onset of Bone Complications Compared to Zometa®
Date:10/10/2010

e discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.  Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

Editor's Note: Denosumab administered as a 60 mg single subcutaneous injection every six months has been approved under the trade name Prolia™ in the United States for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia has also been approved in the EU to treat osteoporosis in postmenopausal women at increased risk of fracture and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. The Prolia trade name may not apply for future indications of denosumab. For full Prolia prescribing information, please visit www.prolia.com.

Denosumab is currently under global regulatory review for the reduction of SREs in patients with advanced cancer. The advanced cancer program is evaluating 120
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SOURCE Amgen
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