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Published Results Show Denosumab Superior to Zometa® in Delaying or Preventing Bone Complications in Patients With Bone Metastases From Advanced Breast Cancer
Date:11/8/2010

e(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 mg denosumab administered as a monthly subcutaneous injection.  CONTACT: Amgen, Thousand OaksChristine Regan: +1 (805) 447-5476 (media)Arvind Sood: +1 (805) 447-1060 (investors)(i)   Coleman RE. Skeletal complications of malignancy. Cancer. 1997; 80(suppl): 1588-1594.

(ii)  Lipton A, Theriault RL, Hortobagyi GN. Pamidronate prevents skeletal complications and is

effective palliative treatment in women with breast carcinoma and osteolytic bone metastases. Cancer 2000;88:1082-1090.

(iii) Saad F, Lipton A, Cook R, Chen YM
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SOURCE Amgen
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