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Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer
Dec 19, 2008

FDA Approves Ferring Pharmaceuticals' Degarelix (Generic Name) for Treatment of Advanced Prostate Cancer Dec 24, 2008

Denosumab Osteoporosis Trial Finds Patients . . . Achieved Significantly Greater Gains in Bone Mineral Density Sept 15, 2008

Amgen Announces Positive Top-Line Results for Denosumab Treatment of Bone Loss in Men With Non-Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy July 14, 2008

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Cougar Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III trial of CB7630 (Abiraterone Acetate) April 1, 2008

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Levitra May Protect the Heart February 16, 2006

Brachytherapy Cesium-131 Claimed to Have Fewer Side Effects Jan 8, 2005

OncoGenex and Isis Expand Antisense Drug Development Partnership in Oncology
March 16 05

Isotron licenses ORNL cancer treatment technology Nov 24 2004. Neutron brachytherapy may be available by 2007.

Amgen Provides Update on Status of Prolia(™) (Denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration

THOUSAND OAKS, Calif., Oct 19, 2009 -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(™) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

The FDA issues Complete Response letters to request additional information needed to complete the review of applications for product approval.

The Complete Response Letter related to the Prolia applications requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. This letter does not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.

The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The FDA acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia.

Amgen is reviewing the Complete Response Letter and will work with the FDA to determine the appropriate next steps regarding these applications.

Amgen expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.

"We are confident that we can quickly respond to the FDA's requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Amgen is fully committed to working with the FDA to make Prolia available to patients in the near future."

Amgen also has submitted Prolia for approval in postmenopausal osteoporosis and bone loss in breast and prostate cancer patients due to hormone ablation therapy in the European Union, Switzerland, Australia and Canada. Amgen is working closely with regulatory agencies in each of these regions to make Prolia available to patients around the world.

About Osteoporosis

Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. In the U.S. today, nearly eight million women suffer from osteoporosis.(i) The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.

The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(ii iii iv) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(v)

Bone Loss Due to Hormone Ablation

In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women. It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

About Prolia

In February 2009, the FDA accepted the BLA, submitted by Amgen for Prolia 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. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which the drug 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.

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. 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 therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K.

Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Oct. 19, 2009, and expressly disclaims any duty to update information contained in this news release.

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