Amgen Statement on Posting of Briefing Documents for the Review of Denosumab by the FDA Advisory Committee for Reproductive Health Drugs

THOUSAND OAKS, Calif. (August 11, 2009) –The U.S. Food and Drug Administration (FDA) today has posted FDA and Amgen briefing documents on its Web site for the Advisory Committee for Reproductive Health Drugs (ACRHD) meeting on August 13, 2009, at which denosumab will be discussed. The materials are available online at www.fda.gov.

Amgen Inc. (NASDAQ:AMGN) issued the following statement regarding the posting of these materials:

“Amgen looks forward to sharing our data on denosumab, for which we are seeking approval in the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate or breast cancer, at the FDA Advisory Committee for Reproductive Health Drugs (ACRHD) meeting on August 13.

Postmenopausal osteoporosis is a major public health concern resulting in fractures that cause significant clinical morbidity, mortality, and healthcare burden, and there remains a need for additional treatment alternatives. Similarly, bone loss due to hormone ablation in the setting of cancer therapy results in significant morbidity, and has no currently approved treatments.

Based on the efficacy and safety results from 30 denosumab clinical studies involving more than 12,000 patients, Amgen considers denosumab to have a favorable benefit:risk profile in postmenopausal osteoporosis and bone loss due to hormone ablation.

Both the Amgen and FDA briefing documents provided to the ACRHD panel include detailed information on the efficacy and safety of denosumab in these patient populations. In its evaluation, the panel will review these data before making their recommendations. The FDA often seeks the advice of an advisory committee when evaluating new drugs but is not required to follow the committee’s recommendations.

Patient safety is Amgen’s top priority. Amgen recognizes and supports the important role the FDA plays in evaluating the safety of products proposed for registration. We look forward to our in-depth conversation with the ACRHD panel on what we view as an important new therapeutic option for patients with postmenopausal osteoporosis and bone loss due to hormone ablation.

We expect the discussion to include consideration of our proposed comprehensive post-marketing surveillance programs, including extensions of studies in the osteoporosis and oncology settings in which more than 5,000 patients will be treated with denosumab for up to 10 years, as well as ongoing studies in the advanced cancer setting. In addition we are proposing an observational study using healthcare databases that will involve approximately 380,000 women with postmenopausal osteoporosis for up to 5 years.“