http://www.amgennews.com/index.php en pmannle@amgen.com Copyright 2010 2010-02-19T23:24:01+00:00 http://www.amgennews.com/index.php/2008NewsService/denosumab_study_published_in_the_lancet_oncology_demonstrated_86_percent_tu/ http://www.amgennews.com/index.php/2008NewsService/denosumab_study_published_in_the_lancet_oncology_demonstrated_86_percent_tu/#When:01:43:00Z THOUSAND OAKS, Calif. (February 9, 2010) – Amgen (NASDAQ: AMGN) issued the following statement on the publication of results online today by the Lancet Oncology. For a summary of the manuscript click here. Pipeline News 2010-02-09T01:43:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_provides_update_on_status_of_proliatm_denosumab_biologics_license_app/ http://www.amgennews.com/index.php/2008NewsService/amgen_provides_update_on_status_of_proliatm_denosumab_biologics_license_app/#When:05:11:00Z 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(TM) (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.  Press Releases, Pipeline News 2009-10-19T05:11:00+00:00 http://www.amgennews.com/index.php/2008NewsService/vectibixr_in_combination_with_chemotherapy_significantly_improves_progressi/ http://www.amgennews.com/index.php/2008NewsService/vectibixr_in_combination_with_chemotherapy_significantly_improves_progressi/#When:03:30:00Z THOUSAND OAKS, Calif. – Sept 24, 2009 – Amgen (Nasdaq: AMGN) today announced detailed results from the Phase 3 ‘203’ trial evaluating Vectibix(R) (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as the first-line treatment of metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved median progression-free survival (PFS) by 1.6 months (9.6 versus 8.0 months for patients treated with FOLFOX alone, (hazard ratio 0.80; p=0.02)) in patients with KRAS wild-type mCRC (primary endpoint). The results were presented at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number 10LBA). Press Releases, Product News, Pipeline News 2009-09-24T03:30:00+00:00 http://www.amgennews.com/index.php/2008NewsService/denosumab_demonstrates_superiority_over_zometar_in_delay_of_complications_d/ http://www.amgennews.com/index.php/2008NewsService/denosumab_demonstrates_superiority_over_zometar_in_delay_of_complications_d/#When:03:35:00Z THOUSAND OAKS, Calif. – Sept. 22 – Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,046 patients with advanced breast cancer that met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. These results were presented today during the Presidential Session at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number 2LBA). Press Releases, Pipeline News 2009-09-22T03:35:00+00:00 http://www.amgennews.com/index.php/2008NewsService/vectibixr_in_combination_with_chemotherapy_significantly_improves_progressi/ http://www.amgennews.com/index.php/2008NewsService/vectibixr_in_combination_with_chemotherapy_significantly_improves_progressi/#When:00:32:01Z THOUSAND OAKS, Calif. – Sept. 22 – Amgen (Nasdaq: AMGN) today announced detailed results from the Phase 3 ‘181’ trial evaluating Vectibix((R)) (panitumumab) in combination with FOLFIRI (an irinotecan based chemotherapy), as a second-line treatment for metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved progression-free survival (PFS) in patients with KRAS wild-type mCRC. These results were presented at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number 14LBA). Press Releases, Product News, Pipeline News 2009-09-22T00:32:01+00:00 http://www.amgennews.com/index.php/2008NewsService/phase_3_trial_shows_denosumab_delayed_skeletal_related_events_in_advanced_c/ http://www.amgennews.com/index.php/2008NewsService/phase_3_trial_shows_denosumab_delayed_skeletal_related_events_in_advanced_c/#When:02:40:00Z THOUSAND OAKS, Calif. – Sept. 21 – Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3 trial evaluating denosumab administered subcutaneously versus Zometa(R) (zoledronic acid) administered as an intravenous infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma. These results were presented today at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number: 20LBA). Press Releases, Pipeline News 2009-09-21T02:40:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_issues_statement_on_outcomes_of_advisory_committee_for_reproductive_h/ http://www.amgennews.com/index.php/2008NewsService/amgen_issues_statement_on_outcomes_of_advisory_committee_for_reproductive_h/#When:15:44:00Z THOUSAND OAKS, Calif. – Aug 13, 2009 – Amgen Inc. (Nasdaq: AMGN) issued the following statement on the outcome of today’s meeting with the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) to review the potential use of Prolia(TM) (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer. Press Releases, Pipeline News 2009-08-13T15:44:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_to_discuss_denosumab_data_at_todays_advisory_committee_for_reproducti/ http://www.amgennews.com/index.php/2008NewsService/amgen_to_discuss_denosumab_data_at_todays_advisory_committee_for_reproducti/#When:05:01:00Z  Committee to Review Denosumab in Women with Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation Therapy for Either Prostate or Breast Cancer THOUSAND OAKS, Calif. – Aug 13, 2009 – Amgen Inc. (Nasdaq: AMGN) today will summarize data from the submitted Biologic License Applications (BLAs) for denosumab for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in breast and prostate cancer patients undergoing hormone ablation at a meeting with the U.S. Food and Drug Administration’s (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD). Press Releases, Pipeline News 2009-08-13T05:01:00+00:00 http://www.amgennews.com/index.php/2008NewsService/studies_published_in_the_new_england_journal_of_medicine_highlight_potentia/ http://www.amgennews.com/index.php/2008NewsService/studies_published_in_the_new_england_journal_of_medicine_highlight_potentia/#When:07:09:00Z Twice-Yearly Administration of Denosumab Resulted in 68 Percent Reduction in Risk for a Vertebral Fracture and 40 Percent Reduction in Risk for a Hip Fracture in Women with Postmenopausal Osteoporosis Denosumab Administered Twice-Yearly Reduced the Incidence of New Vertebral Fractures by 62 Percent in Men with Non-Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy     THOUSAND OAKS, Calif. – Aug. 11 /PRNewswire-FirstCall – Amgen Inc. (Nasdaq: AMGN) today announced the publication of results from two pivotal Phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss. In both studies, published today in The New England Journal of Medicine (NEJM), patients receiving twice-yearly denosumab experienced significant increases in bone mineral density (BMD) compared to placebo, associated with more than 60 percent reduction in vertebral fracture in both patient populations.(1,2) These data were previously reported by Amgen at medical congresses. Press Releases, Pipeline News 2009-08-11T07:09:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_announces_positive_top_line_results_for_denosumab_in_trial_for_delay_/ http://www.amgennews.com/index.php/2008NewsService/amgen_announces_positive_top_line_results_for_denosumab_in_trial_for_delay_/#When:14:15:00Z Second of Three Pivotal Phase Three Bone Metastases Trials Meets Primary Endpoint Denosumab Delayed Time to Skeletal Related Events THOUSAND OAKS, Calif. – Aug. 3 – Amgen (Nasdaq: AMGN) today announced positive top-line results from a pivotal Phase 3 head-to-head trial evaluating denosumab administered subcutaneously versus Zometa (zoledronic acid) administered as an intravenous (IV) infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma. Press Releases, Pipeline News 2009-08-03T14:15:00+00:00