http://www.amgennews.com/index.php en pmannle@amgen.com Copyright 2012 2012-01-26T22:31:00+00:00 http://www.amgennews.com/index.php/2008NewsService/new_amg_386_data_demonstrate_promising_antitumor_activity_in_patients_with_/ http://www.amgennews.com/index.php/2008NewsService/new_amg_386_data_demonstrate_promising_antitumor_activity_in_patients_with_/#When:12:48:00Z AMG 386 Treatment Response Increased With Dose And Exposure AMG 386 Moving Into Phase 3 For Recurrent Ovarian Cancer Separately, Two Analyses Provide Evidence Of Biomarker As Predictor Of Tumor Response To Motesanib THOUSAND OAKS, Calif., June 6, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer.  The results are being presented for the first time in an oral presentation at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. (Abstract Number: 5000) Press Releases, Pipeline News 2010-06-06T12:48:00+00:00 http://www.amgennews.com/index.php/2008NewsService/denosumab_demonstrated_superiority_over_zometar_in_delay_of_complications_d/ http://www.amgennews.com/index.php/2008NewsService/denosumab_demonstrated_superiority_over_zometar_in_delay_of_complications_d/#When:15:27:00Z The Third Of Three Pivotal Head-To-Head Trials Submitted To FDA For Treatment Of Patients With Bone Metastases THOUSAND OAKS, Calif., June 5, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial which compared the efficacy and safety of denosumab versus Zometa(R) (zoledronic acid) in 1,901 patients with hormone-refractory prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated denosumab’s superiority over Zometa in delaying or preventing skeletal related events (SREs). These statistically significant results will be presented in an oral session on June 6, 2010 at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting in Chicago (Late Breaking Abstract Number #LBA4507). Press Releases, Pipeline News 2010-06-05T15:27:00+00:00 http://www.amgennews.com/index.php/2008NewsService/new_analyses_of_denosumab_pivotal_phase_3_trials_reinforce_potential_advant/ http://www.amgennews.com/index.php/2008NewsService/new_analyses_of_denosumab_pivotal_phase_3_trials_reinforce_potential_advant/#When:15:03:00Z Integrated Analysis Shows Denosumab Superiority Over Zometa(R) In Delaying Or Preventing Skeletal Related Events In Broad Population With Advanced Cancer Additional Analyses Demonstrate Denosumab Significantly Delays Onset And Worsening Of Bone Pain Over Zometa Exploratory Analysis Shows Denosumab Superior To Zometa In Delaying Time To First Skeletal Related Event Or Hypercalcemia Of Malignancy THOUSAND OAKS, Calif., June 5, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced positive results from several new analyses of two Phase 3 trials studying denosumab compared with Zometa(R) (zoledronic acid), the current standard of care, for the treatment of bone metastases in patients with advanced breast cancer ("136 study") and solid tumors or multiple myeloma ("244 study").  Results from these trials reinforce denosumab’s consistent ability to delay the complications of bone metastases in patients with advanced cancer.  These results are being presented during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Press Releases, Pipeline News 2010-06-05T15:03:00+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