Thursday, January 24, 2008

KRAS Gene Status May Impact Vectibix(TM) (Panitumumab) Efficacy and Patient Reported Outcomes in Advanced Colorectal Cancer Patients

Data Presented at ASCO GI Further Validate KRAS as a Potential Patient Selection Biomarker for Vectibix Monotherapy

ORLANDO, Fla., Jan 24, 2008 – Amgen (NASDAQ: AMGN) today announced the results of a biomarker analysis which indicated that in metastatic colorectal cancer (mCRC) patients who have failed all other chemotherapeutic regimens, the efficacy of Vectibix(TM) (panitumumab) monotherapy is confined to patients with non-mutated (wild-type) KRAS tumors. Specifically, in patients with non-mutated KRAS tumors, Vectibix significantly increased progression-free survival (PFS) and had an impact on quality of life (QoL) and disease-related symptoms, compared to best supportive care (BSC) alone. These data will be presented at an oral presentation on Saturday, January 26th at the 2008 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).

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Posted in Press Releases, Product News

Thursday, January 24, 2008

Denosumab Osteoporosis Study Met Primary and All Secondary Bone Mineral Density Endpoints in a Head-to-Head Comparison with Weekly Alendronate (FOSAMAX(R))

THOUSAND OAKS, Calif., Jan 24, 2008 – Amgen (NASDAQ:AMGN) today announced findings from a head-to-head, double-blind study comparing the effects of twice-yearly subcutaneous injections of denosumab versus weekly oral doses of alendronate (FOSAMAX(R)) on bone mineral density (BMD) in postmenopausal women with low bone mineral density. The study met primary and all secondary endpoints.

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Posted in Press Releases, Pipeline News

Thursday, January 10, 2008

Amgen Statement on Alzheimer's Case Study

A study titled “Rapid Cognitive Improvement in Alzheimer’s Disease Following Perispinal Etanercept Administration” was published this week in the Journal of Neuroinflammation.  It is important to note that the study published was a case study involving a single patient.  This study was not supported nor endorsed by Amgen. While Amgen and others have long recognized the potential for tumor necrosis factor (TNF) inhibitors to have an effect on neurological conditions, we have carefully examined this study and believe that at this time there is insufficient scientific data to support the use of a TNF inhibitor as a means of treating Alzheimer’s disease.  Amgen will continue to review data on the use of Enbrel® (etanercept) and other anti-inflammatory agents for the treatment of Alzheimer’s disease. 

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Posted in Product News

Friday, December 14, 2007

Pivotal Phase 3 Data Show Denosumab Increased Bone Density Throughout Skeleton in Non-Metastatic Breast Cancer Patients on Adjuvant Aromatase Inhibitor Therapy

A Study Evaluating Twice Yearly Dosing with Denosumab Met All Primary and Secondary Endpoints

SAN ANTONIO – Dec. 14, 2007 – Amgen (NASDAQ:AMGN) today announced results of the first Phase 3 pivotal study to complete in the denosumab oncology development program. The study evaluated denosumab’s effect on bone density across the skeleton in women with non-metastatic breast cancer who were receiving adjuvant Aromatase Inhibitor (AI) Therapy. These results were presented during the Late Breaking Session at this year’s 30th Annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

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Posted in Press Releases, Pipeline News

Monday, December 10, 2007

Pivotal Phase 3 Nplate(TM) Study in Non-Splenectomized Patients Met Primary Endpoints

Data Also Shows Potential of Nplate as a Long-term Treatment Option for Chronic Adult Immune Thrombocytopenia Purpura

ATLANTA – Dec. 10, 2007 – Amgen Inc. (NASDAQ:AMGN) today announced results from a second randomized, pivotal Phase 3 study where Nplate(TM) (romiplostim) increased and sustained platelet counts in non-splenectomized (spleen not removed) adult patients with chronic Immune Thrombocytopenic Purpura (ITP). Additionally, Nplate-treated patients taking concurrent ITP medications such as corticosteroids were able to reduce or discontinue these medications. Adult ITP is a chronic and serious autoimmune disorder characterized by low platelet counts in the blood, a condition known as thrombocytopenia. These Phase 3 data were presented today in an oral session at the 49th American Society of Hematology Annual Meeting (ASH) in Atlanta, Georgia (Abstract #565).

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Posted in Press Releases, Pipeline News