Monday, October 19, 2009

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

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. 

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Posted in Press Releases

Thursday, October 15, 2009

Amgen Announces Webcast of 2009 Third Quarter Financial Results

THOUSAND OAKS, Calif. – Oct. 15 – Amgen (Nasdaq: AMGN) today announced that it plans to report its third quarter financial results on Wednesday, Oct. 21, 2009 after the close of the financial markets. The announcement will be followed by a conference call with the investment community at 2 p.m. Pacific Time. Participating in the call from Amgen will be Kevin Sharer, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Posted in Press Releases

Thursday, September 24, 2009

Vectibix(R) in Combination With Chemotherapy Significantly Improves Progression-Free Survival in First-Line Metastatic Colorectal Cancer

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).

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Posted in Press Releases

Tuesday, September 22, 2009

Denosumab Demonstrates Superiority Over Zometa(R) in Delay of Complications Due to Bone Metastases in Advanced Breast Cancer Patients

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).

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Posted in Press Releases

Tuesday, September 22, 2009

Vectibix(R) in Combination With Chemotherapy Significantly Improves Progression-Free Survival in Second-Line Metastatic Colorectal Cancer

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).

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Posted in Press Releases