Saturday, June 05, 2010

Denosumab Demonstrated Superiority Over Zometa(R) in Delay of Complications Due to Bone Metastases in Advanced Prostate Cancer

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).

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Posted in Press Releases, Pipeline News

Saturday, June 05, 2010

New Analyses of Denosumab Pivotal Phase 3 Trials Reinforce Potential Advantages Over Standard of Care

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.

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Posted in Press Releases, Pipeline News

Friday, June 04, 2010

New AMG 479 Phase 2 Data Show Antitumor Activity in Patients With Metastatic Pancreatic Cancer

AMG 479 Extended Progression-Free Survival And Overall Survival Compared To Gemcitabine Alone

AMG 479 Moving Into Phase 3 For Metastatic Pancreatic Cancer

THOUSAND OAKS, Calif., June 4, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced results from a small, randomized, placebo-controlled Phase 2 study indicating that adding AMG 479 to gemcitabine improved overall survival at six months (primary endpoint) and progression-free survival in patients with metastatic pancreatic cancer.  The study, which also included a separate arm of conatumumab plus gemcitabine, is being presented in a Poster Discussion at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. (Abstract Number: 4035)

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Posted in Press Releases

Tuesday, June 01, 2010

FDA Approves Amgen's Prolia™ (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

Given As An Injection Every Six Months, Prolia Reduced Risk Of Fracture At The Spine, Hip And Other Sites

THOUSAND OAKS, Calif., June 1, 2010 /PRNewswire via COMTEX/ --Amgen Inc.  (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia™ (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional.

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Posted in Press Releases

Friday, May 28, 2010

Prolia® (Denosumab) Granted Marketing Authorization in the European Union

Given as an Injection Every Six Months, Prolia Reduced the Risk of Fractures in Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fractures

First and Only Approved Treatment in Europe for Bone Loss Due to Hormone Ablation in Men with Prostate Cancer

First Prolia® Regulatory Approval

THOUSAND OAKS, Calif., May 28, 2010 /PRNewswire via COMTEX/ --Amgen Inc.  (Nasdaq: AMGN) today announced that the European Commission (EC) has granted marketing authorization for Prolia(R) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein.  The European approval of Prolia marks the first approval of the product worldwide.

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Posted in Press Releases