Monday, July 14, 2008

Amgen Announces Positive Top-Line Results for Denosumab Treatment of Bone Loss in Men With Non-Metastatic Prostate Cancer Undergoing Androgen Deprivation Therapy

 Data From First Pivotal Study in Men Met Primary Endpoint of Increases in Bone Mineral Density and Secondary Endpoint of New Vertebral Fracture Reduction

THOUSAND OAKS, Calif. – Jul 14, 2008 – Amgen (NASDAQ:AMGN) today announced findings from a three-year pivotal Phase 3 placebo-controlled trial evaluating denosumab in the treatment of bone loss in men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer.

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Posted in Press Releases, Pipeline News

Thursday, July 10, 2008

Amgen Commits to PhRMA's Enhanced Code on Interactions with Healthcare Professionals as Part of the Company's 'Clearly Amgen' Initiative

 THOUSAND OAKS, Calif. – July 10, 2008 – Amgen (NASDAQ: AMGN) today announced its intent to comply with the Pharmaceutical Research and Manufacturers of America’s (PhRMA) revised "Code on Interactions with U.S. Healthcare Professionals." The company’s announcement of its voluntary support for the Code is the latest element of Clearly Amgen, the company’s ongoing initiative to provide clear communications about and easy access to Amgen’s policies and practices on ethical research, clinical data disclosure, responsible marketing and other topics of interest to Amgen stakeholders.

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Posted in Philanthropy, Press Releases

Thursday, June 26, 2008

New Data Show Preemptive Treatment May Significantly Reduce Skin Toxicities in Patients Receiving Vectibix(R) (Panitumumab)

Study Adds to Body of Evidence on KRAS Mutational Status As a Predictive Biomarker of Vectibix Response

 BARCELONA, Spain – June 26, 2008 – Amgen (NASDAQ: AMGN) today announced updated results from the STEPP (Skin Toxicity Evaluation Protocol with Panitumumab) trial, the first prospective study to examine differences between preemptive and reactive skin treatment for skin toxicities in metastatic colorectal cancer (mCRC) patients receiving epidermal growth factor receptor (EGFr) therapy. The analysis found that preemptive treatment reduced the incidence rate of grade 2 and greater skin toxicities by over 50 percent without additional side effects when compared to reactive skin treatment. The incidence of grade 3 or greater skin toxicities were 62 percent and 29 percent in the reactive and preemptive treatment groups respectively (odds ratio (95 percent CI): 0.3 (0.1. 0.6)). These data were presented at the 10th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

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Posted in Press Releases, Product News

Wednesday, June 18, 2008

Amgen and Wyeth Statement on Outcome of Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting

 FDA Advisory Committee Recommends Enbrel(R) (etanercept) for the Treatment of Children and Adolescents with Chronic Moderate to Severe Plaque Psoriasis

THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa. – June 18, 2008 – Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today issued the following statement on the outcome of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmologic Drug Advisory Committee (DODAC) regarding the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis.

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Posted in Press Releases, Product News

Wednesday, June 18, 2008

Enbrel(R) (etanercept) Application for the Treatment of Pediatric Psoriasis to be Discussed at FDA Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting

 ENBREL Reviewed As Potential New Treatment Option for Children and Adolescents with Chronic Moderate to Severe Plaque Psoriasis Who Have Tried Another Therapy

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 18, 2008--Amgen (NASDAQ:AMGN) announced that the supplemental Biologics License Application (sBLA) for ENBREL for the treatment of pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy will be discussed today at a meeting of the DODAC. Moderate to severe plaque psoriasis is a serious, chronic inflammatory disease that can have both physical and psychosocial impact. According to a study published in the British Journal of Dermatology, chronic psoriasis can have as much of an impact on a child’s physical, psychological and social functioning as other serious childhood diseases such as asthma, epilepsy and diabetes.

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Posted in Press Releases, Product News