Wednesday, February 18, 2009

FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab

THOUSAND OAKS, Calif. – Feb. 18 – Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen’s submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer.

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Posted in Press Releases, Pipeline News

Wednesday, February 11, 2009

Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial

THOUSAND OAKS, Calif. and CAMBRIDGE, Mass., Feb. 11 and OSAKA, Japan – Feb. 12, 2009 – Amgen (Nasdaq: AMGN), Millennium: The Takeda Oncology Company, and its parent company Takeda Pharmaceutical Company Limited (TSE:4052) today announced the Independent Data Monitoring Committee (DMC) for the MONET1 trial has recommended the trial resume enrollment of patients with non-squamous non-small cell lung cancer (NSCLC) following a three-month enrollment suspension. MONET1 is a Phase 3 study evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced NSCLC. Motesanib is part of a co-development program between Amgen, Millennium and Takeda.

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Posted in Press Releases

Friday, February 06, 2009

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

First and Only Approved Platelet Producer in Europe Represents New Treatment Approach for Serious Chronic Autoimmune Disorder

ZUG, Switzerland – Feb. 6 – Amgen (Nasdaq: AMGN) today announced that the European Commission (EC) has granted marketing authorisation for Nplate(R) (romiplostim) for the treatment of splenectomised adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as second line treatment for adult non-splenectomised ITP patients where surgery is contra-indicated.

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Posted in Press Releases, Product News

Monday, January 26, 2009

Amgen's Fourth Quarter 2008 Adjusted Earnings Per Share Increased 6 Percent to $1.06; Full Year 2008 Adjusted Earnings Per Share Increased 6 Percent to $4.55

Full Year 2008 Revenue Increased 2 Percent to $15.0 Billion; Fourth Quarter 2008 Revenue Flat at $3.75 Billion

Full Year 2008 GAAP Earnings Per Share Increased 38 Percent to $3.90; Fourth Quarter 2008 GAAP Earnings Per Share Increased 20 Percent to $0.91

2009 Total Revenue Expected to be in the Range of $14.8 to $15.2 Billion

2009 Adjusted Earnings Per Share Expected to be in the Range of $4.55 to $4.75

 

THOUSAND OAKS, Calif. – Jan. 26 – Amgen (Nasdaq: AMGN) reported adjusted earnings per share (EPS), excluding stock option expense and certain other expenses, of $1.06 for the fourth quarter of 2008, an increase of 6 percent compared to $1.00 for the fourth quarter of 2007. Adjusted net income, excluding stock option expense and certain other expenses, increased 3 percent to $1,124 million in the fourth quarter of 2008 compared to $1,088 million in the fourth quarter of 2007. Stock option expense on a per share basis totaled 2 cents and 3 cents in the fourth quarter of 2008 and the fourth quarter of 2007, respectively.

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Posted in Press Releases

Thursday, January 22, 2009

Amgen's Breakaway from Cancer Initiative Expands to Help Cancer Patients Access Broad Spectrum of Cancer Resources and Services

THOUSAND OAKS, Calif. – Jan. 22  – In an ongoing effort to raise awareness of the comprehensive continuum of resources available to cancer patients and their caregivers—from prevention to education, patient care to advocacy and financial support --Amgen’s Breakaway from Cancer(TM) initiative has expanded its charitable partners to now include the National Coalition for Cancer Survivorship, Patient Advocate Foundation, Prevent Cancer Foundation and The Wellness Community.

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Posted in Philanthropy