The company expects 2009 capital expenditures to be approximately $700 million.
Fourth Quarter Product and Pipeline Update
The Company provided updates on selected products and clinical programs.
Denosumab: The Company discussed the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) 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 for either prostate or breast cancer. The BLA submission contains data from six Phase 3 trials involving more than 11,000 patients. The Company has also submitted an application in Canada for these indications.
In the European Union, the Company has submitted an application for the approval of denosumab for treatment of PMO in women, and treatment of bone loss associated with hormone ablation therapy in patients with breast and prostate cancer.
Motesanib: The Company discussed the ongoing MONET1 trial evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC). This trial was temporarily suspended following a planned safety data review of 600 patients by the study's independent Data Monitoring Committee (DMC). The DMC also recommended that patients with squamous NSCLC immediately discontinue motesanib therapy but did not recommend discontinuation of motesanib therapy for patients with non-s
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