Friday, April 11, 2008

Amgen: Denosumab, Part III

CLSDF has been paying particular attention to the clinical development of Amgen’s (NASDAQ: AMGN) Denosumab, a monoclonal antibody that targets RANK Ligand, the essential mediator of osteoclasts - the cells that break down bone (Read Part I HERE and Part II HERE). Now, pivotal Phase III data shows Denosumab increased bone density at multiple skeletal sites in early and later-stage postmenopausal women.

Results from a 24-month, 332-patient Phase III pivotal study in women with early and late-stage postmenopausal osteoporosis was published in the Journal of Clinical Endocrinology and Metabolism. In this study, twice-yearly subcutaneous injections of Denosumab increased bone mineral density (BMD) at all sites measured, including in highly cortical areas of the skeleton. Cortical bone comprises 75 percent of skeletal mass and is a primary determinant of overall strength in vertebral and non-vertebral sites throughout the skeleton. Denosumab treatment significantly increased lumbar spine BMD compared with placebo and also produced significant increases in BMD at the hip, wrist, and total body.

Amgen expects the results of its large, pivotal Phase III registrational study, which will evaluate Denosumab's impact on fracture risk reduction, in women with postmenopausal osteoporosis, in the 2H08.

Next week we should have an update on Amgen’s oncology pipeline of five investigational compounds AMG 102 (a fully human monoclonal antibody that targets the action of hepatocyte growth factor/scatter factor), 386 (a recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins), 479 (a fully human monoclonal antibody that binds to insulin-like growth factor-1 receptor without cross-reacting with the closely related insulin receptor), 665 (a fully human monoclonal antibody agonist directed against Death Receptor 5) and 706 (Motesanib diphosphate is a highly selective, oral agent that is being evaluated for its ability to inhibit angiogenesis and lymphangiogenesis by targeting vascular endothelial growth factor receptors 1, 2 and 3).

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