Denosumab's competitive profile

With most of the data now in, Amgen Inc. has steadily built evidence that its denosumab is working in osteoporosis. Assuming no surprises emerge from full disclosure of its FREEDOM trial next month, attention will turn to the opportunity for the company to carve out a substantial market niche for the antibody, based on the agent’s infrequent dosing regimen and the tolerability problems associated with marketed oral bisphosphonates.

Denosumab is a human mAb targeting receptor activator of NF-kappa B ligand (RANKL) that works by blocking bone resorption. Since the beginning of June, the company has been disclosing Phase III data showing the drug has consistently reversed bone loss in clinical trials in patients with osteoporosis or bone-metastatic cancers (see BioCentury, June 2 & July 21)...