Denosumab increases BMD in ADT patients

US biotechnology major Amgen says its drug candidate denosumab can prevent bone loss in men undergoing androgen-deprivation therapy for non-metastatic prostate cancer, according to findings from a three-year pivotal Phase III trial.

In the study of more than 1,400 men, denosumab produced statistically-significantly greater increases in bone mineral density at the lumbar spine - the primary endpoint - and non-vertebral sites compared with placebo at multiple time points. While analysts were positive about the results, they stressed that they do not guarantee that the drug will perform as well in osteoporosis, a bone loss disorder that mainly affects post-menopausal women and represents the main commercial opportunity for the compound.

Amgen has mounted the largest development program in its history for denosumab in the hopes that it will help recover income lost from its anemia franchise after it was hit by safety concerns last year. Fourth-quarter 2007 sales of Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) fell 39% to $462.0 million and 3% to $638.0 million, respectively.