Amgen Sees Positive Data in Bone Drug Study
THOUSAND OAKS, Calif. (AP) — Amgen Inc. said its osteoporosis drug candidate denosumab beat a rival drug in reducing and delaying the rate of fractures in men with prostate cancer during a study.
The drug, also called Prolia, is viewed by Wall Street as Amgen's next blockbuster product and a way to revive the company's revenue. It is under review by the Food and Drug Administration for several uses, including postmenopausal osteoporosis and as a treatment for bone loss in breast and prostate cancer patients undergoing therapy.
The latest study pitted denosumab against Novartis' Zometa and involved 1,901 men with advanced prostate cancer. Amgen said denosumab met all its key goals in the study and the results were statistically significant, though it provided no details. It hopes to present full study results in June at the American Society for Clinical Oncology's meeting.
Side effects were similar between the two drugs, except there were 22 cases of osteonecrosis of the jaw with denosumab, compared with 12 cases with Zometa. The condition involves a loss of blood to the jaw resulting in death of the bone tissue.
Amgen plans to send the test results, along with prior test data, to the FDA later this year as part of a package for denosumab's use in advanced cancer patients.
Shares of Amgen fell 37 cents to $57.09 in morning trading Tuesday.