Amgen Sees Positive Data In Bone Drug Study
From Associated Press (February 9, 2010)
THOUSAND OAKS, Calif. -- 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.
Posted: February 2010
