DOW JONES NEWSWIRES
Amgen Inc.'s (AMGN) denosumab showed promise in a pivotal trial
of the compound's ability to preserve bone integrity in cancer
patients.
But shares were down 1.6% after-hours to $61.86. The stock, up
more than 33% in value since late April, is off only 7.5% from the
52-week high of $66.51.
Amgen has been touting the compound, which could be a
blockbuster drug. A month ago, the drug company released results of
a similar study that found the bone drug was superior to Novartis
AG's (NVS) Zometa in preventing complications related to the spread
of cancer to bones.
The U.S. Food and Drug Administration is also reviewing
denosumab as a treatment for osteoporosis and bone loss caused by
hormone treatment in patients with breast and prostate cancer. The
drug is widely expected to gain approval in October on the strength
of several successful trials and a clean safety profile.
On Monday, Amgen said the treatment met its primary endpoint in
a Phase 3 trial, comparing time to the first bone-related incident
in the patients versus Zometa. The time to a subsequent event, the
secondary endpoint, was also better than Zometa's, though not by a
statistically significant amount.
"We are extremely pleased with these results, which continue to
demonstrate that inhibiting RANK Ligand with denosumab provides a
clinically meaningful benefit for advanced cancer patients with
solid tumors that have metastasized to the bone, and to patients
with multiple myeloma, both groups who routinely suffer SREs," said
Amgen Executive Vice President Roger M. Perlmutter of
skeletal-related events such as fractures.
-By Jay Miller, Dow Jones Newswires; 212-416-2355;
jay.miller@dowjones.com
(Thomas Gryta contributed to this report.)