CORRECTED – (OFFICIAL)-Amgen drug cuts prostate cancer bone problems

* Denosumab delays bone risk by 18 pct vs Zometa

* No improvement seen in survival

* Jaw problem seen in 22 patients vs. 12 Zometa patients
(Corrects percentage change to 18 percent from 21 percent)

By Deena Beasley

CHICAGO, June 5 (BestGrowthStock) – A third pivotal trial of Amgen
Inc’s (AMGN.O: ) denosumab found that it delayed by 18 percent
the risk of fractures and other bone complications in men with
advanced prostate cancer compared with current therapy.

Amgen filed last month for U.S. Food and Drug
Administration approval of the drug as a treatment for cancer
patients. Earlier this week, the agency approved it, under the
brand name Prolia, for use in post-menopausal women suffering
from osteoporosis.

Denosumab, widely considered the most important growth
driver in Amgen’s development pipeline, is the first in a new
class of drugs designed to inhibit proteins that activate
bone-destroying cells.

Roy Baynes, head of hematology/oncology development at
Amgen, said the latest trial results, to be presented here at a
meeting of the American Society of Clinical Oncology, are
“remarkably consistent” with previous trials in patients with
advanced breast cancer, other solid tumors and multiple

The 1,900-patient trial, which compared denosumab with
Novartis AG’s (NOVN.VX: ) Zometa, showed that the Amgen drug
significantly delayed by 3.6 months, or 21 percent, patients’
first skeletal event, such as a fracture or the need for bone

There was no difference between the two groups in overall
survival or the amount of time patients lived without their
cancer getting worse.

Baynes said the rates of adverse events, including
infections, were similar between the two treatment groups, but
the incidence of low blood calcium levels was more frequent in
the denosumab arm.

Osteonecrosis of the jaw — death of jaw bone tissue — was
seen in 22 patients receiving denosumab, compared with 12
patients receiving Zometa. Baynes said encouraging information
about those patients will be detailed at the oral presentation
of the study here on Sunday.

Amgen expects to announce in the second half of this year
results from a pivotal trial looking at whether use of
denosumab in patients with earlier-stage prostate cancer can
prevent the disease from spreading to the bones.

“We believe we have a molecule that has a very favorable
profile,” Baynes said.

The consensus analyst forecast is for denosumab to reach
about $3.3 billion in sales in 2014, according to Thomson
Reuters data.

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(Editing by Gerald E. McCormick)

CORRECTED – (OFFICIAL)-Amgen drug cuts prostate cancer bone problems