DOW JONES NEWSWIRES
Amgen Inc. (AMGN) said its Aranesp anemia drug had no
statistically significant effects on patients with kidney disease,
anemia and type-2 diabetes in a Phase III trial, dubbed Treat.
"In contrast to a recent, smaller study of ESAs in a similar
patient population, Treat did not show a statistically significant
adverse effect on all-cause mortality or cardiovascular morbidity
when patients were treated to a hemoglobin target of 13 g/dL. We
continue to believe that ESAs have a favorable benefit:risk profile
when used according to the approved label."
But the study did show an increase in strokes among patients
The primary endpoints were composites of time to all-cause
mortality or cardiovascular morbidity - including heart failure,
heart attack, stroke, or hospitalization for myocardial ischemia -
and of time to all-cause mortality or chronic renal replacement
The U.S. Food and Drug Administration approved Aranesp in 2001
for the treatment of anemia in patients with chronic renal failure,
including those on dialysis. The next year, the agency also
approved the drug for the treatment of anemia caused by
chemotherapy in patients with nonmyeloid malignancies.
Sales growth of Amgen's anemia drugs Epogen and Aranesp began
evaporating in 2007, when studies showed a link to risks of
cardiovascular disease, cancer progression and death.
In the second quarter, sales of Aranesp dropped 16% to $693
million but still surpassed the Wall Street consensus estimate of
$648 million, according to MDRx Financial. The drop in sales came
from label changes in the drug last summer that restricted the
drug's use in cancer patients, the company said.
Sales of Epogen, an earlier version of Aranesp, rose 3% to $638
million, also beating expectations of $600 million. The increase
was driven by patient growth, as well as a price increase.
Amgen's shares fell 0.2% to $60.45 in after-hours trading. The
stock is down about 5% for the past year.
-By Kathy Shwiff, Dow Jones Newswires; 212-416-2357;