Amgen says higher death risk seen in Aranesp trial

By Ransdell Pierson

NEW YORK (Reuters) - Amgen Inc. on Thursday disclosed negative findings in studies of its Aranesp anemia drug and Vectibix colon cancer treatment, including a higher risk of death among cancer patients not undergoing chemotherapy who were treated with Aranesp.

"There was a statistically significant increased risk of death in the Aranesp-treated group," Amgen said in a release, although no specific unexplained safety concerns could be identified in the late-stage trial. It involved patients with anemia and active cancer who were not receiving chemotherapy or radiation.

"These were patients with an especially dire prognosis," said Roger Perlmutter, Amgen's executive vice president of research and development.

The company said that at the end of 16 weeks, the trial showed no statistically significant difference in the frequency of blood transfusions in the population receiving placebo injections as opposed to those receiving Aranesp.

Perlmutter said the data provides "a lot of hypotheses to test," and Amgen is conducting further studies.

Patients with anemia often need blood transfusions to restore their levels of hemoglobin, the red component of blood that carries oxygen to the rest of the body.

Drugs like Aranesp, whose active ingredient is a natural protein called erythropoietin (Epo), treat anemia by boosting the body's production of red blood cells. Aranesp is Amgen's biggest product, with annual sales trending at more than $4 billion.

Amgen said results of the trial suggest that the risk of taking Aranesp is not warranted for patients with unexplained anemia and active cancer -- who are not in remission and not receiving chemotherapy.

"The risk/benefit ratio for Aranesp use is at best neutral and perhaps negative" for such patients, Amgen said.

Amgen's announcement comes on the heels of a study that cast a negative light on Procrit, Johnson & Johnson's own form of erythropoietin, and possible over-use of such medicines.

The U.S. Food and Drug Administration in November said it would review the study, which showed that kidney disease patients treated more aggressively with Procrit had a higher risk of cardiac complications and death.

The study found that patients given higher doses of Procrit to drive their hemoglobin levels to 13.5 grams per deciliter were more likely to die, have a heart attack or stroke or be hospitalized than patients targeted to reach more moderate hemoglobin levels of 11.3 grams per deciliter.

SETBACK FOR COLON CANCER DRUG

Amgen on Thursday also cited negative data from another trial, involving the first 500 of more than 1,000 patients with metastatic colorectal cancer. The main purpose of the study was to assess whether Vectibix could delay a worsening of their symptoms.

A secondary objective of the trial was to determine the response rate among patients, meaning reduction in the size of their tumors.

Response rates were similar in those receiving Vectibix in combination with standard treatment -- meaning with Genentech Inc.'s Avastin as well as chemotherapy -- and patients who received standard therapy alone, Amgen said.

Moreover, data from the PACCE study showed an increased incidence of diarrhea, dehydration and infection among those taking Vectibix.

Amgen said the side effects are already included in the drug's package insert label.

Amgen, whose shares fell 2 percent in after-hours trading, described the setbacks for Aranesp and Vectibix late Thursday in a press release detailing its fourth-quarter earnings.

(Additional reporting by Deena Beasley in Los Angeles)