New Aranesp safety concerns seen in cancer trial

By Bill Berkrot

NEW YORK (Reuters) - Amgen Inc.'s (AMGN.O) multibillion-dollar anemia drug Aranesp is facing further safety concerns after a medical newsletter reported on Friday that a Danish study of the drug in head and neck cancer was halted due to adverse outcomes seen in patients taking part.

Amgen shares fell more than 2 percent on Nasdaq.

The report in The Cancer Letter said the study was temporarily halted in October after an interim analysis of the first 484 patients turned up a statistically significant increase in disease recurrence in patients receiving Aranesp.

It said a decision not to resume the study was made on December 1 as investigators felt that Aranesp appeared unlikely to improve the effect of radiation in non-anemic cancer patients.

The trial was conducted by the Danish Head and Neck Cancer Group (DAHANCA) and Amgen said it has no control over data from studies done by outside investigators.

"We have not had access to any of their results. It's their data, it's not our data," Roger Perlmutter, Amgen's executive vice president for research and development, told industry analysts on a conference call.

"We don't know anything about the data other than what was posted on the (DAHANCA) Web site."

Amgen said it informed U.S. and European health regulators about the cessation of the study as soon as it was told.

"We are aware of the study data and are looking at it as part of our ongoing assessment of the safety and efficacy of this class of drugs," FDA spokeswoman Karen Riley said.

But Amgen did not disclose the information to analysts and investors during a January 25 conference call on its quarterly results. Company officials acknowledged on Friday it probably should have mentioned the trial halt at the time.

Amgen said full data from the DAHANCA study will not be available until later this year.

It was during that January 25 call that Amgen revealed a statistically significant increased risk of death seen in a different study of cancer patients not undergoing chemotherapy who were treated with Aranesp.

There has been speculation that the drug, which fights anemia in chemotherapy and kidney dialysis patients by boosting production of red blood cells, may be feeding cancerous tumors. Studies have attempted to demonstrate that oxygenation of tumors with Aranesp could improve tumor reaction to treatments such as radiation.

"We believe Aranesp poses no additional risks other than those that appear on the label when used to treat chemotherapy induced anemia," Perlmutter said of the use for which Amgen receives the lion's share of Aranesp revenue.

Aranesp had sales of $1.1 billion in the fourth quarter of 2006 for the world's largest biotechnology company, a 27 percent jump over 2005.