New Aranesp safety concerns seen in cancer trial

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 Dec. 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 Jan. 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 Jan. 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 US$1.1 billion in the fourth quarter of 2006 for the world’s largest biotechnology company, a 27 percent jump over 2005.

Morgan Stanley analyst Steven Harr said in a research note that given mounting safety concerns, investors may have to dial back their future expectations for Aranesp sales.

“This trial raises the question again of whether Aranesp promotes cancer growth, and given some previous trials with similar conclusions and the recent negative data in other areas we expect physicians and regulators are likely to continue to question the proper role of Aranesp, Epogen, and other drugs in the treatment of anemia,” Harr said.

“The multiple threats facing Amgen’s anemia franchise are likely to challenge expected growth rates over the next several years, and investor growth expectations likely need to decrease,” Harr said.

Amgen shares closed down US$1.55, or 2.3 percent, at US$66.73.

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