Aranesp News

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Posted: Fri Jan 26, 2007 1:14 pm Post subject: Aranesp News

http://www.nytimes.com/2007/01/26/busin ... ref=slogin

Amgen Finds Anemia Drug Holds Risks in Cancer Use

By ANDREW POLLACK

Published: January 26, 2007

LOS ANGELES, Jan. 25 — Amgen, the biotechnology company, said Thursday that its anemia drug Aranesp increased the risk of death when used to treat certain cancer patients, a finding that will probably raise more questions about it and similar drugs.

Almost one million Americans a year receive prescriptions for Aranesp or one of two similar products — Epogen from Amgen and Procrit from Johnson & Johnson.

Combined global sales of the three products, which increase the number of oxygen-carrying red cells in the blood, are around $10 billion.

But concern has been rising about the risks from overuse of the drugs. A study published in The New England Journal of Medicine in November found that kidney disease patients treated aggressively with Procrit had a 34 percent higher risk of heart problems or death than those treated less aggressively.

An expert panel of doctors for the National Kidney Foundation is now assessing whether to change guidelines for how patients should be treated.

The latest trial was an attempt by Amgen to expand the use of Aranesp to a new group of patients: those with anemia presumably caused by their cancer. Aranesp is now approved to treat anemia caused by cancer chemotherapy but not by the cancer itself.

The 1,000 patients in the trial had active cancer, meaning they were not in remission, but were not getting chemotherapy or radiation therapy. The goal of the trial was to see if Aranesp could reduce the need for blood transfusions, which anemic people frequently require.

The company found that the drug did not reduce the need for transfusions compared with a placebo, but did increase the number of deaths by the end of 16 weeks by a statistically significant amount.

Amgen, which did not provide any numerical results from the trial, said in a news release that in this particular population the “risk/benefit ratio for Aranesp use is at best neutral and perhaps negative.”

While such use of Aranesp is not approved, doctors do use it off label for that purpose. On a conference call Thursday with securities analysts, George Morrow, Amgen’s executive vice president for global commercial operations, estimated that about 10 percent to 12 percent of Aranesp sales are for such “anemia of cancer.”

Amgen announced the results of the trial along with its fourth-quarter earnings after the close of trading. The company’s shares fell by $2.37, or 3 percent, to $72.48 in after-hours trading, after closing in regular trading at $74.85, down 29 cents.

Several factors could have contributed to the shares’ decline besides the trial results. Amgen’s earnings per share, excluding special items, while up 20 percent for the quarter, were below analyst estimates. The company also announced somewhat disappointing results in a clinical trial involving Vectibix, its recently approved colon cancer drug.

Still, some analysts on the conference call were clearly concerned that the Aranesp results could lead to a cutback in use of Aranesp and Epogen. The two drugs accounted for $6.6 billion, or 46 percent, of Amgen’s $14.3 billion in 2006 revenue.

Amgen executives said that the trial was not intended to measure survival, so it was possible that the patients in the group that received Aranesp might have had a greater risk of dying to begin with than those in the placebo group. They said the results could not be extrapolated to other types of patients, like those getting chemotherapy or those with kidney disease.

Still, Kevin Sharer, Amgen’s chief executive, conceded it was possible that the growing concerns over safety could lead to the drugs’ being given a black-box warning, the strongest kind.

In 2003 Johnson & Johnson halted several studies of Procrit in cancer patients after they developed a higher-than-expected number of blood clots. In those trials, doctors were trying to treat the anemia more aggressively in hopes that an increase in oxygen in the blood would increase the effectiveness of chemotherapy or radiation therapy.