Amgen Finds Anemia Drug Holds Risks in Cancer Use

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January 26, 2007

Amgen Finds Anemia Drug Holds Risks in Cancer Use

By ANDREW POLLACK

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 & .

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, 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, 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 & 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.

http://www.nytimes.com/2007/01/26/business/26amgen.html?th= & emc=th & pagewanted=pr\

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[Guest guest]

It is unfortunate that most people do not understand that all drugs have side

effects and risks and can kill you. Tylenol which is a drug people take for

granted can cause kidney damage and kill you if abused. The risks are there but

rewards are also there and one must weigh the risks vs. rewards carefully. I

find most people do not ask enough questions of their doctors; either because

they are intimidated or feel that their doctors know it all. Plenty of info on

the internet to read and put together a list of questions for your doctors.

Unfortunately until drugs have been out on the market in large numbers of people

for years (Phase IV studies) some of this information is not found out in the

smaller populations that they do earlier clinical trials (Phase II & Phase III).

I have used Epo, Neupo, Aranesp, Rituxan, Campath, which are all biologicals

with great success. I have also had a BMT and a stem cell transplant over the

past 12 years for CLL and am still here, planning on being around for quite a

while longer.

Dean