Fw: F.D.A. Expands Warnings on Anemia Drugs .... NY Times March 7,2008

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NY

Times March 7, 2008 F.D.A.

Expands Warnings on Anemia Drugs By

THE

ASSOCIATED PRESS Filed

at 10:56 p.m. ET WASHINGTON (AP) --

Drug maker Amgen Inc. said Friday it expanded black box warnings about risks of

death and tumor growth of its blockbuster anemia drugs. The warnings approved

by the Food and Drug Administration

state that the company's drugs increased death and accelerated tumor growth in

patients with early stage breast cancer and cervical cancer.

Earlier labeling warned of similar risks in other types of cancer. The changes apply to

Thousand Oaks, Calif.-based Amgen's Aranesp and Epogen, as well as

& 's Procrit. The drugs treat the blood-disorder anemia in patients

with kidney failure and

those on chemotherapy. Amgen manufacturers all

three, though New Brunswick, N.J.-based J & J sells Procrit. The language states

that the problems occurred when doctors treated patients with elevated levels

of the drugs, which increase red blood cell levels. The action came less

than a week before a meeting where government advisers are scheduled to review

the risks of the blockbuster medications. Since FDA began

scrutinizing the drugs last March, shares of Amgen have sunk 27 percent.

U.S. sales of its anemia treatments fell more than 10 percent to $6.3 billion for

the year. Wall Street analysts

expect sales to fall further in 2008 following next week's review by FDA's cancer

experts. The panel could recommend halting use of the drugs for certain types

of cancers, or in all cancer patients. Recommendations will not apply to

Amgen's Epogen, which is used almost exclusively by kidney failure patients on dialysis. If FDA removes only

some cancer indications, Amgen's anemia drug sales could lose between $150

million to $250 million for 2008, according to estimates by Goldman Sachs'

analyst May-Kin Ho. FDA twice updated

anemia drug labels last year, most recently in November. Amgen disclosed new

data in December on the drugs' risks in early stage breast cancer and cervical

cancer patients, sending shares downward nearly 20 percent. The new label

incorporates detail from those studies. Bear Stearns analyst

Mark Schoenebaum said the effect of Friday's changes would be minimal for

Amgen, since cervical cancer accounts for about 1 percent of the Aranesp

market. He also noted that the previous label already highlighted the breast

cancer risks. But Stanford Group Co.

analyst Frykman said the new warnings could attract tougher regulations

from Medicare, the government's health plan

for seniors. Last summer Medicare ruled that it would only pay doctors to

administer anemia drugs if they were prescribed at low levels. Frykman said the new

warnings could convince Medicare to scale back its policy again, perhaps only

paying for the drugs when used in certain types of cancer. Wall Street reacted

positively to the news, sending shares up 1.02 cents, or 2.3 percent, to $45.20

in after-hours trading. Shares fell 14 cents to close at $44.18 in regular

trading.