FDA Expands Warnings on Anemia Drugs

FDA Expands Warnings on Anemia Drugs
March 10, 2008

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 Johnson & Johnson'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 Gregory 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.

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