FDA considers range of restrictions to assure safety of anemia drugs from Amgen and J&J

Shares of Amgen fell to a 52-week low Tuesday ahead of a meeting where regulators will consider limits on the company's anemia drugs, which have been under federal scrutiny for more than a year.

Amgen shares have dropped 26 percent in the last year as safety concerns battered sales of the company's best-selling products. Amgen's stock slipped 6 cents to close at $44.62 Tuesday.

The Food and Drug Administration has toughened warning labels on the anemia drugs — Aranesp, Epogen and Procrit — three times since last March, but now it is considering more drastic action. Amgen manufactures all three drugs, which treat the blood-disorder anemia in kidney-failure or chemotherapy patients, though New Brunswick, N.J.-based Johnson & Johnson sells Procrit.

In documents posted online Tuesday, regulators laid out several options for addressing safety risks, including withdrawing their use for chemotherapy patients.

FDA will ask its panel of outside cancer experts Thursday what action it should take to address growing evidence that the drugs cause blood clots, tumor growth and death.

Thousand Oaks, Calif.-based Amgen saw U.S. sales of Aranesp fall nearly 20 percent last year to $3.2 billion, according to figures from IMS Health Inc., a health care research firm. The company's other anemia drug, Epogen, has been less affected by safety concerns because it is used in patients with kidney dialysis, who face lower risks than cancer patients.

Analysts anticipate lower sales of the drugs in 2008.

Doctors have long used the drugs to raise patients' red blood-cell counts, believing it to be a safer alternative to blood transfusions.

In its review, FDA said that blood transfusions have become much safer since anemia drugs were introduced in the early 1990s. And staffers noted that the drugs never eliminated the need for transfusions, instead just decreased the likelihood a patient would need one by 20 to 30 percent.

FDA will ask its experts if those limited benefits outweigh mounting evidence linking the drugs to increased risk of death.

Scientists from Amgen and J&J are expected to argue that the majority of studies that showed problems with the drugs involved higher-than-recommended doses. But FDA said there is no data to show that lower levels are safer. To find out if they are, the companies have agreed to conduct a large-scale trial, but it will take several years to complete.

Until then, FDA will ask its panel what restrictions should be placed on the drugs.

Panelists will consider several options, from a drastic withdrawal of approval for all chemotherapy patients, to less severe restrictions on uses in certain types of cancer. FDA is not required to follow the panel's advice, though it usually does.

Wall Street estimates Amgen could lose between $750 million to $1 billion in sales if FDA halts use of the drugs in all chemotherapy patients. If the agency only limits use in certain types of cancer, sales could drop off between $150 million to $250 million.

FDA outlined another option for managing the risks of the drugs. Under the plan, patients would have to sign a consent form before starting treatment, and companies would agree to limit promotion and distribution of the drugs.

Amgen has endorsed such an approach.

"It should be up to each fully informed patient in consultation with their physician to decide which treatment approach is in his or her best interest," the company said in a statement Tuesday.

Wall Street analysts had different interpretations of the FDA documents and what they mean for Amgen.

Lehman Bros. analyst Jim Birchenough wrote Tuesday that FDA's consideration of the more benign, risk-management plan suggests regulators are leaning away from withdrawing use of the drug. Birchenough rates the stock "overweight," with a target price of $69.

But Citigroup's Yaron Weber said the documents were "very negative and will likely lead to more restrictions." Weber has a "hold" rating on Amgen, with a target price of $55.