WIDER USE NEAR FOR ANEMIA DRUG AMGEN'S ARANESP TO BE APPROVED FOR CANCER PATIENTS.

Byline: Evan Pondel Staff Writer

THOUSAND OAKS - U.S. regulators are poised to approve Amgen Inc.'s Aranesp to treat cancer patients stricken with anemia, a move that enlivens competition with a similar drug marketed by Johnson & Johnson.

With more than 300,000 patients suffering from chemotherapy-induced anemia, Amgen is attempting to ease a complication of cancer with a drug that's already drawn success. Last September, the Food and Drug Administration approved Aranesp to fight anemia. Administered less frequently than other anemia drugs, Aranesp has already gained notable market share.

``But with the approval of Aranesp in an oncological setting, it's a milestone for Amgen,'' said Dennis Harp, an analyst with Deutsche Bank in New York. ``It allows the company to aggressively market its product and compete.''

That competition pits Thousand Oaks-based Amgen against Johnson & Johnson's Procrit, a drug that has already established a significant community of devotees. When Procrit sales are coupled with its European counterpart Eprex, they accounted for 10 percent of Johnson & Johnson's $33 billion in revenues for 2001.

``Eventually, over time though, a majority of the market will convert to Aranesp,'' Harp said. ``Amgen will just have to convince doctors to try Aranesp.''

Dr. Robert Smith, president of South Carolina Oncology Associates, is already familiar with the drug. He's been using Aranesp for about two years under research conditions. Unlike other drugs with similar properties, Smith said Aranesp has been extremely effective, without causing a trove of toxic side effects.

Anemia is characterized by a shortage of oxygen-carrying red blood cells that normally fuel the body. When a patient's kidneys aren't functioning properly, the body isn't able to produce enough erythropoietin, which stimulates production of red blood cells.

Aside from the value of Aranesp in combating this condition, its approval would also make the drug more accessible to those who couldn't afford an off-label version. Smith said Medicare has covered the drug in the past, but now with the OK from regulators, other insurers will soon add Aranesp to their arsenal.

``Without that FDA approval, reimbursements require a lot of paperwork that becomes clumsy and almost awkward after some time,'' Harp said.

With the introduction of Aranesp in the oncology market, Amgen also stands to fortify its financial health. Amgen shares have been teetering near their 52-week low ever since the biggest biotechnology company announced its acquisition of Immunex. The cash-and-stock deal was valued at $16 billion initially, although it fell to less than $10 billion upon its completion.

Amgen shares declined $3.18, or 8.6 percent, to close Thursday at $33.92. Craig West, an analyst with A.G. Edwards & Sons Inc. in St. Louis, said he anticipates Aranesp sales north of $300 million in 2002 pending its approval. ``But it is obviously difficult to predict such figures,'' West said. ``I do know that all eyes will be on Aranesp if the drug is approved for oncology.''

Warnings about the safety of Johnson & Johnson's Eprex may also invoke more interest in Aranesp. The New Brunswick, N.J.-based company warned kidney patients on Wednesday not to inject its blood-boosting drug.

Johnson & Johnson officials said 141 people had suffered serious side effects from Eprex, including one death. Eprex, a synthetic version of a hormone called EPO, has been linked to inducing a condition known as antibody-mediated pure red blood cell aplasia or PRCA. West said Aranesp could certainly benefit from the spate of bad news circulating about Eprex. What's interesting, he said, is that Eprex is under license from Amgen, while Procrit is manufactured by Amgen.

``But until Aranesp is actually approved in the oncological setting, we'll never know the fate of Procrit or Eprex,'' West said. ``Wall Street will just have to wait.''