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6/5/2003

Amgen study touts effectiveness of less-is-more anemia drug

By Denise Gellene
Los Angeles Times

When it comes to defending its anemia drug business, Amgen Inc. of Thousand Oaks, Calif., is betting that less is more.

Last weekend, the biotech giant released data from a large clinical trial suggesting that patients who take shots of its drug Aranesp every two weeks do as well as those who take weekly shots of Procrit, a rival drug from Johnson & Johnson.

Amgen hopes the study will persuade Medicare to raise payments for Aranesp, which is now reimbursed at a lower rate than market leader Procrit in hospital outpatient clinics. Such clinics account for 10 percent of Aranesp sales.

Medicare payments for anemia drugs used by cancer patients exceed $1 billion annually.

Amgen and J&J; are heated rivals in the anemia drug business. The rivalry dates to the 1980s, when Amgen licensed Procrit to J&J.; Aranesp is a longer-acting version of Procrit that Amgen is using to take back the business it ceded to J&J.;

Medicare said Tuesday that it had received Amgen’s data and was “looking at it.” However, a spokesman for the agency noted the research hadn’t been published in a “peer-reviewed medical journal”; such studies typically have more weight with the agency.

Amgen presented its results at the annual meeting of the American Society of Clinical Oncology in Chicago. The Amgen study involved 1,173 anemic cancer patients, many of them women with breast cancer. They received Aranesp shots every other week for 15 weeks.

At the end of the trial, hemoglobin levels in 71 percent of patients rose by 2 grams per deciliter. The outcome is similar to that in patients in previous tests who received weekly Procrit, said Douglas W. Blayney of Wilshire Medical Oncology Group, an investigator in the Amgen-sponsored trial.

Hemoglobin is a protein in the blood that carries oxygen and used to measure anemia, which is caused by a lack of red blood cells. Chemotherapy treatments can deplete red blood cells in cancer patients and Aranesp and Procrit boost the production of red blood cells.

J&J; disputed Amgen’s contention that one dose of Aranesp equals two doses of Procrit. Hemoglobin rises faster in patients who receive the standard weekly dose of Procrit, said Scott McKenzie, a research director for J&J; unit Ortho-Biotech, which markets Procrit.

Amgen’s study is part of an effort to persuade Medicare to revise the formula it uses to calculate reimbursement for anemia drugs. The current payment formula considers a weekly dose of Procrit the “functional equivalent” of a weekly dose of Aranesp. Amgen argues that the ratio is wrong, but until now did not have a large research study to use as evidence.

If Medicare accepts the study, Aranesp would be more competitive to Procrit in hospital outpatient clinics and possibly cheaper than the rival drug, Amgen said.

However, Medicare said it wanted to see well-controlled, head-to-head studies comparing the two drugs, which to date haven’t been completed by either company. The National Cancer Institute plans to launch such a study for Medicare but it won’t be completed by fall when the agency must set its drug reimbursement rates for next year.

Amgen closed up 51 cents at $64.06 on NASDAQ; J&J; closed up 63 cents at $53.85 on the New York Stock Exchange.