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Safety an issue in anemia drug test

Roche's suspension of enrollment for the trial could be good news for U.S. rival Amgen.

February 24, 2007|From Reuters

Swiss drug maker Roche Holding said Friday that it had suspended enrollment in a clinical trial of its experimental anemia drug because of safety concerns.

The news casts a further cloud over a class of drugs that include Amgen Inc.'s Aranesp and Epogen, and Johnson & Johnson's Procrit.

Roche said it was temporarily suspending recruitment into a mid-stage trial of its drug, Cera, in anemic lung cancer patients because of an "imbalance" of deaths across the four arms of the study.

The company said deaths were unrelated to the study drugs and there appeared to be no association of the events to excessive levels of hemoglobin, the red component of blood that carries oxygen to the rest of the body.

Roche said the deaths were driven in part by the progression of the cancer, a finding that can only fuel a growing concern that drugs composed of the natural protein erythropoietin might feed cancerous tumors and help them grow.

Analysts said the news represented a double-edged sword for Thousand Oaks-based Amgen, the world's biggest biotechnology company, which has been seeking to block Cera from entering the U.S. market and competing with its largest products. Aranesp alone generates annual sales of about $4 billion.

Amgen executives were not immediately available for comment.

The news probably will add to growing concern among regulators about the safety of all erythropoietin drugs, especially when given in higher doses, and it might make it less likely that Cera will be approved by the U.S. Food and Drug Administration -- a potential boon to Amgen.

"Approving Cera has to have fallen a few notches on the FDA's to-do list," said Christopher Raymond, an analyst at R.W. Baird & Co. "This is unequivocally good news for Amgen."

Roche did not reveal the number of deaths in each of the four arms of the trial, which compared patients taking different doses of Cera with patients taking Aranesp.

Raymond and others infer there were more deaths in the Cera arms of the trial than in the Aranesp arm.

Amgen shares fell 51 cents to close at $66.23 on Friday. Shares of Johnson & Johnson slipped 25 cents to $64.15.

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