Swiss trial Halted Sad results

[RandyW]

Swiss drugmaker Roche Holding AG said Friday it had temporarily suspended recruitment in a Phase II trial for its experimental Cera drug in anemic patients with lung cancer who are receiving chemotherapy.

The suspension casts another cloud over the class of drugs, whose active ingredient is a natural protein called erythropoietin (Epo) and which treats anemia by boosting the body's production of red blood cells.

The news comes just a month after Amgen Inc. (down $0.07 to $66.67, Charts) disclosed negative findings in studies of its Aranesp anemia drug, including a higher risk of death among cancer patients not undergoing chemotherapy who were treated with Aranesp.

The trial was divided into four arms, three of which tested different doses of Cera and the other Aranesp, said Christopher Raymond, analyst at R.W. Baird & Co.

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If approved in the United States, Cera would compete with Amgen's Aranesp, used to treat anemia in cancer and kidney dialysis patients.

Amgen is suing Roche for patient infringement. The case is slated to go on trial in September.

"This is unequivocally good news for Amgen," Raymond said.

Roche said it had suspended enrollment in the trial, for patients with advanced non-small-cell lung cancer, due to an imbalance in the number of deaths across the four parts of the study. Further details were not immediately available.

Roche is investigating the causes of the imbalance. Suspending enrollment will allow an in-depth analysis of the data and potentially allow recruitment to restart, Roche said.

"The investigators reported all deaths to be unrelated to the study drugs," Roche said. "There appears to be no association of these events to excessive hemoglobin levels or the administered doses based on the current review of the data."

Another study found that kidney disease patients treated more aggressively with Procrit, Johnson & Johnson's (down $0.35 to $64.06, Charts) own Epo, had a higher risk of cardiac complications and death.

Aranesp is Amgen's biggest product, with annual sales typically more than $4 billion.

Many industry analysts believe Cera could generate global sales of over $2 billion annually.