| "ZURICH (Reuters) - Swiss drugmaker Roche Holding AG said on Friday it 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 is temporarily suspending recruitment of anemic lung cancer patients into a mid-stage trial of CERA (Continuous Erythropoiesis Receptor Activator) because of an "imbalance" of deaths across the four arms of the study. " "The company said the 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 comprised of the natural protein erythropoietin may feed cancerous tumors and help them grow. " "Analysts said the news represents a double-edged sword for 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 roughly $4 billion. " "The news will likely add to growing concern among regulators about the safety of all erythropoietin drugs, especially when given in higher doses, and it may 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 ... read the whole article |