Clinical trial data disappoint Amgen investors

Amgen says that a new trial of its anemia drug Aranesp indicated a higher risk of death among patients with anemia caused by cancer. Aranesp is currently approved to treat anemia caused by chemotherapy and Amgen has been looking to broaden its approval for the drug. The new data raises new questions about the risks posed by Aranesp as well as two similar drugs--Epogen and Procrit--with a combined $10 billion market. Last November a separate study concluded that Procrit increased the risk of death among kidney disease patients by 34 percent.

In the Aranesp trial researchers were exploring whether the therapy could reduce the number of blood transfusions to combat anemia. The trial concluded that the drug did not reduce the number of transfusions but did increase the number of patients in the group by a statistically significant amount. Even though the drug is not approved to treat anemia from cancer, a company official estimated that up to 12 percent of the sales of Aranesp are for the off-label use of the drug for that indication.

In addition, Amgen said a new study of Vectibix as a front line therapy against advanced colon cancer failed to demonstrate any advantage over standard therapy. Vectibix is approved for patients who have failed to respond to chemotherapy. Several analysts said that the pair of disappointing results cast a significant pall over Amgen's ability to grow revenue.

- check out Amgen's press release on the data
- read the article on Aranesp from The New York Times

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