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Aranesp Data Dents Amgen

Adam Feuerstein

Amgen(AMGN Quote) released Friday an interim analysis from another cancer study of Aranesp that showed the anemia drug doesn't help patients, and may in fact harm them.

Executives with the Thousands Oak, Calif.-based biotech firm cautioned that the results from the independent study conducted by a German cancer group are preliminary and therefore no firm conclusions should be made.

But the news, released after the close of regular trading, sent shares of Amgen down $2.25, or 4%, to $53 in the after-hours session. The stock ended regular trading down 21 cents to $55.25.

Amgen shares have been battered all year because of falling sales of its two anemia drugs, Aranesp and Epogen, because of safety concerns.

The German study enrolled 733 breast cancer patients undergoing chemotherapy to shrink their tumors before surgery. One group of patients was given Aranesp in addition to chemotherapy to determine if the anemia drug would augment the effect of the chemotherapy.

It didn't. The study investigators found that there was no significant difference in tumor shrinkage between the Aranesp and control arms of the study.

Patients enrolled in this study are also being followed long term to measure survival and progression of their cancer. After a median follow-up of two years, patients given Aranesp with chemotherapy prior to surgery are reporting numerically more deaths and tumor progressions than patients given chemotherapy alone before surgery.

This is the negative survival signal against Aranesp that has investors concerned, especially since it's not the first study that's linked Aranesp to bad results for cancer patients. In February, an analysis of a Danish study of Aranesp in head and neck cancer patients also showed that use of the anemia drug led to worse outcomes for patients.

Roy Baynes, an Amgen vice president of clinical development, says it's premature to pass judgment on Aranesp's role in survival in this study because patients are still being followed. A formal statistical analysis of survival in this trial will be conducted in early 2009.

In a statement provided by Amgen in its press release, the study's principal investigator, Dr. Michael Untch, agrees: "No definitive conclusions should be drawn from the interim results of the long-term follow up until the final study report is completed," he said.

Baynes also points out that Aranesp was used in the German breast cancer study to maintain hemoglobin levels in patients at a higher level than what is considered safe today.