From: Reuters
Published November 30, 2007 07:24 PM

Interim data show Aranesp no help in breast cancer

By Lisa Baertlein

LOS ANGELES (Reuters) - Amgen Inc said on Friday interim results from an independent study involving breast cancer patients found its anemia drug Aranesp did not enhance the effect of chemotherapy prior to surgery.

Amgen shares fell 4 percent to $53 in extended trade as the company also reported preliminary follow-up data showing that the participants who received Aranesp had numerically more deaths and reports of tumor growth than the control group.

The company cautioned that the results -- which land amid concerns about the overuse and safety of the anemia drug class -- were preliminary and said no conclusions should be drawn until the final study report is completed.

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The study, involving 733 patients, was designed to evaluate whether Aranesp prevented anemia and augmented the therapeutic effects of the chemotherapy regimens, Amgen said.

"This interim analysis shows that the use of Aranesp to support neo-adjuvant chemotherapy has no significant impact on tumor response to chemotherapy at the time of surgery," said Dr. Michael Untch, lead investigator of the study conducted by the German Gynecological Oncology Study Group and the German Breast Group.

There were no deaths during the treatment period, researchers said.

Preliminary long-term follow-up data as of October 30 also showed numerically more deaths in the group receiving Aranesp, 50 of 356 patients, compared with 37 deaths among the 377 in the control group.

There also were more tumor progression events in the Aranesp group, 88 of 356, versus the control group's 70 of 377.

"No definitive conclusions should be drawn from the interim results of the long-term follow up until the final study report is completed," Untch said.

A formal statistical analysis of survival is anticipated in early 2009.

Aranesp and its predecessor Epogen were Amgen's top-selling drugs in 2006, reaping combined revenue of $6.6 billion.

Sales of those Amgen drugs totaled $4.5 billion at the end of the third quarter, down 11 percent from the year earlier.

Anemia drugs, which also include products from Johnson & Johnson and Roche Holding AG, accounted for global sales of about $12 billion last year. They are used to treat anemia in cancer and kidney dialysis patients.

The entire class has been under a microscope as debates rage over whether anemia drugs increase the risk of heart attack and stroke, and whether they may play a role in fueling the growth of cancer.

Shares in Amgen, the largest U.S. biotechnology company by revenue, are down 19 percent so far this year.

(Additional reporting by Bill Berkrot in New York)

(Editing by Braden Reddall and Andre Grenon)

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