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Amgen and Abgenix Complete Biologics License Application for FDA ...

... PharmaLive: Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab FILED FOR APPROVAL Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab THOUSAND OAKS, Calif.

& FREMONT, Calif.-(BUSINESS WIRE)-March 30, 2006 - Amgen (Nasdaq: AMGN) and Abgenix, Inc.

(Nasdaq: ABGX) today announced that Amgen has completed the Biologic License Application (BLA) submission with the U.S.

Food and Drug Administration (FDA) for panitumumab.

The potential indication is for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens.

The rolling BLA submission was initiated in December 2005.

"The pivotal Phase 3 study of panitumumab not only met the primary endpoint of improving progression-free survival in patients with metastatic colorectal cancer, but the results surpassed our expectations based on preset measurement criteria in the protocol," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen.

"Completing the BLA brings us one step closer to realizing our goal of making panitumumab accessible to patients with metastatic colorectal cancer who have failed available treatment options." Amgen and Abgenix previously announced that data from a randomized Phase 3 trial involving 463 patients showed that those who received panitumumab every two weeks showed a 46 percent decrease in t...

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