To: RealMuLan who wrote (501 ) 11/3/2005 3:45:29 PM From: John McCarthy Read Replies (1) | Respond to of 590 EDIT Thousand Oaks, Calif.-based Amgen said the study results mean its drug is the first of its class to improve the likelihood that patients will live without their disease getting worse. ImClone's Erbitux approval is based on a different measure -- tumor shrinkage. Amgen said its drug also decreased tumor size, a measure it had set as a secondary endpoint, and that those results were comparable with mid-stage trials. Panitumumab and Erbitux work in generally the same way, by binding to a protein that is associated with tumor growth. However, Panitumumab is derived solely from human antibodies, while Erbitux is partly made up of mouse antibodies. "The benefit with a fully human antibody is that a human's body is less likely to reject it," said Citigroup analyst Elise Wong. "With Panitumumab you have very low infusion reactions and very low rates hypersensitivity." Though she cautioned that the broad top-line data make firm conclusions difficult, Wong said the results appear "very robust," adding that "it should prove to be a very competitive product to Erbitux" if just based on the safety advantage and its less-frequent dosing regimen (every other week versus once a week). Wong also noted that Amgen's study group consisted of patients that had more advanced cancer than those that Erbitux used to gain its approval last February. Merrill Lynch analyst Eric Ende had said that ImClone shares would be worth between $28 and $31 if the Amgen trial met its endpoint, arguing that a positive study result could lead to Panitumumab dominating the colon cancer market despite Erbitux's head start. Amgen said it plans to start the process of applying for approval from the Food and Drug Administration by the end of the year with the aim of completing its submission in the first quarter of 2006. Abgenix of Fremont, Calif., helped develop panitumumab with its animal research technology -- a method of genetically engineering mice for use in creating antibody therapies. The company stands to get a share of the drug's profits if it is approved. Panitumumab is also in clinical trials for lung and kidney cancer, while ImClone is investigating Erbitux for head and neck cancer.biz.yahoo.com