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|  |  Abgenix And Amgen Announce Panitumumab Significantly Improves Progression-Free Survival In Phase 3 Randomized Metastatic Colorectal Cancer StudyPress Release November 3, 2005 THOUSAND OAKS, Calif. and FREMONT, Calif., Nov. 3 /PRNewswire-FirstCall/ - - Amgen and Abgenix, Inc. today announced that a pivotal Phase 3 study of panitumumab met the primary endpoint of improving progre ssion-free survival in patients with metastatic colorectal cancer (mCRC) who had failed standard chemotherapy. In this randomized Phase 3 trial involving 463 patients, those who received panitumumab every two weeks showed a 46 percent decrease in tumor progression rate versus those who received best supportive care alone (p<0.000000001). This result exceeded the pre-specified measure of progression-free survival that the trial was designed to demonstrate (i.e., a 33 percent decrease in tumor progression rate in patients receiving panitumumab versus those receiving best supportive care, as assessed by central radiology review). A secondary endpoint of objective response rate, as assessed by central radiology review, was also met. Analysis of overall patient survival in this study will occur 12 months after the last patient was randomized. "Amgen is dedicated to developing safe and effective cancer therapies that significantly improve cancer patients' outcomes," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "We are excited that panitumumab, our most advanced investigational cancer therapeutic, improved progression-free survival and response rate in metastatic colorectal cancer patients who had failed multiple prior chemotherapy regimens. These results will support a BLA submission, which we plan to initiate by the end of the year." "We are very encouraged by the results of this pivotal study and what panitumumab could mean for patients with advanced colorectal cancer," said Bill Ringo, president and chief executive officer of Abgenix. "The improvement in progression-free survival shown by panitumumab in this study highlights the value of our proprietary technology and product development capabilities. We continue to work closely with our partner, Amgen, towards the regulatory filing and potential commercialization of panitumumab." Per protocol, administration of panitumumab did not require administration of pre-medication or a loading dose and the incidence of infusion reactions (of any severity) was low. An initial safety evaluation showed that the adverse events observed were consistent with previous clinical studies of panitumumab. The most common side effect was acneiform rash. Other side effects less commonly observed were fatigue, nausea and mild diarrhea. No human anti-human antibody (HAHA) or anti-panitumumab antibody formation was observed.About Amgen Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. About Abgenix Abgenix is a biopharmaceutical company focused on the discovery, development and manufacturing of fully human therapeutic antibodies. The company's antibody development platform includes a leading technology and state-of-the-art manufacturing capabilities that enable the rapid generation, selection and production of high affinity, fully human antibody product candidates to a variety of disease targets. Abgenix leverages its leadership position in human antibody technology to build a diversified product portfolio through its own development efforts and the establishment of collaborations with multiple pharmaceutical and biotechnology companies. For more information on Abgenix, visit the company's website at www.abgenix.com.
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