THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 28, 2007--Amgen (NASDAQ:AMGN), provided investors with an update on the company's late-stage and early-stage pipeline during the previously webcast UBS Global Life Sciences Conference in New York on Sept. 27, 2007. Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development, represented Amgen for the first time at a major investor conference this year; his presentation coincided with the publication of key Amgen studies presented at medical conferences in Europe and the United States.
At the UBS conference Dr. Perlmutter updated investors on the status of Vectibix(TM) (panitumumab) that was released earlier in the week at the European Cancer Conference (ECCO). Dr. Perlmutter said that tumor-specific mutations in the KRAS gene appear to provide a predictive clinical biomarker that could be used to select patients who are more likely to respond to treatment with Vectibix monotherapy. Data from Amgen's analysis of Vectibix responses have been provided to the U.S. Food and Drug Administration and the Committee for Medicinal Products for Human Use (CHMP). Vectibix has been recommended for conditional approval in the European Union for patients with refractory colorectal cancer based in part on KRAS stratification.
Dr. Perlmutter provided a progress report on denosumab, including:
-- Phase 2 data showing a sustained increase in bone mineral density in osteoporotic women receiving denosumab for four years, at the American Society for Bone and Mineral Research (ASMBR) conference in Honolulu earlier this month.
-- Phase 3 study in women with metastatic breast cancer receiving aromatase inhibitors also met all primary and secondary endpoints.
-- Studies on fracture prevention in patients with bone metastases are enrolling.
Dr. Perlmutter concluded his comments at the UBS conference by indicating that AMG 531 is expected to be filed for the ITP indication in the fourth quarter of 2007. He also highlighted Phase 1b data from AMG 785, the Sclerostin antibody, whereby single doses increased bone mineral density in healthy postmenopausal women.
Amgen expects to receive head-to-head denosumab vs. alendronate post menopausal osteoporosis (PMO) trial data to begin analysis in February 2008, to have available Phase 3 PMO fracture data in the second half of 2008, and is on target to review the entire PMO data set in the second half of 2008.
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 deep and broad 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.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Sept. 28, 2007 and expressly disclaims any duty to update information contained in this news release.
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CONTACT: Amgen, Thousand Oaks
David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)