THOUSAND OAKS, Calif.--(BUSINESS WIRE)--May 31, 2006--Amgen (NASDAQ:AMGN), the world's largest biotechnology company, today announced upcoming data presentations at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. Clinical results will be presented on four investigational cancer therapies: panitumumab in metastatic colorectal cancer patients, denosumab in breast cancer patients with bone metastases, AMG 706 in advanced thyroid cancer patients, and recombinant human Apo2L/TRAIL (co-developed with Genentech, Inc.) in patients with advanced cancer. In addition, updated data evaluating every-three-week administration of darbepoetin alfa for the treatment of anemia associated with myelodysplastic syndromes (MDS), and in combination with iron for the treatment of chemotherapy-induced anemia, will be presented.
"At Amgen, we take a comprehensive approach to helping patients in their fight against cancer. From our strong foundation in supportive care to our entry into innovative therapeutics, Amgen researchers are constantly evaluating new pathways and modalities for developing novel treatments," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development. "We are very excited to present new data on multiple agents from our robust pipeline of investigational targeted therapies."
The following are selected studies of interest being presented on Amgen's investigational compounds and marketed products this year at ASCO:
Panitumumab -- Panitumumab antitumor activity in patients with metastatic colorectal cancer expressing low (less than 1-9 percent) or negative (less than 1 percent) levels of epidermal growth factor receptor Abstract #3547 (Saturday, June 3, 8:00 a.m. - 12:00 p.m., Bldg B, Level 1, Hall B5) -- Panitumumab antitumor activity in patients with metastatic colorectal cancer expressing greater than 10 percent epidermal growth factor receptor Abstract #3548 (Saturday, June 3, 8:00 a.m. - 12:00 p.m., Bldg B, Level 1, Hall B5) Denosumab -- Randomized, active-controlled study of denosumab (AMG 162) in breast cancer patients with bone metastases not previously treated with intravenous (IV) bisphosphonates (BP) Abstract #512 (Sunday, June 4, 9:15 a.m. - 9:30 a.m., Bldg C, Level 1, Hall C1, Oral Presentation) -- A randomized trial of denosumab (AMG 162) versus intravenous (IV) bisphosphonates (BP) in cancer patients (Pts) with bone metastases (BM) on established IV BP and evidence of elevated bone resorption Abstract #8562 (Saturday, June 3, 2:00 p.m. - 6:00 p.m., Bldg B, Level 1, Hall B5) AMG 706 -- Safety and antitumor activity of AMG 706 in patients with thyroid cancer: A subset analysis from a Phase 1 dose-finding study Abstract #3030 (Saturday, June 3, 8:00 a.m. - 12:00 p.m., Bldg C, Level 3, Room C306) Recombinant Human Apo2L/TRAIL -- A Phase 1 safety and pharmacokinetic study of recombinant Apo2L/TRAIL, an apoptosis-inducing protein in patients with advanced cancer Abstract #3013 (Saturday, June 3, 3:00 p.m. - 3:15 p.m., Bldg B, Level 3, Room B305) Darbepoetin alfa -- A randomized open-label study of darbepoetin alfa administered every 3 weeks with or without parenteral iron in anemic subjects with nonmyeloid malignancies receiving chemotherapy Abstract #8612 (Saturday, June 3, 2:00 p.m. - 6:00 p.m., Bldg B, Level 1, Hall B5) -- Darbepoetin alfa for treating anemia in low-risk myelodysplastic syndrome patients: Interim results after 27/28 weeks Abstract #6564 (Saturday, June 3, 8:00 a.m. - 12:00 p.m., Bldg B, Level 1, Hall B5) -- Darbepoetin alfa for treating anemia in patients with low-risk myelodysplastic syndromes: Exploratory analysis of baseline predictors of response Abstract #6579 (Saturday, June 3, 8:00 a.m. - 12:00 p.m., Bldg B, Level 1, Hall B5)
Aranesp(R) (darbepoetin alfa) has not been approved by the Food and Drug Administration (FDA) for the treatment of anemia associated with myelodysplastic syndromes. Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events and other serious events.
Amgen will host a webcast with the investment community on Sunday, June 4th, at 6:00 p.m. EDT to discuss data presented at ASCO. Open to members of the news media, investors and the general public, the webcast can be found on Amgen's Web site, www.amgen.com, under Investors. It will be archived and available for replay at least 72 hours after the event.
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.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2005, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
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Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)