AMG 531: Data from the recently completed Phase 3 study of AMG 531
in pre-splenectomy immune thrombocytopenic purpura (ITP) patients have
become available. Review of the data from this study revealed a
favorable efficacy and safety profile, with all endpoints successfully
met. Based on the positive results from this study, along with the
positive results from its other Phase 3 study of patients with ITP
despite prior splenectomy, the company is on track to file in 2007 for
approval of AMG 531 in the ITP indication in both the United States and
Europe. The company has previously received fast track designation from
the Food and Drug Administration (FDA) in this indication. Denosumab:
Data from the 332-patient Phase 3 study in Postmenopausal Osteoporosis
(PMO) have become available to the company. Based on the company's
review of the data, all primary and secondary endpoints were
successfully met. The company expects to see data later this year from
an ongoing Phase 2 study of PMO Treatment and a Phase 3 study in breast
cancer patients undergoing hormone ablation therapy.
ASCO Update: The company expects data results from several of their
programs to be presented at the upcoming annual ASCO meeting in June.
Among the presentations will be details from Phase 1 studies involving a
number of the company's earlier stage oncology programs including
AMG 102, AMG 386, AMG 479, AMG 655 and APO2L/TRAIL, (a molecule being
developed in collaboration with Genentech, Inc.). Additionally, results
from certain of the company's later stage programs will be
presented, including a Phase 2 study of AMG 531 in thrombocytopenic
patients with Myelodysplastic Syndrome and the Phase 2 study of
motesanib diphosphate in patients with locally advanced or metastatic
thyroid cancer.
For more product information or the full prescribing information,
refer to the Amgen Web site at http://www.amgen.com.
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
deep and broad pipeline of potential new medicines, Amgen remains
committed to advancing science to dramatically improve people's
lives.
For more information, visit http://www.amgen.com or call
805/447-4613.
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