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Amgen Oncology Highlights Upcoming Data Presentations at the American Society of Clinical Oncology (ASCO) Annual MeetingClinical Data to be Presented on Seven Investigational Targeted and Supportive Care Cancer Therapies from Oncology Pipeline
THOUSAND OAKS, Calif., May 29, 2007 (BUSINESS WIRE) -- Amgen (NASDAQ:AMGN), today announced upcoming data presentations of interest at the 43rd Annual American Society of Clinical Oncology (ASCO) Meeting in Chicago.
Clinical data will be presented on seven investigational therapies: AMG 531 in thrombocytopenic patients with myelodysplastic syndrome (MDS), motesanib diphosphate (AMG 706) in locally advanced or metastatic thyroid cancer; and AMG 102, AMG 386, AMG 479, AMG 655, and rhApo2L/TRAIL in patients with advanced solid tumors. This is the first time that Phase 1 clinical data for AMG 102, AMG 386, AMG 479 and AMG 655 will be presented. In addition, updated data from the Vectibix(TM) (panitumumab) 250 (EGFR low/negative) study, and health-related quality of life (QOL) and patient reported outcome (PRO) data from the pivotal 408 trial, will be presented.
"As the science of cancer rapidly evolves, Amgen is developing the next generation of targeted therapeutics and novel supportive care agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The data we are presenting at ASCO this year reflect the breadth and diversity of our oncology research pipeline."
The following are selected studies of interest being presented on Amgen's marketed products and investigational compounds this year at ASCO:
Aranesp(R) (darbepoetin alfa)
-- Effects of intravenous iron supplementation on responses to every-3-week darbepoetin alfa by baseline hemoglobin in patients with chemotherapy-induced anemia Abstract No. 9106 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S Hall A2, General Poster Session)
-- Baseline predictors of response to treatment with darbepoetin-alpha in anemic patients with low-risk myelodysplastic syndrome
Abstract No. 7081 (Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session)
-- Second interim analysis of the ARA Plus study: Breast Cancer adjuvant chemotherapy with and without darbepoetin-alpha, analysis of serious adverse events. (This is an independent investigator-led study that is part of the Aranesp Pharmacovigilance program)
Abstract No. 564 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S Hall A2, General Poster Session)
-- Panitumumab activity in metastatic colorectal cancer patients with low or negative tumor epidermal growth factor receptor levels: An Updated analysis
Abstract No. 4082 (Monday, June 4 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session)
-- Patient-reported outcome-assessed clinical benefit of panitumumab in metastatic colorectal cancer patients
Abstract No. 6560 (Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session)
-- Association of skin toxicity severity with clinical outcomes and health-related quality of life with panitumumab
Abstract No. 4038 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S403, Poster Discussion Session)
-- Evaluating safety and efficacy of AMG 531 for the treatment of thrombocytopenic patients with myelodysplastic syndrome: preliminary results of a Phase 1/2 study
Abstract No. 7032 (Monday, June 4, 8:00 a.m. - 12:00 p.m., E451a, Poster Discussion Session)
Motesanib Diphosphate (AMG 706)
-- Initial results from a Phase II trial of motesanib diphosphate (AMG 706) in patients with differentiated thyroid cancer
Abstract No. 6017 (Monday, June 4, 8:00 a.m. - 12:00 p.m., S Hall A2, Poster Discussion Session)
-- Interim results from a first-in-human study of AMG 102, a fully human monoclonal antibody that neutralizes hepatocyte growth factor, the ligand to c-Met receptor, in patients with advanced solid tumors
Abstract No. 3551 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S102a, Poster Discussion Session)
-- First-in-human study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in adult patients with advanced solid tumors
Abstract No. 3522 (Saturday, June 2, 7:45 a.m. - 8:00 a.m., E354b, Oral Presentation)
-- A Phase 1 pharmacokinetic and pharmacodynamic study of AMG 479, a fully human monoclonal antibody against insulin-like growth type 1 receptor, in advanced solid tumors
Abstract No. 3002 (Monday, June 4, 7:45 a.m. - 8:00 a.m., S100a, Clinical Science Symposium)
-- First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors
Abstract No. 3534 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S102a, Poster Discussion Session)
-- Application of pharmacodynamic assays in a Phase 1a trial of Apo2L/TRAIL in patients with advanced tumors
Abstract No. 3535 (Saturday, June 2, 2:00 p.m. - 6:00 p.m., S102a, Poster Discussion Session)
-- A Phase 1b safety and pharmacokinetic study of recombinant human Apo2L/TRAIL in combination with rituximab in patients with low grade non-Hodgkin's lymphoma
Abstract No. 8078 (Saturday, June 2, 8:00 a.m. - 12:00 p.m., S Hall A2, General Poster Session)
(a)This compound is being developed in collaboration with Genentech, Inc.
Amgen will host a webcast with the investment community on Monday, June 4, at 9 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 for at least 72 hours after the event.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure (CRF), for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, and in March 2006, the FDA approved every-three-week dosing in these patients.
Important Safety Information including boxed WARNING
Use the lowest dose of Aranesp that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.
Aranesp and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL
Cancer Patients: Use of ESAs
-- Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL,
-- Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL,
-- Increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy or radiation therapy. ESAs are not indicated for this population.
Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving Epoetin alfa who were not receiving prophylactic anticoagulation. Aranesp is not approved for this indication.
Aranesp is contraindicated in patients with uncontrolled hypertension.
The Aranesp prescribing information, including important safety information and boxed warning, may be accessed at www.aranesp.com.
Vectibix is indicated for the treatment of EGFr-expressing, metastatic colorectal cancer with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal cancer is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Important Product Safety Information
Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGFr-mediated signaling pathways, were reported in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.
Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, fatalities have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.
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 May 29, 2007 and expressly disclaims any duty to update information contained in this news release.
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Christine Regan, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)