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|Amgen Oncology Highlights Upcoming Data Presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting|
|Clinical 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:
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.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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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 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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