Notas de prensa

  • 26 de septiembre de 2007
  • 187

New Analysis Suggests First Cycle Use of Neulasta(R) Reduces Febrile Neutropenia Hospitalizations and Chemotherapy Dose Reductions in Breast Cancer Patients Compared to Current Practice

BARCELONA, Spain--(BUSINESS WIRE)--Sept. 26, 2007--Amgen (NASDAQ:AMGN) today announced results from an integrated analysis showing primary prophylactic use of Neulasta(R) (pegfilgrastim), a granulocyte colony stimulating factor (G-CSF), with unique neutrophil-mediated clearance, decreased febrile-neutropenia (FN) hospitalizations by more than half (4 percent vs. 10 percent) when compared to current practice neutropenia management and reduced chemotherapy dose reductions by nearly two-thirds (9 percent vs. 24 percent). The results were presented as an oral presentation at the 14th European Cancer Conference (ECCO) in Barcelona, Spain (Abstract # 2.033).

"Febrile neutropenia, or a low white blood cell count accompanied by fever, is one of the most serious adverse events related to myelosuppressive chemotherapy and is still a common cause of hospitalizations and associated infection-related deaths," said G. Von Minckwitz, M.D., Ph.D., University of Frankfurt, German Breast Group GBG Forschungs GmbH, Frankfurt, Germany. "These study findings emphasize the benefits of primary prophylactic use of Neulasta."

In this integrated analysis of 2,282 breast cancer patients, 9 percent of patients who received primary prophylaxis with Neulasta had chemotherapy dose reductions compared to 24 percent of patients who received current practice neutropenia management. Additionally, the analysis showed that prophylactic use of Neulasta resulted in 4 percent FN hospitalizations versus 10 percent for current practice. The results presented today expand on the positive outcomes from the same study first presented at American Society of Clinical Oncology (ASCO) Breast Symposium in San Francisco earlier this month, which showed that primary prophylaxis with Neulasta significantly reduced the incidence of FN compared to current neutropenia management (five percent vs. 29 percent).

An abnormally low white blood cell count can be serious because the body´s ability to fight off infections becomes impaired, and even a minor infection can become life-threatening. Importantly, neutropenia is the major dose-limiting side effect of myelosuppressive chemotherapy and is the primary reason for chemotherapy dose delays and reductions. Current European Organization for Research and Treatment (EORTC), National Comprehensive Cancer Network (NCCN), and ASCO neutropenia guidelines recommend routine growth factor primary prophylaxis for patients with an overall FN risk greater than or equal to 20 percent.

About the Analysis

For this integrated analysis, studies involving breast cancer chemotherapy regimens with moderate (15-20 percent)/high (greater than or equal to 20 percent) risk of febrile neutropenia were identified by literature review. Individual patient data were available from eight clinical trials and three observational studies (conducted between 1998 and 2005) involving these regimens and primary prophylactic use of Neulasta (6 mg dose in all cycles) or current practice neutropenia management (defined as no G-CSF or pegfilgrastim / daily G-CSF in any cycle). Of the 2,282 patients analyzed, 1,303 received Neulasta as primary prophylaxis and 979 were treated based on current practice.

About Neulasta

Neulasta is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Similar indications for Neulasta were approved in Europe and Australia in 2002.

Important Product Safety Information

Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing antiallergic treatment.

In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta-treated patients as compared to placebo-treated patients (31 percent vs. 26 percent). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.

Prescribers are recommended to consult regional prescribing information before prescribing Neulasta, particularly in relation to side-effects, precautions and contra-indications.

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. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statements

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. 25, 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.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others´ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

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) or European Medicines Agency (EMEA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA, EMEA or comparable regulatory body 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 or EMEA 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, EMEA or comparable regulatory body can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the applicable FDA- or EMEA-approved labeling for the products, and not the information discussed in this news release.

CONTACT: Amgen Sabeena Ahmad, +41 41 3692 530 (EU media, oncology) Ashleigh Koss, 805-313-6151 (US media, oncology) Arvind Sood, 805-447-1060 (investors) SOURCE: Amgen

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