Notas de prensa

  • 28 de septiembre de 2007
  • 232

Amgen Provides Update on Late-Stage and Early-Stage Pipeline at UBS Global Life Sciences Conference

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 28, 2007--Amgen (NASDAQ:AMGN), provided investors with an update on the company´s late-stage and early-stage pipeline during the previously webcast UBS Global Life Sciences Conference in New York on Sept. 27, 2007. Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development, represented Amgen for the first time at a major investor conference this year; his presentation coincided with the publication of key Amgen studies presented at medical conferences in Europe and the United States.

At the UBS conference Dr. Perlmutter updated investors on the status of Vectibix(TM) (panitumumab) that was released earlier in the week at the European Cancer Conference (ECCO). Dr. Perlmutter said that tumor-specific mutations in the KRAS gene appear to provide a predictive clinical biomarker that could be used to select patients who are more likely to respond to treatment with Vectibix monotherapy. Data from Amgen´s analysis of Vectibix responses have been provided to the U.S. Food and Drug Administration and the Committee for Medicinal Products for Human Use (CHMP). Vectibix has been recommended for conditional approval in the European Union for patients with refractory colorectal cancer based in part on KRAS stratification.

Dr. Perlmutter provided a progress report on denosumab, including: -- Phase 2 data showing a sustained increase in bone mineral density in osteoporotic women receiving denosumab for four years, at the American Society for Bone and Mineral Research (ASMBR) conference in Honolulu earlier this month. -- Phase 3 study in women with metastatic breast cancer receiving aromatase inhibitors also met all primary and secondary endpoints. -- Studies on fracture prevention in patients with bone metastases are enrolling.

Dr. Perlmutter concluded his comments at the UBS conference by indicating that AMG 531 is expected to be filed for the ITP indication in the fourth quarter of 2007. He also highlighted Phase 1b data from AMG 785, the Sclerostin antibody, whereby single doses increased bone mineral density in healthy postmenopausal women.

Amgen expects to receive head-to-head denosumab vs. alendronate post menopausal osteoporosis (PMO) trial data to begin analysis in February 2008, to have available Phase 3 PMO fracture data in the second half of 2008, and is on target to review the entire PMO data set in the second half of 2008.

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. 28, 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), 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 U.S. Food and Drug Administration (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.

CONTACT: Amgen, Thousand Oaks David Polk, 805-447-4613 (media) Arvind Sood, 805-447-1060 (investors) SOURCE: Amgen

Destacadas

  • GENESIS Biomed consolidates its position as a key player in the growth of the Spanish health innovation ecosystem

    Press Office Comunication

    GENESIS Biomed consolidates its position as a key player in the growth of the Spanish health innovation ecosystem

    Leer más
  • Docentes de la Universidad Internacional de Valencia destacan la búsqueda de apoyo como elemento clave en la recuperación del bienestar tras la pérdida

    Farmanews Farmanews

    Docentes de la Universidad Internacional de Valencia destacan la búsqueda de apoyo como elemento clave en la recuperación del bienestar tras la pérdida

    Leer más
  • Un estudio clínico español demuestra por primera vez la eficacia de la terapia génica en pacientes con anemia de Fanconi

    Farmanews Farmanews

    Un estudio clínico español demuestra por primera vez la eficacia de la terapia génica en pacientes con anemia de Fanconi

    Leer más

Newsletter

Suscríbete para conocer las novedades del mundo farmacéutico y sanitario.

¿Qué es?

FarmaNews pone a disposición de los medios y departamentos de comunicación, un canal para publicar notas de prensa y convocatorias del mundo sanitario y farmacéutico.

Contacto

Avda. Mare de Déu de Lourdes, 108,
08757, Corbera de Llobregat
(Barcelona), España