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



    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.