Vectibix(TM) (panitumumab) Receives Positive Opinion for Marketing Authorization in the European Union



    Opinion Based on Positive Benefit / Risk Assessment in Patients with Metastatic Colorectal Cancer with Non-Mutated KRAS

    Amgen (NASDAQ:AMGN) today announced that the European Committee
    for Medicinal Products for Human Use (CHMP) has issued a positive
    opinion recommending a conditional marketing authorization for
    Vectibix(TM) (panitumumab) in the European Union (EU) for patients
    with refractory metastatic colorectal cancer with non-mutated
    (wild-type) KRAS genes.

    "We are pleased that Vectibix has received a positive opinion for
    conditional approval so patients in the EU have further treatment
    options for metastatic colorectal cancer," said Willard Dere, M.D.,
    senior vice president and international chief medical officer at
    Amgen. "This is an important step forward in personalized cancer care.
    Amgen is committed to discovering, validating and implementing novel
    clinically relevant biomarkers to help physicians provide the right
    treatment for patients."

    The CHMP positive opinion for Vectibix is based on a positive
    benefit / risk assessment in a patient population that currently has
    few treatment options available to them. As part of the CHMP review,
    clinical data supporting the utility of KRAS mutation status as a
    biomarker for clinical outcome were provided. These data were
    evaluated in combination with the overall clinical benefit observed in
    the pivotal "408" study and safety database available. The KRAS data
    will be presented for the first time at the 14th European Cancer
    Conference, Barcelona, on September 25th in the Presidential
    Symposium.

    KRAS plays an important role in cell growth regulation and
    oncogenesis. Anti-epidermal growth factor receptor (EGFR) therapies
    work by blocking the activation of EGFR, thereby inhibiting downstream
    events that lead to malignant signaling. However, in patients with
    tumors harboring a mutated or activated KRAS, the KRAS protein is
    always turned "on" regardless of whether EGFR has been activated or
    therapeutically inhibited. Thus, in patients with mutated KRAS,
    signaling continues despite anti-EGFR therapy. Mutant KRAS is detected
    in approximately 40 percent of mCRC.

    About Vectibix

    Vectibix (panitumumab) the first fully human IgG2 monoclonal
    antibody (MAb), targets the epidermal growth factor receptor (EGFr), a
    protein that plays an important role in cancer cell signalling. With
    its demonstrated efficacy, low rate of infusion reactions and
    immunogenicity, and convenient Q2W dosing schedule Vectibix provides
    an important option in the management of metastatic CRC patients.
    Ongoing Phase 3 trials are exploring the potential of administering
    Vectibix in combination with chemotherapy for first- and second-line
    mCRC.

    Approved by the FDA in September 2006 Vectibix is indicated for
    the treatment of patients with epidermal growth factor receptor (EGFr)
    expressing metastatic colorectal cancer after disease progression on,
    or following fluoropyrimidine, oxaliplatin and irinotecan containing
    chemotherapy regimens. The effectiveness of Vectibix for the treatment
    of metastatic colorectal carcinoma is based on progression-free
    survival. Currently no data are available that demonstrate an
    improvement in disease related symptoms or increased survival with
    Vectibix.

    In the EU, Vectibix is indicated as monotherapy for the treatment
    of patients with metastatic colorectal carcinoma expressing EGFR with
    non-mutated KRAS tumours and after failure of fluoropyrimidine-,
    oxaliplatin-, and irinotecan-containing chemotherapy regimens.

    Important Product Safety Information - U.S.

    Dermatologic toxicities, related to Vectibix blockade of EGF
    binding and subsequent inhibition of EGF receptor-mediated signalling
    pathways, included but were not limited to dermatitis acneiform,
    pruritus, erythema, rash, skin exfoliation, paronychia, dry skin and
    skin fissures. Dermatologic toxicities were reported in 89 percent of
    patients treated with Vectibix and were severe in 12 percent of
    patients. 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
    one percent of patients. Severe infusion reactions were identified as
    anaphylactic reactions, bronchospasm, fever, chills and hypotension.
    Although fatal infusion reactions have not been reported with
    Vectibix, they 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.

    About Amgen

    Amgen discovers, develops and delivers innovative human
    therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
    first companies to realise the new science's promise by bringing safe,
    effective medicines from lab, to manufacturing plant, to patient.
    Amgen therapeutics has 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 Statement

    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.