SWOG Phase III Trial Reports REVLIMID(R) (lenalidomide) Plus Dexamethasone Achieves Superior Progression-Free Survival in Newly Diagnosed Multiple Myeloma Patients



    Celgene International Sarl (NASDAQ: CELG) announced that results
    from the Southwest Oncology Group (SWOG) Phase III randomized,
    controlled trial evaluating REVLIMID (lenalidomide) and the steroid
    dexamethasone were presented for the first time at the 49th annual
    American Society of Hematology (ASH) Meeting. The SWOG (S0232) study
    (Abstract #77) evaluated the combination therapy of REVLIMID and
    dexamethasone in patients with newly diagnosed multiple myeloma and
    found that patients given the treatment regimen had superior response
    rates and progression-free survival compared to those who received
    dexamethasone alone.

    According to Brian G.M. Durie, M.D., Chairman of the International
    Myeloma Foundation and co-chair of the SWOG Myeloma Committee,
    "REVLIMID with standard dose dexamethasone is among the most active
    up-front combination regimens against myeloma."

    Overall response rate in patients receiving REVLIMID and
    dexamethasone was 85.3% with 22.1% of patients achieving complete
    responses compared to 51.3% and 3.8%, respectively in the
    dexamethasone only group. Additionally, estimated one year
    progression-free survival was 77% in patients who received the
    combined therapy compared to 55% who received dexamethasone alone. The
    one-year overall survival rates in both arms of the study are among
    the highest ever reported (93% and 91%), influenced by the fact that
    patients in the dexamethasone only arm crossed over and received
    REVLIMID and dexamethasone, at the time of progression or when the
    study was halted.

    "These results demonstrate that REVLIMID plus dexamethasone is an
    excellent treatment in newly diagnosed multiple myeloma," said Dr.
    Durie. "Additionally, REVLIMID offers a quality of life advantage
    through its oral formulation and rare incidence of peripheral
    neuropathy, a treatment-limiting side effect."

    The SWOG trial permanently closed enrollment in May after the
    preliminary one-year survival results from the Eastern Cooperative
    Oncology Group (ECOG) Phase III study (E4A03) were released. The ECOG
    trial showed an unprecedented survival advantage in using REVLIMID and
    low-dose dexamethasone in newly diagnosed multiple myeloma patients.

    Grade 3/4 adverse events were more frequent in multiple myeloma
    patients who received the combination of lenalidomide/dexamethasone
    compared to dexamethasone alone. Neutropenia (13.5%; 27/198) and
    infections (19.1%, 38/198) were the most frequently reported adverse
    events. DVT occurred in 25% of patients receiving REVLIMID and
    dexamethasone compared to 7% with dexamethasone alone, however, with
    the use of aspirin as a prophylaxis the DVT events were 14% and 12%
    respectively.

    About REVLIMID(R)

    REVLIMID is an oral medication currently approved in the United
    States, the EU and Switzerland for treatment of patients with multiple
    myeloma in combination with dexamethasone who have received at least
    one prior therapy. REVLIMID is also approved in the United States for
    transfusion-dependent anemia due to low- or intermediate-1-risk MDS
    associated with a deletion 5q cytogenetic abnormality with or without
    additional cytogenetic abnormalities. REVLIMID has obtained Orphan
    Drug designation in the EU, U.S., Switzerland and Australia.

    About Multiple Myeloma

    Multiple myeloma (also known as myeloma or plasma cell myeloma) is
    a cancer of the blood in which malignant plasma cells are overproduced
    in the bone marrow. Plasma cells are white blood cells that help
    produce antibodies called immunoglobulins that fight infection and
    disease. However, most patients with multiple myeloma have cells that
    produce a form of immunoglobulin called paraprotein (or M protein)
    that does not benefit the body. In addition, the malignant plasma
    cells replace normal plasma cells and other white blood cells
    important to the immune system. Multiple myeloma cells can also attach
    to other tissues of the body, such as bone, and produce tumors. The
    cause of the disease remains unknown.

    About Celgene International Sarl

    Celgene International Sarl, located in Boudry, Switzerland, is a
    wholly owned subsidiary and international headquarters of Celgene
    Corporation. Celgene Corporation, headquartered in Summit, New Jersey,
    is an integrated global pharmaceutical company engaged primarily in
    the discovery, development and commercialization of innovative
    therapies for the treatment of cancer and inflammatory diseases
    through gene and protein regulation. For more information, please
    visit the Company´s website at www.celgene.com.

    This release contains certain forward-looking statements which
    involve known and unknown risks, delays, uncertainties and other
    factors not under the Company´s control, which may cause actual
    results, performance or achievements of the Company to be materially
    different from the results, performance or other expectations implied
    by these forward-looking statements. These factors include results of
    current or pending research and development activities, actions by the
    FDA and other regulatory authorities, and those factors detailed in
    the Company´s filings with the Securities and Exchange Commission such
    as Form 10-K, 10-Q and 8-K reports.