Updated REVLIMID(R) Clinical Results Presented at the 12th International Workshop on Chronic Lymphocytic Leukemia



    Celgene Corporation (NASDAQ: CELG) announced that clinical data
    from two ongoing REVLIMID studies in Chronic Lymphocytic Leukemia
    (CLL) were reported during the 12th International Workshop on Chronic
    Lymphocytic Leukemia in London on Saturday, September 15, 2007.
    Chronic Lymphocytic Leukemia is a hematological cancer that affects
    approximately 75,000-100,000 people in the U.S. About 10,000 new cases
    of CLL are diagnosed each year and an estimated 5,000 Americans are
    expected to die of CLL this year. For the EU-5, the prevalence of CLL
    is estimated to be about 70,000 people with an estimated 11,000 new
    cases each year.

    Asher Channan-Khan, M.D., of the Roswell Park Cancer Institute in
    Buffalo, NY, enrolled 45 CLL patients, who had at least two prior
    therapies. Overall response to lenalidomide monotherapy was 58%, of
    whom 18% achieved a complete remission and 40% partial remission. The
    median time to best response was 5.9 months with a range of 1.6-18.3
    months. Median progression free survival of all enrolled patients was
    19.4 months with a range of 1.2-31.8+ months. Of patients with poor
    prognostic factors with 17p or 11q cytogenetic abnormality, 44% showed
    a clinical response, while 30% of patients with fludarabine refractory
    disease showed a clinical response.

    The incidence of grade III/IV thrombocytopenia and neutropenia was
    45% and 70% respectively. Fifteen percent of the patients experienced
    febrile neutropenia.

    Tumor flare reaction was a common non-hematologic adverse event.
    The study reported grade I/II tumor flare reaction incidence of 50%
    and grade III/IV was 8%. Another non-hematolgic adverse event
    observed, tumor lysis syndrome, had 5% incidence of grade III/IV
    occurrences.

    "In our study, we have seen impressive activity with REVLIMID in
    CLL patients," said Dr. Channan-Khan. "We continue to investigate the
    clinical benefits of REVLIMID in CLL to find an optimal dose level to
    maximize response while maintaining a clinically manageable side
    effect profile."

    Alessandra Ferrajoli, M.D., of The University of Texas M.D.
    Anderson Cancer Center in Houston, TX studied heavily pretreated CLL
    patients with progressive disease with a dose less than that explored
    in the Channan-Khan trial. The overall response rate to single agent
    lenalidomide among 44 patients was 34%, among which 7% of patients
    achieved a complete remission, 2% achieved a nodular partial remission
    and 25% achieved a partial remission. Stable disease was observed in
    23% of the patients. Two complete responses and 4 partial responses
    were observed in patients carrying 11q deletion abnormalities and one
    partial response was observed in a patient with a 17p deletion. With a
    median follow-up of 11 months, the median response duration is 12-plus
    months.

    Grade III/IV hematological adverse events observed in the 325
    courses included neutropenia (39%), thrombocytopenia (15%) and anemia
    (3%). Grade III/IV non-hematological adverse events consisted mainly
    of diarrhea (2%), fatigue (1%) and tumor flare (1%). Additionally, 9
    cases of pneumonia, 6 cases of fever of unknown origin and 2 cases of
    PCP pneumonia were noted. One patient developed disseminated
    mucormycosis that was fatal (day 22) and another patient died on day
    11 of treatment from pneumonia and intracranial bleeding.

    About the Trials

    The IRB approved Phase II clinical trial at the Roswell Park
    Cancer Institute was designed to evaluate and investigate the
    therapeutic potential and safety of REVLIMID(R) oral monotherapy in
    patients with relapsed or refractory CLL. Forty-five patients age
    42-75 (median age 64) with relapsed or refractory CLL have been
    enrolled. Sixty-four percent of patients had advanced Rai stage
    disease and 35.5% had high-risk cytogenetics (17p- or 11q-deletions).
    Fifty-one percent of patients had fludarabine refractory disease.
    Patients in the study received 25 mg of REVLIMID orally once daily for
    21 days in a four-week cycle until achievement of a complete response.
    If progressive disease was observed, rituximab was added to
    lenalidomide.

    The study at The University of Texas M.D. Anderson Cancer Center
    evaluated REVLIMID's activity in CLL in patients who had received
    prior purine analog-based combinations. Forty-four patients age 49-86
    (median age 64) were enrolled. The median number of prior treatments
    is 5 (range 1-15) and the median beta-2-microglubulin level was 4.3
    mg/dL (range 1.6-10.1). Eighty-eight percent of the patients had
    unmutated IgVH genes and 59% carried a poor prognostic genomic
    abnormality (17p- or 11q-deletions). Forty-five percent of patients
    had advanced Rai stage disease, 27% were fludarabine refractory and
    51% had received prior alemtuzumab treatment. Patients received 10mg
    of REVLIMID orally once daily for four weeks, followed by dose
    escalation by 5 mg every 28 days to a maximum dose of 25mg/day.

    Within the EU, Switzerland, Iceland and Norway, REVLIMID(R)
    (lenalidomide) is authorized for marketing and, in combination with
    dexamethasone, is indicated for the treatment of multiple myeloma
    patients who have received at least one prior therapy.

    REVLIMID is currently approved in the United States by the U.S.
    Food and Drug Administration (FDA) for multiple myeloma patients who
    have received at least one prior therapy, and for treatment of
    patients with 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, US,
    Switzerland and Australia for treatment of multiple myeloma, and MDS,
    and, for CLL in the US.

    About REVLIMID(R)

    REVLIMID is an IMiDs(R) compound, a member of a proprietary group
    of novel immunomodulatory agents. REVLIMID and other IMiDs compounds
    continue to be evaluated in over 100 clinical trials in a broad range
    of hematological and oncological conditions. The IMiDs pipeline is
    covered by a comprehensive intellectual property estate of issued and
    pending patent applications in the US, EU and other regions, including
    composition-of- matter and use patents.

    About Chronic Lymphocytic Leukemia

    Chronic lymphocytic leukemia results from an acquired (not
    inherited) injury to the DNA of a single cell, a lymphocyte, in the
    bone marrow. This injury is not present at birth. Scientists do not
    yet understand what produces this change in the DNA of CLL patients.

    This change in the cell's DNA confers a growth and survival
    advantage on the cell, which becomes abnormal and malignant
    (leukemic). The result of this injury is the uncontrolled growth of
    lymphocytic cells in the marrow leading invariably to an increase of
    abnormal lymphocytes in the blood and the bone marrow. These
    lymphocytes do not perform their functions as normal ones would and
    interfere with the production of other blood cells necessary for the
    normal functioning of the blood, leading to a host of complications
    like deficiency of the immune system, coagulation problems, swollen
    lymph nodes, and many other conditions.

    About Celgene

    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 forward-looking statements which are subject
    to 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 expressed or
    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 other factors
    described in the Company's filings with the Securities and Exchange
    Commission such as our 10K, 10Q and 8K reports.