Celgene Reports on REVLIMID(R) (Lenalidomide) Global Regulatory Developments in Multiple Myeloma and Deletion 5Q Myelodysplastic Syndromes



    Celgene International Sarl (NASDAQ: CELG) today announced the
    results of regulatory actions regarding REVLIMID(R) in Australia in
    multiple myeloma (MM), and in Canada and the European Union in
    deletion 5q myelodysplastic syndromes (MDS).

    In Australia, REVLIMID (lenalidomide) has received marketing
    authorisation approval from the Australian Therapeutic Goods
    Administration (TGA) for use in combination with dexamethasone as a
    treatment for patients with multiple myeloma whose disease has
    progressed after one therapy.

    The approval from the TGA was based upon the safety and efficacy
    results of two large, randomized pivotal Phase III special protocol
    assessment trials, North American Trial MM-009 and International Trial
    MM-010--each the focus of a recent study in The New England Journal of
    Medicine--evaluating REVLIMID plus dexamethasone in multiple myeloma
    patients whose disease had progressed after one therapy.

    Multiple myeloma is the second most commonly diagnosed blood
    cancer worldwide.

    In Canada, REVLIMID (lenalidomide) received conditional marketing
    authorisation approval from the Canadian Therapeutic Products
    Directorate (TPD) for the 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.

    The approval by the TPD was based upon the safety and efficacy
    results of a Phase II clinical trial (MDS-003) evaluating REVLIMID(R)
    in patients with transfusion-dependent anemia due to low- or
    intermediate-1-risk myelodysplastic syndromes (MDS) associated with a
    deletion 5q cytogenetic abnormality with or without additional
    cytogenetic abnormalities. Additionally, the U.S. FDA approved
    REVLIMID in December 2005 for the same indication based on this trial.

    "The approvals for REVLIMID in Australia and Canada in two
    different indications continue our stated goal of delivering REVLIMID
    as an innovative oral therapy to patients worldwide as quickly as
    possible," said Aart Brouwer, President of Celgene International.

    In the European Union, the European Medicines Agency´s (EMEA)
    Committee for Medicinal Products for Human Use (CHMP) issued a
    Negative Opinion on the Company´s Marketing Authorisation Application
    (MAA) for Lenalidomide - Celgene Europe for the 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.

    The CHMP concluded that lenalidomide is efficacious in patients
    suffering from deletion 5q MDS. Based on information available to the
    CHMP from the uncontrolled, open-label, 148-patient Phase II study
    (MDS-003), the CHMP was not convinced the data were sufficient to
    assure safety. Celgene intends to apply for a re-examination of the
    CHMP Opinion in accordance with relevant EMEA procedures.

    "We remain convinced of the positive benefit/risk of lenalidomide
    for the treatment of patients with deletion 5q minus MDS, and we look
    forward to continuing work with the EMEA and CHMP to bring this
    Marketing Authorisation Application to a positive outcome for patients
    in the European Union," said Graham Burton, M.D., SVP, Global
    Regulatory Affairs and Pharmacovigilance for Celgene.

    Lenalidomide (REVLIMID(R)) has obtained Orphan Drug designation
    for MDS in the European Union (EU), United States (US), and Australia,
    Orphan Drug designation for multiple myeloma (MM) in the EU, US,
    Australia and Switzerland, and Orphan Drug designation for chronic
    lymphocytic leukemia (CLL) in the US and EU. REVLIMID is currently
    approved for use in the US and Canada for the treatment of patients
    with transfusion-dependent anemia due to low- or intermediate-1-risk
    myelodysplastic syndromes (MDS) associated with a deletion 5q
    cytogenetic abnormality with or without additional cytogenetic
    abnormalities. REVLIMID is also approved for use in the EU, US and
    Switzerland for the treatment of multiple myeloma in combination with
    dexamethasone in patients who have received at least one prior
    therapy, and Australia for patients with multiple myeloma whose
    disease has progressed after one therapy.

    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 more than 100 clinical trials in a broad
    range of oncological conditions, both in blood cancers and solid
    tumors. The IMiDs pipeline is covered by a comprehensive intellectual
    property estate of issued and pending patent applications including
    composition-of-matter and use patents.

    About Myelodysplastic Syndromes

    Myelodysplastic syndromes (MDS) are a group of hematologic
    malignancies that affect approximately 300,000 people worldwide.
    Myelodysplastic syndromes occur when blood cells remain in an immature
    or "blast" stage within the bone marrow and never develop into mature
    cells capable of performing their necessary functions. Eventually, the
    bone marrow may be filled with blast cells suppressing normal cell
    development. According to the American Cancer Society, 10,000 to
    20,000 new cases of MDS are diagnosed each year in the United States,
    with median survival rates ranging from approximately six months to
    six years for the different classifications of MDS. MDS patients must
    often rely on blood transfusions to manage symptoms of anemia and
    fatigue and may develop life-threatening iron overload and/or toxicity
    from frequent transfusions, as well as a risk of transformation into
    acute myelogenous leukemia as a natural progression of the disease,
    thus underscoring the critical need for new therapies targeting the
    cause of the condition rather than simply managing its symptoms.

    About Deletion 5q Chromosomal Abnormality

    Chromosomal (cytogenetic) abnormalities are detected in more than
    half of patients with myelodysplastic syndrome (MDS), and involve a
    deletion in all or part of one or more specific chromosomes. The most
    common cytogenetic abnormalities in MDS are deletions in the long arm
    of chromosomes 5, 7, and 20. Another common abnormality is an extra
    copy of chromosome 8. A deletion involving the 5q chromosome may be
    involved in 20 to 30 percent of all MDS patients. The World Health
    Organization has also recently identified a unique subset of MDS
    patients with a "5q- Syndrome" where the only chromosomal abnormality
    is a specific portion of the 5q chromosome.

    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 the 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.

    REVLIMID(R) is a registered trademark of Celgene Corporation.

    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.