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Amrubicinis Designated as an Orphan Medicinal Product by the European Commission for the Treatment of Small Cell Lung Cancer



    Celgene International Sarl (NASDAQ: CELG) today announced that
    amrubicin hydrochloride has been designated as an orphan medicinal
    product by the European Commission (EC) for the treatment of small
    cell lung cancer following the favorable opinion of the European
    Medicines Agency´s (EMEA) Committee for Orphan Medicinal Products
    (COMP).

    Criteria for designation of orphan medicinal product require that
    the product be intended for the treatment of life-threatening or
    serious conditions that are rare and affect not more than 5 in 10,000
    persons in the EU. In the European Union, small cell lung cancer
    affects more than 57,000 people and approximately 34,000 new cases of
    the disease will be diagnosed this year.

    Orphan medicinal product designation is granted by the EC to
    provide special incentives for sponsors planning to test a product for
    use in a rare disease or condition. These incentives include
    eligibility for protocol assistance and possible exemptions or
    reductions of certain regulatory fees during development or at the
    time of application for marketing approval. Orphan designation will
    provide amrubicin with 10 years of marketing exclusivity following
    marketing approval for the treatment of small cell lung cancer.

    "The decision by the European Commission to designate amrubicin
    hydrochloride an orphan medicinal product continues our efforts to
    deliver innovative therapies worldwide to patients in areas of great
    unmet medical need such as solid tumor cancers," said Graham Burton
    M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene
    Corporation.

    In March 2008, the Company also announced that the U.S. Food and
    Drug Administration has granted orphan drug designation for amrubicin
    in the treatment of small cell lung cancer.

    About Amrubicin

    Amrubicin is a third-generation, synthetic anthracycline analogue
    with potent anti-tumor activity against various human tumor xenografts
    and is a strong topoisomerase II inhibitor. Amrubicin is being studied
    as a single agent and in combination with anti-cancer therapies for
    small cell lung cancer.

    Amrubicin is currently approved and marketed in Japan for the
    treatment of both small cell lung cancer and non-small cell lung
    cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on
    oncology, which licensed Japanese marketing rights from Dainippon
    Sumitomo Pharma, the original developer of the therapy. Dainippon
    Sumitomo also licensed the North American and European marketing
    rights for amrubicin to Pharmion Corporation, which was acquired by
    Celgene Corporation in March 2008.

    About Small Cell Lung Cancer

    Small cell lung cancer is a disease in which malignant cells form
    in the tissues of the lung, and nearly all cases are attributable to
    cigarette smoking, with the remaining cases thought to be caused by
    environmental or genetic factors. While small cell lung cancer
    constitutes approximately 15 percent of all lung cancers, SCLC tends
    to be more aggressive and fast growing than the more common non-small
    cell lung cancer. An estimated 66,000 patients are diagnosed with SCLC
    each year in the US and EU (approximately 32,000 in the US and 34,000
    in the EU). Approximately 60 percent of patients have extensive
    disease at diagnosis, and the remaining 40 percent present with
    localized, or limited stage, disease.

    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.

    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.