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Lenalidomide (REVLIMID(R)) Receives Orphan Medicinal Product Designation from the European Commission for Chronic Lymphocytic Leukemia

- 8:10 - 30/11/2007

    Celgene International Sarl (NASDAQ: CELG) announced that
    lenalidomide (REVLIMID) has been granted orphan medicinal product
    designation by the European Commission (EC) for treatment of chronic
    lymphocytic leukemia (CLL) following the favorable opinion of the
    European Medicines Agency´s (EMEA) Committee for Orphan Medicinal
    Products (COMP).

    Orphan medicinal product designation is granted by the EC to
    promote development of drugs to treat rare diseases or conditions.
    Orphan designation will give lenalidomide (REVLIMID) access to the
    Centralized Procedure for the application for marketing approval;
    reduce fees associated with applying for marketing approval and
    protocol assistance; and provide ten years of market exclusivity once
    approved for treatment of chronic lymphocytic leukemia.

    Chronic lymphocytic leukemia is a hematological cancer that
    affects approximately 165,000 people in the European Union, based on
    an estimated prevalence 3.5 per 10,000.

    "The decision by the European Commission to designate REVLIMID as
    an orphan medicinal product for treatment of chronic lymphocytic
    leukemia supports our efforts to move REVLIMID as quickly as possible
    through the clinical and regulatory development process worldwide,"
    said Graham Burton M.D., SVP, Global Regulatory Affairs and
    Pharmacovigilance for Celgene Corporation. "We continue to be
    encouraged by the growing body of published and presented data on
    REVLIMID by key opinion leaders at major medical meetings, and based
    on these findings, we are committed to accelerating wherever possible
    our efforts to help address the unmet medical needs of patients with
    chronic lymphocytic leukemia worldwide."

    Within the EU, 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 also currently approved in the United States by the
    U.S. Food and Drug Administration (FDA) and in Switzerland for
    multiple myeloma patients who have received at least one prior
    therapy. Additionally, REVLIMID is approved in the United States for
    treatment of patients with transfusion-dependent anemia due to low- or
    intermediate-1-risk Myelodysplastic Syndrome (MDS) associated with a
    deletion 5q cytogenetic abnormality with or without additional
    cytogenetic abnormalities. REVLIMID has already obtained Orphan Drug
    designation in the EU, United States, Switzerland and Australia for
    the treatment of multiple myeloma and in the EU, Australia and United
    States for treatment of MDS.

    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 oncological conditions, both in blood cancers and solid tumors. The
    IMiDs pipeline is covered by a comprehensive intellectual property
    estate of United States and foreign issued and pending patent
    applications 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 EMEA

    The European Medicines Agency (EMEA) is the European regulatory
    body responsible for the authorization and supervision of medicinal
    products for human and veterinary use in member European countries,
    approximately twenty-seven to date. The agency has four key
    objectives; (1) To protect public health by mobilizing the best
    scientific resources existing within the European Union, (2) To
    promote health care through the effective regulation of new
    pharmaceuticals and better information for users and health
    professionals, (3) To facilitate quicker access and the free
    circulation of pharmaceuticals within the European single market, (4)
    To support the European pharmaceutical research and development
    industry by developing efficient, effective and responsive operating
    procedures.

    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.

    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.


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