The International Myeloma Foundation Says New Treatment Regimen for Older Patients Could Soon Be Approved in Europe



    The International Myeloma Foundation (IMF) - supporting research
    and providing education, advocacy and support for myeloma patients,
    families, researchers and physicians - today said the positive opinion
    from the European Medicines Agency (EMEA) could clear the way for a
    new treatment regimen in Europe. The decision recommends approval of
    Thalidomide Pharmion(R) in combination with melphalan and prednisone
    for newly diagnosed patients over 65.

    "Thalidomide is the first of what are called the Novel Therapies
    that - along with VELCADE(R) and REVLIMID(R) - have changed the
    outlook for myeloma patients," said Susie Novis, president and
    co-founder of the IMF. "Thalidomide is available in the United States,
    Australia, New Zealand and elsewhere now, and we would like all
    patients to have safe access to its demonstrated benefits."

    The combination of melphalan and prednisone (MP) was once the
    standard of care for myeloma in Europe, but recent studies have shown
    the combination is greatly improved by the addition of the Novel
    Therapies: This positive opinion for thalidomide MP is based on a
    multi-center clinical trial showing average survival of more than 4
    years, a year and a half more than MP without thalidomide. Studies
    have also shown improved response adding VELCADE to MP and adding
    REVLIMID to MP.

    The recommendation sets the stage for the return of thalidomide to
    Europe with safe distribution for an important indication.
    Thalidomide, developed as THALOMID(R) from the Celgene Corporation,
    was approved for patients in the United States in 2006. Although once
    associated with an epidemic of birth defects when prescribed for
    pregnant women, a proprietary risk management system in the United
    States has seen more than 100-thousand prescriptions without a single
    birth defect, demonstrating the drug can be used safely.

    German hematologist Ralph Naumann, of the University Clinic in
    Dresden, Germany prescribes thalidomide for his patients even though
    he personally has experienced the effects of thalidomide since his own
    mother took it when she was pregnant. He has stated: "Thalidomide is
    not a bad drug, it´s just a drug that was badly used, and for the many
    myeloma patients today who are benefiting from thalidomide, that´s a
    crucial distinction."

    Myeloma, also called multiple myeloma, is a cancer of the bone
    marrow that affects production of red cells, white cells and stem
    cells. It affects an estimated 750,000 people worldwide, and in
    industrialized countries it is being diagnosed in growing in numbers
    and in increasingly younger people. There is no cure, but by using
    therapies in combination and in sequence doctors are moving myeloma
    toward becoming a chronic disease.

    The positive recommendation could lead to marketing authorization
    for thalidomide-melphalan-prednisone in the EU within two to three
    months.

    ABOUT THE INTERNATIONAL MYELOMA FOUNDATION

    The International Myeloma Foundation is the oldest and largest
    myeloma organization, reaching more than 165,000 members in 113
    countries worldwide. A 501 (c) 3 non-profit organization dedicated to
    improving the quality of life of myeloma patients and their families,
    the IMF focuses on four key areas: research, education, support and
    advocacy. To date, the IMF has conducted more than 100 educational
    seminars worldwide, maintains a world-renowned hotline, and operates
    Bank on a Cure(R), a unique gene bank to advance myeloma research. The
    IMF can be reached at +1818-487-7455. The global Website is
    www.myeloma.org with a companion Website in Spanish at
    www.myelomala.org.