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the cause of the movement

  1. Russian

    620 Posts.


    HOMEX - Sydney

    Abbott Laboratories Inc announced on 31 December 2002 that it had
    received U S Food and Drug Administration (FDA) approval to market
    HUMIRA(TM), previously known as D2E7.

    HUMIRA(TM) is the first human monoclonal antibody approved for
    reducing the signs and symptoms and inhibiting the progression of
    structural damage in adults with moderately to severely active
    rheumatoid arthritis (RA) who have had insufficient response to one
    or more traditional disease modifying anti-rheumatic drugs (DMARDs).
    HUMIRA (TM) was created using phage display technology, resulting in
    an antibody with human-derived heavy and light chains variable
    regions and human IgG1:K constant regions.

    The approval by the FIDA to market HUMIRA(TM) is obtained earlier,
    than anticipated. Abbott indicated in their announcement that
    HUMIRA(TM) will offer convenient every other week dosing by
    subcutaneous injection (shot beneath the skin). A specially designed
    pre-filled syringe for RA patients whose hands may be affected by
    crippling joint destruction will be available in pharmacies next
    month. Abbott is confident it can supply sufficient quantities to
    meet patient demand and recently announced a manufacturing expansion
    to meet future demand for HUMIRA(TM).

    Abbott also mentioned in their announcement that the European Agency
    for the Evaluation of Medicinal Products (EMEA) accepted Abbott's
    submission for HUMIRA(TM) for the treatment of RA in April 2002, and
    approval is anticipated in mid-2003. Peptech has earlier announced
    that it could look forward to the receipt of two milestone payments,
    one due upon approval from the EMEA in Europe, and the second upon
    first commercial shipment.

    A full copy of the Abbott media announcement is available on their

    For further information please contact:

    Stephen Kwik Dr Paul Schober
    Ph (02) 9870 8788 Ph (02) 9870 8788

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