+++++++++++++++++++++++++ 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 website.
For further information please contact:
Stephen Kwik Dr Paul Schober MANAGING DIRECTOR INVESTOR RELATIONS Ph (02) 9870 8788 Ph (02) 9870 8788
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