PEPTECH LIMITED 2003-01-02 ASX-SIGNAL-G
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
website.
For further information please contact:
Stephen Kwik Dr Paul Schober
MANAGING DIRECTOR INVESTOR RELATIONS
Ph (02) 9870 8788 Ph (02) 9870 8788
PTD
unknown
PEPTECH LIMITED 2003-01-02 ASX-SIGNAL-GHOMEX - Sydney...
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