Iressa

AstraZeneca PLC
04 January 2005



  GEFITINIB (IRESSA(TM)) MARKETING AUTHORISATION APPLICATION WITHDRAWN IN EU


AstraZeneca today announced that it is withdrawing the European Marketing
Authorisation Application (MAA) for IRESSA(TM) (gefitinib) in treating patients
with non-small cell lung cancer (NSCLC) from the European Medicines Agency
(EMEA).

The company has taken this decision after consultation with the EMEA in view of
the IRESSA Survival Evaluation in Lung cancer (ISEL) survival results, which
will not meet the approval requirements for the current IRESSA MAA.  The
submission of a new MAA will be considered for IRESSA in the future, after
evaluation of the full ISEL dataset and emerging data.

In the preliminary analysis of the ISEL trial, there was a statistically
significant improvement in tumour shrinkage (response rate) and time to
treatment failure, which did not translate into a statistically significant
survival benefit. In the meantime,  AstraZeneca believes it would be premature
to close the IRESSA compassionate use (Expanded Access) programme to new
patients until the full ISEL dataset is reviewed, as the company remains
convinced by the evidence that IRESSA  provides some benefit for patients with
NSCLC.  The status of all ongoing AstraZeneca-sponsored studies in NSCLC is
under review.  Investigator and co-operative groups have been informed, all
trials are open to recruitment and are being reviewed on a trial by trial basis.
Studies in other cancer types are set to continue.

Discussions with the US Food and Drug Administration (FDA), MHLW in Japan and
all other Regulatory Authorities continue about the status of IRESSA.

AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription pharmaceuticals
and the supply of healthcare services. It is one of the world's leading
pharmaceutical companies with healthcare sales of over $18.8 billion and leading
positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience
and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index.


4 January 2005


Media Enquiries:
Edel McCaffrey, Tel: [phone]
Steve Brown, Tel: [phone]

Investor Enquiries:
Mina Blair, Tel: [phone]
Jonathan Hunt, Tel:  [phone]


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