Arimidex

AstraZeneca PLC
06 September 2002





ASTRAZENECA GRANTED U.S. APPROVAL FOR ARIMIDEX(R) (anastrozole) IN EARLY BREAST
CANCER





AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has
approved Arimidex(R) (anastrozole) for the adjuvant treatment of early breast
cancer in postmenopausal women.  The U.S. approval is based on the
groundbreaking results from the ATAC (Arimidex and Tamoxifen, Alone or in
Combination) study-the world's largest ever breast cancer trial - which showed
significant efficacy and tolerability benefits of 'Arimidex' over tamoxifen in
this setting.



'Arimidex' is the first and only aromatase inhibitor to be approved for use in
the adjuvant treatment of early breast cancer in postmenopausal women.  
'Arimidex' is already licensed worldwide for use in advanced disease where it
has become the world's leading aromatase inhibitor with over 600,000 patient years
experience.



'Arimidex' has already been approved as an adjuvant treatment for postmenopausal
women with early breast cancer in Belgium and Mexico and, additionally,
AstraZeneca has a licence to promote this indication in Japan.  AstraZeneca
submitted data packages requesting approval for 'Arimidex' in early breast
cancer in Europe and in other rest of world markets earlier this year. '
Arimidex' sales in 2001 were $191 million, a 22 percent increase over the
previous year.  AstraZeneca's Nolvadex(R)  (tamoxifen) accounted for $630
million in sales the same year.  The early breast cancer market could be worth
approximately $2 billion.



Study Results



The ATAC study - which is now published as a peer-reviewed paper in The Lancet -
demonstrated that 'Arimidex' is more effective than tamoxifen in terms of
disease free survival.  The findings represent a 17 per cent relative risk
reduction for breast cancer recurrence with 'Arimidex' treatment compared to
tamoxifen.  Among women confirmed with hormone-sensitive tumours, the reduction
in relative risk with 'Arimidex' compared with tamoxifen was even more striking,
at 22 per cent.



Additionally, 'Arimidex' shows an important benefit in reducing the likelihood
of the cancer spreading to the opposite breast ('contralateral' breast cancer).
Compared with tamoxifen (which had already shown an almost 50 per cent reduction
in this area versus control), 'Arimidex' reduces the risk by a further 58 per
cent.



'Arimidex' was also found to have many important tolerability advantages over
tamoxifen.  The published results are from the first planned analysis of the
ATAC data at a median duration of 33.3 months follow-up.  Additional follow-up
for safety and efficacy is protocolled in the trial.



'Arimidex' and 'Nolvadex' are trademarks, the property of the AstraZeneca group
of companies.



6 September 2002



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