AstraZeneca PLC
10 December 2001
New Data on Arimidex(R) Herald Entry Into Early Breast Cancer
AstraZeneca today announced that new data presented at the San Antonio Breast
Cancer Meeting demonstrate for the first time that leading aromatase inhibitor
Arimidex(R) is significantly more effective and has important tolerability
benefits compared with the current gold standard, tamoxifen, as an adjuvant
treatment in postmenopausal women with early breast cancer.
Regulatory approval for Arimidex in this new indication will be sought in the
United States and Europe in the first quarter of next year.
Arimidex sales in 2000 were $156 million, a 19 per cent increase over the
previous year. AstraZeneca's Nolvadex(R) (tamoxifen) accounted for $576
million in sales the same year. The early breast cancer market could be worth
approximately $2 billion.
The ATAC (Arimidex, Tamoxifen, Alone or in Combination) Trial is an
international study of over 9,300 postmenopausal women with early breast
cancer, which started in 1996. The trial compares five years of treatment
with tamoxifen alone (20 mg daily), Arimidex alone (1mg daily), or a
combination of both therapies, following initial surgery.
After an average of 33 month's follow-up, Arimidex monotherapy was found to be
significantly more effective in preventing relapse than tamoxifen, with a 17
per cent reduction in risk of breast cancer recurring with Arimidex treatment
compared to tamoxifen.
Arimidex was also found to have many important tolerability advantages over
tamoxifen. Arimidex was associated with significantly fewer reports of
endometrial cancer when compared with tamoxifen. This finding was supported
by a significantly lower incidence of vaginal bleeding and vaginal discharge
among Arimidex-treated patients compared to those taking tamoxifen. Another
known risk associated with tamoxifen is thromboembolic events. In the ATAC
trial, both the overall incidence of thromboembolic events and that of deep
vein thromboses were significantly reduced in the Arimidex group. Important
from the patient's perspective, the incidence of hot flushes and weight gain
were also significantly reduced.
However, as expected, women taking tamoxifen did have a lower risk of
experiencing musculo-skeletal disorders or the types of fractures common in
this age group compared with those taking Arimidex.
The Arimidex/tamoxifen combination showed no additional efficacy or
tolerability benefits compared with tamoxifen alone. There were no specific
safety issues associated with the combination treatment.
Further analysis of the ATAC data will now be carried out, including analysis
of sub-protocols designed specifically to investigate the effect of treatment
on the endometrium, bone and quality of life. In addition, the trial is
continuing, to allow the investigators to collect more data and particularly
to confirm if the observed reduction in relapse rates with Arimidex will lead
to improved long-term survival, as has been seen in earlier trials of
tamoxifen in early breast cancer.
Date: 10 December 2001
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
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Mina Blair Robinson, Tel: +44 (0) 207 304 5084
- Ends -
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