Regulatory Application

AstraZeneca PLC
30 March 2001


ASTRAZENECA SUBMITS NEW DRUG APPLICATION (NDA) TO FDA FOR NEW TYPE OF BREAST
CANCER TREATMENT

AstraZeneca today announced the submission of a new drug application (NDA),
requesting Priority Review with the U.S. Food and Drug Administration (FDA)
for Faslodex, for treatment of locally advanced or metastatic breast cancer 
in postmenopausal women who have previously progressed following hormonal
therapy.

Faslodex is characterised as an Estrogen Receptor Downregulator and works
differently from other hormonal breast cancer drugs in that it targets and
degrades the estrogen receptor.  Currently, advanced breast cancer patients
whose tumours have been shown to use hormones to grow are given drugs like
tamoxifen that act by blocking the estrogen receptor, or aromatase inhibitors
that lessen the amount of estrogen in a woman's body.  After a period of time,
tumours can become resistant to these types of treatments and cancer may
progress.  Faslodex represents a new way to attack cancer cells that have
grown resistant to current hormonal treatment options.

The FDA submission was based on data from two phase III trials which compared
Faslodex to Arimidex, the most widely prescribed aromatase inhibitor, in
measures of time to progression and response rate.  All women in the trial
were postmenopausal and had been treated with prior hormonal therapy, in most
cases tamoxifen, and were randomised after their disease no longer responded. 


In both the North American Trial and the European Trial, the time to
progression and objective response rate were similar for Faslodex and
Arimidex.  In the North American Trial the median duration of response was
19.3 months with Faslodex and 10.5 months with Arimidex.  In the European
Trial, the duration of response for Faslodex and Arimidex were similar. 
Faslodex is administered as a monthly intramuscular injection. 

AstraZeneca is committed to continued research on Faslodex and is currently
evaluating it in a head to head trial with tamoxifen for first line advanced
breast cancer.  Results are expected early next year.  Additional trials are
in the planning stages for early breast cancer and for breast cancer in
pre-menopausal women. 

Priority Review status may reduce the review time of the Faslodex NDA,
potentially allowing the drug to reach patients earlier.

An estimated 192,200 new cases of invasive breast cancer will be diagnosed in
the USA and an estimated 40,200 women will die of breast cancer in 2001.  A
portion of newly diagnosed breast cancer cases will be initially diagnosed in
the advanced or locally advanced stages where cancer has spread to the lymph
nodes and/or other parts of the body.  

30 March 2001

Further enquiries:

Investor Relations:
       
Michael Olsson:     Tel:  [phone]
Jorgen Winroth:     Tel:  [phone]
Ed Seage:           Tel:  [phone]