Regulatory Approval

AstraZeneca PLC
17 September 2001





ASTRAZENECA RECEIVES FIRST REGULATORY APPROVALS FOR CASODEX(TM) 150MG IN EARLY
PROSTATE CANCER



AstraZeneca has gained its first approval for Casodex(TM) (bicalutamide) 150mg
for the treatment of early stages of prostate cancer in the United Kingdom.
Casodex(TM) 150mg represents the first once daily drug therapy available for
treatment of the early stages of this disease.



The UK is acting as the reference member state in a European Union recognition
procedure and, within that procedure, approval for the new indication was also
granted in Greece, Portugal and Austria. Licences in other European markets
are anticipated.



These approvals are based on results from the world's largest prostate cancer
treatment trial that found that Casodex(TM) 150mg can significantly reduce (by 
42 percent) the risk of the disease progressing in patients with early prostate
cancer, when taken in addition to standard therapy (watchful waiting, radical
prostatectomy or radiotherapy), when compared to standard care alone.



Further regulatory submissions and approvals are anticipated, including in the
US, where a submission is planned by the end of the year. In addition,
licences have recently been granted for Casodex(TM) 150mg in Italy and Hungary,
which also authorise its use in the early stages of prostate cancer.



In 2000, Casodex(TM)'s worldwide sales of $433 m showed a 31 percent increase
compared to the previous year.  Casodex(TM) is one of five important AstraZeneca
products, whose growth is being fuelled by life cycle initiatives.



London, 17 September 2001

                                   - Ends -

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