Casodex

AstraZeneca PLC
19 December 2002





                    FDA ADVISORY COMMITTEE REQUESTS FURTHER
                DATA ON ASTRAZENECA'S CASODEX(R) (BICALUTAMIDE)
                        150 MG FOR EARLY PROSTATE CANCER


AstraZeneca announced today that the Oncologic Drugs Advisory Committee (ODAC)
to the U.S. Food and Drug Administration (FDA) did not recommend approval of the
new indication for CASODEX 150 mg for the treatment of early stage prostate
cancer.

The panel recommendation does not impact on the current use and approval of
CASODEX 50 mg formulation, and also does not impact on CASODEX 150 mg
approvals in other countries.


Although the advisory committee could not reach a consensus on the
interpretation of the data and how the results from the trials apply 
specifically to U.S. patients, the committee did agree that the data appears to 
show CASODEX 150 mg is a viable treatment option for patients in other regions 
of the world, such as Europe and Scandinavia.  Despite the decision by the ODAC, 
several panel members did agree that the CASODEX 150 mg data showed positive 
benefits in the non-U.S. trials.


'While we are disappointed with the outcome of the ODAC meeting, we are
nevertheless encouraged by the positive comments from the panel in relation to
the data and the overall quality of the studies,' said Gerard T. Kennealey, MD,
Vice President, Oncology Research, AstraZeneca.


CASODEX 150 mg is already approved for the treatment of early stage disease in
more than 40 countries around the world, including the United Kingdom, Mexico,
Canada, Germany, Italy, and Australia, and AstraZeneca continues to seek
regulatory approvals in other markets.


The Supplemental New Drug Application (sNDA) is based on the
CASODEX Early Prostate Cancer (EPC) Trial Programme, the world's largest
prostate cancer treatment trial ever conducted with more than 8,000 patients in
23 countries.  The programme consists of three prospective, randomised,
double-blind, placebo-controlled clinical trials and was designed on the same
premise as trials of tamoxifen in breast cancer.  Adding tamoxifen to standard 
treatment for early breast cancer, such as surgery, has been proven to reduce 
the chance of the cancer returning and has saved thousands of women's lives.


In the EPC programme, approximately half the patients received CASODEX 150
mg/day and half received placebo, in addition to standard therapy of radical
prostatectomy, radiotherapy, or watchful waiting.  Overall, CASODEX 150 mg
reduced the chance of disease progression or death in the absence of progression 
by 42 per cent compared with placebo.  In addition, CASODEX 150 mg significantly 
reduced the risk of Prostate Specific Antigen (PSA) progression (defined as 
doubling of PSA concentration, objective disease progression, or death).  In 
clinical practice, a rising PSA is frequently used as a biochemical marker for 
progression of prostate cancer.  In the EPC Program, CASODEX 150 mg was shown to 
have a favourable tolerability profile, with the most frequently occurring side 
effect being gynecomastia (breast enlargement; 68 per cent) and breast pain (73 
per cent).  Gynecomastia and breast pain were considered severe in only 6 per 
cent and 5 per cent of patients, respectively.  The overall incidence of other 
side effects was similar for both treatment groups.


Even with the disappointing response from the ODAC, CASODEX continues to
contribute significant sales growth.  2002 sales through the first nine months
were $459M, 18 per cent above sales over the same period in 2001.  The growth is
continuing  to strengthen as additional countries approve CASODEX usage in early 
prostate cancer.  Additionally, usage of CASODEX 50 mg in advanced prostate 
cancer in the USA and elsewhere remains strong.


AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of ethical
(prescription) pharmaceuticals and the supply of healthcare services.  It is one
of the top five pharmaceutical companies in the world with healthcare sales of 
$16.4 billion and leading positions in sales of gastrointestinal, oncology, 
anesthesia (including pain management), cardiovascular, central nervous system 
(CNS) and respiratory products.


CASODEX is a trademark of the AstraZeneca group of companies.


19 December 2002


Media Enquiries:

Steve Brown, Tel: [phone]


Investor Relations:

Mina Blair-Robinson, Tel: [phone]

Jonathan Hunt, Tel: [phone]


Notes to Editors:

Background Information on Prostate Cancer

One in six men is at lifetime risk for being diagnosed with prostate cancer.
According to the American Cancer Society, nearly 190,000 new prostate cancer
cases will have been diagnosed in 2002, or about one new case every three
minutes.  It is the most frequently diagnosed non-skin cancer and is the second
leading cause of cancer death among men after lung cancer.


-Ends-

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