Casodex Priority Review

AstraZeneca PLC
20 February 2002



ASTRAZENECA RECEIVES FDA PRIORITY REVIEW FOR CASODEX 150 MG FOR THE TREATMENT OF
                    EARLY STAGE PROSTATE CANCER



AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has
granted a six-month priority review for the Supplemental New Drug Application
(sNDA) of its oral, once-daily hormonal medication Casodex (bicalutamide 150mg)
for the treatment of early stage non-metastatic prostate cancer.



AstraZeneca filed the sNDA with the FDA for Casodex 150mg on 20 December 2001.
The FDA grants priority review to those products which may offer significant
improvements in the treatment of a disease. Products granted priority review
status are generally reviewed within six months, which potentially allows
earlier patient access.



The sNDA submission is based upon the first analysis of the combined efficacy
and tolerability data from the Early Prostate Cancer (EPC) Programme, which
shows that Casodex 150mg not only nearly halves the risk of tumour progression
or recurrence, but also reduces the risk of developing bone metastases by a
third. These results suggest that Casodex 150mg may be used in treatment of
early prostate cancer just as tamoxifen is used to treat breast cancer.



Prostate cancer affects one out of every six American men.  According to the
American Cancer Society, nearly 200,000 new prostate cancer cases will have been
diagnosed in 2001, or about one new case every three minutes.  It is the second
most frequently occurring malignancy in American men, after skin cancer, and is
the second leading cause of cancer death among men after lung cancer.



Casodex 150 mg for the treatment of early prostate cancer has already been
approved in twelve countries.  In 2001, Casodex's worldwide sales of $569
million showed a 31 percent increase compared to 2000.  Casodex's growth is
being fuelled by life cycle initiatives towards megabrand status within
AstraZeneca's range of products.







20 February 2002


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