Dr. Gerard T. Kennealey, Vice President of Oncology Research at AstraZeneca, said, "Casodex 150mg is currently being evaluated in the largest ever treatment study in prostate cancer - the Early Prostate Cancer (EPC) programme. We strongly believe that the first results from the EPC programme show that Casodex 150mg provides important benefits for patients with the early stages of prostate cancer. We want to fully review our options with the FDA to find the best way forward, including possibly requesting an advisory committee meeting. In addition, the FDA has suggested that we request a public hearing to review the data and discuss the findings in an open forum."

'Casodex' 150mg is currently approved for the treatment of early or locally advanced prostate cancer in 50 countries around the world including the UK, Italy, Austria and Mexico.

One third or more of men that undergo standard care (radical prostatectomy, radiotherapy or watchful waiting) for early prostate cancer, have their disease return. The sNDA submission was based on the first results of the Early Prostate Cancer (EPC) programme, which showed that adding 'Casodex' 150mg to standard care reduces the risk of tumour progression by almost a half and reduces the incidence of bone metastases by a third in patients with localised or locally advanced (early) prostate cancer, compared with standard care alone. AstraZeneca and the FDA clearly had a difference of opinion on the interpretation of the data and how it applies to patients. The EPC programme was designed on the same premise as the adjuvant trials of tamoxifen for breast cancer. The EPC programme is the largest prostate cancer treatment study to date including over 8,000 patients from 23 countries around the world. AstraZeneca remains committed to the Casodex 150 mg EPC programme and continues to seek approval for this indication in countries worldwide.

"Casodex 150mg addresses a current unmet medical need in the treatment of prostate cancer. We have seen how hormonal therapies such as tamoxifen save lives in breast cancer patients, and the initial results from the EPC programme give us hope that we will be able to offer similar benefits to men with early prostate cancer" said Peter Iversen, one of the principal investigators of the Casodex EPC programme.

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, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.