Astrazeneca responds to fda action on supplemental new drug application for casodex 150mg for early prostate cancer

ASTRAZENECA RESPONDS TO FDA ACTION ON SUPPLEMENTAL NEW DRUG APPLICATION FOR CASODEX 150MG FOR EARLY PROSTATE CANCER AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a non-approvable letter for its supplemental new drug application (sNDA) for 'Casodex' (bicalutamide)150mg for the treatment of early prostate cancer. The FDA's decision does not impact on the current use and approval of 'Casodex' 50mg formulation for advanced prostate cancer treatment. 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. 'Casodex' is a trademark of the AstraZeneca group of companies NOTES: Information about AstraZeneca and full prescribing information for all AstraZeneca products are available at www.astrazeneca.com For further information, please contact: Media Enquiries: Investor Relations: Staffan Ternby, 070-557 43 00 Staffan Ternby, 070-557 43 00 Emily Denney, +44 (0) 207 304 5034 Jonathan Hunt, +44 (0) 207 304 5087 Steve Brown, +44 (0) 207 304 5033 Mina Blair Robinson, +44 (0) 207 304 5084 ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/06/21/20020620BIT00950/wkr0001.doc http://www.waymaker.net/bitonline/2002/06/21/20020620BIT00950/wkr0002.pdf