Update on Iressa

AstraZeneca PLC 09 January 2003 ASTRAZENECA ANNOUNCES FDA REQUIRES MORE TIME FOR PRIORITY REVIEW OF IRESSA(R) (ZD1839) U.S. APPLICATION -DECISION EXPECTED BY MAY 5, 2003 The U.S. Food and Drug Administration (FDA) has notified AstraZeneca that it requires more time to review information requested of the company during the six month priority review of the new drug application (NDA) for IRESSA(R) (ZD1839/ gefitinib). AstraZeneca will work closely with the Agency to complete the review in a prompt and effective manner. The extended user fee goal date is May 5th 2003. On September 24, 2002 the Oncologic Drugs Advisory Committee (ODAC) made a clear recommendation to the FDA supporting the approval of IRESSA(R) (ZD1839/ gefitinib). Since that time, AstraZeneca has continued to provide additional information to the FDA as requested by the agency, including extensive safety information on patients involved in clinical trials, the expanded access programme (compassionate use) and clinical use in Japan where the drug is approved. At the urging of patients and physicians, and with the support of the FDA, AstraZeneca continues to provide an extensive compassionate use programme for the drug during the review period. In the past two years, almost 20,000 patients in the U.S. have received IRESSA(R) through this programme. Lung cancer is the leading cause of cancer deaths in the United States, which accounted for approximately 155,000 deaths in 2002. Non-small cell lung cancer is the most common form of lung cancer, accounting for 80 per cent of all lung cancer cases. IRESSA(R) is being considered for use in the most advanced of these patients, who have progressed despite multiple other treatments. Currently no treatment option exists for these patients. 9 January 2003 Media Enquiries: Emily Denney, Tel: +44 (0) 20 7304 5034 Steve Brown, Tel: +44 (0) 20 7304 5033 Investor Relations: Jonathan Hunt, Tel: +44 (0) 20 7304 5087 Mina Blair Robinson: Tel: +44 (0) 20 7304 5084 Notes to editors: For more information on AstraZeneca please visit www.astrazeneca.com This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2001. IRESSA(R) is a trademark of the AstraZeneca group of companies. -Ends- This information is provided by RNS The company news service from the London Stock Exchange

Companies

AstraZeneca (AZN)
UK 100