Crestor

AstraZeneca PLC 10 July 2003 FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF CRESTOR(R) (rosuvastatin calcium) AstraZeneca announced today that the Endocrinologic and Metabolic Advisory Committee to the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval for CRESTOR(R) (rosuvastatin calcium) as an adjunct to diet for the treatment of various lipid disorders including hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. The FDA will now review the Committee's recommendation and make its final decision on granting marketing approval for CRESTOR. 'The Committee's unanimous recommendation to approve CRESTOR represents a vote of confidence in the clinical profile of CRESTOR,' said Howard Hutchinson, Vice President of Clinical Research, AstraZeneca. 'We believe that once approved, CRESTOR will provide patients who are untreated or not at their target cholesterol levels with an important new treatment option in the control of elevated cholesterol.' The clinical development programme for CRESTOR is the largest pre-approval programme ever submitted to evaluate the safety and efficacy of a new statin. More than 12,500 patients are included in the safety database with more than 4,000 patients exposed to the 40 mg dose. The most commonly reported treatment-related adverse events were myalgia, abdominal pain, nausea and asthenia. CRESTOR belongs to the class of lipid-lowering medications called HMG- CoA reductase inhibitors, or 'statins' and has been studied in more than 24,000 patients worldwide. CRESTOR is being studied in an extensive clinical outcomes programme known as GALAXY, which includes more than 19,000 patients from 23 countries. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd. CRESTOR was first approved in the Netherlands in 2002 and approval has recently been granted in 23 other countries. Launches have occurred in a number of countries, including Canada, the Netherlands and the United Kingdom. AstraZeneca (AZN: NYSE) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. 10 July 2003 Media Enquiries: Emily Denney, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Gary Bruell, Tel: +1 302-885-1554 Rachel Bloom-Baglin, Tel: +1 302-886-7858 Investor Relations: Mina Blair Robinson, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 - Ends - This information is provided by RNS The company news service from the London Stock Exchange

Companies

AstraZeneca (AZN)
UK 100

Latest directors dealings