Crestor

AstraZeneca PLC 13 August 2003 CRESTOR(R) RECEIVES FDA APPROVAL CRESTOR Significantly Lowers LDL Cholesterol by As Much As 63% AstraZeneca announced today that its new cholesterol-lowering medication, CRESTOR(R) (rosuvastatin calcium), which has been shown to lower LDL-cholesterol by up to 63 percent, has received approval from the U.S. Food and Drug Administration (FDA) as an adjunct to diet for the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. This follows the successful Advisory Committee Meeting held in the US on 9th July 2003 where the Committee voted unanimously to recommend the approval of CRESTOR. CRESTOR is the newest member of the cholesterol-lowering statin (HMG-CoA reductase inhibitors) class of drug therapy. In addition to its LDL (low-density lipoprotein) or 'bad' cholesterol lowering effects, CRESTOR has been shown to provide a significant increase in HDL (high-density lipoprotein) or 'good' cholesterol. 'We are delighted with the approval of CRESTOR in the United States,' said Sir Tom McKillop, Chief Executive Officer of AstraZeneca. 'We believe that CRESTOR offers an important new treatment option for patients who are either untreated or not at target cholesterol levels.' The FDA has approved the recommended usual starting dose of CRESTOR to be 10 mg once daily with a dose range of 5 to 40 mg available. Therapy with CRESTOR should be individualised according to goal of therapy and response. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20 mg start dose may be considered, and for special populations a 5 mg dose is also available. The clinical development program for CRESTOR is the largest program ever submitted to initially evaluate a statin. In multiple clinical studies, CRESTOR has been shown to be more effective in lowering LDL-cholesterol (LDL-C or 'bad cholesterol') than currently prescribed statins. CRESTOR 10mg gets significantly more patients to their LDL-C goal (both NCEP ATP III (US) and European) than atorvastatin 10mg and, in addition to the dramatic reductions seen in LDL-C, CRESTOR produces a significant increase in HDL-C ('good cholesterol'), as well as reducing total cholesterol and triglycerides. Evidence collected from over 24,000 patients who have taken CRESTOR demonstrates that it is well tolerated with a safety profile comparable to that of other statins. Guidelines issued by the National Cholesterol Education Program's Adult Treatment Panel III have substantially increased the number of patients eligible for cholesterol-lowering drug therapy from approximately 13 million to 36 million. Currently, it is estimated that more than 20 million Americans have an LDL goal of <100 mg/dL, and it is estimated that only about one third of treated patients reach their LDL goal. Cardiovascular disease is the leading cause of death in the United States. According to the American Heart Association, more than 2,600 Americans die from cardiovascular diseases every day - an average of one death every 33 seconds. The global statin market is estimated to be worth approximately $20 billion and growing at a rate of around 13 per cent annually. CRESTOR was first approved in the Netherlands in 2002 and has since been approved in 23 other countries. Launches have occurred in a number of countries, including Canada, the Netherlands and the United Kingdom. 13 August 2003 Media Enquiries: Emily Denney, Tel: +44 (0) 207 304 5034 Chris Major, Tel: +44 (0) 207 304 5028 Investor Relations: Jonathan Hunt, Tel: +44 (0) 207 304 5087 Jorgen Winroth, Tel: +1 212 581 8720 NOTES TO EDITORS *National Cholesterol Education Program's Adult Treatment Panel III • Full US prescribing information for CRESTOR is available at www.astrazeneca-us.com • AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co Ltd, the pharmaceutical company that discovered the drug, in April 1998. • CRESTOR is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Type IIa and IIb); as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); and to reduce LDL-C and total-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. • CVD is estimated to account for a third of all deaths globally and is the leading cause of mortality in Europe and the US. Over 16.6 million deaths each year are due to CVD (more than 45,000 deaths every day, and almost 32 deaths each minute) In Europe, about half of all deaths from CVD are from CHD and nearly one-third are from stroke. • For further information please see www.astrazenecapressoffice.com -Ends- This information is provided by RNS The company news service from the London Stock Exchange

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