Crestor

AstraZeneca PLC 19 February 2003 ASTRAZENECA'S NEW STATIN, CRESTORTM, RECEIVES APPROVAL IN CANADA - COMPANY INTENDS IMMEDIATE LAUNCH AstraZeneca announced today it has received approval for CRESTORTM (rosuvastatin) 10-40 mg from the Therapeutic Products Directorate of Health Canada for the management of primary hypercholesterolaemia, mixed dyslipidaemia, and familial hypercholesterolaemia in Canada. The company will launch Crestor in Canada immediately. The global statin market is currently worth US $18 billion annually and is growing at about 20 per cent a year. The Canadian statin market is valued at Canadian $1 billion a year and is also growing at 20 per cent annually. There are estimated to be 10 million people with dyslipidaemia in Canada. The clinical development programme for CRESTOR now involves over 15,000 patients and includes a number of head-to-head comparative studies. In multiple clinical studies, CRESTOR has been shown to be more effective in lowering LDL-cholesterol (LDL-C or 'bad' cholesterol) than the currently prescribed statins. It has demonstrated reductions of 52 per cent to 63 per cent across the dose range, and compared to the same doses of atorvastatin, CRESTOR provided a significant 8.4 per cent greater reduction in LDL-C. CRESTOR 10mg gets significantly more patients to their European LDL-C goal than atorvastatin 10mg (82 per cent v 51 per cent respectively), simvastatin 20mg (80 per cent v 48 per cent) and pravastatin 20mg (80 per cent v 16 per cent). 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. In addition to the approval in Canada today, CRESTOR was approved in the Netherlands last year and subsequently entered the European Mutual Recognition Procedure, which will lead to further approvals in 16 other countries in Europe -- beginning in the first half of 2003. CRESTOR has also recently been approved in Singapore and is awaiting approval in the USA, Japan and in other markets. Coronary heart disease (CHD) is a major cause of morbidity and the leading cause of death in the Western world. LDL-C is the most significant contributory risk factor to atherosclerosis, a common cause of CHD and elevated levels of cholesterol is one of the most important risk factors in predicting CHD risk in the population. AstraZeneca licensed worldwide rights to CRESTOR from Shionogi & Co Ltd, Osaka, Japan, the company that discovered the drug, in April 1998. AstraZeneca carried out a comprehensive clinical development programme leading to submission. 19 February 2003 Media Enquiries: Steve Brown, Tel: +44 (0) 207 304 5033 Emily Denney, Tel: +44 (0) 207 304 5034 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

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AstraZeneca (AZN)
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