Crestor Japan

AstraZeneca PLC 29 December 2004 COUNCIL RECOMMENDS APPROVAL OF CRESTOR IN JAPAN AstraZeneca announced today that the Pharmaceuticals Affairs Council has recommended that the Japanese Ministry of Health, Labour and Welfare (MHLW) approve CRESTORTM (rosuvastatin) in Japan at a dose range of 2.5-20 mg for the treatment of hypercholesterolaemia. The Council's recommendation is contingent on final agreement of a post marketing surveillance programme. The recommended starting dose of 2.5 mg is in line with normal clinical practice in Japan where, compared to the western world, lower dose ranges of drugs, including statins, are made available. Once pricing and reimbursement have been agreed, AstraZeneca, in partnership with Shionogi, will initiate the marketing of CRESTOR with the agreed post marketing surveillance programme to confirm its benefit-risk profile in the Japanese setting prior to a full-scale launch. Cardiovascular disease (CVD) is the leading cause of death worldwide, resulting in approximately 15 million deaths globally each year. There are 150,000 deaths annually from CVD in Japan alone and the incidence of dyslipidaemia is increasing in this population. Elevated LDL-C and low levels of HDL-cholesterol (HDL-C or 'good' cholesterol) are established major risk factors for CVD and there is overwhelming evidence that a greater reduction of LDL-C is accompanied by a greater reduction in CV events. However, up to 40 per cent of patients with dyslipidaemia in Japan are still not achieving their cholesterol treatment goals described in the Japanese guidelines and remain at an unnecessary risk of CVD. CRESTOR is the most effective statin at lowering LDL-C, with the added benefit of increasing HDL-C, enabling more patients to reach their LDL-C treatment goals than other available statins. CRESTOR has now received regulatory approvals in 68 countries across five continents and has been launched in over 50 countries worldwide, including 19 European markets, the US and Canada. Almost 4 million patients have been prescribed CRESTOR and 14.5 million prescriptions have been written worldwide. Safety data from the post-marketing experience supports the favourable benefit: risk profile of CRESTOR and confirms that the safety profile is in line with other currently marketed statins. AstraZeneca 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 world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. -ends- December 29th 2004. Further enquiries to: Media Enquiries: Chris Major, Tel: +44 (0) 207 304 5028 Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries: Mina Blair, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 Note to News Editors: CRESTOR is a trademark of the AstraZeneca group of companies. This information is provided by RNS The company news service from the London Stock Exchange

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