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| |  Crestor (Rosuvastatin) Recommended for Approval in Japan, for Treatment of Hypercholesterolema WILMINGTON, DE -- December 29, 2004 -- AstraZeneca (NYSE: AZN) announced that the Pharmaceuticals Affairs Council has recommended that the Japanese Ministry of Health, Labour and Welfare (MHLW) approve Crestor® (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 program. 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 program 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 percent 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 favorable benefit: risk profile of Crestor and confirms that the safety profile is in line with other currently marketed statins.
SOURCE: AstraZeneca
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