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.
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