AstraZeneca PLC
10 March 2003
SUCCESSFUL OUTCOME OF THE MUTUAL RECOGNITION PROCEDURE FOR CRESTOR(R) IN EUROPE
AstraZeneca announced today that it has successfully completed the Mutual
Recognition Procedure (MRP) in Europe for CRESTOR(R) (rosuvastatin) 10-40 mg for
the management of primary hypercholesterolaemia and mixed dyslipidaemia. The
Netherlands acted as the reference member state for the MR procedure, and
CRESTOR has been launched in that market. National marketing authorisations in
an additional 13 countries will be issued in the coming months.
Germany, Spain and Norway have been withdrawn from the MR process, and
discussions will be held with their agencies to progress further regulatory
options.
The global statin market is estimated to be worth approximately $19 billion and
growing at a rate of around 15 per cent annually.
The clinical development programme for CRESTOR now involves over 16,000 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 currently prescribed statins. CRESTOR 10mg
gets significantly more patients to their European LDL-C goal than atorvastatin
10mg (82% v 51% respectively), simvastatin 20mg (80% v 48%) and pravastatin 20mg
(80% v 16%). 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.
CRESTOR has been approved in Singapore and in Canada, where it was recently
launched. It is awaiting approval in the USA, Japan and in other markets.
Cardiovascular disease is the leading cause of death worldwide, responsible for
up to 17 million deaths per year. CRESTOR, a member of the statin class, is a
once daily treatment for dyslipidaemia, a key risk factor in the development of
cardiovascular disease, providing important benefits for both patients and
health care professionals.
CRESTOR is a Trade Mark of the AstraZeneca group of companies.
10 March 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Notes to Editors:
• European MR countries include: Austria, Belgium, Denmark, Finland, France,
Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal,
Spain, Sweden, the United Kingdom, Iceland and Norway
-Ends-
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