Crestor
AstraZeneca PLC
07 November 2002
ASTRAZENECA'S NEW STATIN, CRESTORTM, RECEIVES FIRST APPROVAL IN EUROPE
Other European markets should follow in 2003
AstraZeneca announced today it has received the first approval for CRESTORTM
(rosuvastatin) 10-40 mg from the Medicines Evaluation Board (MEB) in the
Netherlands for the management of primary hypercholesterolaemia and mixed
dyslipidaemia.
Sir Tom McKillop, Chief Executive of AstraZeneca, said, 'We are delighted to
have received this first approval of CRESTOR, which represents another milestone
for the company. CRESTOR is an outstanding product that will enable more
patients across the world to reach their target LDL cholesterol levels, and aid
in the global fight against coronary heart disease.'
The Netherlands MEB will act as the Reference Member State for the European
Mutual Recognition Procedure leading to further approvals in 16 other countries
in Europe--beginning in the first half of 2003. CRESTOR is also awaiting
approval in the USA, Japan and in other markets.
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% to 63% across the dose range, and compared to the
same doses of atorvastatin, CRESTOR provided a significant 8.4% greater
reduction in LDL-C. 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.
The excellent efficacy of CRESTOR, together with a safety profile, which the
company believes is comparable to the marketed statins, will position CRESTOR as
a highly effective competitor in the global statin market, estimated to be worth
more than $18 billion and growing at a rate of about 20 per cent annually.
Dr Hamish Cameron, Vice President and Head of Cardiovascular Therapy Area at
AstraZeneca, said, 'Despite many medical advances, hypercholesterolaemia remains
poorly controlled. Approximately half of the people on cholesterol lowering
therapy are still not reaching their cholesterol targets and are at risk of
heart attacks and strokes. With the efficacy we've seen in clinical studies,
CRESTOR could make a real difference to these patients' lives.'
A copy of the English version of the approved label for CRESTORTM in The
Netherlands (rosuvastatin) can be found at
www.astrazeneca.com/redirector/index.asp?id=6
Details on the approval of CRESTORTM (rosuvastatin) will be provided by Dr
Hamish Cameron at 08.30 GMT today as a part of the company's Annual Business
Review. Dial in details for this event can be found at
www.astrazeneca.com/redirector/index.asp?id=5
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of ethical (prescription)
pharmaceuticals and the supply of healthcare services. It is one of the top
five pharmaceutical companies in the world with healthcare sales of over $16.4
billion and leading positions in sales of gastrointestinal, oncology,
anaesthesia including
pain management, cardiovascular, central nervous system (CNS) and respiratory
products. AstraZeneca has more than 40 years experience in cardiovascular
medicine and aims to increase lifespan and improve quality of life by reducing
the risk, prevalence and impact of cardiovascular disease. AstraZeneca has a
comprehensive cardiovascular portfolio including CRESTOR, ATACAND, ZESTRIL,
TENORMIN, SELOKEN ZOK /TOPROL XL AND PLENDIL. This heritage is complemented by
an innovative pipeline including the first oral direct thrombin inhibitor,
EXANTA, and a novel treatment for type 2 diabetes / metabolic syndrome, GALIDA.
7 November 2002
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
Notes to editors:
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.
CRESTOR, ATACAND, ZESTRIL, TENORMIN, SELOKEN ZOK /TOPROL XL, PLENDIL, EXANTA and
GALIDA are Trade Marks of the AstraZeneca group of companies.
- Ends -
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