AstraZeneca PLC
19 February 2003
ASTRAZENECA'S NEW STATIN, CRESTORTM, RECEIVES APPROVAL IN CANADA - COMPANY
INTENDS IMMEDIATE LAUNCH
AstraZeneca announced today it has received approval for CRESTORTM
(rosuvastatin) 10-40 mg from the Therapeutic Products Directorate of Health
Canada for the management of primary hypercholesterolaemia, mixed dyslipidaemia,
and familial hypercholesterolaemia in Canada. The company will launch Crestor
in Canada immediately.
The global statin market is currently worth US $18 billion annually and is
growing at about 20 per cent a year. The Canadian statin market is valued at
Canadian $1 billion a year and is also growing at 20 per cent annually. There
are estimated to be 10 million people with dyslipidaemia in Canada.
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 per cent to 63 per cent across the dose range, and
compared to the same doses of atorvastatin, CRESTOR provided a significant 8.4
per cent greater reduction in LDL-C. CRESTOR 10mg gets significantly more
patients to their European LDL-C goal than atorvastatin 10mg (82 per cent v 51
per cent respectively), simvastatin 20mg (80 per cent v 48 per cent) and
pravastatin 20mg (80 per cent v 16 per cent). 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.
In addition to the approval in Canada today, CRESTOR was approved in the
Netherlands last year and subsequently entered the European Mutual Recognition
Procedure, which will lead to further approvals in 16 other countries in Europe
-- beginning in the first half of 2003. CRESTOR has also recently been approved
in Singapore and is awaiting approval in the USA, Japan and in other markets.
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.
19 February 2003
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
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.