Dr Gunnar Olsson, Vice President and Head of Cardiovascular Therapy Area at AstraZeneca, said, "Canada is the first major commercial market to receive approval for CRESTOR, and as well as being another important milestone, it is also great news for the 10 million people with dyslipidaemia in Canada. With the efficacy we’ve seen in clinical studies, CRESTOR could make a real difference to these patients’ lives.”
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 $1bn a year and is also growing at 20 per cent annually.
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.
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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. 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.
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Emily Denney +44 (0)20 7304 5034
Steve Brown +44 (0)20 7304 5033
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Mina Blair-Robinson +44 (0)20 7304 5084
Jonathan Hunt +44 (0)20 7304 5087
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- 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.
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