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20 March 2001
ASTRAZENECA PRESENTS NEW PHASE III CRESTOR DATA CONFIRMING EXCITING POTENTIAL

AstraZeneca today presents Phase III clinical trial results of its superstatin, Crestor (rosuvastatin - previously known as ZD4522), at the American College of Cardiology (ACC), in Orlando, Florida. The data show that:

Superior Efficacy

Data from two of the trials involving over 1,000 patients, show a significantly better reduction in LDL-C (a major marker for the development of cardiovascular disease), with CRESTOR compared to three currently available statins. These data show that CRESTOR (10mg) lowered LDL-C by 49 percent whereas simvastatin (20mg) lowers LDL-C by 37 percent and pravastatin (20mg) by 28 percent. Against atorvastatin, CRESTOR (10mg) reduces LDL-C by 43 percent whereas atorvastatin (10mg) lowers LDL-C by 35 percent.

In addition to LDL-C lowering, these data show that CRESTOR 10mg increases HDL-C (sometimes referred to as 'good' cholesterol) more than atorvastatin (12 percent increase vs. 8 percent increase respectively) and to a similar extent compared to simvastatin and pravastatin.

'These data confirm our confidence in the future potential of Crestor as a new statin,' said Dr Hamish Cameron, Vice President and Head of the AstraZeneca Cardiovasular Therapy Area.

Greater numbers of patients to guidelines

Current research suggests that a significant number of patients receiving therapy fail to achieve their LDL-C goal. However, the CRESTOR studies show there are significantly greater numbers of patients, in each individual risk category, achieving target LDL-C levels. In the comparative trial of CRESTOR 5mg or 10mg versus atorvastatin 10mg, almost 30 per cent more high-risk patients on CRESTOR reach their target LDL-C levels compared with atorvastatin. These data show that CRESTOR 10mg brings 47 percent of high risk patients to their target LDL-C level (as defined by the National Cholesterol Education Program Expert Panel), whereas atorvastatin 10mg brings only 19 percent of patients to their goal.

'These findings are crucial because the majority of patients are initiated and remain on a statin at the lowest available dose, which is why so many fail to reach their goal, so it is logical to give that patient the most effective statin available', stated Dr Michael Davidson, President of the Chicago Centre for Clinical Research, and Principal Investigator for the atorvastatin comparative study.

Similar findings were seen when CRESTOR 5mg or 10mg was compared with pravastatin 20mg or simvastatin 20mg. CRESTOR 10mg brings 67 percent of high risk patients to their target LDL-C level, whereas only 7 percent of patients receiving pravastatin 20mg and 19 percent of patients receiving simvastatin 20mg achieve their target LDL-C levels.

'Even when taken at either 5 or 10mg, rosuvastatin enables most patients to reach target LDL-C levels at a lower dose than the dose recommended in international guidelines. This will provide a tremendous additional weapon in the global fight against coronary heart disease,' stated Philip Barter, Professor of Cardiology at the Royal Adelaide Hospital, Australia.

Global sales for the cholesterol and trigylceride reducers was $15.9 billion in 2000. This is the second largest therapy class worldwide (source: IMS HEALTH, World Review 2001).

Regulatory submission for Crestor is on track for Q2 2001 in Europe and USA.

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 $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

Further enquires to:

Media Relations

Steve Brown
+44 (0)20 7304 5033

Lucy Williams
+44 (0)20 7304 5034


Investor Relations

Michael Olsson
+44 (0)20 7304 5087


Note to News Editors:

  • Impact of LDL-C and HDL-C on progression of atherosclerosis
  • LDL-C is the most significant contributory risk factor to atherosclerosis, a common cause of cardiovascular disease, the world's leading cause of death.
  • Low levels of HDL-C and elevated triglycerides have also been associated with progression of atherosclerosis and an increased risk of coronary heart disease (CHD).

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