Regulatory Application

AstraZeneca PLC
27 June 2001


 
ASTRAZENECA SUBMITS ITS NEW SUPERSTATIN, CRESTOR, FOR REGULATORY APPROVAL IN
THE US AND EUROPE
   
DEVELOPMENT OF VIOZAN COPD TREATMENT TO BE DISCONTINUED; RESOURCES TO BE
REALLOCATED TO MORE PROMISING PRODUCTS IN R&D PIPELINE
 
AstraZeneca announced today that the regulatory file for Crestor
(rosuvastatin), a new statin for lipid lowering, has been submitted in the USA
and Europe and that it had discontinued further development of Viozan, the
D2B2 agonist for the treatment of Chronic Obstructive Pulmonary Disease
(COPD). 
 
CRESTOR
 
Crestor has been submitted to the Food and Drug Administration (FDA) and
European authorities for the management of hypercholesterolaemia, mixed
dyslipidaemia and isolated hypertriglyceridaemia.  
 
The submissions are based on data from the clinical development programme
involving over 4,000 patients including head-to-head comparative studies which
demonstrate that Crestor has a dramatically beneficial effect on lipid levels
and can quickly get patients to the recommended US and European cholesterol
guidelines.  The data show that Crestor is superior to three other currently
available statins in lowering low density lipoprotein - LDL-C (sometimes
referred to as 'bad' cholesterol) and that greater numbers of patients could
reach their target cholesterol level with Crestor than with other widely
prescribed statins.  In phase II clinical trials Crestor demonstrated
significant dose-dependent reductions in LDL-C of up to 65 per cent across the
dose range.
 
Coronary heart disease (CHD) is a major cause of morbidity (health impairment)
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 high cholesterol levels are one of the most important risk factors in
predicting CHD risk in the population.  It is estimated that 65 million
Americans need some type of intervention for high cholesterol, and of these,
36 million will need medical intervention.
 
The global statin market is estimated to be worth more than $14bn and is
growing at a rate of more than 20 per cent.
 
AstraZeneca licensed worldwide rights to Crestor from Shionogi & Co Ltd, the
company that discovered the drug, in April 1998 and carried out a
comprehensive clinical development programme leading to submission.
 
VIOZAN
 
AstraZeneca announced results of comparative Phase III clinical studies with
Viozan which confirmed the levels of safety and efficacy reported in Phase II
studies but had not shown the sustained additional longer term benefits that
were expected in comparison with other available therapies.  As a result, the
decision to discontinue Viozan has been taken to allow the company to focus
its resources on more promising products in AstraZeneca's rich pipeline.
 
Research on Viozan formed part of the work on Respiratory and Inflammatory
treatments at AstraZeneca's Charnwood R&D Centre, near Loughborough in the UK,
where development of new treatments for respiratory diseases will continue. 
AstraZeneca has recently launched Symbicort for asthma in Europe. 

27 June 2001

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