AstraZeneca and Shionogi & Co. Ltd. today announced an agreement to co-market Crestor, a new treatment for dyslipidaemia, in Japan.
AstraZeneca filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare on April 23 (2002) for Crestor, a highly effective addition to the statin class of lipid-lowering medicines, for the treatment of hypercholesterolaemia.
"This agreement is an important part of our global marketing strategy for Crestor. Japan is the second biggest pharmaceuticals market in the world with a highly competitive statin sector. Shionogi is a powerful force there with a high reputation for its R&D and sales and marketing capabilities and we are delighted to have Shionogi and AstraZeneca in partnership during the launch of Crestor. Co-marketing will accelerate penetration of Crestor into the Japanese market", said Dr. Tom McKillop, Chief Executive Officer of AstraZeneca.
"It is also a pleasure to be working with Shionogi because it is the company that originally discovered the Crestor molecule".
HMG-CoA reductase inhibitors or statins lower cholesterol in the blood. AstraZeneca has implemented Crestor clinical studies involving over 9,000 patients worldwide. The results of the studies suggest that Crestor improves overall lipid values to a significant extent and is generally well tolerated.
The efficacy of Crestor has been confirmed and data show:
Greater effect in lowering LDL-C ('bad' cholesterol)- a risk factor in coronary heart disease (CHD) - compared with the leading currently marketed statins.
Greater effect in raising HDL-C ('good' cholesterol) - low levels of HDL-C are an additional risk factor for the development of CHD - compared with the leading currently marketed statins.
Excellent lowering of triglyceride - also a risk factor for the development of CHD
An adverse event profile similar to other currently marketed statins.
CHD is the leading cause of death in Europe and the US. As 36 million patients in the US will need some kind of treatment for dyslipidaemia, improved lipid control is necessary to reduce the number of patients with CHD. In Japan, the average cholesterol value has risen to that seen in Europe and US as the Japanese diet has been westernised. This tendency is shown especially in young people under 20 years and in men in their thirties and forties.
The global statin market is estimated to be worth more than $14 billion and is growing at a rate of more than 20 per cent. Licensed from Shionogi in April 1998, CRESTOR has been developed globally by AstraZeneca. Crestor was submitted simultaneously for regulatory approval in the US and Europe in June 2001.
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.