AstraZeneca gets wider US indications for Crestor; enters cancer drug development deal with UK charity

The US Food and Drug Administration yesterday approved Anglo-Swedish drug major AstraZeneca's blockbuster cholesterol-lowerer Crestor (rosuvastatin calcium) for additional indications. Last year the drug, which is marketed under license from Japan's Shionogi, generated revenues for the UK-headquartered firm of $4.5 billion and $1.26 billion in the last three months of 2009, an increase of 20% on the like period of the previous year (The Pharma Letter January 28).

The news was welcomed by investors, who pushed AstraZeneca's share price up 2.18% to £28.405 by 10.30GMT, in London trading volume of nearly 1.8 million this morning. The new indication will likely increase sales of the drug, although some observers warn that this could be tempered by the advent of lower priced generic versions of blockbuster cholesterol drugs such as Pfizer's Lipitor (atorvastatin), which itself suffered from the arrival of generic simvastatin, and is due to lose patent protection in November next year.

The new indication is to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men greater than or equal to 50 and women greater than or equal to 60), high-sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.