When AstraZeneca, the Anglo-Swedish pharmaceuticals group, received regulatory approval for its anti-cholesterol drug Crestor it seemed set for the launch of a “blockbuster”. A little over two years later, the mood of the market is distinctly more reserved.
The latest negative sign came in a report this week by Deutsche Bank, Astra Zeneca’s broker, highlighting that the company had informed regulators in December of a case of a patient taking Crestor who died in late 2004. While there is considerable debate about the significance of the case, it follows a string of bad news over the drug.
Last autumn David Graham, a scientist at the US Food and Drug Administration, darkened the mood when he told a congressional hearing that Crestor also known as rosuvastatin was one of five medicines that should be withdrawn from the market on health grounds.
The FDA, which played down Mr Graham’s general criticisms, refuses to comment on the specific case, but it may not yet have had its last word. Sidney Wolfe from Public Citizen, a consumer watchdog that has waged a war against the drug, says: “The FDA is intensively looking at Crestor.”
Public Citizen, which lobbied the FDA to make AstraZeneca remove a statement on its website claiming that the regulators had no safety concerns with Crestor, argues that it should be withdrawn.
Dr Wolfe says: “It is a doomed drug. It is not going to survive.” He suggests it has caused more than 100 life threatening incidents.
AstraZeneca rejects such claims. Gunnar Olsson, vice-president of the company’s cardiovascular division, stresses that Crestor was authorised during a climate of heightened sensitivity, just as the FDA was withdrawing Baycol, a rival drug in the same class of ‘statins’, from the market.
Mr Olsson says the company used a far larger group of patients in clinical trials some 12,500 than is normal to test its efficacy and safety, and has ongoing trials with 45,000. There are 15m prescriptions of Crestor to 4m patients in 50 countries.
By this summer, he says AstraZeneca should have detailed safety results, but autopsies showed that so far the only two previous suspicious deaths of patients taking Crestor were the result of other factors. He points out that many other explanations may have been behind the latest case.
The principal concern with the statins is that in rare cases they can cause a potentially life-threatening muscle condition known as rhabdomyolysis, triggering kidney failure.
Mr Olsson says that the results for Crestor suggest a lower risk than other statins. Baycol, which had 10m prescriptions, was linked to 31 deaths, for example.
“The key is to look at the data,” he says. “I’m scared that if we have a lot of negative publicity about statin risks that forces people to stop therapy, the net effect will be very bad for society. Their beneficial effects are so well documented.”
Aside from public health, it is precisely this kind of press that could damage AstraZeneca’s financial position. Sales of Crestor this year are projected to reach about $900m (Â£480m), and to peak at up to $3.4bn by 2008, making it one of the company’s top three drugs.
“The question is whether the publicity which has helped cut Crestor’s US market share from 8.5 per cent to 5.6 per cent will be sustained,” says one analyst. “If it becomes a $1.5bn drug, that could cut AstraZeneca’s earnings per share from 12 per cent to 10 per cent.”
In the months ahead, medical researchers will be scrutinising the safety data closely and investors will in turn be studying their analyses more closely than ever.