AstraZeneca IS considering launching new safety trials of Crestor, its cholesterol treatment, in an effort to shore up confidence in a drug that the group desperately needs to be a blockbuster.
The pre-launch marketing of Crestor was derailed last week when a similar product, Bayer's Baycol, was withdrawn from sale. Baycol's use in combination with another cholesterol treatment, gemfibrozil, is believed to have killed 31 people by causing severe muscular weakness.
Crestor's use in combination with gemfibrozil has been tested on just 15 patients. Another 84 patients were monitored using Crestor in combination with another drug in the same class as gemfibrozil.
A spokesman for AstraZeneca said the company was considering additional trials. "The studies evolve and continue even after regulatory filing, so it is clearly something that we are looking at."
AstraZeneca has emphasised its confidence in the safety profile and efficacy of Crestor, pointing to successful clinical trials involving more than 4,200 patients. But the shares have been hit by suggestions that the withdrawal of Baycol (also known as Lipobay) will delay Crestor's launch, which is scheduled for the second half of next year.
The drug was filed for approval with US and European regulators in the first half of this year, and analysts have suggested that the safety concerns could prompt the US Food and Drug Administration and European authorities to demand additional safety information.
Last week, the European Medicines Evaluation Agency said it was launching an investigation into the safety of similar products already on the market.
Analysts forecast that Crestor sales could rise to as much as £3.5bn a year by 2005, assuming a launch shortly after the middle of next year.
AstraZeneca has been heavily promoting Crestor in the pharmaceuticals industry and spurned licensing deals with bigger drug companies in favour of marketing the product using its own salesforce.
The group needs to maximise sales from new products as its current lead drug, the ulcer treatment Losec, loses its patent protection later this year. Losec currently accounts for more than a third of AstraZeneca's sales. AstraZeneca received a further setback at the weekend when it emerged that America's most powerful health lobby plans to seek tougher warnings on cholesterol-lowering drugs. Public Citizen, a long-time campaigning body on health issues, is to petition the Food And Drug Administration to demand "black box" warnings on the drugs, highlighting the safety fears.
Yesterday, French health minister Bernard Kouchner criticised Bayer's decision to withdraw its anti-cholesterol treatment saying it was overly hasty. He said he shared the concerns of French health professionals who now needed to find alternative treatments for thousands of patients who had been prescribed Baycol. "Of course Bayer has the right to withdraw its product. But I do not understand the haste and logic of its decision. US authorities had not demanded the withdrawal of the treatment," he said.
He added: "If Bayer intended to withdraw its product and did not warn us.... I would reproach them with that too. There will probably be consequences in this affair."Reuse content