When Britain's AstraZeneca PLC launched its new cholesterol-busting drug last year, CEO Sir Tom McKillop knew it wouldn't be easy. The market for cholesterol-lowering drugs, known as statins, is not only hugely competitive but also plagued by safety concerns. Three years ago, Germany's Bayer Group was forced to withdraw its statin, Baycol, after muscle-related side effects resulted in 31 deaths. But with numerous studies proving that, dose per dose, Crestor is more potent than other statins, McKillop reckoned it was only a matter of time before Crestor captured 20% of the $26 billion global statin market.
McKillop may have a long wait. On June 10, European regulators demanded that the company toughen warnings on Crestor's label regarding potential side effects such as muscle damage. Last October, The Lancet, a prestigious British medical journal, published a scathing editorial calling into question Crestor's safety and McKillop's integrity. The journal accused AstraZeneca of pushing "its marketing machine too hard and too fast." Then in March, the consumer group Public Citizen petitioned the U.S. Food & Drug Administration to remove Crestor from the market. Dr. Sidney Wolfe, director of Public Citizen's health research group, contends that Crestor is the only statin to cause kidney failure, even in people without statin-induced muscle damage, a charge the company refutes. "It's a question of when, not if, this drug comes off market," says Wolfe.
At least for now, the FDA disagrees. "There is no evidence that this is similar to Baycol," says Dr. Mary Parks, deputy director of the FDA's division of metabolic and endocrine drug products. "There is no evidence that the label needs to be changed."
Still, the barrage of negative publicity is likely to hurt sales of a drug its maker is counting on to drive future growth. "The reality of the pharmaceuticals industry is that marketing matters," says Dr. Gbola Amusa, senior research analyst at Sanford C. Bernstein & Co. in New York. And with Merck & Co. and Schering-Plough Corp. set to launch a new medicine -- a combination of two existing drugs that together are thought to be as powerful as Crestor -- AstraZeneca needs to grab market share fast. Amusa estimates that Crestor is likely to account for 67% of revenue growth from 2005 to 2008: "If its uptake is delayed, it has serious implications for the company's growth prospects."
PFIZER ON THE OFFENSIVE?
If AstraZeneca IS to keep Crestor sales on track, it needs to make serious headway in the U.S., which accounts for 60% of global statin sales. Although Crestor has 5.6% of the U.S. market, there are signs that sales are starting to slow. Health insurers are reluctant to add Crestor to their lists of recommended drugs when others on the market have a longer track record. Moreover, rivals such as market leader Pfizer Inc.'s Lipitor, which pulled in more than $9.2 billion last year alone, are likely to use Crestor's recent labeling change as ammunition against it. "If Crestor doesn't do well in the U.S., AstraZeneca will have a huge problem," says Mike Ratcliffe, U.S. research director at consultant Wood Mackenzie Ltd. in Boston.
AstraZeneca remains confident about Crestor's potential. "It is the most efficacious statin available, with a similar safety profile to all the other statins on the market," says Gunnar Mölndal, AstraZeneca's head of cardiovascular therapy. He says that the few cases of muscle-related side effects occurred mainly in patients with predisposing risk factors. "More than 90% of the patients who have reported [those] side effects have recovered," he says. "The important thing is there have been no fatalities."
Whether or not that will be enough to convince the medical community and the market isn't clear. While McKillop knew it wouldn't be easy, he never could have predicted selling his new superstatin would be this hard.
By Kerry Capell in London