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Crestor Comes Under Fire

Jun 25, 2004 | Wall Street Journal

A U.S. consumer group again is calling for AstraZeneca Plc's (AZN) cholesterol drug Crestor to be pulled from the market due to its side effects, but the company stands by the drug's safety profile.

In a letter published in this week's edition of Lancet, a British medical journal, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, alleged that the drug causes more cases of muscle deterioration than other so-called statin drugs like Pfizer Inc.'s (PFE) Lipitor, and is also associated with cases of acute kidney failure.

"There's nothing new in the Public Citizen letter," AstraZeneca spokesman Gary Bruell said. "Much of what Dr. Wolfe is saying is an inappropriate and misleading interpretation of the data. In fact both the FDA and the regulatory authorities in 60 countries continue to say that Crestor is safe when used according to its label."

Bruell said two million people have taken Crestor and five million prescriptions have been written.

"The safety profile continues to be similar to all the other marketed statins," Bruell said.

A Public Citizen spokeswoman wasn't immediately available to comment.

Wolfe is saying that none of the approved doses of Crestor are safe. In a press release on the Public Citizen Web site, Wolfe says that from the time of its approval in August 2003 to mid-April, 18 patients, including 11 in the U.S., suffered severe muscle deterioration. In addition, there have been eight reported cases of acute kidney failure and four of kidney insufficiency, according to data obtained by Public Citizen from the FDA.

Most of these patients were using the low 10 milligram dose, the consumer group said. More than 20 additional cases of rhabdomyolysis, the name for this kind of muscle deterioration, have been reported to the FDA since mid-April, agency sources have said, according to Public Citizen.

"Without further details on the cases described by Wolfe, it is difficult to predict what might constitute the tipping point for the FDA to change its position on Crestor," Bear Stearns analyst Alexandra Hauber wrote in a Friday research note. "However, we would expect the new attack to have some impact on prescription data in the coming weeks."

Hauber doesn't own shares of the company. Bear Stearns has been compensated by AstraZeneca for non-investment banking related services in the last year.

An FDA spokeswoman wasn't immediately available to comment.

"The key to this debate in our view, is reported vs. confirmed cases of side effects," Merrill Lynch analyst James Culverwell wrote in a Friday research note. "Before Baycol (the last new statin to be launched before Crestor), awareness of (muscle deterioration) was low. With heightened sensitivity since Baycol's withdrawal, doctors are inclined to report the slightest abnormality." That has led to a major distortion to current and historic reporting, he said. "The reported cases are not translating into confirmed cases."

Bruell echoed that sentiment. "Reports don't mean a confirmed case," he said. So far, this muscle deterioration has been confirmed in 0.01% of the patients on the drug, he said.

Culverwell said the kidney-related issues are already in the drug's label and that long-term studies have shown it isn't a problem.

While Public Citizen said Crestor and Lipitor work equally well, Culverwell said it takes four times as much Lipitor to equal the efficacy of Crestor. Crestor also raises so-called good-cholesterol and is cheaper at the 10 mg dose than either 20 mg or 40 mg of Lipitor, he said.

Culverwell thinks the Public Citizen letter might have an influence on Crestor's market share trends, but said it shouldn't affect its long-term potential.

In March, Public Citizen filed a petition with the FDA to have the drug taken off the market. The petition is still pending.

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