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EU launches drug probe
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August 10, 2001: 1:10 p.m. ET
Cholesterol-lowering drugs face review following Bayer's product withdrawal
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LONDON (CNN) - European watchdogs are reviewing the continued sale of anti-cholesterol drugs similar to Bayer's Baycol to ensure they are safe to use.
Leverkusen, Germany-based drugmaker Bayer (FBAY) withdrew Baycol from sale this week in response to evidence linking it to the deaths of as many as 40 patients.
The European Medical Evaluation Agency, under whose authority the review of similar drugs will take place, said it had called for warnings on Baycol labels to be toughened just weeks before Bayer pulled it from the shelves.
The EMEA in June told the United Kingdom, the European Union state in which Baycol was first approved for marketing, to require the manufacturer to add a warning that the drug should not be taken by patients also using gemfibrozil, another cholesterol product, because the combination increased the risk of fatal side effects.
Baycol is a member of a class of drugs called statins that aim to reduce cholesterol levels. Statins have been available commercially since the late 1990s.
David Woodburn, a pharmaceuticals analyst at Prudential Securities, believes Baycol's withdrawal from the market could open up $1 billion in worldwide sales for rival statin manufacturers to grab.
"Based on the conversations we've had, the literature we've analyzed, and the fact that the FDA appears to recommend all of the remaining statins as replacements for Baycol, we think that Baycol's problems might be unique unto itself," Woodburn said in a research note Friday.
Drug sales worth billions
The best selling statins are Lipitor, made by New York-based Pfizer (PFE: Research, Estimates) and already generating sales of about $5 billion a year, and $2.9 billion-a-year Zocor from the world's No. 2 drugmaker, White House, N.J.-based Merck & Co. (MRK: Research, Estimates).
Other statins on the market include Pravachol by Bristol-Myers Squibb (BMY: up $0.02 to $56.50, Research, Estimates), Mevacor by Merck (MRK: up $1.16 to $68.98, Research, Estimates) and Lescol by Basel, Switzerland-based Novartis (NVS: down $0.86 to $33.44, Research, Estimates).
Woodburn believes Pfizer, Merck and Bristol-Myers in particular will gain 1 or 2 percent in earnings per share through Baycol's exit.
The EMEA's safety review will look at statins that have the same mode of action as Baycol, the agency said, adding that not all statins work in the same way.
The EMEA would not name the products it will review, but London's Financial Times reported they include Lipitor and Zocor.
A Pfizer spokeswoman told CNNfn.com Friday that the EMEA had not as yet requested any information.
"Obviously we would provide the regulatory authorities with any information they requested," Pfizer spokeswoman Vanessa McGowan said. "But Lipitor has an extensive clinical trial program, and the safety of the program has been proven safe through the 10-80 milligram dose range."
McGowan added that 10 deaths have been tied to Lipitor since its introduction in 1996, of which all the victims were simultaneously using gemfibrozil. Pfizer logged $3.5 billion in U.S. sales of Lipitor in 2000 and $5 billion in sales worldwide, she added.
Merck spokeswoman Donna Cary also said the company had not been contacted by the European panel about Zocor, but that it too would comply with any requests.
"I think the data on our product will speak for itself," Cary said. "It's been on the market for 13 years and has been used by 33 million people."
Zocor had $5.3 billion in sales last year, she said, but could not say how many deaths have been related to the drug.
The Food and Drug Administration, the U.S. drug authorization agency, said this week it had received reports of 31 deaths of U.S. users of Baycol, which also was sold as Lipobay. A handful of other fatalities have been reported outside the U.S
The drug's side effects included a muscle-wasting condition called rhabdomyolysis that could lead to the failure of the liver or other organs.
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Information uncovered by the FDA, "would, of course, be taken into consideration" in the safety review, said Noel Wathion, the head of the EMEA unit responsible for the continuing monitoring of drugs already approved for sale in the EU.
The FDA said this week that "while all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins."
"There is no need for a black box warning label. Our drug is very safe," Bonnie Jacobs, a spokeswoman for New York-based Bristol-Myers Squibb told the Associated Press Thursday.
In the European review process, which began before Bayer's withdrawal of Baycol Tuesday, the watchdog will study all currently available information concerning the drug's safety. If those data prove insufficient for the EMEA to make a recommendation to the EU, drug authorities could request additional information from manufacturers, Wathion said.
For Bayer, the withdrawal of Baycol means the loss of a product that had been expected to generate sales of about  1 billion this year, and which analysts said was one of the company's best hopes for buoying up its pharmaceutical arm. Lipitor is even more crucial to Pfizer, accounting for about one-sixth of the company's overall sales of just over $30 billion. 
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