- The Washington Times - Saturday, January 19, 2002

LEVERKUSEN, Germany, Jan 18 (Agence France-Presse) Bayer AG said yesterday that the estimated number of deaths with a possible link to Lipobay, its anti-cholesterol drug that was withdrawn from the market, has risen to 100.
The drug, known as Baycol in the United States, previously was thought to have been linked to 52 deaths. It was pulled from the market in August.
Buried deep in a 252-page filing the company was required to file with the Securities and Exchange Commission as part of its planned listing on the New York Stock Exchange next week was a sentence acknowledging that the number of deaths was twice as high as thought.
"We are currently aware of approximately 100 patients … who have died," it said.
The NYSE listing, originally scheduled for September 2001, was postponed after Bayer shares plunged on news it was withdrawing the drug from the market.
The German drug giant voluntarily pulled the product after increasing reports of side effects of muscular weakness, or rhabdomyolysis, especially in patients being simultaneously treated with another drug called gemfibrozil.
Bayer faces lawsuits in the United States and Europe from patients seeking damages. The company insists the claims are groundless and that it worked closely with regulators on both sides of the Atlantic.
At the height of the debacle in August, Bayer had estimated the number of deaths possibly linked with Lipobay/Baycol at 52 worldwide.
The higher figure sparked a new sell-off in Bayer's shares in Frankfurt yesterday.
Bayer closed 1.1 percent lower at $31.28, off an intraday low of $30.60.
The company was forced to withdraw Lipobay previously regarded as one of its most promising products after news emerged that people who had taken it in combination with another drug had died.
The mixture appeared to cause rhabdomyolysis, a serious muscle-wasting condition that in some cases can lead to life-threatening kidney failure.
Bayer said in its SEC filing that on top of the 100 cases in which patients had died, it was also aware of about 1,600 patients "assessed with nonfatal cases of rhabdomyolysis."
In November, Bayer estimated that the withdrawal of the drug alone could hit 2001 earnings by as much as $792 million.
But the company also could face further billions of dollars in litigation.
On Monday, German lawyer Michael Witti said he would file a class-action suit in the United States on behalf of German victims of Lipobay.
Mr. Witti said he was filing the suit in Minnesota rather than in Germany because damage payments were often larger in the United States.
He said he was representing 2,000 German victims and expected payments of billions of dollars.
Last year, U.S. lawyer Edward Fagan estimated that all of the estimated 700,000 Americans who took Lipobay could potentially seek damages in what could become "one of the largest litigation efforts in pharmaceutical history."
Lipobay was already the reason for Bayer's decision to set back its Wall Street listing from September to Jan. 24. So the latest news could hardly come at a worse time, analysts said.
"It's not the best time to go to Wall Street, because the problems connected with Lipobay litigation and the sudden departure of their pharmaceuticals chief are hardly going to boost investor confidence," said WestLB analyst Andreas Theisen.
An analyst at WGZ Bank, Leslie Zacher, agreed.
"If you open any U.S. newspaper, you'll find loads of ads from law firms looking for Lipobay patients to go to court," she said.
Analysts suggested Bayer might attempt to shift the spotlight away from such issues by announcing a high-profile tie-up in the area of pharmaceuticals, most likely a plasma products deal with Aventis-Behring.
Bayer needs a NYSE listing because it will provide the key to one of the world's biggest and most important capital markets.
It also will broaden the group's international shareholder base.

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