- The Washington Times - Saturday, October 20, 2001

TORONTO (AP) The Canadian government's decision to override the patent for the anthrax antibiotic Cipro and buy a generic version brought threats yesterday of legal action from manufacturer Bayer AG.

Officials at the Germany-based drug maker, which holds a patent through 2003 to sell Cipro in Canada, said they wanted talks with the Health Ministry over the decision made public Thursday.

"We will meet with the Ministry of Health as soon as possible to discuss this matter," Bayer spokeswoman Christina Sehnert said.

In Canada, Bayer officials were more belligerent, saying a lawsuit was possible. Bayer Canada Vice President Doug Grant was quoted in two newspapers as saying the company would "consider all options in order to defend our patent."

In the United States, officials have said they have the right to override a similar Bayer patent on Cipro but haven't done so.

The U.S. Food and Drug Administration ordered all private Cipro shipments arriving from overseas to be stopped at the border, a move to crack down on illegal Internet antibiotic sales spurred by the anthrax scare.

The FDA also is investigating reports that Internet sites are selling fake Cipro instead of the real medication.

The FDA's alert to U.S. Customs Thursday is the agency's first step in stopping any such sales.

The FDA also is poised to begin sending foreign Web sites warning letters to immediately cease Cipro shipments here, an agency official said yesterday.

Bayer has promised to triple production of the drug and says it can meet the U.S. government's needs, but some are unconvinced.

"If we increase the number of manufacturers producing Cipro, we're more likely to have enough on hand should we need it," Sen. Charles E. Schumer, New York Democrat, said this week. "Knowing we have enough Cipro just in case would go a long way toward calming the public about potential shortages and hopefully dissuade people from buying, stockpiling and taking a drug they currently don't need."

Canadian Health Minister Allan Rock insisted his government's decision to buy 900,000 generic Cipro tablets for more than $665,000 was a necessary precaution to bolster supplies, even if the threat of anthrax in Canada remained low.

"We are doing what is necessary to protect Canadians," he said. "I make no apologies."

Apotex, the Canadian company contracted by the government to supply the generic Cipro, said it would charge the government less to produce the pills than Bayer.

Anthrax attacks in the United States have been a mixed blessing for Bayer. Cipro was Bayer's top seller before the attack, with $1.6 billion in U.S. sales last year.

Bayer's pharmaceutical division has been in trouble since the withdrawal of Baycol, its cholesterol-lowering drug, after reports it was associated with the deaths of more than 50 patients worldwide.

Baycol, sometimes marketed as Lipobay, was the company's No. 3 drug, and sales were expected to reach $890 million this year.

Bayer said there is no way increased sales of Cipro can make up for losing Baycol.

One reason is that the company does not make as much per tablet on its bulk sales to governments as it does selling drugs through pharmacies.

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