SHAWNEE, Kan., March 21 /PRNewswire/ -- Bayer Corporation today filed with
the U.S. Food and Drug Administration (FDA) a Notice of Participation, the
next step toward a hearing where the company will present an analysis of new
government data supporting the continued use of Baytril(R) (enrofloxacin), a
vital antibiotic that helps ensure a safe food supply by eliminating serious
bacterial infections in poultry. The company today also reached out to the
nation's veterinarian community and food animal industries, asking for help to
correct public misperceptions about Baytril.
In October 2000, the FDA's Center for Veterinary Medicine (CVM) proposed
the withdrawal of Baytril in part to address concerns about a reported
national increase in fluoroquinolone-resistant Campylobacter infections in
people during 1999. Based upon a scientific review, Bayer disagreed with
CVM's conclusion about Baytril and requested a hearing to review the science
on the issue. On February 20, 2002, the Agency granted Bayer's request for
the hearing. The hearing date has not yet been announced.
"We will demonstrate that the therapeutic use of Baytril in poultry is a
benefit to public health, rather than a threat, and we look forward to
presenting the evidence," said John B. Payne, Senior Vice President, Bayer
Animal Health. "Bayer will also demonstrate that removing Baytril will not
reduce antibiotic resistance in humans and that instead the leading causes of
fluoroquinolone-resistant Campylobacter are related to other factors. The FDA
hearing should provide for a thorough, thoughtful review of the science."
Bayer Dispels Baytril Myths
In a separate effort to dispel publicly held misperceptions about Baytril,
Bayer called on America's veterinarians and food animal industry leadership to
help separate fact from fiction. In a letter sent today, Bayer said, "Various
false assertions have been put forward in the public that if perpetuated could
cause undue alarm."
One recent misperception emerged following the terrorist attacks on
America. Despite evidence to the contrary, it was reported that the use of
Baytril in poultry might reduce the effectiveness of Cipro(R) (ciprofloxacin)
in treating anthrax exposure in people. "This assertion is false. In fact,
the FDA has responded to media inquiries, stating 'it is not aware of any risk
of reduced effectiveness from the use of Cipro to treat human anthrax
infections resulting from the use of Baytril in poultry,'" Payne said.
"There is also persistent confusion that Baytril is used for growth
promotion and preventative treatment of disease in food animals," he said.
"These assertions are not only false, but using Baytril in such a manner is
both impractical and inconsistent with the FDA-approved labeling of the
product."
Approved by the FDA in 1996, Baytril is a fluoroquinolone antibiotic used
by veterinarians to treat chickens with serious bacterial infections, helping
ensure only healthy chickens enter the nation's food supply. Baytril is
labeled only for use under the supervision of a veterinarian and is currently
used in less than 1 percent of chickens, and only when serious disease is
threatening the health of the flock, which can number up to 30,000 chickens.
Both Cipro and Baytril are antibiotics in the fluoroquinolone class,
highly regarded for their effectiveness against bacterial infections in people
and animals, respectively.
Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion
in 2000 and is one of Fortune magazine's Most Admired Companies. The company
employs 23,200 people. It is a member of the worldwide Bayer Group, a $29
billion international health care and chemicals group based in Leverkusen,
Germany. The Bayer Group stock is a component of the DAX and is listed on the
New York Stock Exchange (ticker symbol: BAY).
Forward-Looking Statements
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation,
development or performance of the company and the estimates given here. These
factors include those discussed in our public reports filed with the Frankfurt
Stock Exchange and with the U.S. Securities and Exchange Commission (including
our Form 20-F). The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or
developments.
SOURCE Bayer Corporation
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Related links:
http://www.bayerus.com
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/092575.html
CONTACT:
David B. Reeder of Bayer, +1-412-777-5666
NOTE TO EDITORS: For a copy of the letter by John B. Payne,
Senior Vice President of Bayer's Animal Health Division, please
visit http://www.BayerUS.com.
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