Bayer Reiterates Position on Baytril for Poultry

11/20/2002

From: Robert S. Walker of Bayer Corp., 412-777-5666

PITTSBURGH, Nov. 20 -- Bayer officials said that the body of scientific evidence continues to grow, showing that prudent use of the antibiotic Baytril for poultry is an important safeguard for the nation's food supply. This was among the primary messages Bayer shared with several members of an activist group who visited Bayer's campus in Pittsburgh Tuesday.

Baytril is a broad-spectrum fluoroquinolone antimicrobial used to treat serious bacterial infections in poultry, cattle and companion animals. The visitors delivered letters from individuals in opposition to treating sick poultry with the antimicrobial in the concern that a connection exists between use of the product and the incidence of fluoroquinolone-resistant Campylobacter infections in humans.

In receiving the visitors and accepting their letters at Bayer's U.S. headquarters and research campus, the company said its scientists and other authorities believe the concerns to be well-intentioned but based on incomplete and inaccurately interpreted data.

"Judged on scientific data rather than emotion and speculation, there is no justification for withdrawing Baytril and, thereby, exposing poultry flocks to unnecessary illness, poultry farmers to unnecessary hardship and the American people to unnecessary hygiene risks in one of America's favorite and most healthful foods," said John B. Payne, president and general manager, Bayer Animal Health. "In fact, withdrawing Baytril from poultry farming could very well cause more harm than good while doing nothing to reduce the risk of resistant bacteria infecting humans."

The bacterial organism Campylobacter is common in undercooked meat, unpurified water and around farm animals. Infection causes cramping, fever and diarrhea but is easily prevented by properly handling and cooking food.

Among the scientific findings cited by Bayer:

-- The rate of Campylobacter infections in humans has decreased 41 percent since the FDA approved Baytril for use in poultry, while chicken consumption in the United States has increased more than 10 percent.

-- Latest data from the Centers for Disease Control indicate that the rate of fluoroquinolone-resistance in human Campylobacter cases is virtually unchanged since Baytril was approved in 1996.

-- Foreign travel is the leading risk factor associated with fluoroquinolone-resistant Campylobacter infections.

-- Fluoroquinolone-resistant Campylobacter was present before the introduction of Baytril for poultry.

In an exchange of letters, Ron Staib, site manager at the Bayer headquarters, presented the activist organization, Keep Antibiotics Working (KAW), with documentation that Bayer will send to each of the group's supporters who wrote a letter regarding Baytril. Baytril (enrofloxacin) was approved in 1996 by the FDA for treatment of diseases in chickens and turkeys. It is marketed by Bayer Animal Health as Baytril 3.23 Percent Concentrate Antimicrobial Solution. Highly regulated by the FDA, Baytril is the only effective antimicrobial available for some of the most serious bacterial diseases in poultry.

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. The following year, however, showed resistance rates had dropped substantially, calling into question conclusions based on the 1999 data. Pointing to flaws in the resistance data and backed by leading scientific authorities on the causes and pathways of resistant bacteria, Bayer requested a hearing to review the science on the issue. Early in 2002, the agency granted Bayer's request. The hearing is expected to conclude by the end of 2003.

"Scientific data clearly show that the judicious use of Baytril in poultry and under the direct supervision of veterinarians contributes to human health by helping to ensure the safety of the nation's food supply. It is important that it be made clear that Baytril is used only for therapeutic purposes and in less than 1 percent of the U.S. chicken population. It is never used for growth promotion.

"We respect the views of KAW and fully recognize the importance of antibiotics to human health, our first priority. We look to the FDA hearing process to provide a thorough and complete review of the science," said Payne.

Best known for its flagship product, Bayer Aspirin, Bayer Corp. produces a broad range of health care, crop protection, polymer and chemical products that help diagnose and treat diseases, purify water, preserve local landmarks, protect crops, advance automobile safety and durability and improve people's lives.

Headquartered in Pittsburgh, Bayer Corp. had sales of $10.1 billion in 2001 and is one of Fortune magazine's Most Admired Companies. The company employs 21,500 people. It is a member of the worldwide Bayer Group, a $27 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 (NYSE: BAY).

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 Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.