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Bayer to Appeal FDA Judge's Decision.

Business Editors/Health/Medical Writers


Bayer said today that it will appeal an Administrative Law Judge's decision regarding the use of Baytril 3.23% in poultry. An appeal of the Judge's decision will be submitted to the commissioner of the Food and Drug Administration (FDA) and represents the next step in an FDA legal process that began in October of 2000. The decision does not represent a final judgment requiring the withdrawal of Baytril from the market. Approved by the FDA in 1996, Baytril is used therapeutically for the treatment of air sacculitis, a pneumonia-like infection in poultry.

A significant argument in Bayer's case was based on new data, which demonstrate that weight variations in birds with air sacculitis contribute to errors in processing that lead to increased levels of bacterial contamination. These data clearly identify the human health benefit and the need to have Baytril available to fight disease and, thereby, ensure a healthy food supply.

"Having made a strong scientific argument during the hearing process, we are surprised and disappointed in the Administrative Law Judge's decision. We believe that the human health benefits of Baytril were not fully considered when arriving at his decision," said John B. Payne, president and general manager, Bayer HealthCare LLC, Animal Health Division. "This is an extremely complex issue that deserves additional review of the scientific arguments, which we firmly believe support the continued use of Baytril to fight disease in poultry. We will fully examine all of the details in the judge's decision and prepare our appeal accordingly."

About Bayer Animal Health

Bayer, the maker of Baytril(R) (enrofloxacin) 3.23% Concentrate Antimicrobial Solution, is a worldwide leader in parasite control and prescription pharmaceuticals for dogs, cats, horses, cattle and poultry. In addition, the company is increasing its presence in the hygiene market with products to control pests in the environment. Bayer Animal Health is a division of Bayer HealthCare LLC, and its U.S. operations are headquartered in Shawnee, Kan.

Bayer HealthCare, a subgroup of Bayer AG with annual sales amounting to some 10 billion euro, is one of the world's leading, innovative companies in the health care and medical products industry. Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceutical divisions. More than 34,000 employees work for Bayer HealthCare worldwide. Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

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.
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Publication:Business Wire
Date:Mar 17, 2004
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