Press Release

Suzan Holl	(301) 734-6464
Jerry Redding	(202) 720-6959

USDA ISSUES CONDITIONAL LICENSE FOR WEST NILE VIRUS TREATMENT FOR HORSES

WASHINGTON, Aug. 19, 2003--The U.S. Department of Agriculture today announced that it has issued a conditional license to Novartis Animal Vaccines Inc. Larchwood, Iowa, for an equine-origin antibody product intended to aid in the treatment of horses with the disease caused by West Nile virus.

West Nile virus is a mosquito-borne virus that was first detected in the United States in 1999. The virus, which can cause encephalitis or inflammation of the brain in animals and, in some cases, humans, has been found in Africa, western Asia, the Middle East and the Mediterranean region of Europe. Most recently it has spread to most regions of the United States.

West Nile virus infection in horses may include both central nervous system and peripheral nervous system signs. Although horses can be infected by the virus, there is no documentation that infected horses can spread the virus to uninfected horses or other animals. In 2002, there were 14,717 reported cases of horses infected with the virus.

The most common signs of West Nile virus infection in U.S. horses have been stumbling or lack of coordination, weakness of limbs, partial paralysis, muscle twitching and death. Fever has been detected in less than one-quarter of all confirmed cases. Approximately one-third of horses that become ill with West Nile virus die or must be euthanized.

USDA’s Animal and Plant Health Inspection Service issues conditional licenses for veterinary biologics products to meet an emergency situation, limited market, local situation or special circumstance. The special circumstance addressed here is the need for a product to aid in the treatment of disease caused by West Nile virus.

Under these regulations, a product that is shown to be pure and safe and demonstrates a reasonable expectation of efficacy may be licensed while data to establish efficacy and potency are still being obtained.

Conditional licenses are generally issued with restrictions and for a limited period of time. At the end of the conditional license period, data obtained in support of the product’s efficacy, potency and product performance are evaluated to determine if the conditional license should be renewed or if a regular product license may be issued.

In keeping with these regulations, the product described above has been issued a conditional license for 1 year. The product is restricted to use by a veterinarian in those states where use of the product has been approved by the appropriate state regulatory authorities.

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