Bayer gets FDA approval for EPM treatment

Shawnee Mission, Kan.- Bayer announces it has received approvalfrom the Center of Veterinary Medicine of the Food and Drug Administration(FDA) for Marquis (15 percent w/w ponazuril) Antiprotozoal Oral Paste forthe treatment of equine protozoal myeloencephalitis (EPM). Marquis offersequine veterinarians and their clients the first FDA-approved treatmentfor EPM, combining safety, efficacy and convenience, the company says.

"EPM has caused more concern among veterinarians and horse ownersthan perhaps any other equine disease in recent memory," says JohnPayne, senior vice president with Bayer. "Because exposure to the diseaseis so widespread among the equine population and because the resulting neurologicalproblems are so devastating, Bayer committed extensive research and developmentefforts over the past three years toward finding a treatment of EPM thatis safe, effective and convenient."

The active ingredient in Marquis in ponazuril, an anticoccidial compoundwith cidal activity against Sarcocystis neurona, the protozoal parasitethat causes EPM. It acts against the parasite at several different stagesof the life cycle. Ponazuril crosses the blood/brain barrier to reach thecentral nervous system (CNS) where damage from EPM occurs.

With Marquis, equine veterinarians can offer their clients a treatmentwith a once-daily dosage of just 5 mg/kg, which is administered for 28 days.The product is packaged with a reusable plunger and a calibrated dosingring that assures dosing accuracy, the company says.

"EPM is a debilitating and often fatal disease. Accurate diagnosiscan be challenging even for the most experienced clinicians. Until now,current therapies were not approved for the treatment of EPM and some ofthese treatments have legitimate safety issues, says Dr. Kenton Morgan,senior technical services veterinarian with Bayer. "Marquis will offerthe veterinarian and horse owner a product that is safe, efficacious andconvenient."

EPM is considered the leading cause of neurological disease in horsesin the United States. Almost every region in the country now has reportedcases of EPM, the company says. The clinical signs of EPM can vary betweenhorse to horse, because actual signs are related to the location and severityof the lesions that randomly develop in the animal's central nervous system,the company says.

"We believe that education plays a key role in the diagnosis andtreatment of this disease," says Allyn Mann, Bayer equine productsmanager. "In addition to offering Marquis, Bayer will be providingeducational tools to equine veterinarians that provide crucial informationon EPM including prevention, accurate diagnosis, proper treatment and therapy."

Bayer has established Web sites for veterinarians (www.EPMnews.com) andclients (www.EPMinfo.com) that will offer up-to-date findings, researchand information on Marquis and the disease itself.

For more information on Marquis, contact Bayer Animal Health at (800)633-3796.