Jaguar Animal Health, whose nonprescription Neonorm Calf is its only commercial offering, reported Tuesday the filing of its ninth Investigational New Animal Drug (INAD) application.
The San Francisco company hopes the proposed treatment for ulcers and ulcer-related diarrhea in horses, along with other drug candidates, will fill its product pipeline in coming years. The INAD application is an early step in the regulatory process and precedes studies designed to investigate a drug’s safety and efficacy.
The latest contender from Jaguar contains an anti-secretory agent derived from the Croton lechleri tree. The drug is formulated to treat and prevent the recurrence of ulcers throughout a horse’s stomach, intestines and colon. The formulation also could be used to treat diarrhea in ulcer-stricken horses.
“There are currently no FDA-approved new animal drugs available for the treatment of colonic ulcers in horses, thus making this product a complete, first-in-class ulcer and gut treatment for more active horses like performance and racing horses as well as for horses used recreationally,” said Tim Dotson, Jaguar’s executive director of regulatory affairs.
Citing a study published in the Journal of Equine Veterinary Science, the company reported that 97 percent of performance horses have either a colonic or a gastric ulcer and that 54 percent have both.
The INAD application came four months after the company’s eighth filing, a treatment for obesity-related metabolic dysfunction in dogs.
Jaguar’s first New Animal Drug Application (NADA) was filed in December with the U.S. Food and Drug Administration. If approved, the drug Canalevia would be used to treat dogs stricken with watery diarrhea during chemotherapy.
The first to market is Neonorm Calf, a nonprescription product formulated to treat watery diarrhea, or scours, in preweaned dairy calves.
Jaguar on Feb. 5 announced the signing of a multiyear agreement with master distributor Vedco Inc. for the marketing and sale of Neonorm Calf. The product will be available from distributors Henry Schein Animal Health, Merritt Veterinary Supply, Miller Veterinary Supply, MWI Veterinary Supply, Penn Veterinary Supply and Patterson Veterinary Supply.
Jaguar also plans to showcase Neonorm Calf in February at the 2015 World Ag Expo in Tulare, Calif., and at Western Veterinary Conference in Las Vegas.