Jaguar Animal Health, which last year launched its initial gastrointestinal product, over-the-counter Neonorm Calf, expects to enter the prescription drug market in the first half of 2016.
The San Francisco company has submitted data to the U.S. Food and Drug Administration in support of Canalevia, which would be used to treat chemotherapy-induced diarrhea in dogs. Jaguar is requesting MUMS (minor use in a major species) status.
Also in the prescription pipeline is a formulation of Canalevia to treat acute diarrhea in dogs. A pivotal efficacy trial could begin by year’s end, and Jaguar hopes to file a New Animal Drug Application (NADA) in 2016.
Both Canalevia versions contain the active ingredient crofelemer, a botanical extract of the Croton lechleri tree. Jaguar is investigating Canalevia formulations for cats and horses.
The manufacture of enteric-coated crofelemer tablets would be done by Patheon Inc. of Durham, N.C., under a contract signed in mid-October. Patheon makes a similar product for human HIV patients suffering from noninfectious diarrhea.
In other news announced this month, Jaguar:
- Signed a four-year supply agreement with India-based Glenmark Pharmaceuticals Ltd. for the production of crofelemer.
- Completed an additional field study of Neonorm Calf, an enteric-coated tablet administered to preweaned dairy calves twice a day for three days. The medication, which contains another Croton lechleri extract, is formulated to normalize stool formation and gut water flow. The study, done in Wisconsin, found that test subjects given Neonorm Calf gained more weight than did placebo-treated calves.
- Reported that researchers at the Cornell University College of Veterinary Medicine completed a study that found Neonorm Calf optimized “the intestinal microbiome profile” in preweaned dairy calves.
- Expects to release Neonorm Foal Plus, an oral paste, in December for use in young horses suffering from watery diarrhea.
- Continues research into a prescription drug code-named NP-500, which might be used to treat metabolic syndrome in horses, diabetes mellitus in cats and obesity-related metabolic dysfunction in dogs. Investigational New Animal Drug applications were filed in 2014.