Zomedica Opens Investigational New Animal Drug Application with FDA Center for Veterinary Medicine for Anti-diarrheal Medication ZM-007

Ann Arbor, Michigan, UNITED STATES

Complements previously announced ZM-012 formulation for dogs

ANN ARBOR, Mich., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (TSX-V:ZOM), a veterinary pharmaceutical company, today announced that it opened its third Investigational New Animal Drug (INAD) application with the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) for ZM-007. ZM-007 and the previously announced ZM-012 are complementary oral formulations being developed for the treatment of diarrhea in dogs.

The active pharmaceutical ingredient for both ZM-007 and ZM-012 is metronidazole, an anti-infective not yet approved by the FDA-CVM for veterinary use but commonly prescribed by veterinarians for their canine patients using human-approved products. The FDA-CVM requires the use of animal approved drugs when available over human-approved drugs in veterinary species.

ZM-012 is a novel tablet formulation being developed to replace the large, bitter tasting human-approved generic tablet routinely prescribed by veterinarians. Zomedica’s canine-specific tablet aims to maximize patient compliance while keeping treatment regimens affordable.

ZM-007 is an oral suspension formulation being developed to provide veterinarians with a means to accurately dose smaller dog breeds and puppies. With this oral suspension, Zomedica hopes to offset the veterinarian’s reliance on compounding pharmacies for medication supply and bring associated pharmacy revenue back into the veterinarian’s clinic. Metronidazole suspension is one of the most frequently compounded drugs for dogs.

“It is commonly recognized that metronidazole is one of the clinical veterinarian’s most preferred anti-diarrheal treatments for dogs,” stated Zomedica’s Chief Medical Officer William MacArthur, MS, DVM. “Our goal with these formulations is to give veterinarians full confidence that the medication they are using to treat their canine patients is indeed safe and effective rather than relying on data from human trials.”

By taking ZM-007 and ZM-012 through the rigorous FDA-CVM approval process, Zomedica intends to validate these drugs as safe and effective for veterinary use in dogs. Both formulations support Zomedica’s veterinary-focused mission by providing products specifically formulated for companion animals to positively impact patient care and practice management.

About Zomedica
With U.S. operations based in Ann Arbor, Michigan, Zomedica is a veterinary pharmaceutical company targeting health and wellness solutions for companion animals (canine, feline and equine) through a ground-breaking approach that focuses on the unmet needs of clinical veterinarians. Zomedica is building a diversified portfolio of products comprised of the discovery, development and commercialization of innovative drugs alongside novel drug delivery systems, devices and diagnostics. With multiple clinical veterinarians in executive management, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.

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