Zomedica Opens Investigational New Animal Drug Application

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News Desk 2018
Zomedica Opens Investigational New Animal Drug Application with FDA Center for Veterinary Medicine for Anti-diarrheal Medication ZM-007

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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Reader Advisory Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of the release.

Except for statements of historical fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: uncertainty as to whether our strategies and business plans will yield the expected benefits; availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to future clinical trials, regulatory approvals, safety and efficacy of our products, the use of our product, intellectual property protection and the other risk factors disclosed under our profile on SEDAR at www.sedar.com . Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact Shameze Rampertab, CPA, CA srampertab@zomedica.com +1 647.283.3630 Barry Mire, Renmark Financial Communications Inc. bmire@renmarkfinancial.com +1 416.644.2020 or +1 514.939.3989 Media Contact Andrea Eberle aeberle@zomedica.com +1 734.369.2555

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