ANN ARBOR, Mich., May 10, 2016 (GLOBE NEWSWIRE) – Zomedica Pharmaceuticals Corp. (TSX-V: ZOM), a veterinary pharmaceutical company, today announced that it opened its first Investigational New Animal Drug Application (INAD) with the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) for ZM-012, an anti-infective therapeutic for companion animals.
“By taking ZM-012 through the rigorous FDA-CVM approval process, Zomedica intends to validate this drug as safe and effective for veterinary use and garner FDA exclusivity,” stated Zomedica Chief Medical Officer William MacArthur, MS, DVM. “Also, ZM-012 supports Zomedica’s veterinary-focused R&D strategy by providing products specifically formulated for companion animals to positively impact patient care and practice management.”
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.
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. In particular, forward-looking information in this press release includes, but is not limited to the potential validation of ZM-012 as safe and effective and the garnishment of FDA exclusivity in respect of ZM-012. 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.
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Investor Relations Contact
Shameze Rampertab, CPA, CA