Zomedica Announces Achievement of Therapeutic Development Milestones
“We are pleased that we have achieved the milestones we established earlier this year,” stated
ZM-012 and ZM-007: Metronidazole for acute diarrhea in dogs
ZM-012 and ZM-007 are complementary oral formulations of metronidazole targeting the treatment of acute diarrhea in dogs. Key development milestones achieved for ZM-012 and ZM-007 in 2017 include:
- Finalized novel tablet formulation for ZM-012 to replace the large, bitter tasting human-approved generic tablet commonly prescribed by veterinarians for their canine patients. The beef-flavored oral tablets are intended for dogs greater than nine pounds or four kilograms.
- Finalized the oral suspension formulation for ZM-007, which is intended for small breeds and puppies under nine pounds or four kilograms. According to
Brakke Consulting, metronidazole is one of the most frequently compounded drugs for dogs.
- Completed pilot testing for both ZM-012 and ZM-007 at
Michigan State University College of Veterinary Medicineto measure metronidazole’s effectiveness to treat acute diarrhea in dogs.
December 2017pre-submission meeting with the U.S. Food and Drug Administration Center for Veterinary Medicine(FDA-CVM) to present the regulatory strategy and development plan for ZM-012.
Zomedica expects to commence a pivotal safety study for ZM-012 in the first half of 2018 for completion in the second half of 2018.
Zomedica also expects to hold a pre-submission meeting in the first half of 2018 with the FDA-CVM specific to the product development strategy for ZM-007 as a bioequivalent to ZM-012. Drugs that are considered to be bioequivalent are, for regulatory purposes, essentially the same, meaning the absence of significant difference between the extent and rate of absorption over the course of a specific period of time at the same dose and under the same conditions. If deemed acceptable by the FDA-CVM, the implementation of this bioequivalent strategy is contingent on FDA-CVM approval of the new animal drug application (NADA) for ZM-012. If the FDA-CVM permits Zomedica to rely on the bioequivalence of ZM-007 to ZM-012, Zomedica anticipates that this regulatory pathway will conserve significant development costs because a bioequivalence study could replace the need for pivotal safety and efficacy studies for ZM-007.
ZM-006: Transdermal methimazole for hyperthyroidism in cats
Zomedica has finalized its transdermal methimazole formulation for ZM-006, which targets hyperthyroidism in cats, one of the most commonly diagnosed hormone disorders in middle-aged to older cats according to the
Zomedica expects to complete pilot testing of ZM-006 in the first half of 2018. Assuming such pilot testing is successful, Zomedica intends to commence and complete a pivotal safety study of ZM-006 in the second half of 2018.
ZM-011: Transdermal fluoxetine for inappropriate urination in cats
Zomedica has finalized its transdermal fluoxetine formulation for ZM-011, which is also intended to be applied to the cat’s ear using an applicator pen. Most commonly known by its human pharmaceutical brand name Prozac®, fluoxetine is frequently prescribed by veterinarians using a human-approved oral tablet or compounded drug to treat feline behavioral disorders such as inappropriate urination1.
Zomedica expects to complete pilot testing of ZM-011 in the second half of 2018.
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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.
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1 Kaur, Gagandeep,
Investor Relations Contact
Shameze Rampertab, CPA, CA