Zomedica Pharmaceuticals Corp. (NYSE American:ZOM) (TSX-V:ZOM)
(“Zomedica” or “Company”), a veterinary pharmaceutical and
diagnostic company, today announced a development update on the
Company's four therapeutic candidates for use in companion animals,
namely dogs and cats.
“We are pleased that we have achieved the milestones we
established earlier this year,” stated Gerald Solensky, Jr., Chief
Executive Officer at Zomedica. “2017 was an important year for our
pipeline development as we finalized formulations for all four of
our lead therapeutic candidates. We look forward to sharing future
advancements as development progresses.”
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 Medicine to measure
metronidazole’s effectiveness to treat acute diarrhea in dogs.
- Scheduled December 2017 pre-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 American Association of Feline Practitioners.
Intended for application to the cat’s ear using an applicator pen,
the transdermal gel is an alternative to conventional oral tablets
already approved by the FDA-CVM for cats. However, according to
Brakke Consulting methimazole continues to be one of the most
frequently compounded drugs because of the associated difficulties
with administering pills to cats.
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.
About ZomedicaBased in Ann Arbor, Michigan,
Zomedica is a veterinary pharmaceutical and diagnostic company
creating products for companion animals (canine, feline and equine)
by focusing on the unmet needs of clinical veterinarians.
Zomedica’s product portfolio will include innovative therapeutics
and diagnostics that emphasize patient health and practice health.
With a team comprised of clinical veterinary professionals, 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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1 Kaur, Gagandeep, Victoria L. Voith, and Peggy L. Schmidt. “The
Use of Fluoxetine by Veterinarians in Dogs and Cats: A Preliminary
Survey.” Veterinary Record Open 3.1 (2016):
e000146. PMC. Web. 11 Dec. 2017.
Investor Relations ContactShameze Rampertab,
CPA, CAsrampertab@zomedica.com+1 647.283.3630
PCG Advisory GroupKirin Smith, COOksmith@pcgadvisory.com+1
646.863.6519www.pcgadvisory.com
Media ContactAndrea
Eberleaeberle@zomedica.com+1 734.369.2555
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