Zomedica Pharmaceuticals Corp. (NYSE American:ZOM) (TSX-V:ZOM)
(“Zomedica” or the “Company”), a veterinary diagnostic and
pharmaceutical company, today provided a product development
update.
Diagnostic Update
ZM-017: Circulating tumor cell assay platform for
dogs
As previously disclosed, Zomedica has partnered with Celsee,
Inc. (“Celsee”) to develop Celsee’s circulating tumor cell, or CTC,
assay, also known as a “liquid biopsy” for use by veterinarians as
a cancer diagnostic. The liquid biopsy is a blood test that we
believe has the potential to detect the presence of CTCs, which are
cells that have shed from a primary tumor into neighboring blood
vessels and are transported throughout the body’s circulatory
system. We are focusing our development work on testing for
difficult to biopsy cancers such as hemangiosarcoma and
osteosarcoma in canines. If our development work is successful, we
believe this liquid biopsy test will enable veterinarians to detect
these hard-to-diagnose cancers with a simple blood draw. In line
with the Company’s previously disclosed estimates, clinical
validation of ZM-017 began during the first half of 2018. Assuming
the successful conclusion of the clinical validation, we continue
to expect to commence the marketing of ZM-017 during the second
half of 2018.
ZM-020: Point-of-care pathogen detection platform for
fecal and urine specimens
As previously announced, Zomedica has partnered with Seraph
Biosciences, Inc. (“Seraph”) to develop Seraph’s in-clinic
diagnostic analyzer for use in the detection of pathogens in
companion animals. Our development work is focusing on the use of
Seraph’s technology for comprehensive fecal and urine analysis.
Detection of fecal parasites, urine bacteria (“urinary tract
infection” or “UTI”) and crystals is time-consuming, error-prone
and often requires additional outside testing for comprehensive
evaluation. If our development work is successful, we believe our
analyzer will be able to perform these analyses in seconds, without
the need for centrifugation or the use of reagents. The Company is
also developing the ability to detect leptospirosis in the urine of
infected animals. Leptospirosis is a potentially life-threatening
zoonotic disease. Current diagnostic solutions are limited by
interference with vaccination and can take days for a confirmatory
diagnosis. If our development work is successful, we believe our
analyzer will be able to overcome these limitations.
The company expects to begin marketing of ZM-020 in the second
half of 2018.
In the longer term, Zomedica also intends to develop additional
applications for this technology, including further development of
the pathogen detection library for urine and fecal analysis, as
well as for respiratory and dermatological analysis. Targeted
pathogens may include bacteria, antibiotic resistant bacteria,
viruses and fungi.
Therapeutic Update
ZM-007 and ZM-012: Metronidazole for acute diarrhea in
dogs
ZM-012 is the Company’s tablet formulation of metronidazole
targeting the treatment of acute diarrhea in dogs, currently only
available as a human generic. ZM-007 is a complementary oral
suspension of metronidazole targeting the treatment of acute
diarrhea in small dog breeds and puppies under nine pounds or four
kilograms, currently only available via compounding pharmacies.
The Company previously designated ZM-012 as its lead therapeutic
drug candidate and ZM-007 as a follow-on candidate as a
bioequivalent. As previously disclosed, the Company expected to
commence a pivotal safety study of ZM-012 in the first half of
2018, which it expected to complete in the second half of 2018. The
Company held a pre-submission meeting for metronidazole with the
U.S. Food and Drug Administration Center for Veterinary Medicine
(“FDA-CVM”) on December 13, 2017. Based on the feedback received
from the FDA-CVM at that meeting and in light of additional market
research demonstrating approved alternatives to compounded drugs,
the Company has decided to prioritize its development of ZM-007
over ZM-012. The Company expects to commence a pivotal safety study
of ZM-007 in the first half of 2019. The Company expects to pursue
approval pf ZM-012 as a bioequivalent to ZM-007 assuming ZM-007 is
approved by FDA-CVM.
ZM-006: Transdermal formulation of
methimazole
ZM-006 is a transdermal gel formulation of methimazole targeting
hyperthyroidism in cats. The Company previously disclosed that it
expected pilot testing of ZM-006 to be completed in the first half
of 2018 and, assuming that such pilot testing was successful, to
commence and complete a pivotal safety study of ZM-006 in the
second half of 2018. In an effort to improve dosing requirements,
the Company has decided to continue its pilot testing of ZM-006,
which it now expects to complete in the second half of 2018.
Assuming that such pilot testing is successful, the Company also
intends to commence a pivotal safety study of ZM-006 in the second
half of 2018.
ZM-011: Transdermal fluoxetine for feline behavioral
disorders
ZM-011 is a transdermal formulation of fluoxetine, most commonly
known as Prozac®, which is intended to treat behavioral disorders
in cats (e.g., inappropriate urination). Consistent with the
Company’s earlier guidance, the Company expects to complete pilot
testing of ZM-011 in the second half of 2018.
About ZomedicaBased in Ann Arbor, Michigan,
Zomedica (NYSE American:ZOM) (TSX-V:ZOM) is a veterinary diagnostic
and pharmaceutical 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
novel diagnostics and innovative therapeutics that emphasize
patient health and practice health. With a team that includes
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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Reader AdvisoryNeither 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; uncertainty as to the likelihood and
timing of regulatory approvals, 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 in our filings with the
Securities and Exchange Commission and 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 ContactsShameze 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
Zomedica Pharmaceuticals (TSXV:ZOM)
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