Zomedica Pharmaceuticals Corp. (NYSE American: ZOM) (TSX-V: ZOM), a
veterinary diagnostic and pharmaceutical company, today
announced it has entered into a development and supply agreement
with Qorvo Biotechnologies, LLC (Qorvo), a wholly-owned subsidiary
of Qorvo, Inc. (Nasdaq: QRVO) focused on bringing its
piezo-electric Bulk Acoustic Wave (BAW) sensor to the veterinary
health sector. Under the terms of this agreement, Zomedica has
exclusive, global rights to develop and market Qorvo’s
investigational point-of-care diagnostic platform for veterinary
use.
Under the agreement, Zomedica and Qorvo will collaborate on the
development of veterinary diagnostic assays with the goal to
deliver reference-lab performance at the point of care. The joint
development work initially targets five assay cartridge candidates
to detect the following thyroid and adrenal disorders in dogs and
cats, which currently require reference lab immunoassay testing for
diagnosis and treatment management:
- Hypothyroidism in dogs: one of the most common endocrine
diseases with a prevalence rate estimated at 0.2 percent to 1.89
percent.i,ii
- Hyperthyroidism in cats: a significant cause of morbidity in
older cats having an estimated prevalence of 4.5 percent.iii
- Cushing’s disease in dogs: another common endocrine disorder in
dogs with an estimated incidence of 1 to 2 cases/1,000
dogs/year.iv
Assuming the development work is successful, Zomedica expects
marketing to commence in Q4 2019 for the initial five assay
candidates, which do not require pre-market regulatory approval by
U.S. regulators.
According to a 2018 MarketsandMarkets.com report, the
immunodiagnostics segment is expected to account for the largest
share of the veterinary diagnostics market in 2018 with the overall
veterinary diagnostics market expected to grow at a compounded
annual growth rate of 8.8 percent to reach $4.0 billion by 2023.
Furthermore, approximately 200 million veterinary visits occurred
in the U.S during 2016 of which 41 percent or 80 million included
the performance of at least one diagnostic test, according to a
2018 Raymond James report.
“We believe Qorvo’s patented diagnostic technology has the
potential to significantly expand the capability of our
point-of-care diagnostic portfolio to deliver reference lab
precision to the veterinary clinic on a cost-effective basis,” said
Gerald Solensky, Jr., Chairman and Chief Executive Officer at
Zomedica. “We believe our collaboration with Qorvo, a pioneer and
leader in BAW sensor technology and advanced manufacturing, will be
a major step forward in our efforts to bring reference lab testing
capabilities to clinical veterinarians, which we expect will
improve the standard of care for companion animals while increasing
practice productivity. We are excited to collaborate with a company
the size of Qorvo in developing a product for the clinical
veterinarian.”
“We believe that Zomedica’s drive to bring novel and innovative
diagnostic tools to the companion animal market makes it the right
partner to bring our technology to the animal health space,” said
David Lacinski, Senior Director of Strategy and Business
Development at Qorvo.
The diagnostic platform uses Qorvo’s differentiated BAW sensor,
derived from the fundamental BAW filter technology that is deployed
in millions of mobile devices worldwide, to enable a non-optical
and fluorescence-free detection system. The final product, referred
to as ZM-024 in Zomedica’s pipeline, is expected to be comprised of
a table-top instrument that uses disposable assay cartridges to
test a range of samples including whole blood, serum, plasma, and
urine. Qorvo has conducted preliminary analytical and functional
sensitivity testing on its investigational BAW platform as well as
feasibility testing for certain initial immunoassay candidates in
its other development work. Zomedica believes ZM-024 may have
potential utility in other veterinary diagnostic areas such as
molecular diagnostics and multiplexing capabilities.
The agreement with Qorvo covers the development and validation
of assays to be specified by Zomedica for use with Qorvo-designed
diagnostic instruments and related assay cartridges. Qorvo will be
responsible for the development and verification of the assays,
instruments and cartridges, and all related development costs other
than certain non-recurring engineering expenses which will be paid
by Zomedica. Qorvo will supply the instruments and the related
assay cartridges to Zomedica. Zomedica will be solely responsible
for the validation, marketing and sale of the assays, instruments
and related assay cartridges.
The agreement, which is exclusive worldwide in the practice of
veterinary medicine for the health and wellbeing of any non-human
animal, has an initial term of ten years (subject to early
termination and extension in certain circumstances).
Zomedica has agreed to pay Qorvo U.S.$1.0 million in cash within
14 business days of the execution of the agreement and to issue to
Qorvo unregistered common shares having a value of U.S.$3.9
million, consisting of an aggregate of 2,565,789 common shares to
be issued at an ascribed price of U.S.$1.52 (approximately C$2.00).
Zomedica has agreed to pay Qorvo additional milestone payments in
cash or, if elected by Qorvo, additional unregistered common shares
having a value calculated as specified in the agreement. The total
amount of additional milestone payments (if all milestones are met)
will be U.S.$10 million (if paid entirely with cash) or up to
U.S.$10.9 million (consisting of cash in the amount of U.S.$7
million and unregistered common shares having a value of U.S.$3.9
million, if Qorvo elects to receive compensation partially in
equity). In connection with the agreement, Zomedica and Qorvo have
entered into a registration rights agreement providing Qorvo with
certain registration rights with respect to the common shares to be
issued by Zomedica.
The ZM-024 is an investigational device, is not currently
available for sale, and is limited to investigational use only.
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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About Qorvo BiotechnologiesQorvo
Biotechnologies, LLC is a wholly owned subsidiary of Qorvo, Inc.
(Nasdaq: QRVO) that is developing a point-of-care (POC) diagnostics
system based on a sensor application of Qorvo’s Bulk Acoustic Wave
(BAW) filter technology.
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 Zomedica 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: the
validation of Qorvo’s technology for diagnostic use in animals and
our ability to successfully develop and market ZM-024; uncertainty
as to the acceptance of ZM-024 by veterinarians, uncertainty
regarding the usage rates of ZM-024; 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 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
iIsabelle Cattin, Jordi Puig. A Look at Canine Hypothyroidism.
Vet Times, June 25, 2012
iiSundburg C.R., Belanger, J.M., Bannasch, D.L., Famula, T.R.,
Oberbauer A.M., December 8, 2016 “Gonadectomy effects on the risk
of immune disorders in the dog: a retrospective study”. BMC
Veterinary Research, 12:278
iiiMcLean, J.L., Lobetti, R.G. & Schoeman, J.P.,
2014.‘Worldwide prevalence and risk factors for feline
hyperthyroidism: A review’. Journal of the South African Veterinary
Association 85(1), Art. #1097, 6 pages.
ivde Bruin C1, Meij BP, Kooistra HS, Hanson JM, Lamberts SW,
Hofland LJ.. Cushing's disease in dogs and humans. Horm Res. 2009
Jan;71 Suppl 1:140-3.
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