Can-Fite Enters Projected $3 Billion Veterinary Osteoarthritis Market: Signs Agreement with Vetbiolix for Development of Picl...
28 June 2021 - 9:00PM
Business Wire
- All pre-clinical, clinical, and regulatory development work
to be conducted and financially covered by Vetbiolix
- Veterinary market has potential for a shorter path to
regulatory approval and product revenues
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver
diseases, today announced it has signed a development and
commercialization agreement with Vetbiolix, a France-based
veterinary biotech company, for the development of Piclidenoson for
the treatment of osteoarthritis in companion animals including dogs
and cats.
Vetbiolix will have the exclusive right to Piclidenoson in the
veterinary osteoarthritis market for two years, during which time
Vetbiolix will conduct proof-of-concept studies and cover all
associated costs. If the studies yield positive data and Vetbiolix
exercises its option to obtain the license from Can-Fite, then
Vetbiolix will be obligated to pay Can-Fite upfront and milestone
payments, in addition to royalties on sales upon regulatory
approval for veterinary use.
The canine osteoarthritis market is projected to reach $3
billion by 2024. According to Grand View Research, the broader
global companion animal health market is estimated at a value of
$20 billion in 2021 and is expected to grow to $27 billion by
2028.
Current treatments for canine osteoarthritis include oral
non-steroidal anti-inflammatory drugs (NSAIDs) which only treat
symptoms and carry significant harmful side effects, and an
injectable disease modifying osteoarthritis drug (DMOAD) that
targets the progression of the disease. Piclidenoson, an oral drug
that has a favorable safety profile in humans and in animal
studies, offers a potentially safe and effective oral treatment for
canine osteoarthritis.
“The veterinary market is a significant opportunity where our
drugs may have an impact. Both the size of the market and the
shorter timelines to regulatory approval have the potential to
result in milestone and royalty revenues for Can-Fite. We believe
Piclidenoson’s safety and efficacy data in over 1,000 humans, as
well as preclinical data from small animals, indicate it may offer
relief to the growing number of companion animals with
osteoarthritis,” stated Can-Fite VP of Business Development, Dr.
Sari Fishman.
Matthieu Roquette, President at Vetbiolix commented, “The
quality of preclinical and clinical data generated by Can-Fite on
Piclidenoson and its pharmacological profile make this highly
selective A3 Adenosine Receptor Agonist a drug candidate likely to
meet the unmet veterinary medical need to date in the management of
osteoarthritis pathology in dogs and cats. Moreover, the mechanism
of action of Piclidenoson makes this product a strong candidate for
a large spectrum of inflammatory disease indications affecting
Pets. We are aiming to enter in veterinary regulatory development
by the end of 2022 based on clinical proof of concept data we will
generate within the next 12 months.”
In 2019, the U.S. Patent and Trademark Office issued to the
Can-Fite patent #10,265,337 titled “Use of A3 Adenosine Receptor
Agonist in Osteoarthritis Treatment” for Piclidenoson in the
treatment of osteoarthritis in mammals.
About Vetbiolix
Vetbiolix develops innovative products for treatment and
prevention of diseases affecting pets. As pharmaceutical and
biotech companies research novel molecules and compounds for human
medicine, tests in different species often reveal exciting
possibilities for pets. Vetbiolix has developed a unique approach
focused on turning this potential into innovative prescription
medicines and care products for pets. To date, veterinarians have
still few therapeutics and real preventive care products at their
disposal that have been specifically developed and approved for
pets. Along with a virtual VetBiotech organization, Vetbiolix
exclusively focuses on clinical developments of prescription
medicines, diagnostics, nutraceuticals and care products for pets,
thanks to its qualified external R&D partners in Europe &
the US. Vetbiolix is supported by the Eurasanté Bio-Incubator, the
northern France health cluster ranked among the top 20 best
European incubators fostering pharm/biotech start-up development
(Labiotech.eu 2019).
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an
advanced clinical stage drug development Company with a platform
technology that is designed to address multi-billion dollar markets
in the treatment of cancer, liver, inflammatory disease and
COVID-19. The Company's lead drug candidate, Piclidenoson, is
currently in a Phase III trial for psoriasis and a Phase II study
in the treatment of moderate COVID-19. Can-Fite's liver drug,
Namodenoson, is headed into a Phase III trial for hepatocellular
carcinoma (HCC), the most common form of liver cancer, and a Phase
IIb trial for the treatment of non-alcoholic steatohepatitis
(NASH). Namodenoson has been granted Orphan Drug Designation in the
U.S. and Europe and Fast Track Designation as a second line
treatment for HCC by the U.S. Food and Drug Administration.
Namodenoson has also shown proof of concept to potentially treat
other cancers including colon, prostate, and melanoma. CF602, the
Company's third drug candidate, has shown efficacy in the treatment
of erectile dysfunction. These drugs have an excellent safety
profile with experience in over 1,500 patients in clinical studies
to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite’s expectations, beliefs or intentions regarding, among
other things, market risks and uncertainties, its product
development efforts, business, financial condition, results of
operations, strategies or prospects. In addition, from time to
time, Can-Fite or its representatives have made or may make
forward-looking statements, orally or in writing. Forward-looking
statements can be identified by the use of forward-looking words
such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or
“anticipate” or their negatives or other variations of these words
or other comparable words or by the fact that these statements do
not relate strictly to historical or current matters. These
forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or
with the approval of one of Can-Fite’s authorized executive
officers. Forward-looking statements relate to anticipated or
expected events, activities, trends or results as of the date they
are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to
risks and uncertainties that could cause Can-Fite’s actual results
to differ materially from any future results expressed or implied
by the forward-looking statements. Many factors could cause
Can-Fite’s actual activities or results to differ materially from
the activities and results anticipated in such forward-looking
statements. Factors that could cause our actual results to differ
materially from those expressed or implied in such forward-looking
statements include, but are not limited to: our history of losses
and needs for additional capital to fund our operations and our
inability to obtain additional capital on acceptable terms, or at
all; uncertainties of cash flows and inability to meet working
capital needs; the impact of the COVID-19 pandemic; the initiation,
timing, progress and results of our preclinical studies, clinical
trials and other product candidate development efforts; our ability
to advance our product candidates into clinical trials or to
successfully complete our preclinical studies or clinical trials;
our receipt of regulatory approvals for our product candidates, and
the timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain strategic
partnerships and other corporate collaborations; the implementation
of our business model and strategic plans for our business and
product candidates; the scope of protection we are able to
establish and maintain for intellectual property rights covering
our product candidates and our ability to operate our business
without infringing the intellectual property rights of others;
competitive companies, technologies and our industry; statements as
to the impact of the political and security situation in Israel on
our business; and risks and other risk factors detailed in
Can-Fite’s filings with the SEC and in its periodic filings with
the TASE. In addition, Can-Fite operates in an industry sector
where securities values are highly volatile and may be influenced
by economic and other factors beyond its control. Can-Fite does not
undertake any obligation to publicly update these forward-looking
statements, whether as a result of new information, future events
or otherwise.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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