Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication
30 Januar 2024 - 1:00PM
Business Wire
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncological and inflammatory diseases,
today announced that it has expanded its out licensing transaction
with Ewopharma AG. to include the pancreatic cancer indication of
Can-Fite.
During 2021, Can-Fite entered into an exclusive distribution
agreement for Piclidenoson with Switzerland-based Ewopharma AG for
the treatment of psoriasis and Namodenoson for the treatment of
hepatocellular carcinoma (HCC) and nonalcoholic steatohepatitis
(NASH). Under the terms of the distribution agreement, Ewopharma AG
paid Can-Fite an upfront payment of US$2.25 million with up to an
additional US$40.45 million, payable upon the achievement of
regulatory and sales milestones, plus 17.5% royalties on net sales.
In exchange, Ewopharma AG received the exclusive right to market
and sell Piclidenoson in Central Eastern European (CEE) countries
and Namodenoson in CEE countries and Switzerland.
Ewopharma AG exercised its right to expand the distribution
agreement to include the indication of pancreatic cancer and the
transaction terms of the distribution agreement are applicable to
such indication.
Ewopharma is a pharmaceutical sales and marketing firm that
helps pharma companies access markets in CEE and Switzerland. In
addition to Can-Fite, Ewopharma AG has distribution agreements with
many leading healthcare companies including Eisai and Biogen.
“We are very pleased to expand the distribution agreement with
Ewopharma, a leader in pharmaceutical distribution in Central
Eastern Europe and Switzerland and include the pancreatic cancer
indication. We consider this to be an important transaction for
Can-Fite that will enable penetration into Ewopharma’s territory
right after approval of the drug for this indication, where there
are no other efficacious drugs,” stated Can-Fite VP Business
Development Dr. Sari Fishman.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with
high affinity and selectivity to the A3 adenosine receptor (A3AR).
Namodenoson was evaluated in Phase II trials for two indications,
as a second line treatment for hepatocellular carcinoma, and as a
treatment for non-alcoholic fatty liver disease (NAFLD) and
non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in
diseased cells whereas low expression is found in normal cells.
This differential effect accounts for the excellent safety profile
of the drug. In the last 2 years Can-Fite started to develop
Namodenoson for the treatment of pancreatic carcinoma. Based on
pre-clinical studies which demonstrated robust anti-tumor effect of
the drug on experimental models of pancreatic carcinoma, the
company decided to initiate an exploratory Phase II study in
patients with pancreatic carcinoma who failed first line
treatment.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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, and inflammatory disease. The
Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis and is expected
to commence a pivotal Phase III. Can-Fite's cancer and liver drug,
Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of steatotic liver disease (SLD), a Phase III pivotal
trial for hepatocellular carcinoma (HCC), and the Company is
planning a Phase IIa study in pancreatic cancer. 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
1,600 patients in clinical studies to date. For more information
please visit: www.canfite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite’s expectations, beliefs or intentions regarding, among
other things, its product development efforts, business, financial
condition, results of operations, strategies or prospects. All
statements in this communication, other than those relating to
historical facts, are “forward looking statements”. 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.
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 known and
unknown risks, uncertainties and other factors that may cause
Can-Fite’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Important factors that could cause actual results,
performance or achievements to differ materially from those
anticipated in these forward-looking statements include, among
other things, 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
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; risks
related to the COVID-19 pandemic and the Russian invasion of
Ukraine; risks related to not satisfying the continued listing
requirements of NYSE American; and statements as to the impact of
the political and security situation in Israel on our business.
More information on these risks, uncertainties and other factors is
included from time to time in the “Risk Factors” section of
Can-Fite’s Annual Report on Form 20-F filed with the SEC on March
30, 2023 and other public reports filed with the SEC and in its
periodic filings with the TASE. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Can-Fite
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20240130659110/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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