·
The agreement calls for a minimum of 500,000
bottles in sales over 18 months
·
T-Cell Protect to invest 1 million euros in
Todos to support development of Tollovir, the Company’s 3CL Protease Inhibiting
Antiviral Drug Candidate
New York, NY, and Tel Aviv, ISRAEL – 
and related solutions company, together with its joint venture partner NLC
Pharma, Ltd., today announced that it has entered into an exclusive European licensing
& distribution agreement with T-Cell Protect Hellas S.A. (T-Cell Protect or
T-Cell) for a product based on its Tollovid® and Tollovid Daily™ 3CL protease
inhibitor and immune support dietary supplements. The product will be marketed
under the T-Cell Protect brand throughout 30 countries in Europe with the agreement
calling for a minimum of 500,000 bottles in sales over 18 months. T-Cell has
placed an initial purchase order for 50,000 bottles of the Tollovid Daily
product that is expected to meet the demand of an initial rollout to a subset
of the 11,000 stores located throughout Greece. More information about the
product can be found at www.tcellprotect.com.
Under the terms of the agreement, T-Cell Protect will purchase finished product
at wholesale from Todos until such time as T-Cell Protect establishes
manufacturing capabilities at a facility it currently operates in Greece to
support the European market. At such time, Todos will then receive double-digit
royalties on the sales of the licensed product manufactured by T-Cell Protect. The
Company anticipates revenue to be generated from this agreement beginning in
the current quarter.
Concurrent with this announcement, T-Cell Protect has made
an investment of 1 million euros in Todos Medical to support the clinical development of Tollovir, the
Company’s 3CL protease inhibiting antiviral drug candidate, and has also received exclusive
marketing rights for Tollovir in Greece. T-Cell Protect intends on initiating the
process for conditional Emergency Use Authorization of Tollovir to meet the
increasing demand for the prevention and treatment of Coronaviruses, including
COVID-19.
“We are very
excited to introduce and launch this new daily dietary supplement to the
European Market based on the Tollovid dietary supplement formulas for people
looking for additional targeted immune support,” said
Themis Filippopoulos, President & CEO of T-Cell Protect. “It was
clear to us that we should focus on natural supplements because it’s an area that
we are aligned with and where we believe we can make a real difference to
people’s lives across the world. With consumers becoming increasingly more
focused on immune support products that utilize natural ingredients, we believe
that the formulations utilized in the Tollovid products will ideally position our
new T-Cell Protect supplement products to capture a significant market
share for the rising class of 3CL protease inhibitors. We are
also excited to invest in the development of Tollovir, especially with
the recent significant increase in interest in 3CL protease inhibitor antiviral
products. We intend to work diligently with the team at Todos to secure market
authorization as quickly as possible.”
Mr. Filippopoulos continued, “We expect to see very strong
demand in Greece and the rest of the European market as people are looking for
additional layers of immune support heading into the winter. Moving forward, we
will be using this initial period for the rest of 2021 and early 2022 to
prepare for a larger European rollout, initially in the 8 largest countries in
Europe that have been equally impacted by the Coronavirus pandemic, where we
have our strongest retail footprint after Greece, and thereafter the rest of
Europe. We believe that the Tollovid family of products marketed under the
T-Cell Protect brand will be extremely well received in Europe where people are
focused on more natural ways to support and maintain healthy immune function.
The potential for Tollovid and Tollovid Daily in Europe is quite significant
and we are excited to bring them to market.”
“We believe this distribution agreement & related
investment validates our commercial approach for our Tollovid and Tollovid
Daily products,” said Gerald E. Commissiong, President & CEO of Todos
Medical. “As we continue to make significant progress with our Tollovir 3CL
protease inhibiting biology programs, we believe this promising therapeutic will
have a significant impact on human health going forward.”
“We look forward to working with T-Cell Protect to bring our
game-changing therapeutic product candidate Tollovir to market to treat
patients with COVID-19 in Greece,” said Dr. Dorit Arad, Founder & Chief
Scientific Officer of NLC Pharma, Todos’ 3CL biology joint venture partner.
For more information, please visit www.todosmedical.com.
For more information on the Company’s CLIA/CAP certified lab Provista
Diagnostics, Inc. please visit www.provistadx.com.
About Tollovid® & Tollovid Daily™
Tollovid and Tollovid Daily are dietary supplement products,
made from natural ingredients, that helps support and maintain healthy immune
function, and are also 3CL protease inhibitor products based upon in vitro
functional assays that show inhibition of 3CL protease activity. Tollovid’s 3CL
protease inhibition activity release criteria is at least twice as stringent as
Tollovid Daily’s 3CL protease inhibition release criteria. Tollovid has a 5-day
dosing regimen, with 4 doses of 3 pills taken each day that provides maximum
immune support. Tollovid Daily is a twice daily immune support product that is
designed to provide ongoing daily immune support for the person on the go.
About Tollovir®
Tollovir® is a 3CL protease inhibitor and anti-cytokine
therapeutic candidate for the treatment of the nidovirus subcategory of
coronaviruses that includes SARS-CoV-2, COVID-19, SARS-CoV-1, MERS and 229E.
Tollovir is made from all natural ingredients that are qualified to ensure
strong inhibition of the 3CL protease in vitro, as well as strong anti-cytokine
activity. Tollovir is currently in a Phase 2 clinical trial in Israel for the
treatment of patients hospitalized with COVID-19. Tollovir will be developed
for the treatment of hospitalized COVID-19 (severe and critical), moderate
COVID-19, long-haul COVID and potentially pediatric COVID-19.
About
T-Cell Protect Hellas S.A.
T-Cell Protect Hellas (www.tcellprotect.com), based in
Athens, Greece, is a European nutraceutical manufacturer and supplier of immune
support dietary supplement products that is led by a world-class management
team. The company has 11,000 stores throughout Greece. Mr. Filippopoulos, the founder of the
company, has been in the natural supplement industry for over 35 years and has
launched some of the most well-known products in Europe with his vast retail
network relationships. T-Cell Protect is rolling out the Tollovid family of
Products under the T-Cell brand throughout Europe.
About
Todos Medical Ltd.
Founded in Rehovot, Israel with offices in
New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving
diagnostic solutions for the early detection of a variety of cancers. The
Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses
(TBIA) is a proprietary cancer-screening technology using peripheral blood
analysis that deploys deep examination into cancer’s influence on the immune
system, looking for biochemical changes in blood mononuclear cells and plasma.
Todos’ two internally-developed cancer-screening tests, TMB-1 and TMB-2, have
received a CE mark in Europe. Todos recently acquired U.S.-based medical
diagnostics company Provista Diagnostics, Inc. to gain rights to its
Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID
testing and Provista’s proprietary commercial-stage Videssa® breast cancer
blood test.
Todos is also developing blood tests for the
early detection of neurodegenerative disorders, such as Alzheimer’s disease.
The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test
that determines the ability of peripheral blood lymphocytes (PBLs) and
monocytes to withstand an exogenous mitogenic stimulation that induces them to
enter the cell cycle. It is believed that certain diseases, most notably
Alzheimer’s disease, are the result of compromised cellular machinery that
leads to aberrant cell cycle re-entry by neurons, which then leads to
apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a
surrogate for neuronal cell function, suggesting a common relationship between
PBLs and neurons in the brain.
Todos has entered into distribution
agreements with companies to distribute certain novel coronavirus (COVID-19)
test kits. The agreements cover multiple international suppliers of PCR testing
kits and related materials and supplies, as well as antibody testing kits from
multiple manufacturers after completing validation of said testing kits and
supplies in its partner CLIA/CAP certified laboratory in the United States.
Additionally, Todos has entered into a joint venture with NLC Pharma to pursue
the development of diagnostic tests targeting the 3CL protease, as well as 3CL
protease inhibitors that target a fundamental reproductive mechanism of
coronaviruses.
For more information, please visit https://www.todosmedical.com/.
Forward-looking
Statements
Certain statements contained in this press
release may constitute forward-looking statements. For example, forward-looking
statements are used when discussing our expected clinical development programs
and clinical trials. These forward-looking statements are based only on current
expectations of management, and are subject to significant risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements, including the risks and
uncertainties related to the progress, timing, cost, and results of clinical
trials and product development programs; difficulties or delays in obtaining
regulatory approval or patent protection for product candidates; competition
from other biotechnology companies; and our ability to obtain additional
funding required to conduct our research, development and commercialization
activities. In addition, the following factors, among others, could cause
actual results to differ materially from those described in the forward-looking
statements: changes in technology and market requirements; delays or obstacles
in launching our clinical trials; changes in legislation; inability to timely
develop and introduce new technologies, products and applications; lack of
validation of our technology as we progress further and lack of acceptance of
our methods by the scientific community; inability to retain or attract key
employees whose knowledge is essential to the development of our products;
unforeseen scientific difficulties that may develop with our process; greater
cost of final product than anticipated; loss of market share and pressure on
pricing resulting from competition; and laboratory results that do not
translate to equally good results in real settings, all of which could cause
the actual results or performance to differ materially from those contemplated
in such forward-looking statements. Except as otherwise required by law, Todos
Medical does not undertake any obligation to publicly release any revisions to
these forward-looking statements to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events. For a more
detailed description of the risks and uncertainties affecting Todos Medical,
please refer to its reports filed from time to time with the U.S. Securities
and Exchange Commission.
Todos Corporate and
Investor Contact:
Richard
Galterio
Todos
Medical
732-642-7770
rich.g@todosmedical.com