NanoViricides Completes Licensing
for Coronavirus Field which Includes Current COVID-19 Drug
Development
Shelton, Connecticut - September 14, 2019 -- InvestorsHub
NewsWire -- NanoViricides, Inc. (NYSE
Amer.: NNVC) (the "Company"), a global
leader in nanomedicines against viruses, announced today that it
has completed the process of licensing the human Coronavirus field
for drug development and commercialization from TheraCour Pharma,
Inc. ("TheraCour"). The Company executed a license agreement for
the field comprising anti-viral treatments for coronavirus derived
human infections with TheraCour Pharma, Inc. on September 8, 2021
(the "Agreement").
The licensed field includes antiviral drugs to treat
SARS-CoV-2 and its variants that cause the COVID-19 disease
resulting in a global pandemic that continues to rage through the
world, wave after wave, as new variants develop and take hold.
There was no upfront cash payment for the license and the
compensation terms were generally consistent with prior licenses,
and are summarized further below.
NanoViricides is currently working on taking its two COVID-19
lead drug candidates, namely, NV-CoV-2- and NV-CoV-2-R, into human
clinical trials. The Company believes that the essential
preclinical work is substantially complete for taking these drugs
into human evaluation.
The Company believes that these broad-spectrum
anti-coronavirus drugs will continue to be effective even as the
virus continues to mutate developing into a number of variants of
concern. Antibody protection afforded by vaccines and the
effectiveness of antibody drugs have continued to decline
progressively as new SRAS-CoV-2 variants have emerged. The Company
believes that its unique anti-viral nanomachine technology
overcomes these issues.
The Company believes it is well poised to deliver an
out-patient oral medicine to treat COVID-19 infections. The Company
has found that its anti-COVID-19 drugs exhibited strong antiviral
effectiveness when given orally in animal studies.
The Company also believes that its COVID-19 drugs will be
suitable for use in pediatric patients, and we plan to include
pediatric cohorts into clinical trials at the appropriate stages.
We believe that pediatric use of these drugs is feasible based on
the excellent safety profile we have observed in animal studies. As
the variants evolve, pediatric infections and their severity have
begun to rise, causing major worldwide concerns even as the world
is trying to move towards normalcy in education and child social
interactions.
The Company's anti-COVID drugs are based on polymeric micelle
nanomedicine technologies developed by TheraCour Pharma, Inc. and
its affiliate, AllExcel, Inc. The inventors have filed a PCT patent
application that forms the basis of the Company's two lead drug
candidates, namely, NV-CoV-2 and NV-CoV-2-R. The new patent
application covers the new technologies, compositions,
formulations, processes, manufactured products, and methods of use,
among other specifics. This patent application was filed on June
25, 2021, application number PCT/US2007/001607, entitled
"Self-Assembling Amphiphilic Polymers As Anti-Covid-19 Agents". Its
nominal expiry date would be 20 years, after filing and if issued,
i.e. June 24, 2041, and could be extended in certain countries
under regulatory extensions to as late as into the year 2043,
providing a significant commercial runway.
Under the Agreement, NanoViricides has obtained a world-wide,
exclusive, sub-licensable, license to use, promote, offer for sale,
import, export, sell and distribute antiviral drugs that treat
human Coronavirus infections using TheraCour's proprietary as well
as patented technology and intellectual property, including the new
patent application cited above. The discovery of ligands and
polymer materials as well as formulations, the chemistry and
chemical characterization, as well as process development and
related work will be performed by TheraCour under the same
compensation terms as prior agreements between the parties, with no
duplication of costs allowed.
NanoViricides will not make any upfront cash payments to
TheraCour and has agreed to the following milestone payments to
TheraCour: 100,000 shares of the Company's Series A Convertible
Preferred Stock, par value $0.001 per share (the "Series A
Preferred Stock") upon the execution of the Agreement; 50,000
shares of Series A Preferred Stock after the grant of the approval
of Licensee's Investigational New Drug (IND) Application, or its
equivalent; cash payments of $1,500,000 after the initiation of
Phase I clinical trials or its equivalent; $2,000,000 after the
completion of Phase 1 Clinical Trials or its equivalent for at
least one product within twelve (12) months from the date of the
acceptance of the IND; $2,500,000 no later than six (6) months
after the completion of Phase 2A Clinical Trials or its equivalent
for at least one product within twenty (24) months from the date of
the completion of Phase 1 or its equivalent; 100,000 shares of
Series A Preferred Stock after the initiation of Phase 3 clinical
trials or its equivalent; and, at TheraCour's option, $5,000,000 in
cash or 500,000 shares of Series A Preferred Stock, no later than
six (6) months after the completion of Phase 3 Clinical Trials or
its equivalent for at least one product within thirty-six (36)
months from the completion of Phase 2 Clinical Trials or its
equivalent. In addition, the Company agreed to pay to TheraCour
fifteen percent (15%) of net sales of licensed products and any
income from sublicensed products, consistent with previous
agreements. Under the Agreement, TheraCour retains the exclusive
right to develop and manufacture the Licensed Products. The
Agreement contemplates that the parties will enter into a separate
Manufacturing and Supply Agreement for the commercial manufacture
and supply of the drug products if and when NanoViricides intends
to engage into commercialization of the drugs. The Agreement
provides that the Manufacturing and Supply agreement would be on
customary and reasonable terms, on a cost-plus basis, using a
market rate based on then-current industry standards, and include
customary backup manufacturing rights, as with prior
agreements.
To assist in the analysis of the terms of the Agreement,
NanoViricides commissioned research reports on Coronavirus drug
market sizes for the Coronavirus antivirals field from an
independent consulting agency, Nanotech Plus, LLC. Additionally,
the Company obtained business analysis and valuation reports for
potential licensing terms for a coronavirus drug from an
independent consultant. NanoViricides was represented by McCarter
& English, LLP while TheraCour was represented by DuaneMorris
LLP.
The Series A Convertible Preferred Shares are only
convertible upon a "change of control" of the Company as defined in
its full specification, are non-transferrable and have no trading
market. Each Series A share carries 9 votes, and is convertible
only upon a change of control into 3.5 shares of the Company's
common stock.
The Company's drug development business model was formed in
May 2005 with a license to the patents and intellectual property
held by TheraCour that enabled creation of drugs engineered
specifically to combat viral diseases in humans. This exclusive
license from TheraCour serves as a foundation for our intellectual
property. The Company has a worldwide exclusive license to this
technology for several drugs with specific targeting mechanisms for
the treatment of a number of human viral diseases including
coronaviruses, herpesviruses, VZV, HIV, Influenza, and
others.
* PCT = Patent Cooperation Treaty. Enables global
intellectual property protection.
About NanoViricides
NanoViricides, Inc. (the
"Company")(www.nanoviricides.com)
is a development stage company that is creating special purpose
nanomaterials for antiviral therapy. The Company's novel
nanoviricide® class of drug candidates are designed to specifically
attack enveloped virus particles and to dismantle them. We are
developing clinical candidates for the treatment of COVID-19
disease caused by SARS-CoV-2 coronavirus. Our other lead drug
candidate is NV-HHV-101 with its first indication as dermal topical
cream for the treatment of shingles rash. In addition, the Company
has several antiviral programs in various pre-clinical
stages.
The Company is now working on tasks for completing an IND
application for its COVID-19 drug candidates. The Company cannot
project an exact date for filing an IND for this drug because of
its dependence on a number of external collaborators and
consultants. The Company is currently pursuing two separate drug
candidates for the treatment of COVID-19 patients. NV-CoV-2 is our
nanoviricide drug candidate that does not encapsulate remdesivir.
NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2
with remdesivir encapsulated in it. The Company believes that since
remdesivir is already US FDA approved, our drug candidate
encapsulating remdesivir is likely to be an approvable drug, if
safety is comparable. Remdesivir is developed by Gilead. The
Company has developed both of its own drug candidates NV-CoV-2 and
NV-CoV-2-R independently.
The Company intends to re-engage into an IND application to
the US FDA for NV-HHV-101 drug candidate for the treatment of
shingles once its COVID-19 project moves into clinical trials,
based on resources availability. The NV-HHV-101 program was slowed
down because of the effects of recent COVID-19 restrictions, and
re-prioritization for COVID-19 drug development work.
The Company is also developing drugs against a number of
viral diseases including oral and genital Herpes, viral diseases of
the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1
bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue
fever, and Ebola virus, among others. NanoViricides' platform
technology and programs are based on the TheraCour® nanomedicine
technology of TheraCour, which TheraCour licenses from AllExcel.
NanoViricides holds a worldwide exclusive perpetual license to this
technology for several drugs with specific targeting mechanisms in
perpetuity for the treatment of the following human viral diseases:
human Coronavirus infections, Human Immunodeficiency Virus
(HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster
Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses,
Japanese Encephalitis virus, West Nile Virus and Ebola/Marburg
viruses. The Company's technology is based on broad, exclusive,
sub-licensable, field licenses to drugs developed in these areas
from TheraCour Pharma, Inc. The Company's business
model is based on licensing technology from TheraCour Pharma Inc.
for specific application verticals of specific viruses, as
established at its foundation in 2005.
As is customary, the Company must state the risk factor that
the path to typical drug development of any pharmaceutical product
is extremely lengthy and requires substantial
capital.
As with any drug development efforts by any company, there
can be no assurance at this time that any of the Company's
pharmaceutical candidates would show sufficient effectiveness and
safety for human clinical development. Further, there can be no
assurance at this time that successful results against coronavirus
in our lab will lead to successful clinical trials or a successful
pharmaceutical product.
This press release contains forward-looking statements that
reflect the Company's current expectation regarding future events.
Actual events could differ materially and substantially from those
projected herein and depend on a number of factors. Certain
statements in this release, and other written or oral statements
made by NanoViricides, Inc. are "forward-looking statements" within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. You should not
place undue reliance on forward-looking statements since they
involve known and unknown risks, uncertainties and other factors
that are, in some cases, beyond the Company's control and which
could, and likely will, materially affect actual results, levels of
activity, performance or achievements. The Company assumes no
obligation to publicly update or revise these forward-looking
statements for any reason, or to update the reasons actual results
could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future. Important factors that could cause actual
results to differ materially from the company's expectations
include, but are not limited to, those factors that are disclosed
under the heading "Risk Factors" and elsewhere in documents filed
by the company from time to time with the United States Securities
and Exchange Commission and other regulatory
authorities. Although it is not
possible to predict or identify all such factors, they may include
the following: demonstration and proof of principle in preclinical
trials that a nanoviricide is safe and effective; successful
development of our product candidates; our ability to seek and
obtain regulatory approvals, including with respect to the
indications we are seeking; the successful commercialization of our
product candidates; and market acceptance of our
products.
FDA refers to US Food and Drug Administration. IND
application refers to "Investigational New Drug" application. cGMP
refers to current Good Manufacturing Practices. CMC refers to
"Chemistry, Manufacture, and Controls". CHMP refers to the
Committee for Medicinal Products for Human Use, which is the
European Medicines Agency's (EMA) committee responsible for human
medicines.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
Source:
NanoViricides, Inc.