SHELTON, Conn., Sept. 14, 2021 /PRNewswire/
-- 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").
NanoViricides is developing oral and pediatric drugs to fight
COVID-19 designed to be effective against most variants.
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.
View original
content:https://www.prnewswire.com/news-releases/nanoviricides-completes-licensing-for-coronavirus-field-which-includes-current-covid-19-drug-development-301376002.html
SOURCE NanoViricides, Inc.