NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that
the Construction Phase for its total renovation program of the
facility at 1 Controls Drive, Shelton, CT is now complete. The City
of Shelton has issued a Certificate of Occupancy for this facility
after inspection of the new facility. NanoViricides is now
performing specific modifications for its custom equipment and
utilities needs. Simultaneously, the facility validation process
has also been started. The Company is in negotiations to purchase
this facility rather than to lease it.
The Company also reports that its CEO, Dr. Eugene Seymour, MD,
MPH, will be presenting at the BIO Business Forum in the 2014 BIO
International Convention in San Diego today at 2pm PST (Session ID
2775). He will provide an update on the Company’s programs and
objectives.
The fully customizable manufacturing facility in Shelton, CT,
will enable cGMP manufacture of all of our nanoviricides® drug
candidates in kilogram scale, sufficient for pre-IND and human
clinical studies. In addition to the state of the art modern clean
room suites for cGMP production, the facility also houses extensive
R&D and Analytical suites.
The Company recently reported that it was in the preliminary
list of additions to certain Russell Indexes including Russell
2000, Russell 3000, and the Russell Small Cap. The final
reconstitution of these indexes is expected to take place on
Friday, June 27, after close of business.
The Company’s first drug candidate is injectable FluCide™ for
all influenzas in hospitalized patients. The market size for an
effective influenza drug for treating severely ill hospitalized
patients has been estimated in the billions of dollars, worldwide,
depending upon the therapeutic value and cost savings. Currently,
there is no effective therapeutic available for this indication.
The Company believes that it could supply a substantial portion of
the demand for this drug from its new small scale cGMP clinical
drug facility. This drug is currently in IND-enabling studies.
This drug candidate has demonstrated an unparalleled 1,000-fold
reduction in lung viral load in a lethal animal model study. In the
same study, the current standard of care, oseltamivir, (Tamiflu®,
Roche) exhibited only a 2-fold reduction in lung viral load at the
same time point. The Company intends to begin the safety/toxicology
studies of this Injectable FluCide™ drug candidate as soon as
feasible, and is producing sufficient drug substance for these
studies at its existing facility.
This broad-spectrum FluCide drug is expected to work against
most, if not all, forms of influenza virus, including epidemic,
pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9,
and “bird flu” such as H5N1.
The total market size addressed by the Company’s current drug
programs is estimated at about $50 billion. In addition to
Injectable FluCide, the Company is working on five more
commercially important drug candidates, namely: DengueCide™,
HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a
broad-spectrum antiviral drug for viral diseases of the external
eye. All of our programs are for therapeutics to treat viral
infections. Our drugs are expected to be useful as prophylactics as
well. DengueCide has recently received orphan drug designation by
the US FDA as well as the European EMA.
NanoViricides recently received an important international
award, the “IAIR Award 2014 for Leadership in Nanomedicines in the
North American Sector”.
The Company currently has approximately $36 million cash-in-hand
and cash-like-instruments. These funds are estimated to be
sufficient for taking at least one of our drug candidates through
initial human clinical trials, and possibly take another drug
candidate into human clinical trials.
The Company has undertaken the production of certain quantities
of its FluCide anti-influenza drug for use in detailed pre-IND
Safety/ “Tox Package” studies at its current facilities in West
Haven. This process is expected to take some time due to the
limitations of scale at the current facility. The Company is making
progress in making this material in the required quantities.
The Company has previously reported that it has engaged
Inno-Haven, LLC, to renovate the Shelton facility as per
NanoViricides’ requirements for expanded R&D facility and a
cGMP pilot scale (kg scale) production facility including clean
room suites suitable for injectables active pharmaceutical
ingredient (API) manufacture. Inno-Haven, LLC, a private company,
is controlled by Anil R Diwan, PhD, who is also the President of
NanoViricides, Inc. Dr. Diwan initially raised funding since 2011
to purchase an 18,000 sq.ft. facility at this site and to renovate
it and build a fully customizable modern nanomedicines
manufacturing plant to manufacture drug substances for clinical
trials in compliance with the US FDA cGMP and equivalent
international guidelines for manufacture of pharmaceuticals.
NanoViricides, Inc. has assembled a marquee team of experienced
personnel to help with the design, architecture, and engineering of
this facility. Mr. Andrew Hahn continues to provide overall
stewardship for this project. He was formerly Senior Director of
Engineering, Pharmaceutical Facilities, Global Engineering, at the
Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He
has almost 30 years of experience in architecture, design and
project management in the creation of new and refurbished
facilities at Bristol-Myers Squibb Company. Mr. Phil Mader and his
firm, MPH Engineering, LLC (“MPH”), continue to help with the
overall project management and design engineering of the laboratory
and cGMP pilot production facility. Prior to founding MPH, from
2000 to 2007, Phil Mader served as the Senior Capital Project
Manager at Bristol-Myers Squibb Company in Wallingford, CT (“BMS”).
He was involved in the design, implementation, and commissioning of
various biology and chemistry laboratory projects within budget and
in a timely manner. Ms. Kathyann Cowles of ID3A, LLC, serves as the
Principal Architect. Ms. Cowles, co-founder of Id3A, has over
thirty years of experience as a licensed Architect and Senior
Project Manager for diverse and complex design and construction
projects in the academic, science, technology, corporate and
research sectors.
NanoViricides has signed a Memorandum of Understanding with
Inno-Haven to lease the facility. No lease has been signed at
present. NanoViricides engaged an external Consulting Firm in order
to study the lease or purchase options for this facility. Based on
the Consultants’ report, the Company believes that purchase of the
facility is the favorable option for its shareholders. The Company
is currently negotiating a purchase of this facility from
Inno-Haven, LLC.
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating
special purpose nanomaterials for viral therapy. The Company's
novel nanoviricide® class of drug candidates are designed to
specifically attack enveloped virus particles and to dismantle
them. The Company is developing drugs against a number of viral
diseases including H1N1 swine flu, H5N1 bird flu, seasonal
Influenza, HIV, oral and genital Herpes, viral diseases of the eye
including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue
fever, and Ebola virus, among others.
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
which 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
pre-clinical 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.
NanoViricides, Inc.Amanda Schuon, 310-550-7200info@nanoviricides.com
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