By Business Wire, February 26, 2013, 07:00:00 AM EDT
WEST HAVEN, Conn.--(BUSINESS WIRE)--
NanoViricides, Inc. (OTC: NNVC)
(the "Company"), announced that the renovation of the facility for its
new clinical scale cGMP production plant has begun.
The Company reports today that its project for enabling clinical scale
drug product cGMP capability has reached a new milestone with the
commencement of renovation of the facility at 1 Controls Drive in
Shelton, CT. The design of this facility allows a very high degree of
customization of the production process. This facility is thus expected
to enable cGMP production of all of the Company's several nanoviricide®
drug candidates, in various delivery forms ranging from injectables,
oral, eye drops, to skin creams.
The Company has previously reported that it has approximately $20M cash
in hand (including prepaid expenses) after the recent $6M raise. This
raise involved only three family offices and a charitable foundation,
all of who have been long term investors in and supporters of the
Company. In addition, the Company has developed an innovative strategy
to minimize its capital costs burden in the construction of its clinical
drug product scale cGMP production facility, as previously described.
The Company is moving forward on all of its initiatives at a steady
pace. NanoViricides technology continues to pioneer highly effective
novel antiviral drugs, including the recently demonstrated oral
anti-influenza drug in the FluCide™ program. The Company's drug
candidates continue to demonstrate significant superiority to standard
of care drugs for every virus that they have been developed against.
On February 25, an unusual pattern in the trading of the Company's
common stock was brought to its attention by concerned shareholders.
This highly unusual pattern involved selling of very large amounts of
the Company's common stock shares in a short time prior to the close of
trading, leading to a large drop in the share price. The Company does
not have any knowledge of who the sellers were.
The Company advises that it is unaware of any fundamental basis for such
an unusual trading pattern or the associated share price drop. The
Company has no knowledge of any business related events or of any
fundamental changes in its business, programs or technology
developments, that would constitute an adverse business event. All of
the Company's programs are on track, and the Company has sufficient cash
in hand to execute on its current plans.
With the current strong cash position, the Company believes that it has
sufficient funds available to perform the necessary IND enabling studies
for its anti-influenza drug candidates and to begin human clinical
studies in a reasonable timeframe.
The Company is developing its injectable anti-influenza drug, NV-INF-1,
towards IND-enabling studies. This drug is intended for use in
hospitalized patients with influenza. The Company believes it will be
useable in immuno-compromised populations, and may receive an orphan
drug classification for this indication.
The Company is also advancing its oral broad-spectrum anti-influenza
drug candidate, NV-INF-2. This may be the first ever nanomedicine drug
of any kind that is active when administered orally. This drug is being
developed for out-patient influenza cases, and may also be useful for
influenza prophylaxis, as in use for the protection of health care
workers. Both of these drugs in the anti-influenza FluCide™ program have
demonstrated very high effectiveness in a lethal influenza animal model,
routinely showing substantial superiority to oseltamivir (Tamiflu®), the
current standard of care.
Including the Flucide program, the Company currently has six
commercially important drug candidates in its pipeline that together
address a market size greater than $40 Billion. These drugs include the
aforementioned drugs against all Influenzas, HIVCide™, HerpiCide™,
DengiCide™, and a broad-spectrum nanoviricide eye drop formulation
against viral infections of the eye. These programs are based on the
Company's platform technology that enables specifically targeting a
particular type of virus with a novel mechanism of action. In addition,
the Company continues its other research and development programs. These
include broad-spectrum nanoviricides against a number of Neglected
Tropical Diseases, and its novel ADIF™ ("Accurate Drug In Field"™)
technologies which promise a way to attack novel viruses, whether
man-made (bioterrorism) or natural (such as SARS), before they cause a
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. 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.
Source: NanoViricides, Inc.