WEST HAVEN, Conn., Jan. 7, 2015 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), has completed the purchase
of the state of the art cGMP-compliant Manufacturing and R&D
facility located in Shelton,
Connecticut, from Inno-Haven, LLC.
The Company purchased the facility solely by repaying for the
costs borne by Inno-Haven, LLC, in acquiring and renovating the
property. NanoViricides Board of Directors had approved the
purchase of the facility on these terms in July, 2014.
NanoViricides now intends to move its operations to the new
facility in a phased manner in order to minimize any potential
impact on ongoing projects. The Company expects to manufacture its
drug candidates for human clinical trials at the new facility. The
Company further reports that all of its drug development programs
are progressing satisfactorily.
NanoViricides believes that its cash in hand enables this
purchase without impacting any of its drug development programs.
Further, the Company believes that this purchase represents a net
positive cash flow impact as compared to the leasing option, over
the long term.
All of the infrastructure systems needed for production of the
nanoviricides® drug candidates are now operational at the new
facility, and have either been validated by outside experts, or are
in the process of such validation.
The 18,000 sqft building at 1 Controls Drive, Shelton, CT, was completely renovated in order
to build a modern, state-of-the-art c-GMP-compliant manufacturing
facility for the production of clinical scale quantities of a wide
variety of injectable nanomedicines drug substances and drug
products, modern nanomedicines research and development facilities,
as well as an on-site state-of-the-art nanomedicines analysis and
characterization facility. The new facility comprises a small
office space, R&D Chemistry Labs, R&D Biology Labs, R&D
Analytical Lab and cGMP supporting Analytical Lab, cGMP-compliant
raw materials handling and dispensing area, and c-GMP compliant
Clean Room Suites for nanomedicines production and product
packaging processes. All of the R&D labs employ class 100,000
or cleaner air systems. The clean room suites comprise class 10,000
air quality areas as well as class 1,000 and the ultra-clean class
100 air quality areas (the class specifies the number of particles
per 1,000 liters of air). This allows production and handling of
nanomedicines with minimal risk of entraining foreign particles.
All of the R&D labs employ deionized water. For critical
processes, WFI-quality water is also produced on site in quantities
needed to support the production scale (WFI = water for injection,
comprises a specification of water quality that specifies minimal
endotoxins and maximum sterility).
The Company reported previously that it had reached an agreement
with Inno-Haven to purchase the building outright, rather than to
lease it from Inno-Haven. Since the decision to purchase the
facility, NanoViricides has been conducting extensive due
diligence. NanoViricides CEO, Dr. Seymour and Kane-Kessler firm
attorneys representing NanoViricides, helped by external
consultants, have been performing due diligence regarding this
purchase with Inno-Haven executive Dr. Diwan. The extensive due
diligence involved, a study of the original floor plans and
drawings, the final floor plans, engineering drawings, as well as
installed equipment and lab furniture, as well as a number of
additional aspects of the purchase. The due diligence process also
involved inspection of the accounts of Inno-Haven and detailed
accounting of actual costs involved in this project. The due
diligence process further involved a study of the facility
description documents submitted by the construction management firm
of MPH Engineering, LLC. In addition, the due diligence process
also involved a study of the reports on (a) the Lease vs. Purchase
options for buying this facility, and (b) price of the facility in
comparison to other like facilities. These reports were
commissioned from Nanotech Plus, LLC, a specialized consultancy
firm, by NanoViricides. These reports determined that the facility
had a replacement value substantially in excess of $15 Million. Dr. Diwan recused himself from the
NanoViricides's processes pertaining to the lease or purchase of
the facility including the discussions with consultants,
commissioning and study of reports, as well as the Board of
Directors meetings and discussions.
Dr. Diwan originally purchased the existing building and land at
this location in August, 2011, using his savings, funds he had
raised from a sale of his founders stock under a 10b-5 plan, and
certain private loans from other private parties. Inno-Haven, LLC
was formed as a special purpose limited liability company, with Dr.
Diwan as its controlling member, to execute this project. The
facility was intended to be a stand alone contract manufacturing
operation supporting multiple clients, including NanoViricides,
Inc. Later, Inno-Haven obtained additional non-bank commercial
loans to further modify the facility as per the stringent
specifications of NanoViricides, Inc. At the time that Dr. Diwan
engaged into this project, NanoViricides Inc. had limited finances
available, and was unable to raise funding to engage into this
critical project on its own. NanoViricides common stock (NNVC) was
trading on OTC bulletin board, with limited trading volume. The
Company had already identified in 2006 that cGMP manufacturing
capability was going to be critical for advancing its drug
candidates towards human clinical trials and licensure. The Company
diligently investigated contract manufacturing as well as leasing
of existing cGMP facilities to satisfy its needs. However, as a
result of the novelty of its technology, it became apparent that
external parties did not have the necessary expertise. Dr. Diwan
therefore took an extreme personal risk in order to advance the
Company's goals, and engaged into this facility development
project.
Subsequently, NanoViricides and Inno-Haven executed a Memorandum
of Understanding (MoU) in January, 2013, in which NanoViricides
agreed to lease the facility from Inno-Haven upon completion, with
a right to purchase. NanoViricides, Inc. also commissioned external
consultants for the purposes of determining (a) fair lease ranges,
and (b) the pros and cons of leasing as opposed to purchasing the
facility. Based on these reports, the Company determined that it
was in the best interests of the Company and its shareholders to
purchase the facility rather than to lease it. Dr. Diwan recused
himself from this entire process, including hiring of external
consultants, their reports, and the determination of the
appropriate strategy.
Since February 2013,
NanoViricides, Inc. has raised more than approximately $48 Million dollars. Therefore, the Company is
now in a strong financial position and is capable of purchasing the
facility outright without adversely impacting its R&D programs.
The Company also determined that purchasing is the low cost option
in the long term.
About NanoViricides:
NanoViricides, Inc.
(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. 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.
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SOURCE NanoViricides, Inc.