Full Press Release Details
NanoViricides - Fireside
the first in a series of "Fireside Chats" with Dr. Eugene Seymour, Chief
Executive Officer of NanoViricides.
weeks ago I emailed Dr. Seymour with several questions about the Company and the
state of it's business model. In his reply, Dr. Seymour suggested that I publish
his answers in a series of, "Fireside Chats," so as to make this information
more readily available to not only my readership, but to all other shareholders
company that I have been writing about since August, 2005. At that
time, NanoViricides was truly a developmental stage company, it's common stock
selling at about 10c a share. We have watched it grow, like a proud parent, past
milestone after milestone with it's share price similarly growing-up with the
Company. Today, with it's share price up over 1,000% in three years, it's time
to take another look at NNVC to find out where it is in it's quest to become a
global biotechnology force against some of the most deadly biological threats to
follows is a series of Q&A sessions between Dr. Seymour and myself, fireside
chats focusing on the Company and what the future may hold in terms of corporate
growth, contributions to modern medicine and bottom line benefits flowing
through to the Company's shareholders.
Inc. (www.nanoviricides.com) (the "Company") 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 H5N1 bird flu, seasonal influenza,
HIV, EKC (epidemic kerato-conjunctivitis or severe pink eye disease), hepatitis
C, rabies, dengue fever, and Ebola virus, among others.
interview contains forward-looking statements that reflect the Company's current
expectations regarding future events. Forward-looking statements involve risks
and uncertainties. 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.
These forward looking statements are subject to known and unknown risks,
uncertainties and other factors that may cause actual results, performance, or
achievements of the company to be different from those expressed or implied
including the success of the Company's research and development efforts, the
availability of adequate financing, the successful and timely completion of
clinical studies and the uncertainties related to the regulatory process,
described in the "Management's Discussion and Analysis" section of the Company's
Form 10-KSB and other reports and filings with the Securities and Exchange
Can you give us a short history and overview of NanoViricides, Inc?
Seymour: The Company was founded in mid-2005 by Dr. Anil Diwan, Dr. Eugene
Seymour and the former CFO of the Company as NanoViricide, Inc. ("NVI"). NVI
then acquired and merged into a Pink Sheet shell, Edot-com.com, Inc., changed
its name to NanoViricides, Inc. and its stock symbol to "NNVC". Following the
effectiveness of the Company's registration, since June 29, 2007 the Company's
Common Stock has been quoted on the Bulletin Board under the symbol NNVC.OB.
When and if the Company meets one or more of the filing requirements for the
NASDAQ National Market, the Company anticipates applying for a listing on that
market. Those requirements can be found on NASDAQ's website.
Would you comment on the pathway from the lab to approval of a drug for use by
Seymour: This is a very complex question. In general, a company requests a
"pre-IND" meeting with the Food and Drug Administration ("FDA") to receive
guidance as to what specific pre-clinical studies will be necessary. Following
this meeting, toxicology as well as the pharmacokinetic and dynamic studies of
the drug are performed. When completed, a dossier is prepared and filed with the
FDA. If there are no objections, human Phase I safety studies can then start.
This is a study where a number of healthy volunteers are given the drug and
various physiological parameters are measured. Next is a small Phase IIa
efficacy study, followed by an expanded Phase IIb, and then a Phase III efficacy
study. Hopefully, the drug can then be approved for sale. In case of drugs for
the treatment of chronic diseases, such as various cancers, the studies can last
for years. In cases of infectious diseases with a limited time course, the
process can be much quicker. In diseases such as rabies or Ebola, where it would
be unethical to withhold potentially effective treatments, studies in animals
may be substituted for human efficacy studies. This is at the discretion of the
FDA. There are also "orphan diseases" or "rare diseases" where there are
generally less than 200,000 cases in the US per year. There are thought to exist
between 5,000-8,000 distinct "rare or orphan diseases". There are certain
advantages to developing treatments for viral "orphan diseases" which include
extended patent protection and certain tax credits. In addition, approval time
has historically been considerably shorter for drugs designated as "orphan
be an important component of the NanoViricides' growth strategy since we believe
our core nanoviricide can quickly be modified to deal with new or existing
viruses that are present, but not in large numbers in the U.S. such as bird flu,
West Nile, hanta, dengue, and rabies. There are no current treatments for these
the FDA pathway appears to be an all or nothing proposition in terms of money,
for biotech companies that license their drugs to large pharmaceutical
companies, there are a number of revenue-producing events that occur during the
FDA process. Typically, a biotech company may receive an upfront licensing
payment, then milestone payments as the drugs moves through the process,
followed by royalty payments once sales of the drug commence. In certain cases,
the large pharma may even fund the clinical trials. We plan
to license each nanoviricide optimized for a different disease to one or more
pharma companies. This may allow for a constant income stream from each of the
various licensed compounds during the approval process.
the next 12 months, the Company anticipates having 2 sets of animal studies
performed for at least 10 different diseases. If we are successful in that
endeavor, we will attempt to license each and every candidate to a large
pharmaceutical company.
also a large potential market for the development of pharmaceuticals for animal
treatment market for our products that we are now just beginning to explore.
Further, the approval process and the route to revenue is much shorter in the
animal disease market. The Company is currently in discussions with a
veterinarian (who is also an NNVC investor) who owns an animal diseases drug
distribution company regarding pursuing licensing agreements with some of the
large pharmas that have animal health divisions.
NanoViricides pursuing strategic partnerships and collaborations with other
pharmaceutical companies?
Seymour: As announced previously , we have an expression of interest from a