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Ushercell product in
Phase III for HIV and Phase II clinical trials as a contraceptive, is an entry inhibitor
that is not absorbed by the body, minimizing the chance of side effects
Polydex Pharmaceuticals Limited
421 Comstock Road,
Toronto, ON M1L 2H5 Canada
George G. Usher
Chairman, President and CEO
Interview conducted by:
Walter Banks, Publisher
December 1, 2005
George G. Usher
Chairman, President and CEO
Educated at Malvern College and the University of Guelph, Ontario, where he obtained an
Honours degree, Mr. Usher joined the Company from university in 1982. He held several
positions in production and management before becoming President for Canadian Operations
in 1986. He was elected to serve on the board of Polydex in 1988, becoming President in
1993, CEO in 1996 and Chairman in 1998.
Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the
research, development, manufacture and marketing of biotechnology-based products for the
human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for
the worldwide veterinary pharmaceutical industry.
CEOCFO: Mr. Usher, lets start by telling us how long
youve been with Polydex Pharmaceuticals and what changes have taken place since youve
been with the company?
Mr. Usher: The company was originally started in 1936,
by my father in England, and we moved to Canada in 1969. I joined the company in 1982 in
production and moved up through the ranks. The main changes that weve seen is more
of a focus on trying to be profitable, while maintaining research and development
programs. In the past, my father may have been the consummate entrepreneur and attempted
to go after many different projects all at the same time. However, my focus has been more
on projects that look like they have great potential, but also have backing from other
partners. As a small company, we do not have the resources either financially or personnel
wise to undertake significant research projects, which is now why we focus on one
particular product that we call Ushercell; a name that my father thought up. This product
has received backing from CONRAD, which is a not-for-profit organization based at the
Eastern Virginia Medical School in Arlington, Virginia, which itself assimilates funds
from USAID the US Agency for International Development, and philanthropic foundations such
as the Rockefeller Foundation, the Hewlett Foundation and the Bill and Melinda Gates
Foundation with mandates to develop products for womens health. This seems to be
going very well and we are thrilled to say that our product is now into Phase III clinical
trials for the prevention of HIV and has just finished a Phase II trial for contraception.
We also have some other clinical trials planned, but it seems that this approach is
working considering the progress that weve made.
CEOCFO: Can you explain what makes Ushercell applicable to
HIV as well as being used as a contraceptive?
Mr. Usher: It is a bit difficult to explain when you
mention one product that acts as a contraceptive, anti-STD, herpes, gonorrhea, Chlamydia
as well as anti-HIV. It sounds like snake oil; how can one product possible do all this?
By its nature, Ushercell is a very viscous material and so in the contraceptive
application it will significantly reduce the mobility of sperm. It inactivates them, it
does not kill them. It inactivates them so that they cannot bind with the ovum and result
in a pregnancy. As far as the anti-STDs in general, although it is not safe to generalize,
to be brief, it seems to inactivate them. We believe that by attacking the outer coat or
casing of the virus, we could thereby inactivate it.
CEOCFO: Is Ushercell considered a drug?
Mr. Usher: It is certainly called a drug, because we
hope to be able to make claims with it once it is approved and as soon as you make claims,
it is a drug. The concept behind this product is that it is a gel and it would be in a
tube-like applicator that a woman would insert into her vagina, prior to intercourse,
perhaps even several hours in advance. It then coats the vaginal wall and, I guess for all
intents and purposes, acts as a sort of barrier or entry inhibitor type product.
CEOCFO: Are there any side effects related to the use of your
Mr. Usher: None that we have seen so far! Because it is
a an extremely high molecular weight product, it is actually not absorbed into the blood
stream and so as far as we know, there are no side effects. However, I would have to
emphasize that this is what we know so far, because we are still in trials and always
gathering more data.
CEOCFO: I know that you mentioned where you are in the trial
process; could you give us a little more details?
Mr. Usher: This is a bit complicated because we have
several applications going on. One application is as a contraceptive and for that we have
finished a Phase II study; those results are being analyzed as we speak. The general
concept is that preclinical studies cover in vitro work and animal work. Once you are into
Phase I, you are testing on humans. Phase I is safety and tolerance, Phase II and Phase
III you would start getting into efficacy trials. We have started Phase III, for
preventing male to female transmission of HIV, and that is presently going on in two
locations in Nigeria. We have another study for the same prevention of male to female
transmission of HIV in Uganda, South Africa and India, which are just getting going.
CEOCFO: This all sounds very exciting; is the Ushercell your
main product focus currently?
Mr. Usher: I should say that this is our main R&D
focus right now, however, we do have an ongoing business that is generating sales and
CEOCFO: Can you tell us about your ongoing business and
revenues, as well as if youll need to raise funds to complete your trials?
Mr. Usher: Id like to start with the raising of
funds, because we really dont have to do that. Im thrilled to say that all due
to the efforts of CONRAD, in Arlington, they have managed to raise funds to pay for the
clinical trials and the development of Ushercell, potentially right through to market.
That is our hope. Because of the generosity of USAID and the Bill and Melinda Gates
Foundation, which I mentioned earlier and others; through their generosity Ushercell is in
these clinical trials. Therefore, we are not looking to raise funds at this time. For our
ongoing business, we have a manufacturing site here in Toronto, of 30,000 square feet,
employing 27 people. Last year we sold our manufacturing site in Kansas City, USA, which
was devoted to finished dosage forms of animal pharmaceuticals. The aim of that was so
that we could focus on our R&D project for Ushercell. Hence, we have this one site
here in Toronto, where we are producing Dextran, which is a polysaccharide that we further
derivatize to produce other materials. Our main product is Iron Dextran for the treatment
of anemia in piglets and we are one of the three main producers of that in the world. The
other products are used in biotechnology applications such as DNA hybridizations, so they
are all lab based and some are used to help in production of other human pharmaceutical
products. However, from our point of view we are really not sure what they all are,
because the use is so varied it is hard to keep track.
CEOCFO: Of the products that are on the market, are they
brought through partnering or by a Polydex sales force?
Mr. Usher: The products are actually marketed by
Dextran Product Limited, which is the company here in Toronto. We then go through agents
worldwide, who have connections with other companies in other countries.
CEOCFO: Of all of your products, does Ushercell, currently in
clinical trials, represent the largest market potential?
Mr. Usher: By a huge long shot! Absolutely! The
potential applications for Ushercell, just dwarf any other products that we have on the go
CEOCFO: What would you say is the most interesting aspect of
Mr. Usher: Ushercell is an entry inhibitor or barrier
method that is not absorbed by the body, so the theory and the hope is that the chance of
side effects are extremely minimal.
CEOCFO: Do you do much investment outreach and how is that
done, through an outside IR firm or in-house?
Mr. Usher: We do have an investor relations firm, the
work is done by Linda Hughes, who can be reached at 877-945-1621, and she handles all of
this work. But, we are trying to increase our investor awareness.
CEOCFO: Do you have float available?
Mr. Usher: I regret to say that our float right now is
extremely limited, however we are looking at ways to increase the liquidity of the stock
without harming our existing shareholders.
CEOCFO: Do you have any closing comments for our readers?
Mr. Usher: Without making any recommendation to buy the
companys stock, I will say that to consider Polydexs little story, with
possibly one of the leading compounds in the world in development against HIV
transmission, I do think that it is a stock worth watching
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