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is the First Company to Market Non-Injectible Insulin Receives Regulatory Approval
in South America
Biotechnology and Drugs
Generex Biotechnology Corporation
33 Harbour Square, Suite 202
Toronto, ON M5J 2G2
Chairman, President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
May 19, 2005
Anna E. Gluskin: Chairman, President, CEO. Gluskin has held these senior positions
with Generex Biotechnology Corporation since 1998. Gluskin plans, coordinates, and manages
Generex's business activities, focusing especially on new opportunities for applying
Generex's platform technology. Gluskin holds a Masters degree in Microbiology and Genetics
from Moscow State University.
Generex Biotechnology is a Toronto-based, Delaware Corporation with a market-ready
solution to a central challenge in diabetes treatment ending the pain and hassle of
insulin injections. Ever since scientists early in the 20th century learned that diabetes
was caused by the bodys inability to produce a normal supply of insulin, patients
have had to administer insulin by injection. Alternatives that have been developed in
recent years pumps or needle-less pens are still invasive and/or
expensive. Pharmaceutical companies have tried to develop a truly non-invasive insulin
product that is pain-free, easy to use and free from serious side effects.
Among todays competing technologies, only
Oral-lyn, an insulin spray to treatment diabetes, meets all those tests. After 10
years of development, Oral-lyn is ready for market and is set to produce enormous
revenue growth for the company. Generex is little known outside a small community of
investors focused on drug delivery and diabetes treatment. The commercial entry of
Oral-lyn in South America has now rapidly raised Generexs profile sharply,
with a commensurate rise in the share price. Small companies in drug and medical-device
development area, of course, inherently high-risk investments. But aggressive investors
who take an early stake in these firms can profit several times over. Generex has the
profile of being one such potential winner.
Gluskin, what was your vision for Generex and how has it played out?
Ms. Gluskin: The idea, when the company was organized,
was to be involved in drug delivery and drug discovery, working with medications that have
been on the market for a long time and have been proven to be safe.
is the need for new drug delivery systems?
Ms. Gluskin: The need for new drug delivery systems is
that the existing drug delivery does not achieve proper absorption value. The patients are
not compliant. When new diseases are happening, people are now living longer, because they
are able to combat their diseases with existing drugs, but can have greater success
because of the new delivery systems.
you tell us what you are doing at Generex?
Ms. Gluskin: We are working with a large molecule and a
protein, which means it is by injection only and we have developed an oral insulin spray,
which absorbs within ten minutes. We have also developed other products based on the same
technology, which include a platform in aerosol spray, medicinal gum, and a number of
Lets talk about the insulin spray; would people be more likely to take insulin
rather than some of the other medications in use if insulin did not have to be injected?
Ms. Gluskin: Yes, that is the idea. All the other drugs
that have been given so far have only been given instead of insulin because people refuse
to inject themselves. They are all measured. They are only delaying the use of insulin,
but by delaying it, they are causing the patients to develop a number of serious
complications such as heart disease, blindness and amputations of lower extremities.
are you in getting this product to market?
Ms. Gluskin: We are very pleased to have made the
announcement that we have received approval to market Oral-lyn in South America. In
parallel track, we expect to start phase III clinical trials in Europe and Canada this
did you choose South America first?
Ms. Gluskin: South America has the biggest problem,
where all of the population has the gene that could cause that disease. They recognize
that the problem is big. We have been doing our trials there for over seven years, so they
are prepared to proceed with the registration of this drug.
mentioned that it does not go into the lungs, what is the significance of that?
Ms. Gluskin: Competitive products have been bringing it
into the lung, because when insulin was discovered in Canada in 1921, and it was given by
injection, there was already an understanding that if it would be prepared into a very
small particle mist, it could get into the lungs. The problem is that it was not safe. If
you continuously send small particles of insulin into the lungs, it creates fibrosis
because it cuts the tissue. Our spray liquid aerosol does not harm the tissues.
us about the manufacturing process.
Ms. Gluskin: We will be doing the entire manufacturing, but will license marketing and
distribution to other companies that are going to take it to market.
you tell us about the Australian patent and some of the other areas of Generex?
Ms. Gluskin: Generex has acquired a company called
Antigen Express. It is a company in Massachusetts that prosecutes therapeutic technology.
It is a class of technology that allows the T helper cells in the body to recognize cancer
in their bodies. When the T helper cells in the immune system of the body are trained to
recognize the cancer cells, it kills the cancer cells. This technology is going to be
extremely important for patients that are undergoing surgery. There are still loose cells
of the tumor traveling through the body and it is very difficult to detect and kill them
with chemotherapy. The best way is to use our technology in a therapeutic format. Patients
with breast cancer and other cancers could expect in using our technologies, to be able to
see a much higher survival rate. Presently we are in the clinic with this technology and
we are dosing patients and we are hoping that in the next six months we will be
are you funding all of the areas in which you are working?
Ms. Gluskin: It is expensive and it is difficult to
fund privately, so the company is public, money from public markets. Now, we are hoping
that the next move for funding and development is going to come from marketing of our
licenses. Money from these licenses go directly to the bottom-line. By selling the
territorial licenses instead of licensing the whole, we will be able to generate
CEOCFOinterviews: Do you
see partnerships on the horizon or strictly the licensing?
Ms. Gluskin: We have a number of big Pharmas that are
interested in dealing with us. We believe that by staying involved longer and purchasing
the patents that we have and taking the product to market, that we will eventually make
Generex grow as a company and as a stock.
should potential investors know that maybe they do not realize when they first look at the
Ms. Gluskin: People are always impressed by
partnerships with big Pharma; I would like to remind them that they should check the
record of big Pharma, particularly companies like Pfizer Inc. (NYSE: PFE) and Merck &
Co. (NYSE: MRK), because they brought new products to market and because of safety issues,
they had to take them off the market. What we have is a simple and effective system and
safety, which is a paramount issue, taken care of and has been proven for forty to fifty
years. We know that many drugs hurt the stomach if they get there to fast, so our motto is
quality of life.
closing, I noticed you mentioned that innovation and opportunity as a formula for success,
and it sounds like you have both!
Ms. Gluskin: Absolutely, and we are still not out there
enough, and people need to know us. We believe that with the news of our registration and
good support and applications, that we will be able to get the word out.
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