Here's a 12/00 interview with R. Medford I don't remember seeing.
AtheroGenics, Pioneering therapeutic treatment of coronary artery disease by targeting chronic inflammation
Biotechnology & Drug, Sector: Healthcare, NASDAQ: AGIX
AtheroGenics, Inc.
8995 Westside Parkway, Alpharetta, GA 30004 Phone:
678-336-2500 Fax: 678-336-2501
Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer
Interview conducted by: Walter Banks Co-Publisher
CEOCFOinterviews.com - December 2000
CEOCFOinterviews – Dr. Medford, please share some of your career
highlights.
Dr. Medford – “I am an MD cardiologist with a Ph.D. in molecular
biology, with training at Albert Einstein College of Medicine, Harvard
Medical School and most recently as Director of Molecular Cardiology at
Emory University in Atlanta, GA. My interests have always focused on
the transition and translation of basic science discoveries, from the
bench to the application of drugs for clinical diseases.”
“In the early 1990's, Wayne Alexander, now the Chairman of Medicine at
Emory University, and I developed a hypothesis or a theory that led us
to view coronary artery disease and atherosclerosis as inflammatory
diseases. These diseases are the major causes of death in the country,
and result in over half a million heart attacks every year. There are
twelve million Americans with coronary disease. Our theory, in which a
small set of genes expressed by the blood vessels that feed the heart,
might play an important role in coronary artery disease and
atherosclerosis. We have now proven this theory to be true, showing
that inflammatory responses which cause chronic diseases, such as
heart disease, could be targeted specifically, and that by blocking those
inflammation processes we could block the progression of
atherosclerosis leading to heart disease. This led to the genesis of
AtheroGenics back in 1993.”
“This concept of inflammation that we have identified, chronic
inflammation, is an abnormal response of the body to injury or disease
that may last for many years. This contrasts with normal inflammation,
such as the redness and swelling on a cut in your hand, where white
blood cells affect repairs in tissue and then resolve after a few days to
weeks. By focusing on that pathway, we’ve established, and now others
have confirmed, that the inflammation mechanism underlies several of
the major diseases that many people suffer from, such as coronary artery
disease, atherosclerosis, arthritis and asthma, as well as the inflammatory
complications of cystic fibrosis and transplant rejection. So by utilizing
this technology platform, AtheroGenics has developed the first set of
small molecule therapeutics or medicinal drugs that are now in clinical
trials for these major diseases, leading with coronary artery disease.”
CEOCFOinterviews - Can you explain to the reader why your studies
and research focus on treating chronic inflammation?
Dr. Medford – “Inflammation is a normal process where the body heals
itself in response to an infection, injury or disease. The normal response
is self-limiting; it resolves itself. What we have learned over the years,
especially for coronary disease, is that some diseases are affected by an
abnormal form of inflammation, known as chronic inflammation, in which
the inflammatory cells, the cells that will normally repair and correct
damage, never turn off. They are always resident in the area of the tissue
that is under repair. Normally, the white blood cells would disappear,
leaving a normal tissue, but in the case of chronic inflammation, the
white blood cells never leave. They continue to actively secrete
biological products in an attempt to continually repair an apparently
ongoing insult to the tissue. The inappropriate activation and residence
of these white blood cells breaks the tissue down.”
“A major driver in coronary disease and atherosclerotic plaques, chronic
inflammation, is also a characteristic feature of asthma, arthritis in the
joints and pulmonary inflammation associated with cystic fibrosis. We
actually identified within the chronic inflammatory system, which
represents only a small portion of normal immune responses, a gene
called VCAM-1, which plays an important role in this chronic
inflammatory event. That protein is expressed on the surface of cells that
line blood vessels, called endothelial cells. Endothelial cells are located
throughout the body in all varieties of different tissues. VCAM-1 allows
the white blood cells of chronic inflammation to bind to an area of
inflamed tissue, and activates this abnormal chronic inflammatory
response. At AtheroGenics, we’ve identified a way to specifically inhibit
the expression of VCAM-1 in endothelial cells and a pathway that
controls the expression of VCAM-1 and other associated genes for
chronic inflammation. By developing VCAM-1 inhibiting drugs, we have
now found in our animal models of inflammation that this is a very
effective method of blocking the inflammation of atherosclerosis and the
progression of disease.”
“We’ve done extensive preclinical studies and have also tested our
compound in over four hundred and fifty patients in eight different
studies. We’ve seen no evidence that there is any effect on the general
immune system for the body. Based on all of the characterizations of
this drug, it should have no effect on general immune responses.”
CEOCFOinterviews - What is the name of your lead drug?
Dr. Medford – “The name of AtheroGenics’ lead drug is AGI-1067. It is a
compound that was discovered and developed by chemists and
scientists at AtheroGenics and at one of the country’s leading
pharmaceutical companies, Schering-Plough Corporation, with whom we
successfully partnered in October of 1999. This agreement called for
Schering-Plough and AtheroGenics to co-develop AGI-1067 for the
treatment of restenosis, a complication of a procedure used in cardiology
to open up blocked coronary arteries due to atherosclerosis. A catheter
is placed inside one of the blood vessels that feed the heart with blood,
and either a balloon plasters the plaque (the atherosclerotic blockage)
against the wall of the vessel, or a metal mesh stent is put in place to
keep the vessel open and allow blood to flow through. Unfortunately, up
to forty percent of the patients (one million a year) will re-block that same
coronary artery within six months.”
“While the procedure is very good, it induces vascular damage,
triggering the same set of inflammatory responses that we developed
AGI-1067 to block. So with the help of Schering-Plough, we have now
moved AGI-1067 into clinical trials. In September 2000, we announced
the completion of enrollment for a major trial of over three hundred
patients to test whether AGI-1067 can block the re-closure, or restenosis,
that occurs in these patients with coronary artery disease. By the middle
of next year, we will be able to report whether or not AGI-1067 is
effective in a complication that affects over a million patients a year
worldwide.
CEOCFOinterviews - How does your company fare in the race to find an
answer for restenosis?
Dr. Medford – “Two companies located here in Georgia, Novoste and
Theragenics, put a radioactive source inside the blood vessel with the
stent to destroy the cells that might lead to a progression of restenosis
over time. There are other companies trying to coat the metal mesh of the
stent with drugs that kill dividing blood cells, such as vascular cells.”
“I think that it is important for our investors to know that currently there
are no drugs or pills on the market that will block restenosis. All of the
other methods actually present, specifically at the insertion of the
device, an event that occurs very locally. The promise of AGI-1067 is
that through a simple pill that the patient would take once a day, we can
prevent restenosis from occurring in and of itself, without placing
radiation implants into coronary arteries, or by using cytotoxic drugs in
the stent. In addition, AGI-1067 was designed to block the inflammatory
process that leads to the progression of disease. It’s important to note
that when we try to correct for restenosis using stents or radiation
implants or chemically coated devices, we are only treating a local
problem, a local abnormality that’s induced by damage. The disease
itself that leads to the placement of the stent, the atherosclerosis in
coronary artery disease, is not being treated by these interventions.
AGI-1067 is designed not only to prevent the restenosis from occurring
but also to block the progression of atherosclerosis that leads to further
disease in other parts of the blood vessel. We hope that this represents
an effective therapy that not only blocks the restenosis, but that also
could be utilized to prevent the progression of the disease that causes
the need for stent placement in the first place.”
CEOCFOinterviews - What are the advantages for oral delivery?
Dr. Medford – “I think that if the compound is successful, its profile
would mean that taking a single drug once a day for some defined period
of time would prevent you from having to come back into the doctor’s
office or into the hospital because of a restenosis event. I think that
profile, with a safe and effective drug, would be superior to
manipulations in the coronary artery itself, which could lead to
complications that we don’t know about yet. However, putting radiation
therapy, for example, or toxic drugs on the stent itself may result in
complications that would not be as optimal as a simple drug that you
take once a day for a defined period of time.”
CEOCFOinterviews - Are there any side effects to AGI-1067?
Dr. Medford – “We have done seven Phase I, or the safety clinical trials
on AGI-1067, with over one hundred and fifty men and women, and there
were no dose limiting side effects for this drug. That allowed us to move
to the next stage of clinical trials without any problems, which is the
Phase II program.”
CEOCFOinterviews - Are there any companies specifically following
your lead in this area of biotechnology?
Dr. Medford – “Because of the interest in inflammation as the
underpinning of major chronic diseases, the Wall Street Journal, for
example, recently published a large article on the role of inflammation in
coronary artery disease. Based on work coming out of the New England
Journal of Medicine, in which coronary artery disease is characterized
by inflammatory signals, it’s important to recognize these diseases as
diseases of inflammation.”
“It’s important to note that AtheroGenics is a pioneer in the area of
viewing coronary disease as a chronic inflammatory disease. We, as a
pioneering company in this area, helped not only to establish this new
and exciting concept of disease treatment, but also to put forward with
Schering-Plough the first compound to clinical trials designed
specifically to target this pathway. We are also comforted to know that
what we have started has been accepted by the industry as an important
approach for therapeutic intervention. There are additional companies
that are now following in our lead, which include large pharmaceutical
companies as well as biotechnology companies, but we believe that we
are well ahead of their efforts.”
CEOCFOinterviews - Tell us about your patent position and how it can
influence your lead on the competition.
Dr. Medford – “We have a very robust patent position. We have the
strongest types of patents, called composition patents, issued for our
lead compound AGI-1067, and also the compounds that are likely to go
into clinical trials in the future.”
“We also have been granted U.S. patents that describe this new
pathway of regulating genes in a specific way to control the chronic
inflammation of atherosclerosis and other diseases that are characterized
by this inflammatory response. We have a strong intellectual property
position both on compounds, mechanisms and the use of these
compounds for the use in treatment of human disease. That’s one
element that keeps us ahead of the competition. Additionally, we are
doing the best science for the new generations of compounds that are
more effective, more selective and that would increase their therapeutic
utilities for an even broader range of diseases characterized by this
signaling pathway. Our experience of combining our scientists with our
development experts provides us with a unique and highly competitive
position in terms of rapidly identifying new compounds and bringing
them forward into clinical trials. So we believe that this combination
gives us a compelling and sustainable advantage against the
competition.”
CEOCFOinterviews - Do you think that AGI-1067 could be useful in the
prevention of the disease itself?
Dr. Medford – “Initially our goal is to correct one major problem
associated with coronary artery disease, restenosis. I think that we will
learn in additional clinical trials, whether the compound itself would be
an appropriate therapy for very long-term use for the prevention of the
coronary artery disease itself.”
CEOCFOinterviews - Please discuss your agreement with
Schering-Plough and its benefits to AtheroGenics.
Dr. Medford – “I think the critical element is that we have an important
and very positive relationship with Schering-Plough Corp., one of the
leading pharmaceutical companies in this country. Our agreement,
reached in October of 1999, represents $189 million in up front and
milestone payments from Schering Plough, if all milestones are reached.
There are also significant royalties on net sales of AGI-1067 when it’s in
marketed form. For both the short and long term, the Schering-Plough
relationship is very important and positive for our company.”
“Schering has done extensive research on our program and their
agreement represents a validation of the science and clinical
development capabilities that AtheroGenics has demonstrated as an
emerging pharmaceutical company. I think that it is also important to
note that AtheroGenics is running these clinical development trials in
partnership with Schering-Plough. We have built a capable emerging
pharmaceutical company, dedicated to not only identifying and
practicing cutting edge science, but also to using the best science to
develop new compounds for the treatment of chronic inflammatory
disease. We have the discipline, expertise and experience base
necessary to move compounds from the laboratory into the clinical trial
process. Our goal ultimately is to establish for us and our investors new
compounds and therapeutic approaches that are effective in humans for
the treatment of major diseases.”
CEOCFOinterviews - What is your business model for building value
on your science?
Dr. Medford – “As stated in our prospectus, we believe we can most
rapidly build value from our cutting-edge science through the
development of drugs using medicinal chemistry. The second
component of our strategy looks at the clinical indications that we are
targeting, and if they represent very large markets. Atherosclerosis is
the largest market, which necessitates an early partnering strategy with a
major pharmaceutical company. Our partnership with Schering-Plough
will allow us to effectively develop and commercialize a drug requiring
enormous sales forces and worldwide commercialization capabilities.”
“We have also identified clinical market targets that are amenable to a
growing company, such as ours, to rationally build out our own sales
and marketing efforts for smaller market treatment categories like solid
organ transplant rejection or cystic fibrosis. There are specialized centers
where these conditions are treated and these centers would be most
amenable to a focused and specialized sales force. By identifying
distribution channels and a small focus market, in a step-wise fashion,
we will begin to build a small but effective sales force for these drugs.”
CEOCFOinterviews - How big are the markets that you are targeting
for your drug?
Dr. Medford – “There are multiple drugs being used for the treatment of
atherosclerosis, but let’s focus on one product category, called statins.
These drugs lower the bad cholesterol, LDL cholesterol, and are selling
somewhere between $12-15 billion a year. Lipitor, a major drug sold by
Pfizer, is one of the leading statins and it is producing multiple billions of
dollars a year in sales. So you’re looking at many millions of patients,
10-20 million in the U.S. alone, that are candidates for these drugs.
Coronary disease is the major cause of death and morbidity in the United
States and the western world. Another chronic inflammatory disease we
are targeting, asthma, represents over 12-15 million patients in the United
States alone. So the sizes of the markets that we are going after are
extremely large.’
“Any successful product would have a potentially large impact from a
revenue standpoint. We anticipate that we have an exciting technology
with an approach that should enable us to hopefully exploit some of
those markets with new compounds, but also importantly presenting the
physician as well as the patient with new options for the treatment of
some diseases that are currently very difficult to treat. In terms of
atherosclerosis, none of the drugs that are currently available deal
directly with the underlying inflammation of the blood vessel that drives
the process, which AGI-1067 is designed to target.”
CEOCFOinterviews - What is your external growth strategy?
Dr. Medford – “We are always looking at opportunities, other companies
and other technologies in the industry that offer synergy and may
augment our product portfolio. We are always reviewing potential
acquisitions and licensing opportunities to accelerate and balance out
our product line. At the end of the day, we are a product company, a
drug development company, and our goal is to optimize our
profile so that we can most rapidly and effectively bring products to
market.”
CEOCFOinterviews - Where do you envision your company three years
from now?
Dr. Medford – “I hope that we will no longer be considered an emerging
pharmaceutical company, but a bonafide pharmaceutical company with a
balanced and compelling product pipeline of new and important
products for the treatment of chronic inflammatory diseases.”
CEOCFOinterviews - Do you have the cash and/or credit for your
plans?
Dr. Medford – “The capital that we have raised at our public financing
will see us through the foreseeable future to meet all of the business
goals that we’ve set in the S-1.”
CEOCFOinterviews - What is your current burn rate?
Dr. Medford – “We’re currently running on the quarter about three
million dollars.”
CEOCFOinterviews - What is the key thought that you convey to your
staff which may give investors confidence in the future of your
company?
Dr. Medford – “We are a highly motivated and passionate group, which
has combined the innovation and idealism of biotechnology in the
treatment of major diseases, with the experience and discipline of large
pharmaceutical partners to reduce the operational risk of bringing new
drugs to the market.”
“We’ve built an environment at AtheroGenics that combines the most
enthusiastic and cutting-edge science with the discipline of optimizing
the best chances that this science will result in helping people. I think
what drives our people here is that we are going after the development of
new drugs for the treatment of serious diseases that will affect millions of
people. Knowing that what they’re working on will have an impact on
the health of many, many people makes it exciting for our employees to
get up in the morning.”
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