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PolyMedix uses a proprietary computational drug design technology
to create small molecules that mimic the activity of proteins and apply this technology to
membrane protein and protein-protein targets, with a commercial focus of serious, life
threatening acute disorders, which are also major market opportunities
Healthcare
Biotechnology
(PYMX-OTC: BB)
PolyMedix, Inc.
170 Radnor-Chester Rd.,
Suite 300
Radnor, PA 19087
Phone: 484-598-2340
Nicholas Landekic
Co-Founder, President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published – April 12, 2007
BIO:
Nick has had one of the most successful and respected careers of any healthcare executive,
and has done some of the largest and most important financing and corporate licensing
deals in the healthcare industry. From 2000-2002, he was President & C.E.O. and the
first employee of Locus Discovery, where in two years he raised $83 million in two venture
financings, hired over 50 employees, started 12 drug discovery programs, built one of the
most powerful supercomputers in the world, and earned for the company the accolade
"One of the 10 hottest biotech start-ups" from Drug Discovery Today magazine.
Prior to Locus, from 1995-2000 he was Sr. Vice President Corporate Development &
Investor Relations at Guilford Pharmaceuticals, where he concluded a $465 million deal
with Amgen and a $100 million deal with Rhone-Poulenc Rorer. His deals have twice been
nominated for "Allicense Deal of the Year". Prior to Guilford, from 1991-1995 he
was Sr. Director, Business Development at Cephalon; from 1988-1991 Sr. Manager, Strategic
Marketing at Bristol-Myers Squibb; from 1985-1988 positions in Finance and Business
Development at Johnson & Johnson Corporation (McNeil Pharmaceutical); and has also
worked in the research laboratories at the Mt. Sinai Medical Center from 1982-1983. He
holds a M.B.A. from the State University of New York at Albany, M.S. Biology from Indiana University,
and B.S. Biology from Marist College.
Company Profile:
PolyMedix is a development-stage biotechnology company focusing on treating serious,
life-threatening acute disorders with biomimetics - novel small molecule drugs which mimic
the activity of proteins. These are designed with a proprietary computational technology
developed at and licensed from the University of Pennsylvania, focused on membrane protein
and protein:protein interaction targets.
The Company is developing products in two therapeutic
areas: infectious diseases, with novel antibiotic drugs which mimic the activity of the
host defense proteins; and acute cardiovascular, with a new heparin antagonist. The
Company is conducting advanced preclinical development and lead optimization for its i.v.
antibiotic (PMX-30016, PMX-10129); and Heparin /Low Molecular Weight Heparin (LWMH)
antagonist (PMX-60054) product candidates.
PolyMedix’s product opportunities have been
rationally selected to strive to mitigate risk. Both the antibiotic and heparin antagonist
have fast clinical trials with acute dosing (single dose to days), plus the possibility of
accelerated development paths; straightforward endpoints, to objectively determine if the drug works; are
areas where animal models and Phase I clinical data generally considered predictive of
success; and represent major unmet medical needs and significant market opportunities.
CEOCFO: Mr. Landekic, please tell us your vision when you
founded PolyMedix and where you are today?
Mr. Landekic: “The vision when we
founded PolyMedix is that there are a great many high-value medical targets that are very
difficult to get drugs for, specifically, membrane proteins and protein-protein
interactions. Within these areas, there are huge market opportunities that exist in
infectious disease and acute cardiovascular disorders. PolyMedix has a proprietary
computational technology that lets us design small molecules that mimic the action of
proteins, essentially, making small things do the job of big things. We sought to marry
the capabilities of our computational technology with our commercial goals of developing
new pharmaceutical products with rapid clinical development timelines, straightforward
objective endpoints, areas where animal models are considered predicting of human
activity, major market opportunities, and areas where Phase I clinical trials are often
considered the critical human proof of principle. What we came up with was to develop new
antibiotic drugs that work very differently than classic antibiotic drugs, in ways that
would make bacterial resistance very difficult to develop, as well as some of our new
products for acute cardiovascular disorders, such as a heparin antagonist. That was the
vision when we started. We started PolyMedix 4 years ago and we have raised over $30
million to date, and are now a public company. We are now on the verge of taking two
products into clinical development in 2007.”
CEOCFO: Why
should the size of the molecule make a difference?
Mr. Landekic: “The term “small
molecule” is generally used for most of the drugs that people are familiar with.
These are drugs that you would take as a pill or injection. Small molecule is generally a
term used to describe something that is made artificially; a synthetic compound made in a
laboratory. The majority of drugs that are on the market are small molecules. Large
molecules usually refer to proteins and peptides; these are biologic agents, such as that
our own bodies produce. Proteins are built of building blocks called amino acids; our
bodies make active molecules out of these amino acids. However, the problem with making
drugs as proteins is that they can be very expensive and difficult to make. They are also
not orally active, and often even if given by injection, the body may reject a foreign
protein thus making it not useable for systemic applications. It has been one of the holy
grails of medicine to try to create synthetic small organic molecules that mimic the
activity of proteins. This is very hard to do, but this is the heart of what we do at
PolyMedix.
For example, we applied our technology to the problem
of infectious diseases. Bacterial infections are the 4th leading cause of death
in this country. After heart attack, cancer and stroke, a person has a greater chance of
dying from a bacterial infection than any other cause. We applied our computational
technology to create new small organic molecules that mimic the host defense proteins to
come up with a new way of fighting bacterial infections.”
CEOCFO: Where are
you in the process?
Mr. Landekic: “We started PolyMedix about 4 years
ago, essentially with computational algorithms. Since then we have designed, synthesized
and tested several hundred compounds in both the both the antibiotic and cardiovascular
programs. We hope to start our first clinical trials in 2007.”
CEOCFO: Will you
be doing the clinical trials on your own or partnering?
Mr. Landekic: “We are going forward under the
assumption that we will be doing clinical studies on our own, particularly the initial
Phase I clinical trials, which are relatively inexpensive and easy for a small company to
do. The areas that we chose to operate in, infectious disease and acute cardiovascular
disorders are areas that are characterized by relatively straightforward, fast and
comparatively easy clinical trials. There are many different products that can be
developed in the antibiotic program. Our own internal focus has been primarily on
intravenous products for the hospital market. We hope to partner other applications such
as oral and topical products. ”
CEOCFO: What
would you keep for yourself and how much are you willing to give away?
Mr. Landekic: “We are planning on keeping North
American rights to injectable forms of our products, and are open to partnering everything
else. Selling products into the North American hospital sector is relatively
straightforward for a small company to do. With a marketing and sales force of perhaps 50
or 60 people, one can effectively reach the hospital market. We did that with a couple of
my prior companies such as Guilford Pharmaceuticals Inc (NASDAQ: GLFD) and Cephalon Inc.
(NASDAQ: CEPH). There are a number of other companies that have successfully built
hospital based marketing and sales forces, such as Cubist Pharmaceuticals. However,
selling oral products to the primary care market requires a much bigger sales force of
thousands, which would be very difficult for a small company to do. What makes sense is to
partner our oral products and products in the primary care market, which is what we plan
to do, but to keep the injectable products for ourselves, because we can sell these on our
own.”
CEOCFO: You also
have applications that are not in the medical field like in paints and plastics; will you
tell us about those?
Mr. Landekic: “These are polymeric forms of our
antimicrobial compounds, and based on our same core invention of creating synthetic
organic molecules that mimic the activity of proteins. For the drug applications of
antibiotics, we are developing classic small molecules. For the non-drug applications, we
are developing polymer materials. Essentially, one can think of polymers as taking
monomeric active small molecule units and linking them together, like pearls on a necklace
or beads on a chain. Polymer synthesis can be easy and inexpensive. These polymers can be
used as additives to paints, plastics and textiles to make materials self-sterilizing,
specifically, medical devices, consumer products and for industrial applications. This is
one of the reasons we chose infectious diseases as a core area to work in, because we
could develop both drug and non-drug applications from the same basic invention and
technology, giving us multiple shots on goal and mitigating risk with minimal additional
expenditures. The development of polymer materials is generally risk independent from the
development of a drug.”
CEOCFO: What is
the financial picture of the company?
Mr. Landekic: “We have raised about $31 million
dollars so far since starting PolyMedix; about $27 million in equity financing, and about
$4 million in grants. In early 2006, we went public via reverse merger public offering,
raised over $21 million in a PIPE financing. The financial resources we have now will
allow us to continue to operate the company through end of 2007 or early 2008 and will
allow us to continue the development of our core programs. Like any small company we need
to be opportunistic and flexible regarding seeking future financings, because developing
any drug is an expensive endeavor.”
CEOCFO: Why
should investors be looking at PolyMedix as opposed to the many other Biotechs out there?
Mr. Landekic: “Several reasons; first, the two
therapeutic areas we have chosen to develop - infectious diseases and acute cardiovascular
applications - are both areas that are characterized by having relatively short clinical
development paths, objective endpoints, major market opportunities, and animal models that
are generally considered predictive of human activity. For example, in the antibiotic
world, if you can kill Staph bacteria in a rat, you are likely to be able to kill the same
Staph bacteria in a person. In both of these areas, clinical trials are relatively fast;
it’s a single dose with a heparin antagonist, or dosing for a week or two with an
antibiotic. We have tried to mitigate risk in many ways, but are still addressing massive
market opportunities. For example, bacterial infections are now one of the biggest medical
problems and one of the biggest market opportunities, because of rapidly growing
resistance to current antibiotics. Bacterial infections are the fourth leading cause of
death in this country. It is a $45 billion worldwide market, and the unfortunate reality
is that resistance can develop to all conventional antibiotics. Any antibiotic that acts
biochemically, which all current antibiotics do, is susceptible to resistance; many
consider it inevitable. Our approach to developing antibiotics is fundamentally different;
our compounds act with a biophysical rather than a biochemical mechanism. This approach
makes bacterial resistance much less likely to develop.”
CEOCFO: Will you tell us about your background?
Mr. Landekic: “I started out as a scientist, and
have graduate and undergraduate degrees in biology. I worked for a while in research in
the laboratories at Mt. Sinai Medical Center. I then realized that the greatest wonder of
science is where the next grant will be coming from. That is when I cut off my ponytail
and shaved my beard, and went back to school for my MBA, about 25 years ago. I then worked
at Johnson & Johnson (NYSE: JNJ) for several years in finance and business
development. I then went to work at Bristol-Myers Squib Co. (NYSE: BMY) for several years
in marketing and product management. From there I went to Cephalon in business
development. While with Cephalon, I in-licensed Provigil, which continues to be
Cephalon’s lead product with over $750 million in annual sales. I then worked for
Guilford Pharmaceuticals for five years as Senior Vice President of corporate development
and investor relations, where I did over $500 million dollars worth of licensing deals.
From there I went to become the President and CEO and first employee of Locus
Pharmaceuticals, Inc., a venture capital backed drug design technology company, and raised
$83 million in venture capital financing. Finally, four years ago I founded
PolyMedix.”
CEOCFO: So you
have the business and the science!
Mr. Landekic: “Yes, I do. Developing
pharmaceutical products is a complicated, difficult, technology-driven business. I
personally think it is important to understand and appreciate both the business and the
science if one wants to successfully turn science into profits”.
CEOCFO: In
closing, what should people reading this interview remember most about PolyMedix?
Mr. Landekic: “What we try to do at PolyMedix is
innovation, but with risk mitigation. We are focused on developing innovative products;
small molecules that mimic the activity of protein as a disruptive business model, this is
a big deal. We have shown that we can successfully create products with our technology,
and hope to have two compounds entering clinical development this year. The therapeutic
areas we have chosen to work in have been rationally and strategically selected; acute
cardiovascular and infectious diseases are both characterized as having relatively fast,
inexpensive and straightforward clinical trials, and are both areas where Phase I human
trials, the first human testing, is often considered clinical proof of principle. However,
these are also blockbuster market opportunities. At the same time we are developing drugs,
we are also trying to mitigate risk by developing antimicrobial polymers for materials
uses. Our scientific founders from The University of Pennsylvania are world renowned,
members of the National Academy of Sciences, and universally regarded as the world leaders
in biochemistry and biophysics. Most importantly, we have a highly experienced management
team in place at PolyMedix - all of us have turned science into profits many times before,
and we plan to do it again at PolyMedix.”
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