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MIGENIX is focused on
advancing its pipeline of product candidates in the areas of infectious and degenerative
diseases
Healthcare
Biotechnology
(MGIFF-OTC: BB; MGI: TSX)
MIGENIX Inc.
BC Research Building
3650 Wesbrook Mall
Vancouver, B.C. V6S 2L2 Canada
Phone: 604-221-9666
James DeMesa, M.D., MBA
President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
June 30, 2005
BIO:
JAMES DEMESA, M.D., MBA
President & Chief Executive Officer
Dr. DeMesa joined MIGENIX in October 2001. Dr. DeMesa has served as a senior executive
with several international companies in the areas of corporate management, pre-clinical
and clinical pharmaceutical and medical device product development. In addition to his
knowledge of medical and regulatory affairs, Dr. DeMesa brings a wealth of knowledge and
expertise to the Company in the scientific and administrative areas. Dr. DeMesa was most
recently the President & Chief Executive Officer and a director of GenSci Regeneration
Sciences Inc., a public company. Prior to that, he served as Chief Executive Officer and
President of GenSci OrthoBiologics. From 1992 to 1996, he was Vice President, Medical and
Regulatory Affairs at Biodynamics International, Inc. He attended the University of South
Florida where he received his M.D. and MBA degrees.
CEOCFOinterviews: Dr.
DeMesa, what was your vision when you came to MIGENIX and how has that played out?
Dr. DeMesa: The vision was to build a significant
biotechnology company. At the time, the company only had one product, an inexperienced
management team, and no partnerships with pharmaceutical companies. The vision and the
strategy were to focus first on people, pipeline and partnerships, which was somewhat our
mantra for about a year or two. We got the right people with experience in the
pharmaceutical and biotech industry, mostly from the United States. We started doing some
acquisitions and in-licensing, and built a pipeline where we now have multiple product
opportunities. We created some partnerships by licensing some of our products. It has gone
quite well and we have completed our transformation. Now, with clinical success, that
vision of building a substantial biotech company is in sight.
CEOCFOinterviews: What
are your main areas of focus with the drugs?
Dr. DeMesa: We started focusing solely on infectious
diseases or anti-infective drugs. With a recent acquisition of a San Diego-based company
called MitoKor, we brought in a portfolio of drugs in neurodegenerative and metabolic
diseases. We have these two broad areas now; infectious and degenerative diseases.
CEOCFOinterviews: What
are your strengths in this area?
Dr. DeMesa: Our strength is in product development. We
are a small R and large D company. We can take products from lead optimization through the
late stages of clinical development. From the scientific standpoint, most of our staff is
very experienced in the areas of infectious diseases, mitochondrial dysfunction and
degenerative diseases. We have the expertise scientifically, and from an experience
standpoint, we know how to develop drugs by taking them in the early stages and adding
value by progressing them through the pre-clinical and the clinical development process.
CEOCFOinterviews: What
are the major projects under development now?
Dr. DeMesa: Our two latest stage programs are in Phase
III stage of development; one is in Phase III and another is ready to go into Phase III.
These are topical anti-infective products. The first one is for preventing catheter
related infections, which is a large problem responsible for tens of thousands of deaths
in the United States alone each year. This is one product that we have in Phase III, which
is currently partnered with a specialty pharmaceutical company in the U.S. called Cadence
Pharmaceuticals, Inc. We also have an acne product that is also topical. It is ready to go
into Phase III and we are currently in partnering discussions with several dermatology
companies for that product. The other two clinical products are probably our biggest value
driving opportunities. The first is a Phase II product candidate, which is directed at
hepatitis C and enrolling patients in a Phase II clinical study, a monotherapy study, and
we are planning to start a combination study for that product. From the acquisition of
MitoKor, we have a clinical program focused on neurodegenerative diseases. Those are our
main value driving programs in the clinic. Pre-clinically we have several things I
mentioned already. We have a lipopeptide antibiotic that we acquired a couple of years ago
that is in pre-clinical development for systemic hospital infections.
CEOCFOinterviews: When
partners are looking to work with you, how important is the expertise and background of
your people?
Dr. DeMesa: It varies. For example, we did a licensing
agreement partnership a couple of years ago with Fujisawa Healthcare, Inc. (now Astellas).
They needed a lot of our product-specific expertise. We worked quite closely with them to
help the development process. On the other hand, in the license deal we have with Cadence
Pharmaceuticals, they are expert in hospital products. They do not require as much of our
input as in other deals. We are not experts in acne, so when we do a license deal with a
dermatology company for our acne product, we expect that they will conduct most of the
development on their own. From the standpoint of product development, our expertise played
a major role in these license agreements because these companies rely on us to some degree
for our knowledge, experience, and specifically our experience with these products. If you
had to break it down, the product itself is a larger portion of the attractiveness, but
the expertise and experience of our team definitely plays a role.
CEOCFOinterviews: Are
you looking for more acquisitions?
Dr. DeMesa: We have a full plate now, so although we
remain opportunistic, we are not as proactive in our efforts at this point because we have
a very full pipeline and with a small company of only 35 people, we definitely have plenty
to deal with at this point.
CEOCFOinterviews: Do you
have the funds needed to go forward?
Dr. DeMesa: We have a cash position right now in the
neighborhood of C$17 million. We are not in an urgent situation, although our burn rate is
about a million dollars per month. We have about one and half years of cash, which is
sufficient to take us beyond our main value-driving clinical milestones.
CEOCFOinterviews: Why
should potential investors be interested and what should they know about the company that
they might not realize upon first glance?
Dr. DeMesa: We have been on many road shows and have
had many meetings and it is quite clear now that we are a late stage company with Phase II
and Phase III programs. Our Phase III programs are relatively low risk from a clinical and
regulatory perspective, with a solid market potential. Our Phase II product opportunities
are possible blockbusters. What is attractive to investors is on the one hand, there are
relatively low risks, late stage niche opportunities that can achieve reasonable sales in
the low hundreds of millions of dollars. Then we have blockbuster opportunities just
behind it in Phase II that can drive value significantly and make us a billion dollar
company if the clinical trials that we have ongoing in the next few months turn out to be
successful. Our pipeline behind that is quite strong, so we have many opportunities for
future development and future value driving potential. All of that with a market
capitalization that is in the $30 million dollar range, most people get pretty excited
when they see all of that potential with a significantly low valuation. It looks to be
quite a value play.
CEOCFOinterviews: What
are your challenges going forward?
Dr. DeMesa: For any biotech company to be successful,
clinical success is essential. Products must be advancing toward commercialization, and
ultimately some kind of commercial visibility and a prospect for profitability. Every
person on our senior VP group have developed and/or brought products to market. For
investors that is a very important factor and for us it is an important factor. We know we
can develop drugs and take them to commercialization and we intend to do so.
CEOCFOinterviews: In
closing, what role does your board play for MIGENIX?
Dr. DeMesa: We have a strong, experienced board of
directors. We have several CEOs on our board, who are operating biotech companies
currently, and people on the strategic and financial side that can help us to build our
company. They are supportive and see the opportunity to create a significant biotech
company here.
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