|
 Company
Profile:
Concert Pharmaceuticals, Inc. is a clinical
stage biotechnology company dedicated to creating medically and commercially
important new medicines through a novel approach utilizing the
naturally-occurring element deuterium. Concert applies its innovative
platform to create highly differentiated compounds based on well-understood
biological targets and drug molecules, yielding a rich pipeline of new
chemical entities (NCEs). By leveraging decades of pharmaceutical experience
to design NCEs from proven therapies, Concert’s drug candidates have
potential for first-in-class use in under-served medical conditions, as well
as best-in-class efficacy and safety, while reducing R&D risk, time, and
expense. The Company has over 100 patent applications for new drug
candidates addressing a broad range of therapeutic areas, including
HIV/AIDS, vasomotor symptoms, and renal disease, among others. Since its
inception in 2006, Concert has raised more than $96 million and has been
financed by leading venture capitalists and institutional investors.
 Dr.
Roger Tung, President and Chief Executive Officer of Concert
Pharmaceuticals, Inc., co-founded the Company in April 2006 based
on research he carried out as an independent scientist. Before Concert, Dr.
Tung worked in venture-backed start-up and major pharmaceutical companies,
including Vertex Pharmaceuticals Inc., where he was a founding scientist,
Merck, Sharp & Dohme Research Laboratories, and The Squibb Institute for
Medicinal Chemistry. At Vertex, Dr. Tung was most recently Vice President of
Drug Discovery and led their drug discovery programs at its San Diego site.
He co-invented and headed discovery of Vertex’s two commercial HIV protease
inhibitor products, Lexiva® and Agenerase®. He also headed development of
Agenerase, in collaboration with Glaxo, through FDA and EMEA approval. Dr.
Tung has overseen the discovery of 14 new chemical entities which have been
studied in the clinic. He has numerous publications and has been granted 40
U.S. patents. Dr. Tung received his Ph.D. in Medicinal Chemistry at the
University of Wisconsin-Madison from Professor Daniel H. Rich.
|
Healthcare
Biotechnology
(Private)
Concert Pharmaceuticals, Inc.
99 Hayden Avenue, Suite 500
Lexington, MA 02421
Phone: 781-860-0045
www.concertpharma.com |
|
Concert Pharmaceuticals,
Inc.
Print Version
Interview conducted by: Lynn
Fosse, Senior Editor, CEOCFOinterviews.com, Published – February 19, 2009
CEOCFO: Dr. Tung, what was your vision when
you founded Concert Pharmaceuticals and where are you today?
Dr. Tung: “I have a long background as
an R&D executive in the biotech and pharmaceutical industry. It was clear to
me that the paradigm for drug research and development has become
increasingly difficult for a number of reasons. The vision behind Concert is
to take a different tack at drug discovery that would enable the creation of
new chemical entities (NCEs), first-and best-in-class new medicines, in a
way that substantially reduces the risks associated with current drug
development approaches and increases the likelihood of their successful
commercial development.”
CEOCFO: What is different about the
approach of Concert Pharmaceuticals?
Dr. Tung: “We generally believe that
starting with drugs with proven human pharmacology is the most straight
forward way of producing better medicines, by capitalizing on what is known
about those compounds and making very directed improvements. Technologically
we replace certain hydrogen atoms in successful drugs with deuterium atoms
and leave the rest of the molecules generally unchanged. The approach has
the advantage that the potency and selectivity of these new chemical
entities is, for all intents and purposes, identical to that of the existing
drug. However, in some cases, there are very substantial differences in drug
metabolism that we believe can be medically very important.”
CEOCFO: What is deuterium?
Dr. Tung: “Deuterium is a safe,
naturally-occurring element that is related to hydrogen. Deuterium is
abundant in nature and we as humans have a couple of grams of deuterium in
our bodies. Deuterium has the same shape and size as hydrogen, but it has a
greater mass, which results in its forming stronger bonds with other atoms.
It is sourced by distillation of water to produce what is called D2O,
which is the feedstock that we use for deuterium chemistry.”
CEOCFO: Where did the idea come from to
use deuterium to create new drugs?
Dr. Tung: “After spending several
decades in the pharmaceutical industry, I thought about technology that
might be able to increase the success rate in producing important new
medicines. Specifically, I was thinking of approaches to leverage the
knowledge around existing medicines and to create better ones. Deuterium has
been used quite extensively in human clinical studies, but never as a way of
producing a differentiated commercial new entity. I believed using deuterium
as a platform approach would allow us to create a pipeline of better
medicines while reducing R&D risk, time and expense. With the idea, filing
new patent applications and its initial seed capital, Concert was founded in
2006.”
CEOCFO: What are you doing at Concert
today?
Dr. Tung: “We are actually in really
good shape as a company both scientifically and financially. We have raised
$96 million since our inception putting us in strong financial position to
advance our pipeline and create significant value. We have a very robust
pipeline. One compound is in clinical testing and a second is poised to
enter the clinic in 2009. We also have a number of exciting research
compounds behind that focusing on areas including cancer, cardiovascular
disease, and renal disease, among others. We have in many ways an
embarrassment of riches, with a lot of opportunities that we could pursue,
but we of course are mindful of making sure that we are as focused as
possible given the current capital climate. In 2009, we intend to focus our
development on CTP-518. CTP-518 is an oral HIV protease inhibitor that we
believe eliminates the need for co-administration with a protease inhibitor
booster. We believe CTP-518 has the potential to be the best-in-class
compound in what has been a very important therapeutic area. This is a
therapeutic modality in which we can get very rapid proof-of-concept since
the relationship between drug exposure and efficacy are very well
understood.”
CEOCFO: Why is there a need to eliminate
a protease inhibitor booster from HIV treatment regimens?
Dr. Tung: “There are happily a lot of
therapies that are now available for an HIV infected patient. As a result,
those patients are living much longer, and much healthier lives. The
emphasis for new medicines are ones that minimize the side effects and make
the therapies easier to use. Although there are now many approved HIV drugs,
many of them have substantial side effects. Therefore, our focus has been to
further the field by simplifying the dosing regimen and by what we believe
will be a reduction in side effects of an important existing drug, an HIV
protease inhibitor. It’s important to understand that in the HIV protease
class, the current standard of care is to give those drugs co-dosed with an
entity called ritonavir. The function of ritonavir is to increase the
biological half-life of the HIV protease inhibitors resulting in increased
trough concentrations in the blood - that’s the lowest concentration that is
in the bloodstream before taking the next pill. It works quite well, but
unfortunately, there are a lot of side effect issues with ritonavir, in
particular nausea. There are also potential cardiovascular safety issues due
to the fact that ritonavir increases triglyceride levels and LDL
cholesterol. In addition, it is another pill to take, another co-pay and is
inconvenient to patients because the formulation for that drug requires
refrigeration when temperatures are above 78 degrees Fahrenheit. So, as you
can see, there are many things that make ritonavir not ideal. What we have
done through the use of our technology is to start with one of the leading
protease inhibitors, currently on the market, and to change the metabolism
in a way that would enable dosing the compound, we believe, without
ritnoavir as part of the combination. So it will have all of the benefits of
a potent, market leading agent, but with the further advantage of reducing
the number of pills that the patient has to take and enhancing the
tolerability of the therapy.”
CEOCFO: Where are you in the process of
developing of the HIV protease inhibitor?
Dr. Tung: “We expect to enter clinical
evaluation of CTP-518 in the second half of 2009.”
CEOCFO: You have 100 patent
applications; tell us about some of the other compounds that you have in
your pipeline.
Dr. Tung: “We have quite a few compounds
that we have covered, in terms of filing applications for deuterium-modified
versions of those compounds.
The initial compound that we took into the
clinic, CTP-347, is a compound that we remain quite interested in as a
potential first-in-class non-hormonal treatment for vasomotor symptoms or
hot-flashes. This is an indication, which is very wide spread. In addition
to the peri- and post-menopausal population, it is experienced by many
patients undergoing cancer chemotherapy, particularly for breast cancer,
prostate cancer and other hormone related cancers. Therefore, there is a
very large patient population that could benefit from a treatment for
vasomotor symptoms that in particular are contra-indicated from taking
hormone replacement therapy. We think that there is a great market for it
and we have a compound that we believe may significantly improve upon the
safety profile of the existing agent by changing the metabolic fate of the
compound.”
CEOCFO:
Tell me about CTP-347 and why you believe you have developed a better drug?
Dr. Tung: “The hydrogen analog of
CTP-347 is a serotonin modulator that has the effect of producing a
metabolite which is quite reactive and inactivates irreversibly one of the
important liver metabolic enzymes. It therefore creates a lot of drug-drug
interactions. By using our technology, we have changed the metabolic fate of
the compound so it no longer produces, at least to the extent we can detect,
that reactive metabolite. As far as we are aware, we are the first to
demonstrate the ability to do that with deuterium substitution.”
CEOCFO: What would you say to investors
who are putting companies on their radar screen as to why should they
consider Concert Pharmaceuticals?
Dr. Tung: “We are pioneering what we
believe is a very important and powerful approach to creating
differentiated, first-in-class and best-in-class medicines. We have
demonstrated as an organization that we can execute very quickly. We have
great experience in the company. As a management team, we have put five
drugs onto the market between us, so we understand the issues with the
process of drug R&D unusually well. We also have a very interesting product
platform opportunity and that is very rare in the small molecule space.
There are areas in large molecule therapeutics, such as antibodies, for
example, and RNAi that have that potential to be a platform, but in the
small molecule space, there are very few cases of a technology that allows
you to broadly access a wide range of therapeutic areas and to do so rapidly
and with an enhanced likelihood of success. Therefore, Concert is a pretty
unique organization.”
CEOCFO: Final thoughts, what should
people reading about Concert Pharmaceuticals remember most?
Dr. Tung: “We have the pieces to be a
truly successful organization. As I indicated, Concert has the personnel and
the technology platform, where we are the pioneers and the most advanced
company working in this area. In addition, we have the cash to be able to
execute on our plans and to ride out the current market situation. We also
have a strong intellectual property position for many different molecules.
On top of all that, we have received our first notice of allowance for one
of our patent applications, so this is an area that is being recognized by
the Patent and Trademark Office as novel and inventive. Concert is putting
all of those pieces together to create what we think will be one of the
winning organizations.”
disclaimers
Any reproduction or further distribution of this
article without the express written consent of CEOCFOinterviews.com is prohibited. |
