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Synta
Pharmaceuticals’ lead compound STA-4783 now in Phase III trials is offering hope to
patients with melanoma, a large and urgent unmet need
Healthcare
Diagnostic Substances
(SNTA-NASDAQ)
Synta Pharmaceuticals Corp.
45 Hartwell Avenue
Lexington, MA 02421
Phone: 781-274-8200
Safi R. Bahcall, Ph.D.
Co-founder, President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published = May 25, 2007
BIO:
Safi R. Bahcall, Ph.D.
Director, President and Chief Executive Officer
Dr. Bahcall co-founded Synta with Dr. Lan Bo Chen and has been Chief Executive Officer and
a member of the board of directors since July 2001, and President since December 2003. He
has led Synta through four rounds of private financing, two acquisitions, an initial
public offering, and the advancement of multiple therapeutic programs from conception
through late stage clinical trials. Prior to founding Synta, Dr. Bahcall was a consultant
at McKinsey & Company serving investment banks and pharmaceutical companies on key
issues of strategy, technology, and operations. Dr. Bahcall also founded a drug discovery
company focused on novel ion channel research, now part of Synta. He received his B.A.
summa cum laude from Harvard University, was awarded his Ph.D. from Stanford University in
theoretical physics, and was a Miller postdoctoral fellow in theoretical physics at U.C.
Berkeley.
Company Profile:
Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering,
developing, and commercializing small molecule drugs to extend and enhance the lives of
patients with severe medical conditions, including cancer and chronic inflammatory
diseases. Synta has a unique chemical compound library, an integrated discovery engine,
and a diverse pipeline of clinical and preclinical-stage drug candidates with distinct
mechanisms of action and novel chemical structures. All Synta drug candidates were
discovered and developed internally.
In September 2006, Synta announced positive results
for its lead cancer drug, STA-4783, in a blinded, randomized, multi-center trial in
patients with metastatic melanoma, showing a doubling of time patients survive without a
worsening of their condition. In November 2006, Synta received Fast Track
designation from the FDA for the development of STA-4783 in melanoma. Synta plans to
initiate a pivotal, Phase 3 clinical trial for STA-4783 in melanoma, and Phase 2 trials in
additional indications, in 2007.
CEOCFO: Dr. Bahcall, what was your
vision when you started with the company and where are you today?
Dr. Bahcall: “Our goal when we started
was to build a company that is a center for scientific and operational excellence,
creating and developing new drugs that extend and enhance the lives of patients all over
the world. We have achieved an enormous amount since then, with the announcement that our
first drug is helping patients with melanoma, and we are working hard to bring that drug
to the market and to continue to create innovative, new drugs.”
CEOCFO:
How do you do that?
Dr. Bahcall: “The foundation of our
technology is a chemical compound library that has been collected and developed over the
past two decades. The library contains unique chemical structures not typically
found in the collections of pharmaceutical companies or commercial chemistry service
companies. We discover new drugs by screening our library for compounds that have
beneficial effects on the underlying biology of diseases. The library and our ability to
rapidly screen and optimize drug candidates is the core of our technology platform.”
CEOCFO:
What makes these compounds unique and is there a common thread in what you have?
Dr. Bahcall: “What makes the compounds
unique is their origin – primarily private collections from individuals or
institutions, as well as certain natural product extracts, that we have acquired and have
not been previously accessed. The common thread is the library and the way we have tested
and optimized the drugs before we advance them into human clinical trials, making sure we
have a good handle on the science of how they work.”
CEOCFO:
Please tell us what you are working on now and why you have chosen these compounds to work
with?
Dr. Bahcall: “We are developing new
drugs for treating cancer and inflammatory diseases. Our focus is novel drugs that have
the potential to be first-in-class or best-in-class therapies for high severity diseases.
We’ve made this choice because we believe our library and screening abilities give us
an advantage in developing category-leading drugs, and because the market opportunity for
novel therapies in areas of high unmet medical need – such as cancer and inflammation
– is tremendous.”
CEOCFO:
Where are you specifically with some of the products in your pipeline?
Dr. Bahcall: “We are very excited by
our lead cancer drug, which is called STA 4783. In September of last year, we announced
what is the first positive result for a new drug in a blinded clinical trial in metastatic
melanoma in almost thirty years. Patients with metastatic melanoma are in the terminal
stages of a devastating disease, with very few treatment options and a life expectancy of
less than a year. What we found was that patients who received STA-4783 survived without
their disease getting worse twice as long as patients who did not receive STA-4783. That
is a very important and meaningful benefit for patients, and offers real hope that we may
increase how long these patients live.”
CEOCFO:
Where are you in the process with STA-4783?
Dr. Bahcall: “After receiving the
results from our melanoma trial, we very quickly shared the data with the FDA. The FDA
granted us what is called Fast Track designation, a recognition that our drug has
potential to address an important unmet medical need, and an indication that the FDA will
work closely with us to bring the drug as rapidly and safely as possible to patients.
Subsequently, we met with the FDA and agreed on the design of the final, pivotal, Phase
III clinical trial, the purpose of which is to confirm the results from our prior trial.
Our immediate task is to conduct this trial as efficiently and effectively as possible, to
the highest standards of operational excellence. If the results are positive, which we
expect to know by the end of next year, we would then file for approval and, once
approved, begin to distribute the drug to melanoma patients.
The approval of STA-4783 in melanoma is our highest
priority. A next priority is to expand the market of potential uses for STA-4783. Based on
the science of how this drug works, we do not feel there was anything specific about the
underlying biology of melanoma that led to the positive results – we believe that
STA-4783 could benefit patients with other types of cancer, and we want to explore that as
soon as we can.”
CEOCFO:
Do you have a marketing plan?
Dr. Bahcall: “Marketing is a bit
different for this kind of disease, and in this industry, than it is in other industries.
For a disease as severe as metastatic melanoma, where the majority of patients are dying
in less than a year and there are so few treatment choices, the most important thing is to
get compelling scientific data on the safety and efficacy of our drug, and then clearly
communicate those results to the scientific and medical communities.
It’s hard to describe just how devastating this
disease is, and how few choices patients and physicians have. One physician expressed his
sense of frustration and desperation very graphically: “If I could grind up my desk
and give it to patients and it would make them better, I would.” With strong
scientific data on safety and efficacy, the focus of our marketing would be effective
education of both physicians and patients, in order to achieve rapid uptake and broad
usage in the melanoma population.”
CEOCFO:
What else is in your pipeline?
Dr. Bahcall: “We have a total of five
drugs in our pipeline. In addition to STA-4783, we have two other cancer drugs and two
drugs for treating chronic inflammatory conditions. Our second cancer drug, STA-9090, acts
to inhibit a protein inside cancer cells that is critical to the uncontrolled cell growth
that is the main feature of cancer. We have seen some terrific results with this drug in
models of leukemias for which there are no current treatments, as well as in other cancers
that have been very resistant to traditional therapies. That drug will begin clinical
trials in cancer patients later this year. Our third cancer drug, STA-9584, attacks the
blood vessels that feed tumors. While angiogenesis inhibitors, a recently successful class
of anti-cancer drugs, prevent the formation of new
blood vessels, STA-9584 goes beyond and attacks established
blood vessels. We have seen some very strong preclinical data with this drug as well, and
expect to advance the program into human clinical trials next year. Finally, in addition
to the three cancer drugs, we have two drugs with novel mechanisms for treating chronic
inflammatory or immune conditions. The applications include rheumatoid arthritis,
psoriasis, allergy, asthma, and transplant rejection.”
CEOCFO:
Synta is about quality of science, speed of execution and passion for improving the lives
of patients; will you tell us about the speed of execution?
Dr. Bahcall: “What we mean by speed of
execution is the ability to set, meet and exceed ambitious milestones month after month,
quarter after quarter and year after year. This commitment is absolutely key to
demonstrating to our shareholders, partners, physicians and patients that Synta can
deliver. If we want to succeed in our mission to extend and enhance the lives of patients;
if we want to create a world-class center of scientific and operational excellence; if we
want to maintain the level of urgency and creativity at which we operate today – we
have to be focused not only on the quality of our science and our work, but also on the
speed of our execution. There are too many companies that have great ideas but are unable
to bring them to the market in a timely and effective way. Those companies will fail to
deliver benefit to patients, they will fail to create the excellence that attracts the
best people, they will fail to maintain the sense of urgency needed for innovation and for
competitive advantage, and ultimately they will fail to attract the resources needed to
continue to generate new products. And then they will disappear.
We have to continue to deliver, with urgency and with
speed, in order to survive and to succeed in our mission to extend and enhance the lives
of patients around the world. That’s what we mean by speed of execution.”
CEOCFO:
What is the financial picture of the company?
Dr. Bahcall: “We have a strong
financial position. We began the year with over $90 million in cash. We have retained full
rights and ownership to all five of our programs. That gives us many options. We can
choose to continue to develop those programs on our own, or we can partner some of those
programs with larger pharmaceutical companies, which will bring in capital and reduce our
expenses. I believe that for our company, at our size and stage, continuing to develop all
five programs, in all therapeutic areas, in all geographies around the world, entirely on
our own, is not feasible, and is not the best model for our shareholders. We have
therefore entered into discussions with several pharmaceutical companies on possible
collaborations, and have been pleased with the progress of those discussions. The
partnership terms we are discussing are of the magnitude to add significantly to our
financial position.”
CEOCFO:
You recently added to your management team; do you still need to add?
Dr. Bahcall: “We are in growth mode,
and looking for extremely talented people. Right now the groups that are growing the
fastest include our clinical and commercial areas, and I expect we will continue to add in
those areas.”
CEOCFO:
Aside from all the additional paperwork, what has changed since you have become a public
company and why is this the time to do that?
Dr. Bahcall: “One nice change is that
people have stopped asking me the question I got most often in the past two years –
when we are going public. Other than that, not all that much has changed operationally for
us. We have been operating like a public company for the last two or three years, in terms
of internal processes and reporting. We are continuing the research, development, and
business plans that were in place before we went public. We are continuing our
regular review of those plans and of our strategy and budgets. In that sense, the public
offering was just another financing event.
One important benefit, however, has been the
increased visibility and credibility of being a public company. That helps both with
advancing our programs and in recruiting talented people to the company. And, of course, I
am pleased that we can offer liquidity to the investors who have supported us and the
employees who have worked so hard to get us to where we are today.”
CEOCFO:
Why should potential investors be looking at Synta and how do you stand out from the
pack?”
Dr. Bahcall: “Drug discovery and
development is very difficult, with a high failure rate. There are very few companies in
our industry, at our size, that have a drug that works – and a drug that works is
very valuable. We have a drug that has been shown to be effective, in rigorous clinical
testing, in an area of major unmet medical need. That is the first reason I think we stand
out. Second, our drug is novel, not a me-too or copycat drug, and has tremendous
potential to define an entirely new category of treatment. This represents a very large
and attractive market opportunity, which distinguishes Synta from companies working on
more niche opportunities, or pursuing a me-too strategy. Third, many biotechnology
companies today have in-licensed or acquired their drugs from third parties, for example,
programs that previously failed in large pharmaceutical firms. Synta, on the other hand,
has developed all of its own drug candidates, based on our proprietary technology
platform. That has led to the deep pipeline that we have today, and an engine that will
continue to generate innovative products. The ability to continue to create new products
internally presents a more sustainable, long-term model than continually seeking to
acquire drugs from third parties. Fourth, and finally, we have a strong track record of
effective execution. The ability to execute effectively is critical to being able to
capture the value of our drug candidates for our shareholders.
CEOCFO:
Final thoughts for our readers?
Dr. Bahcall: “When you combine passion
for a great cause, incredibly talented people, and strong underlying technology – in
a culture of discipline, focus, and unrelenting high standards – it is amazing what
you can achieve.”
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