conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 4,
Mr. Sitchon, what is the overall vision at S1?
Our vision for S1 was to have a leaner, faster-moving biopharmaceutical
company focused on one therapeutic area without the constraints of big
pharma. In addition, we wanted to target a therapeutic area that affects a
large population and one with no FDA-approved solution.
CEOCFO: What did you decide to target,
and will you tell us about that arena in general?
We decided to target women’s sexual dysfunction. That is, women’s libido.
The indication is Hypoactive Sexual Desire Disorder (HSDD), which is an
indication affecting more than 26 million women. I have seen personally the
very real distress it can cause in patients with the disorder and we feel
that it has been overlooked by the medical and biopharma community for
various reasons. We also wanted to go after it because there is a high
investment upside and the timing is right.
CEOCFO: What have you developed to help
take care of this problem?
Mr. Sitchon: Our lead product is called
Lorexys. For a drug as safe as it is, it had surprisingly and
disproportionately high efficacy relevant to HSDD in the small studies we
have done, and we think that implies a synergistic effect between its
components. It comes in an oral dose form. It had rapid speed of onset,
which means that when you take it you do not need to wait three or four
weeks before it kicks in. We expect that you can simply take it and four
hours later you will know it is working. It is also, by design, very safe.
It is a combination of two drugs that have already been approved for other
indications in the past. Therefore, there is a large positive safety
database, which will support our submission for a 505(b)(2) regulatory
pathway. It is also centrally acting, so its molecular targets are in the
central nervous system and it is non-hormonal.
CEOCFO: How does Lorexys work?
Right now, the understanding of HSDD, as far as central control, involves a
balance of neurotransmitters. What we understand of Lorexys and its
mechanism of action is that it puts back into harmony the imbalanced
neurotransmitters in the brain in those who are affected by the disorder.
CEOCFO: How does it do that?
The mechanisms of action act by reuptake inhibition of the neurotransmitters
norepinephrine and dopamine; and through specific serotonin receptor
targets. Putting those neurotransmitters back into balance is the key to
restoring central control of libido
CEOCFO: Where are you in the development
We have filed our Investigational New Drug application, IND, with the FDA
and we are currently in that review period. Our plans are to initiate our
Phase I clinical protocols this summer.
CEOCFO: How does S1 work differently
from big pharma and what are the advantages of being a small company
addressing one specific target?
This is a relatively controversial topic in our industry at the moment with
strong opinions on both sides. Do you invest more in large pharma R&D or do
you decrease big pharma R&D budgets and promote the proliferation of a
larger number of smaller biopharmas allowing them to take on the higher
risk, effectively diversifying the approach to innovation like an overall
biopharma industry innovation portfolio? Clearly we are in the latter camp.
We believe that the way to foster innovation and get biopharma back into
doing its duty for society in a much more efficient way is to allow the
proliferation of focused smaller biopharmaceutical companies. These are
companies that do not have the slow moving, scripted decision-making
characteristics of large companies, and who can afford to make higher
risk-reward choices without the interference of a far-removed executive body
that might over emphasize canned metrics for go, no-go decisions. To quote
Bernard Munos formerly of Eli Lilly, “You cannot script innovation”….”You
cannot boil it down to a code of best-practices…” Having more companies like
us frees up biopharma-at-large to innovate. In that greater context, we at
S1 Pharma believe that if the goal is to develop medicines that work, it is
best to focus on one therapeutic area, become intimately familiar with the
science behind that therapeutic area, and align the whole business to that
end. As an example, we can select our individual scientific advisory board
members and clinical advisors for a more personal and invested team dynamic.
We can select our business board members to be in line. Everything can be in
alignment from science to clinic to commercialization. We can make choices,
such as executing a riskier clinical protocol that would benefit a subgroup
patient population in need, that might not otherwise make it past all of the
hurdles in a larger company.
CEOCFO: What is the competitive
landscape; are many companies looking for remedies in the HSDD arena?
As far as we know, there have been a handful of attempts, but there are only
two clinical development programs that are going after HSDD right now. We
actually do not believe that we are direct competitors with them, because we
are the only current developer of a therapy for HSDD with CNS molecular
targets. In fact, we are positioned as an adjunct therapy to any hormonal
therapies that might make it to market.
CEOCFO: S1 Pharmaceuticals made some
recent additions to its advisory board; is it complete now and how does that
round up the picture for you?
We are thrilled about our scientific advisory board. There seems to be an
increased awareness of us; in recent months we have had prominent thought
leaders approach us to join our board. It is a very exciting thing. From the
beginning we have had Dr. Robert Taylor Segraves, who is a well known and
well respected key opinion leader, thought leader, in the field. We have
added Dr. Molly Katz, another prominent thought leader, and there will be a
press release soon with a number of additions whom we are very excited
about. Then that should do it for our Phase I plan, and perhaps as we move
into Phase II and start going after our EMA development plans, we may add
some more to represent the larger international academic community.
CEOCFO: Are you funded to move forward?
So far, we have been privately funded. We are currently seeking our first
institutional round, that is, our Series A to support our $6.5 million
clinical development program that we have for Phase I.
CEOCFO: Why should investors pay
attention to S1 Pharmaceuticals today?
Aside from the strength of our pipeline and team, we think the timing is
right. There has been a lot of work done in the medical community since the
late 1990’s, which has led to a greater recognition of the prevalence of FSD
and HSDD, and need for a treatment of the disorder. In that time there has
been a handful of development programs and with each attempt, an increased
awareness with FDA, clinicians, and the patient community. We think that
those groups believe that a solution will eventually come and we believe
they are waiting. In our interactions with the FDA so far, indications are
that they would be ready to approve a first-time medical and much needed
solution for the disorder.
CEOCFO: How does working with two known
drugs make it a much easier process?
The 505(b)(2) regulatory path typically carries less risk since there is
usually a large positive safety database out there from prior studies. This
can also help in terms of cost. The 505(b)(2) regulatory path is one of the
main pillars of our value proposition.
CEOCFO: Would you tell us more about the
value proposition that S1 presents?
We have a lead product that addresses an unmet medical need with poor
therapeutic options. There is a potential $2.5 billion global HSDD market.
Our lead product Lorexys has excellent scarcity value: it serves a
blockbuster market, has no baggage, three years to market, manageable
development cost and risk, and a strong IP position. We also have a proven,
what we call, a “60/300” clinical study design and methodology that allows
for unprecedented cost and robustness in a clinical trial for a drug of
Lorexys profile. In addition, we plan to run studies that benefit 3.5
million women with breast cancer-linked HSDD. Lorexys will also help 3
million post menopausal women with HSDD in the United States, and millions
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