CC 8/7 part 2
William Koster, Neurogen Corporation - President, CEO [6]
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Thank you, Jim. Earlier, I mentioned that we continue to make progress on our
discovery programs. What I would like to do is add a few comments of note to
that. In the VR-1 program, we found and continue to find new lead matter with
very high potency and desirable drug-like characteristics. NGD 8695 is the first
of what we expect to be multiple pre-clinical candidates. Multiple candidates
are desirable, since there are many potential therapeutic applications for VR-1
antagonists, in diverse areas, ranging from bone cancer, osteoarthritis, and
neuropathic pain to urinary incontinence, and asthma. Our program illustrates
our strategic move to reduce risk, by creating clinical candidates with multiple
utilities. And in this program, Neurogen owns all commercial rights. On our CRF
program -- this is a depression/anxiety program, targeting discovery of CRF-1
Receptor Antagonists. CRF is the corticotrophin releasing factor, which is a key
hormone, regulating physiological response to stress. And it's elevated in
patients with major depression. We're partnered with Aventis on this one.
Together, we have one of the largest efforts in the industry. And our R&D
organizations are working closely together on the late stages of candidate
optimization.
The CRF 1 program is a high priority for both Aventis and for us. On the MCH
program, here we're targeting indications for obesity and diabetes. The goal is
to block, specifically, the MCH-1 receptor with an antagonist. MCH is the
melonin-concentrate hormone. And it is an important central mediator of food
intake. At this point, we're in the lead-candidate optimization stage. We have
potent compounds, with good efficacy, demonstrated in multiple animal models.
And we're now refining the drug-like properties of these agents. Again, Neurogen
owns commercial rights there. So with that, we've covered our financials, as
well as the more advanced portions of our R&D pipeline. And at this time, I'll
turn the mic back to our conference coordinator to open the floor for questions.
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Questions and Answers
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Operator [1]
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Lines are now open for Q&A. If you'd like to register for a question (CALLER
INSTRUCTIONS). Greg Wade, Pacific Growth Equity. (ph)
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Greg Wade, Pacific Growth Equity - Analyst [2]
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Good morning. Congratulations on some good progress in the quarter. I was
wondering if you might be able to tell us when you expect 8695 could possibly
get into Phase I studies?
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Company Representative, Neurogen Corporation - Speaker [3]
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One of the things, Greg, is that we are in pre-clinical development here. And
we try not to give guidance around that. Clearly, we're in the process of
scaling up and (indiscernible) frequent (indiscernible) toxicology and doing
formulation work. And it is difficult to put a time-line around that. I hesitate
to give you a number at this point.
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Greg Wade, Pacific Growth Equity - Analyst [4]
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Would you expect it would take -- do things usually take about a year?
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Company Representative, Neurogen Corporation - Speaker [5]
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That's usually the time-line. I think that the best guidance I can give you.
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Greg Wade, Pacific Growth Equity - Analyst [6]
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Okay. Thanks, I appreciate that. On 96-3 and Pfizer's continuing safety
evaluation, what type of studies do those entail. And, in general terms -- with
respect to industry practices, how long could this go on, in Phase I, there?
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James Cassella, Neurogen Corporation - SVP of Clinical Research & Development
[7]
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Hi Greg, this is Jim. In the insomnia program, it's very important, with the
competition out there, to have a safe compound. And it is hard to predict how
long those things will take. Pfizer is doing a thorough safety assessment. And I
don't think we can really be in position to put a time-line on that. It's their
program. It's their study. So, we're probably not in the best position to
comment at this time.
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Greg Wade, Pacific Growth Equity - Analyst [8]
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Okay. So what they've done in pharmacokinetics -- I'm just curious as to sort
of what the nature of the ongoing safety studies are? I'm just not to familiar
with what they would be doing?
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James Cassella, Neurogen Corporation - SVP of Clinical Research & Development
[9]
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In Phase I, it's very important to thoroughly understand the safety
pharmacokinetics of the compound. In this case, Pfizer has actually done some
work on the proof of concept. So, in that regard, they're just doing a thorough
evaluation of the safety, before they move on.
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Greg Wade, Pacific Growth Equity - Analyst [10]
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Lastly, on the VR-1 program. You described that you're working on a variety of
different molecules for potentially different indications. Can you help me to
better understand why different molecules structures would be better for various
indications in targeting this receptor?
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Company Representative, Neurogen Corporation - Speaker [11]
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I think when you look at the different patient populations that could benefit
from a VR-1 receptor antagonist, you're talking about totally different disease
states. Even within the pain arena, you to be looking at a cancer population or
for bone pain. On the other end of the spectrum, you could be looking at a very
wide spectrum of patients for treatment of osteoarthritis pain. I think falling
into those two populations, you would want to look at two different drugs,
mainly because you've got different risks associated with those populations. So,
I think it's -- from a risk perspective, it's a good thing. From a point of view
of cutting across different therapeutic indications -- for example, urinary
incontinence and asthma -- you may want a different distribution, in terms of
the pharmacokinetics profile. So, there are a whole bunch of reasons for looking
at multiple compounds in this area.
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Greg Wade, Pacific Growth Equity - Analyst [12]
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Great. Thanks very much.
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Operator [13]
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(CALLER INSTRUCTIONS) It appears we have no further questions at this time.
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William Koster, Neurogen Corporation - President, CEO [14]
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Okay. I want to thank everybody for joining us this morning. And we continue to
look forward to keep you updated on the progress of our programs in the clinic,
as well our pre-clinical development pipeline. So once again, thanks. And we'll
be talking to you again. |
