Thank you very much.

My name is Mercy Gawa [ph] from Epka [ph], and we are going to
ask you about the IBD. So the- for the- in case that you raise the adverse event that we
would like to report that. And that material document has been already sent, so I assume
that you've already seen that.
Right.
So is your staff okay?
Yes.
Now, today, the purpose of this interview is- well, we would like to know update about the
approaches of your therapy and the- we would like to get your opinion regarding the
message of the new product and also the data regarding of that new product, and we would
like to make it as a reference. So the data and the material that we are going to show you is
not there for the purpose of the promotion. So I would like to get your candid opinion.
Thank you. Yes, thank you.
So let me check your situation that you are the GI internist and you are working at the
university hospital, and also the 20 years for the clinical experiences, and also for the
information that I've got the- for the 150 for the UC and the Crohn's disease at the 70 cases
per month. Is that correct?
Yes.
And regarding the UC, the moderate and the severe cases about the 30%. And the Crohn's
disease, the moderate, and also the severe cases, 40%. And also, in the case of the UC for
the advanced therapy for the last suggest JAK inhibitor and also the biologics, the 30% for
the UC patients and also the CD, the 60% of them are treated with these advanced therapy.
That's what I've got as your information. And under such circumstances, what is your first
line- preferred first line for the advanced therapy?
Like the JAK therapy- JAK inhibitor, and also the biologics.
What about the UC? What is the most preferred one?
For the past one year, filgotinib was the most frequently used one.
And what was the second one?
Let me see. The filgotinib was also most frequent. So after some other, and then the
filgotinib.
And what is the reason why you select this?
First of all, after launch, it is a quite new ones, so I wanted to try it. And also the- I totally ask
for the patients for their selection, and also their selection most of them are selecting this.
Now, what about the CD cases?
For the CD, ustekinumab is the most frequently one that I used.
What is the reason?
In this case, by consulting with patients. Well, of course, I showed the priority, but the final
decision is made by this patients and that was selected.
So at your university hospital, is it possible to prescribe your preferred the drugs without any
limitation?
That's right, yes.
So in such environment for the treatment of the UC and CD as total, as for the currently
available therapy, the score for 1 to 10, one is not at all satisfied and 10 completely
satisfied, what is the level your satisfaction score?
Seven.
What is the reason?
Regarding the profile of these, the therapy we don't know yet precisely. So we wonder
which one is the most suitable for the particular cases. So under such circumstances, many
of them respond to these, but some of the patients are not responding to any. For instance,
maybe the third line would be in the responsive ones. So if such a case we have to select
the third one, but sometimes that we have to try the other ones. And then finally at the third
drug, it was responsible.
Now for the UC and DC, there is the product X, which is going to be obtained, the indication
for the UC and CD, and we would like to show some information about this product X, and
we prepare some material. And so I would like you to see that material. It is a total of more
than 10 pages. I would like you to see one by one. So if you go through one page, then if
you say that you're finished, then I move the page to the next one. So please refer to this
one please first.
Yes. Then next one. Yes. Next one. Yes. Yes. Yes, please.
And then from this page it is according to UC.
Next one please. Next one. Next one. Next one. Next one. Next, please.
So that's all. Now by looking at this new material, as for the overall impression, can you give
us your impression about this?
Well, for both UC and Crohn's disease, it seems to be the very effective ones according to
the clinical data. So it can be managed at these diseases.
And what about the differentiation compared to the other drug?
Well, in the ustekinumab, the data- comparison data is available.
Well for these data, if the analogy is taken for the manufacturer of the car. So what kind of
car manufacturer is the- it can be the analogy for this drug for the Japanese cars
manufacturers and also the overseas ones?
Well, data was very good, that's why Toyota, since the data was good.
Thank you. Now let me see in detail. So this is the mechanism of action, and there is the
alternative ones. This is X1 and this is X2. These two are available.
So either one.
The another one is also available. So this is the third version. Which one is the best?
The first one is the best for me.
Why do you say so?
Well, regarding the MOA.
What is the impression? Well, what I want to know is that what about the differentiation
compared to the other drugs and also does it leading to the motivation to prescribe of this
drug?
Well, the CD-63, the binding to that CD-64 that is a very strong point. That would be the
selling point, I guess. So compared to the other drug, but for only for the product X, and that
part is well emphasized in the first version.
So in this page, well, if- what is the point that you are looking at the impressive ones
compared to the other drug differentiation? So could you put the green color, but the good
ones, but the no differentiation, and that would be the yellow and the- if it is not so important
and it is not motivating for the prescribing, so that would be colored in a pink or the red. So
the CD-64, that would be the important one. This is it?
Yes. For the X, Y, and Z, these are three drugs at the bottom that would be is visualized
good. And we don't know whether the CD-64 is very good for the binding, but the data that
is coming later seems to be good. So if it is, so then at the very first page, since we
remember the CD, it is binding to the CD-64. That's why at least that these are good ones.
So the three different products that should be in green color.
Do you have anywhere that you would like to put in yellow or red? You don't need to force
yourself to put that.
No.
So do you think it's better to have the Y and Z along with X?
Yes, I think so, because we can compare with Y and Z because now it is saying this is
unique and you want to differentiate. And if you just show the product next, and then if you
show that in the products next in CD-26, 24, the binding space, if you showed in product Y
and Z along with an X, the viewer, the people will be able to see that not only X can have
the CD-64.
I would like to move on to the next page, and then this is about the trial design. So what's
your impression about this?
Oh, well, prescription intention. I don't know what to say. Ustekinumab, comparison against
ustekinumab.
So when I look up this diagram.
Yes, that part.
So then a comparator needs ustekinumab.
I think that's good.
So shall I put green here?
Yes, please.
And subcutaneous?
Well, several patterns, both subcutaneous. Well, it's not unique. Probably other drugs, and
could have the several patterns. But what I like is- then only this product X this has a
comparison against the other drug. So only this part should have the green box.
Thank you. CD two. Let's move on to CD two. So what do you think about this?
It shows a difference against placebo, so I think it's good. However, I think left one and the
week 12 and the right one, one year. Am I right?
Yes.
So I cannot expect an add-on effect. In case of the UC, then we saw some add-on effect,
and then when I saw UC, and I thought the one on the right had the higher outcome. Well,
so out of the patients, and if we showed the clinical response at the time of the 12 week,
and then those who were able to get the endoscopic negative response was shown here.
Oh, so all of them?
This is for old that one year.
OK. Sorry, this was not very clear. Let me check then you see later. So if that is the case,
they were able to maintain an efficacy, if that is the case- those- the patient, if we had an
add-on effect, there was nothing-