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PARTICIPANT:

yes yes that's fine

INTERVIEWER:
Thank you So, we will use the information from this interview for research and reports published
by Clarivate and our affiliated companies. We will list you and your professional affiliations in
our research. But we will not use your name. We may publish quotes from this interview in our
research, but we will not attribute any quotes to you. Is it okay with you?

PARTICIPANT:
Yeah. its okay

INTERVIEWER: Okay, thank you. Also, before we begin, I must ask you to confirm a few
items. Could you please confirm that your participation is not prohibited or restricted by any
employment professional or legal obligations, and that you have obtained any necessary
approvals from your Institute to participate?

PARTICIPANT:
yeah I have

INTERVIEWER:
Just yet. In addition, it is not an intent to elicit any confidential information, please confirm that
you will not provide us with any confidential or proprietary information that belongs to your
employer or any other third party or relates to clinical trials.

PARTICIPANT: Yeah, okay, good.


INTERVIEWER: Finally, Clarivate is a global business and your data may be transferred to
countries with different privacy and data protection laws than your own, including to countries
such as United States. We will handle your personal information with getting as required by
our privacy policy, which is available at www.clarivate.com. Please confirm that this is okay.

PARTICIPANT: Yeah, that's okay.

INTERVIEWER:
So professor now I'll start with the interview. And I have a couple of questions around
epidemiology. Could you please help me understand what is the treatment percentage for
osteoporosis in Germany?

PARTICIPANT: I would say it's about.., depends if you're looking at men or women, but in
average, it's about 30% to 40%.
INTERVIEWER: Okay, and what do you think are the barriers that hinder the treatment of
patients?
PARTICIPANT: Ah this is… There are several factors affecting that. One barrier is that the
access to doctors who treat osteoporosis is difficult because we have very long waiting time for
some specialists. So you get sometimes an appointment in the six-month period. So a lot of
patients are frustrated and they don't seek treatment. Second barrier is that not all doctors who
treat orthopedic patients are familiar with diagnosis and therapy of osteoporosis, because even
for the orthopedic surgeon, this is now a couple of years included into the training program.
Really mental means that they just need some basic information which they have to know for
their exam to become an orthopedic surgeon, but then in the field when they are outside in the
practice they don't really care about this area. Even those who treat osteoporosis have very time-
consuming patients, because all the setting is not made for orthopedic surgeons. With the patients
in the five to seven minutes’ procedure you cannot handle difficult osteoporosis patients in that
short time. And the fourth aspect is that general practitioners now just start with the treatment of
… osteoporosis and these governmental programs increase that their way. So, this is the main
aspect and one major aspect is also that financial reimbursement for treatment of these patients is
very low compared to the amount of time which is necessary to spend with these patients as there
are rather difficult work which has to be done. This is the, I think the main aspect, if the
reimbursement would be better, then a lot of practices could change the focus and keep lots of
these patients. But now there is very difficult aspects for practices to take care of the situation.
INTERVIEWER: Okay, and moving from the treatment, what would you say is the percentage
of the patients that are drug treated? And do you feel that this percentage is likely to change? Be
it showing an increase or decrease in the coming 10 years?
PARTICIPANT: untreated, you mean, or no treatment
INTERVIEWER: No. The ones that are treated with the drug
Participant: with the drum?
Interviewer: Drug. As in they are given.
Participant: Ah with the drug, oh!
Interviewer: Yeah yeah
PARTICIPANT:
Yeah. Yeah. I think like at the moment we are on a way the government and the medical system
is building up so called the disease management program. We have this for certain diagnosis
like cardiovascular disease, diabetes, and so on. And then doctors have A special slot for
treatment
or get special reimbursement. So they can put the focus on the disease. And there is a program
for osteoporosis on its way. And it's based, mainly in the general practitioner area. And this is, of
course, has a big impact as we have a lot of nurse practitioner. But on the other hand, the general
practitioner has never treated osteoporosis so far. So it's a completely new field for them. And
that means there is a lot of knowledge to be gained within the next time. But if you look at the 10
years, my opinion is definitely that the treatment will increase.
INTERVIEWER: Right okay,
Participant: You too. Thank you
Interviewer: I understand. So, moving towards the therapies, what is your opinion on the
bisphosphonates? And how are they performing? And what do you think are the advantages and
disadvantages that are associated with these bisphosphonates

PARTICIPANT: Oh bisphosphonates include the basis of treatments, they are cheap, there's no
difficulty in prescription. This is making them available for a broad variety of patients. And most
of the patients have little or no side effects. So they are a little bit complicated in the usage, so
the patient has to be aware of certain aspects like taking them in upright position, drinking,
enough, not eating after dosage. But these are things which currently happen only once a week,
or once a month and patients after they are … and the majority of patients who get treated with
these bisphosphonates. And these bisphosphonates …
INTERVIEWER: Okay. And, Professor, how do you think is the compliance
Participant: I don ‘think it is
Interviewer: Okay, what how do you think is the compliance when we talk strictly about oral
bisphosphonates?
PARTICIPANT: blank as with all of the oral medications, all in all other candidates get not so
good if you do not have good follow up. I would say that we can increase the whole situation the
compliance with better performed follow up with explanations to the patients and so check If
they do it. if they see that we put the focus on it, they’ll start doing it and we can measure the
compliance by measuring several blood levels of values to see if it adds weight on
bisphosphonates. That makes it better and but we need to do a follow up otherwise it is an easy
work.
INTERVIEWER: Okay. And between all the oral bisphosphonates that we have, is there a
particular therapy that you prefer to prescribe to your patients? And why is that?
PARTICIPANT: I prefer risedronate but I also give alendronate but risedronate has a slightly
better rejection to kind of tolerance in most patients. So this is my primary focus if I give an oral
bisphosphonates and I do not change an existing therapy if it is prescribed.
INTERVIEWER: Okay, and what are your thoughts on the IV bisphosphonates ? And how do
you think that that people forms? And does it have any advantages over all the other
bisphosphonates that are being given for osteoporosis
PARTICIPANT: Well, I view Risedronate has strong advances, as it can be given only one year,
and I see that medication in the patient. So, the compliance as long as the patient appears in the
practice is 100%.
Interviewer: Oh
Participant: Of course, we have patients who do not come for the follow up medication, but the
other hand, I view the alendronate, as a much longer persistence drug even If you do not apply it
after 12 months, as recommended by the manufacturer, so you give it every two years still has a
very good or sometimes even better performance, but is not covered by medical studies. That's
an experience. So, I am very open to treatment with IV bisphosphonates like zoledronic as long
as the patient has no kidney problems and is not taking diuretics or non-thyroidal and rheumatic
drugs, as we have the risk for [inaudible] from all other patients, except for the situation that I
need to explain for IV applications, and they need the line infusion to prevent kidney problems.
It's a very nice treatment, but it's not a nice reason for patients who are completely on therapy,
not new, concerning osteoporosis with this patient had never had these bisphosphonates before
about 1/3 to developing strong immune reactions, like it is with Astra Zeneca immunization
having heavily influenced like symptoms for up to three days, which makes it very difficult for
patients to get back for the second dose.
INTERVIEWER: Right. So, moving from the bisphosphonates maybe talking a little bit about
prolia. What How do you think the therapy has been performing and where does it fit in your
treatment practice as in which patients are suitable for this therapy and what do you think are the
advantages and disadvantages of prolia?
PARTICIPANT: With prolia?
INTERVIEWER: Yes.
PARTICIPANT: With the [inaudible] map you mean?
INTERVIEWER: Yes, yes, that's correct.
PARTICIPANT: Yes. Well. This is treatment for patients who have problems with
bisphosphonates at all, like those with oral bisphosphonates and cannot get an IV bisphosphonate
due to kidney function. So, with all patients who have deteriorated kidney function in their
medical history, we don't have really somebody who can get any treatment except the map of
ploria which is with patients with low numeral filtration rates of below 40 I would say or 35 for
the bisphosphonate. So, these patients biggest group who need the nasal map for osteoporosis
treatment and all other treatments in borderline setting and we need very narrow monitoring to
see that they are in the critical kidney function stages to go on with the treatment. So I would not
recommend any other grants for patients if in further stage, 3D kidney function gets another
treatment then in map on the secondary to osteoporosis, but the main focus to get the treatment
or the other second is to cannot follow this oral bisphosphonates because of the problem and you
do not want to risk therapies with IV because of the flu like symptoms, then the next step would
be then you need a stronger treatment, in women you still have other options like hormone
replacement therapy which you can use Yeah.
INTERVIEWER: So, do you feel that the patient share for denusomap will increase in the
coming 10 years

PARTICIPANT:
well I think that the amount of treatment will increase, but maybe not the percentage as we might
get access to a bigger group of grocery stations due to the changes in the political medical
political system in Germany, because of the disease management program, the moment where
you have access to more patients, which maybe you will not find more you will find more
because you have access to less in in severe cases because it's to the UK they will get treatment
because they are already now here and the doctor knows who I am to do something but the
moment where you start screaming your face the GP starts screening for osteoporosis he will
find a lot of moderate or mild okay do something and then the number of treatment with
bisphosphonates will rise up increase the percentage of treatment, but the absolute amount will
increase because we will maybe hopefully get face to face only 30 to 40% of osteoporosis
patients come to a stage where we treat maybe 60 70 or 80% but then in this setting, the majority
of cases will be not be severe not in the services the point the other point is that maybe
awareness of kidney function will also increase. So, I but I think this is not the majority of cases
the absolute amount will increase, but the relative amount will be higher for the company.

INTERVIEWER:
Okay, okay. Understand. Now moving towards the anabolic therapy, what I our thoughts on
Teriparatide and how do you think the therapy is doing and also how do you feel the prescription
pattern has changed with biosimilar in the market?

PARTICIPANT:
terrified by a very special focus, very clear case of osteoporosis will increase. So that more
patients will not stay on a long term or long term treatment without having an anabolic is in
between. So my opinion is that we will with the gaming market of people in Germany also get
more patients who will get the reaction of Teriparatide tariffs are very effective in patients with
severe osteoporosis for therapy in the UK like mild moderate to severe cases and doctors will be
more alert but there's also an option for the severe cases as we will see the shift from the
specialist to the general practitioners for the mild, moderate and severe cases will be the focus of
the specialist. And then in the specialist area, the amount of therapy will decrease.

INTERVIEWER:
Okay, I understand. And then moving towards the second anabolic therapy that has just recently
launched, how do you think abenity has been performing and how has been your experience and
the patient's experience so far with the therapy

PARTICIPANT:
quite long into the pandemic makes it a little bit difficult, because we do not have real meeting,
impact ravages if activity and tolerance, things like this side effects. So this will be a topic for the
next meeting, after the pandemic, or maybe under circumstances. So far the information we can
write is very small percentage of patients is beautiful. And it will also have better developments
in numbers of patients, maybe one or two years, and patients then will also access the medical
system again, because now a lot of patients save on their therapies, whatever happened, because
of the risk of being infected. waiting area hospitals are specialty, specialty ambulances. So this is
something we'll see. We'll see maybe in one or two years.

INTERVIEWER:
Okay. And because you said that there might we might see an increase in patients. I'm just
curious that maybe in the coming 10 years, how would you see abenity growing with the
percentage of new patients be higher compared to the patients who might shift from Teriparatide
to abenity? Or do you feel that the shift from Teriparatide to infinity will not be that significant?

PARTICIPANT:
When I think there will be definitely some event, foundry prioritizes events and applications.
And, of course, now the pharmacy company or to pharmacy companies standing behind and
making advertisements and meetings and so on. The awareness system will also be very helpful
for this medication. On the other hand, Teriparatide is not anymore under protective. So there are
no companies who will be the one standing on the other side and making also advertisement for
it. So the market is the playground is open for one company and then they can now focus on the
other hand financial restrictions. The other aspect, which makes it a little bit more difficult to use
this treatment as we have very highly priced therapy here. But I think, of course, abenity will
take the path of Teriparatide and yeah, the normal developer.

INTERVIEWER:
Okay. And how do you think so? Because we see that now you also mentioned that now we have
to anabolic therapies. So Teriparatide, patients might be shifting to abenity, hopefully in future,
but then so then also map will lose its patent in 2022 or 2025, depending on whichever region we
want to talk about. But do you feel that once we have generic denusomap, how do you think that
the market will shape or how do you think that will affect the prescription patterns? Is there any
impact that you expect to see on anabolic after we have the biosimilar of abenity?

PARTICIPANT:
don't think that the market for the anabolic treatment decreased today. It will be rather shift from
the borderline cases from the bisphosphonates follow up treatment. As you treat more patients
you have more patient and long term treatment. And that makes visitors and new changes you
can create spaces for 10 to 20 years only with bisphosphonate. So there will be definitely a
growing market for denosumab, especially in the fear of the aspects of patient restrictions, which
go away and then the price will go down. At the moment, the main aspect of not prescribing
denosumab for the majority of patients is just that it's too expensive. One decrease price on many
higher than the bisphosphonate. Then, we should have prescriptions before the end of the year
shooting. They don't have the monthly specialist meetings, we do have four times a year, we do
not have complications. The iframe. So I think the health insurance companies will also see the
benefits of the therapy which is applied and has a good compliance with supplies is much lower.

INTERVIEWER:
And you mentioned about selective estrogen receptor modulators. So how do you think that the
patient share will change for some in the coming years? And do we see the patient share
increasing? Or do we see a fall in the prescription patterns for this kind of drug class?

PARTICIPANT:
When it's a very special group of patients who get them you have only women diagnosed with
moderate or mild osteoporosis setting. I think that the market will be stable for them. I do not
expect big increases. Maybe? I don't think so, to be honest. Because special and you have some
restrictions where you think okay, we have to see where it goes. Yeah.
INTERVIEWER:
Okay. And what are your thoughts on the hormone replacement therapy? How do you see a shift
there or do you anticipate any shift in the coming 10 years?

PARTICIPANT:
sorry what was the last one

INTERVIEWER:
So, do you see there is any shift that might happen in the hormone replacement therapies will
there be an increase in the use or decrease in uptake for such therapies?

PARTICIPANT:
Whether we had a very restrictive situation in the last 10 years or 20 years where we said who
hormone replacement therapy now the endocrinologist and endocrine gynecologist claim that
there is a new situation and that hormone replacement therapy has its advantages. And it is not
yet finally decided where the whole system goes. I think there's still quite a big advantage for
hormone replacement therapy is in a setting where the gynecology, breast cancer and so on
maybe with therapies who are more focused and do not innovate and so on, I think the hormone
replacement therapies will definitely have some advantages are the same as modern markets.

INTERVIEWER:
Now few questions on the emerging therapies. So radius health, the manufacturer for abala
bipartite subcutaneous formulation, they released a press release very recently where they stated
that they are planning to refile abala bipartite subcutaneous formulation in Europe and the
tentative time that they have provided is maybe around fourth quarter this year. So what are your
thoughts and do you feel That physicians would be keen and willing to prescribe abala paratide
subcutaneous formulations and do you feel that there might be any challenges that the therapy
will face if approved in Europe?

PARTICIPANT:
I think it is a discussion we have already. So, nothing what we do not expect. We noticed from
conferences and we know that they are way which will be much easier application there are a lot
of companies working on different applications and are working on daily basis, this problem is
not reading the cooling of the medication and things like this Like this module, but formulate and
developed anabolic statements will definitely find place in treatment of our people. But, of
course, these statements will be available for the market. The market will be shared between the
abenity abala paratide in the one group where they challenge each other.

INTERVIEWER:
Right okay and because we're talking about formulation, so the same company is also developing
the transdermal patch of abala paratide . And how do you see the future changing for that? And
do you feel that with availability of Teriparatide sorry, with availability of the transdermal for
abala paratide, we might see a significant uptake in the anabolic therapies, what do according to
you would be the change in treatment paradigm?

PARTICIPANT:
I think it will be definitely an advantage. In the patient groups, we have already transdermal
applications of hormone applications of pain therapies, the application is already something
which patients access with patient’s life. And I'm pretty sure that this will be definitely much
more convenient than the subcutaneous injection. So, I definitely see an advantage with different
formulations for the anabolic treatment.

INTERVIEWER:
Right, okay. And then there is another company which is entura, which is developing the oral
formulation of Teriparatide, which is Eb 613. So then we're talking about let's see, if everything
gets approved, we're talking about another very convenient route of administration for another
anabolic therapy. So what are your thoughts on this and how do you think the uptake will be and
what is the likelihood to prescribe if it gets approved?

PARTICIPANT:
Yeah, the tablet is usually the easiest way form of application for medications. And if the GI
tract is not the problem, it will definitely be of good use. It depends what patient's like but the
opportunity to change between different formulations applications make it much easier.
Otherwise, you only have if you only have one choice to say yeah, you have to get this and
whatever happens, we only have this way of application, then it is always difficult to see if we
can help the patient different types of formulations. The patient's themselves get options of
deciding and being part of the decision, it makes it much better in terms of compliance, this will
be a big advantage. Then in treatment of osteoporosis on the other hand, we have different
companies showing different types which will be not any more the situation that some doctors
are using are just an invention of one company to make money. There are several players on the
market. Nobody thinks about this anymore. Typically, human situations. We also would see with
vaccinations If he would have 25 properties, using COVID-19 vaccinations, nobody would
discuss everything good thing or not, because it seems to be a normal procedure, but he says only
one company, people always think there's somebody just doing it for their own benefit. And this
makes it typically human way of thinking, but this is something which we really what I really
encourage, if we have different players on the market, the market always has a big win for all of
it.

INTERVIEWER:
Okay? And what would you say are the major unmet needs for osteoporosis, we can maybe talk
about the overall picture where we include the management, the diagnosis and the treatment, but
keeping the whole picture in mind what are the main unmet needs in osteoporosis right now,

PARTICIPANT:
I can only talk for the sake the unmet need is access to medical treatment. And on the other hand,
the barriers for treatment, reimbursement for the treatment must be definitely adjusted to put the
focus on the disease, and we have lots of things which are more focused in osteoporosis. So we
are in all doctors needs to be agreed, and medically and also financially. So this is the biggest
thing. Patients we have enough patients come with their problems, but they have to be diagnosed,
correctly and treated correctly. And this the thing is where a lot of work still has to be done. The
majority of doctors also has good use of the diagnostic procedure and good knowledge of the
therapeutic option to treat patients correctly.

PARTICIPANT:
Okay great So I think Professor with the interest of time I will be closing my questions now. But
before I end, I think this was a fantastic interview. Thank you so much for your insights and
inputs because they were really, really helpful.

PARTICIPANT:
Okay, that's nice. I'm happy that I could have you so where are you based if I may ask?

INTERVIEWER:
am sorry
PARTICIPANT:
where are you based

INTERVIEWER:
Yes, yes. So I am based out in India, in Gurgaon.

PARTICIPANT:
Gurgaon where is this

INTERVIEWER:
This is near Delhi. So Delhi is the capital of India. Yeah, so Gurgaon is very close to Delhi
around one hour away from that.

PARTICIPANT:
I'm quite happy to know because I have friends in Poona, which I visit regularly, but now due to
the fact that pandemic

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