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Executives

Jesper Brandgaard – Executive Vice President and Chief Financial Officer

Mads Krogsgaard Thomsen – Executive Vice President and Chief Science Officer

Peter Kristensen – Senior Vice President, Global Development

Peter Kurtzhals – Senior Vice President, Diabetes Research

Alan Moses – CVP & Global Chief Medical Officer

Analysts

Michael Novod – Nordea Markets

Carsten Lønborg Madsen – Carnegie

Sachin Jain – Bank of America Merrill Lynch

Brian Bourdot – Barclays Capital

Sam Fazeli – Bloomberg Industries

Novo Nordisk A/S (NVO) Investor and Analyst Meeting at EASD 2012 Call October 3, 2012 12:00 PM ET

Jesper Brandgaard

All right welcome to EASD, Berlin. Welcome to the Novo Nordisk Investor Conference here in Berlin. We have the entire brain trust of the management here, able to answer any questions you have I think. What I will be, we will be going through will of course making predications about the future and therefore we have included this outlining the limitations of making forward-looking statements and also highlighting the products that we have here, and we are going to talk about insulin Degludec is a product which have not yet been approved for use in diabetes in U.S. and Europe and we have also highlighted that Victoza so far is only approved for treatment of type 2 diabetes. So that has been highlighted and hopefully is clear to everybody.

My name is Jesper Brandgaard, I’m the CFO for Novo Nordisk, been so for the last 12 years. My role here will be basically to give you a short introduction, and then leave the discussion and Q&A session, which we expect to get through in approximately 50 minutes.

The agenda you see here and next on the podium will be Mads, who will basically reviewing the Novo Nordisk diabetes strategy, then Peter Kristensen, our Head of Global Development will review some of the key trials for both Tresiba and Ryzodeg at EASD, and Peter Kurtzhals, our Head of Diabetes Research will basically review with you the results for our next generation GLP-1 semaglutide.

And then finally, our Global Chief Medical Officer, Alan Moses, will give you some clinical insight from using Liraglutide or Victoza in a clinical setting, and that should then lead us to the Q&A in approximately 50 minutes.

First and of course a key focus area is, how is the regulatory process proceeding for both Tresiba and Ryzodeg in the various geographies. And first, the U.S. both products were submitted NDAs to the FDA on 29 of September 2011, and as you also aware there is an FDA review ongoing, and this has scheduled, sensitively scheduled advisory committee meeting for 8 of November and that looks like that will be the case.

In Europe, we submitted a few days before the NDAs on 26 of September, the EMA review is ongoing and proceeding well, and we anticipate that there will be a CHMP hearing within the next few months, and potentially with a positive outcome.

In Japan, we have made even more progress despite only submitting the NDA for Tresiba on the 22 of December, they have already managed to conclude, and we have obtained an approval for Tresiba. Do note that Ryzodeg in Japan was submitted 2.5 months later on the 9 of March and there the regulatory process is proceeding, and its proceeding well. We have in addition also file NDAs for both Tresiba and Ryzodeg in the countries listed on the slides, including core markets like Canada, Brazil.

If you look at what are things going on at the EASD, there has a lot of focus on Tresiba. It is a core product for Novo Nordisk basically enabling us to provide patients with even better phase of insulin and of course that has also led to a significant focus in terms of the aspects we have presented 23 related to Tresiba, one related to Ryzodeg, seven on Victoza and the other sides on the other products you will see on the slide.

And with those comments on EASD, I'll handover to Mads Krogsgaard Thomsen, our Chief Science Officer.

Mads Krogsgaard Thomsen

Thank you, Jesper. It’s a pleasure to see here and to be in Berlin for the event of the EASD. What I will do is actually highlight just you can see at a very high level, the way our company seeing diabetes and the future management of this chronic disorder. A beautiful molecule over here, I think Peter Kurtzhals had send Peter Kristensen, have already told you about that and will hear more in a little while.

Now it all starts with the unmet need and the fact of the matter is that people among the 366 million diabetes suffers all over the world on average not in control. Familiar reasons for that from a pharmaceutical perspective one of the major reasons is obviously that we are really lacking highly efficacious anti-diabetic medications that are devoid or at least have only a minimal hypoglycemic risk.

Also aggravating the problem is that many of the therapists who are actually treating patients with even worsening the problem of overweight would be instant resistance further aggravating the vicious circle of declining pancreatic β-cell function overtime. The fact that medication is the target complementary disease pathways is important, I think it’s obvious from some of the data that we have released headline results from very recently namely when you combined agent such as a internal tropic one like GLP-1 and a insulin that has the action of the insulin, you will get complementary effects on basal glucose control and boost pinto glucose control. And overall even on the side effect profiles you have some complementarity. So there is no doubt that whatever Novo Nordisk can do to deploy its protein design technology platform on whatever target would lend it so to future therapy, that’s our game.

Now if you look at the attitudes among patients and physicians in insulin glargine type 2 diabetes, the GAPP2 study that is being announced you can see overtime because there are continuous findings from important study. I think it goes without seeing that when you look at the respondents and in this case, it’s the patients, but we have the similar data from 1,600 physicians, healthcare providers, in this case it’s 3,500 and if you were the patients with diabetes, where we’re getting their response, questions related to hypoglycemia. And the vast majority of them actually have experienced hypoglycemic events and below the 80% number up there actually is 36% of them, more than a third of them actually have reported a hypoglycemic event in the last month. And on average that actually reported three hypoglycemic episodes in that month.

So in the real life setting hypoglycemia is indeed not a trivial issue and it probably is happening at a much higher rate than in the highly selected populations that we tend to study in our Phase III programs.

Also the notion that people do not comply with the therapy because either of the perceived fear of hypoglycemia or the reality that they actually experience hypoglycemia is evidenced by the fact that half of them actually increased their blood glucose monitoring and that decreases the quality of life, and increases cost of glucose drips and so on, but more importantly or as importantly many tend to reduce the dose of basal insulin following high dose to avoid a U1 from occurring or they do not take the insulin as prescribed to avoid of nocturnal hypoglycemia. This split between diagonal and nocturnal high boost are approximately 3 to 1, and this really that more or less equivalates what we also see in clinical trials, where there it’s 3 or 4, to one relationship between diagonal and then nocturnal episodes.

So overall this is a vastly overlooked problem and as the patient population all over the world, hopefully will get into better control, with better remedies as time goes by, of course all other things being equal, you’ll start seeing more hypoglycemia as the patient gets closer to the normal glycemic range.

Now, just a quick overview before some of the doctors on the panel here will go through details on the BEGIN and BOOST programs. It is so that the overall insulin Degludec and Degludec + program for Phase 3a and the NDA approval so to speak has been very all encompassing. We've looked very significantly in the important insulin-naïve type 2 diabetes population, with the major comparator being insulin glargine and the way the studies have been designed as Peter will allude to in a minute has been very much consistent from trial-to-trial, enabling also these pre-specified meta analysis of hypoglycemia, that further corroborate and make robust the findings from the individual trial.

We’re also for a health economic and other purposes of course have compared other teams who had eased that up similar price on a per day basis such as a DPP-4 Inhibitor Sitagliptin, and obviously, we were and also embarking on even a three-times weekly regimen, where you will recall from yesterday’s presentation by presents the speech from the Netherlands, that in as much as there was good control on day one and two, you could actually see that on day three from Friday to the ensuing Monday, there was after all a deterioration that made us just not make it on the non-inferiority criteria and for which reason, we will not submit a new drug application on the three times weekly regimen. It did however significantly highlight the ultra-long-acting profile of insulin Degludec.

We will not talk so much today about the Degludec + program, but obviously there we gone up against the usual suspects being glargine, being NovoMix and being Levemir, in each case with some very exciting results.

Now the take home message from the overall BEGIN and BOOST program is that as shown by Peter Kristensen has on numerous occasions, we stand with a basal insulin that has a clearly flatter, much less variable, approximately effect full, less variable profile with a doping in half life from 12 to 24, 24 hours compared to a insulin glargine.

Efficacy wise, we have achieved in all the once daily studies, the non-inferiority criterion in the target regimen that the agent is asking us to do. That’s actually a (inaudible), it’s a prerequisite for going for approval, that you had non-inferiority, and actually not superiority, because then you can compare apples and apples in terms of side effects hypoglycemia, et cetera. But we saw that in the phase of improve fast in glucose control, because of the ultra long-action of the insulin Degludec.

Safety wise, the meta analysis confirmed the notion that there is a lower rate of overall hypoglycemia that is especially evident in the nocturnal state during night time, between midnight and 6 a.m. in the morning.

Convenience wise, we have documented that there’s a high degree of dosing flexibility than alternate the doses from eight hours to 40 hours without any untoward risk confirmed upon the patient. That enables administration at least if you need so, at any point in time of the day on any day of the week. The pen system is the PDS290 FlexTouch auto-injector that has not only the easy touch dosing mechanism, but also because of our high strict formulation the U200, the ability to deliver the same dose in half the volume or alternatively double the dose in the same volume such as in the case of the high volume consumers or high dose consumers that can take up to 160 units in one injection of the insulin Degludec.

My final slide really highlights in an idealized world how Novo Nordisk sees the treatments has guide in the diabetes. We’ve been telling you for the past five years, that we actually only see the need from a physiological perspective, for three different treatment categories that will enable really good therapy for people with diabetes, and here I'm speaking about type 2 diabetes. The first one is metformin, and metformin is a well established agent after that no longer supplies us typically three years into the treatment (inaudible). And feel that an impetus such as GLP-1 agonist is the next natural step to add on the top of the GLP-1 following which of course insulinization becomes needed, but in a way where the GLP-1 should be kept on board in the therapy faced on all its both you can see not hypoglycemic but also weights bearing actions.

Today, Novo Nordisk stands with offerings all the way down cascade from NovoNorm over Victoza and introduce combination of Victoza and insulin and of course we have the modern insulin on stage.

Tomorrow being in the future I believe, we hope and of course this is a forward-looking statement with all the disclaimers associated with that. We hope to be able to offer even therapies for the pre-diabetic and obese state here the 3 milligram Liraglutide program i.e. intervening in the disease process at a much earlier stage and as you are aware, many studies including the UKPDS and DCCT have shown that early intervention is the way to go, if you want to avoid complications.

We also hope to break the greatest barrier that has been for the last 90 years named the injection barrier, through the creation of the highly specific you can say, bio-available analogs of the long-acting GLP-1 and basal insulin, and obviously we would like to compliment the Victoza once daily GLP-1 analog program with a two once weekly human GLP-1 analog with the characteristics that have been presented to you yesterday, very nicely by Professor Michael Nauck from Germany.

Do not put too much into where I have positioned the IDegLira this is just essentially to say that at the point in time where people intensified from GLP-1 to insulin, one way of doing it is the fixed combination with the data that you've recently seen highlighted from the first of big IDegLira trials, obviously this combination can be used later in the disease and it can even be used early in the disease, if patients have high A1cs at entry into the injection regimen, this is something that Novo Nordisk will be working on until we submit the new drug application openly towards the middle of next year.

And then obviously, we see the modern insulins, Levemir and NovoMix and NovoRapid being superseded by the analogs Tresiba, Ryzodeg and the FIAsp NN1218 where we hope to provide some final Phase I data around, you can say the full year of 2012. So we see a very exciting future, a future when Novo Nordisk can continue to fulfill on that needs from a patient and societal perspective and a future where our challenge may will be to launch approximately one new product year-over-year for the next five years or so.

So with that over to Peter Kristensen who will give you some more flavor about the introducing the degludec highlights from this conference. Peter.

Peter Kristensen

Thank you. Thank you, Mads. We have picked two of the FX percentage, so we have 23 presentations of insulin degludec and degludec plus here and of course we can through them here. But we picked two of the important ones, one on Tresiba and one on Ryzodeg. And the first study is the two year extension, it’s the extension of the, call a basal treatment in type 2 diabetes that some of you may have seen [Burnis Innman] present yesterday and what you’re looking at here is of course a very central study with more than 1,000 participants, three to one randomization in order for us to get a sufficient exposure of this, of a lot of patients who were not previously treated with insulin.

This was to see to get a sufficient safety database and as some of you might have been at the [Jason Boras] presentation this afternoon, where we look at antibodies over one year which was of course also to a large part derived from this trial. And as it is a trial with an extension, we are looking at two groups of exposure. First one where we have approximately close to 80% of patients finalizing, the first part of the trial and then patients ask would you like to go into the extension trial of 8% to 10% to go in and of that also then continue 6% to 8% go out, so we include around 60% of the patients.

And if we look at the efficacy of treatment, we could see here on the list, the change in HbA1c over time that this is a treat to target trial. We are treating the patients to a self monitored glucose target for the two insulins. So we should achieve the same HbA1c of note actually even after two years, we only get 40% of the patients to actually achieve the target of below five millimolar. We have heard a lot of discussion about very aggressive targets and all those to stay is that you have to have very aggressive targets just even to get 40% of the patients to get down there. And what you also see here is two different sets of data, which didn’t have the extension trial sets and the fullerenes say so that’s what you are seeing of the patients who are going through the entire trial has no big difference out here, but just to show you that of concept. These are the compliant patients and the other patients who are more willing to go into a trial and so you’ll see that’s a usual thing that you will see.

What you note here on the FPG over time to the right here is a big change here and that’s because we did a washout after 52 weeks because we wanted to assist antibodies, so patients were transferred to NPH while so that we did not have an interference with glargine or insulin degludec in the analysis then they were titrated down. Of course, we don’t have a measurement between these two. So and we had to see the previous problem in outlook like that but we could see that. And what you note is that as in number of our other studies, we see a significant difference in fasting glucose to the advantage of insulin degludec. And people have often asked so why do you see a significant difference in fasting, but you don’t see a significant difference in HbA1c.

And this is actually a finding we had across the whole program and the explanation in my mind but I kind of course approved that with data is because insulin degludec has lower variability. So we simply have an ability to talk go lower that the patients have an ability to go lower and they don’t actually fluctuate as much below that level and above that level. So in the end point, you look at the fasting type of glucose which is what’s measured in the hospital, there you see a difference. So that’s what this is reflecting.

If we look at the hypoglycaemia over time, you can see that we have a difference clearly in between the two treatments. The 16% lower rate in confirmed hypoglycaemia does not become significant but we see the same trend over time. But when we look at nocturnal hypoglycemia, we see in this study a significant finding of pure hypoglycemias with the treatment of insulin degludec. And along the lines that [Burnis Innman] mentioned in his presentation, here we can see that you can actually would need to treat five patients over one year to avoid one nocturnal hypoglycemia. So that in the main study, I think we leave this number was 4 point something, so this effect is maintained over the two year treatment period.

So in conclusion, we believe that this study has shown that this as very nice treatment results we got over the main study, completely maintained in the extension period. We also see that the significant difference we saw in the severe hypoglycemia is maintained, the number needed to treat to avoid one severe hypoglycemia in this entire treatment period is 67 patients. And that’s reflected by I think we saw six patients having seven hypos for insulin degludec and we saw seven patients having eight hypos for glargine, but remember this is 3 to 1 randomization. So we will have a number of severe hypos being approximately the same, it’s clear that we have a difference also on severe hypos. So the doses were approximately similar between the 260 units or 0.63 units per kilogram, and we’re quite happy with this study because it’s a main target for basal initiation that we have shown here and we did not see any safety findings that we’re concerning.

The other study I’d like to go through with you is the study we have done, the only study we have presented was Ryzodeg at this meeting, a study where we have looked at Asian subjects, mainly in Japanese patients where we have a 150, approximately 150 patients in each arm and the patients who was previously treated with OID. And in this study we actually saw a treatment difference in the HbA1c, you can say we are also in particular in Japanese patients working with patients where we have a very carbohydrate rich diet, and what we offer them here is to be able to treat themselves with a combination of a long acting insulin and a fast acting insulin and the patients could take that at the meal they preferred, I’ll come back to where when they took it in a moment. But those of you who are sharp can see that out here is while obvious that they probably took at the evening meal. Because as you can see, we have clearly there’s a question of the post-prandial glucose in at the evening meal.

So if we summarize the results, you can see here the HbA1c, mean HbA1c they can actually achieve the difficult – difference of 0.3% approximately. We have 58% of the patients in IDegAsp. Achieved an HbA1c of less than 7% in contrast to 40% in the Insulin glargine and the number of patients who achieved this HbA1c was 40% – without confirmed hypoglycemia was 43% as opposed to 25% with insulin glargine.

And as we did the study a little later than the other study I mentioned and we have of course received the number of questions and critics from different type audience around, so we did not register when patients took insulin glargine but we left it to the treatment physician to do that for legal. So in this study, we actually did register. And you have these data here to the right. Insulin – degludec insulin, the spot was dosed at the largest meals at the preference of the patients that 80% before evening meal, 15% before morning meal and 4% before launch. Insulin glargine was dosed, 66% at bedtime, 32% before breakfast.

And we looked at subdividing these different groups to see if there was a difference, but the rates did not differ between the different times of the need. So we are quite confident that that there is no reason to believe that the difference we see between insulin degludec and insulin glargine is dependent on when glargine is dosed.

So if we look at hypoglycemia rates, this was a very small study that was around 150 patients per arm, so we could not expect to see a significant difference but we did confirm the difference in confirmed hypoglycemia rates and in the nocturnal hypoglycemia rates. So we saw a lower frequency with insulin degludec compared with IDegAsp compared to insulin glargine.

And I think that’s quite impressive because remember in contrast to most of the studies we have presented to you on the comparison, we did not achieve the same HbA1c here. We actually achieved a lower HbA1c with Ryzodeg but even doing that we still see that the numerical different points to lower frequency of hypoglycemia. So we know from all of our studies that these two things work against each other is the lower you go, the higher the rates go for hypoglycemia. So for us this is a very, very strong signal that we have a very good combination here of an easy to use meal related fast-acting insulin and a basal insulin that last for 24 hours and a product that does not need to be shaken overall, but whatever you do with mixed insulin’s, but what you can immediately (inaudible).

So with that, I will give the way to Peter who will present on new what if you want.

Peter Kurtzhals

So I will continue explaining you about our approach in the area of once we if you wants and this is another product that does need to be shaping the road, not even prepared on the table top. This is a ready for use mutual solution ready to go in a nice pen. Semaglutide and semaglutide is shortfall for a week so that’s where that name comes from if you refer to do product.

As some of you will now, we had kind of an internal competition of who could do best, the formulation, people all the chemist, the formulation people we are trying to do with once we can product of liraglutide and the chemist were trying to do a launch weekly product by molecular engineering and the end of that was communicated on to you mid this year and semaglutide you say that the chemical approach was in the end the most successful approach in our and the basis for coming to that conclusion is also cost to a large extent the data from Phase I and Phase II that I’ll share with you here today and many of you also would have seen in post us all at we conduct presentation yesterday for the Phase 2data.

So semaglutide is molecular engineered on the basis of human GLP-1 so its very similar to the GLP-1 molecule itself like liraglutide modified in a few positions as a major modification in position 26 where we have (inaudible) like liraglutide but we saw the difference and there was some difference on launching of to make this molecule half life as you can see in this slide approximately one week doses from10 to 20 micrograms per kilogram.

And then half life of your portfolio, you can see a nice dose dependence on pharmacokinetics as we see in Phase 1 trials. We can also see that there is something that looks like first of kinetics and the ranging seminal half life there is ranging between 150 and 170 hours a week, its 168 hours and that means that we talk about half side for the computer effect of between 6.5 and 7 days at typically relevant doses.

And another thing that we’re looking for in the Phase I is safety signals and general safety signals were very mild or absent with the same appetite as expected as hoped for. The only side effects really came at 10 micrograms and above, and were related to as we also expected to GI side effects, like we know, as a cost effect for (inaudible) phase compounds.

So overall, this was very successful demonstration from Phase I of very long half life of this molecule. That means if we dose half life, a drop with a half life of one week with a once, one weeks intervals will end up with a various state to state profile, actually even more stable than what we know with regular type of dosing 24 hours, what has a half life of approximately $12. So this one will be even flavor in its action profile than director type.

Of even more interest of course is phase 2 data in which we do explore, I should really explore a full dosage large profile. So that means we need to start low, and we need to go as high as possible to make sure that we cover the whole area of concentrations and has the best possible phases for choosing doses for Phase III. In that way, this study was also quite successful. We started low at 0.1 milligram and ended up at high doses up to 1.6 milligram, once weekly. The larger doses were titrated from what 0.8 milligrams, also on a non-titrated arm, titrated of either over one week or over two weeks for the 1.6 milligram dose compared to see what both placebo in one arm and the two approved doses of liraglutide 1.2 and 1.8 milligrams. The study ran over the period of 12 weeks and then with a five week follow-up period, following a completion of the study, approximately 400 subjects in total were included in this study.

The data were highly confirmatory of a very important mistakes on glycemic control. As you can see here, we started at A1cs of around 8.2, and brought that down in a very clear dose independent manner with approximately 1.7% in the top dose and as you can see here, very important also actually compared to liraglutide and actually at the highest dose here significantly more lowering of A1c as compared to the (inaudible) as well. The internal note here is that, I think this is the first time ever that we've seen something be superior to liraglutide on glycemic control. With respect to weight loss, the other main parameter, of course that we're looking for and for the one phase compound also a very potent defect, you can see here that started from the base line approximately 85 to 90 kilograms. We did lower body rate by 4.8 kilograms in the highest dose 3.5 milligrams with dose there, and again that’s exit significant not only compared to placebo what you have out yet, but also significant compared to the liraglutide results here.

So again supportive of not only liraglutide once-weekly may be attractive for compliance benefits for that individual molecules may actually also have incremental differences on the some clinical end points, and semaglutide looks at least from this started to be very effective on body weight also as compared to its effect on glycemic control.

With respect to glycemic control and body weight is also interesting to see how is that with these data in [comparison] to clinical guidelines, and for semaglutide on glucose control here we’re talking about 70% and 80% of subjects at the two high-doses here come into guideline control that means below HbA1c of seven at the end of the trial. So that is one of the best set of data, I think we've ever seen for any glucose that one (inaudible).

Of course other side of the coin is safety and various events. We’re also looking for in phase 2 studies, and again here remember that phase 2 is really there to keep guidance as to dose selection for phase 3 studies, and it's clear that we start particularly in the arm that we’ll start titrated to 0.8 milligram, un-titrated arm with a fairly high insulin of nausea in those subjects, we can see a very clear impact of titration, if you look at 0.8 milligram titrated dose here, when you get to 0.8 milligram at this point here as compared to the un-titrated point of here. So you see a very substantial impact of going step ways to 0.8 as compared to going directed to 0.8. So, (inaudible) said here is highly indicative of an importance of titration and of course also a parameter that we will be looking at be going to phase 3 clinical trials here.

Apart from that you'll see in other GLP-1 trials also that nausea really use it in very phenomenon comes down overtime in all dose all dose groups and after few weeks to see that the majority of the patients are without nausea at least we have a nausea frequency here of less than 10%.

Another highlight from this study is that the majority of these skills of nausea were categorized as mild and moderate. That means having either minor or a small impact on the ability for the subjects to conduct the daily operations.

So following that part of efficacy, I think it’s also maybe for you interesting to note that actually the body weight loss was similar in subjects unaffected by nausea as in the food population of (inaudible) by nausea. So we did not see a direct correlation between effect body weight and nausea in the study.

So in summary, we have conducted a phase 2 12-week study compared to placebo and to the liraglutide of semaglutide highly conservative of – of the efficacy of semaglutide both on A1c and also on body weight. We have found intestinal side effects as we would expect for HbA1c compound, that will generally moderate and did – we didn’t overtime. And in the future trials that we into phase 3 clinical trials that will be often coming here, of course, we will have dose selection and (inaudible) scheme that takes the findings with respect to pretty tight side affects from phase 2 into account.

And with these words from GLP-1 with once-weekly on to GLP-1 once-daily liraglutide and Dr. Alan Moses.

Alan Moses

Thanks Peter. Part of that in 2012, we’d not be talking about that we will mere in the stable, but you still acting like a fully in terms of energy in some of the new data. So what I’d like to do over the next couple of minutes is, talk to you about three studies that were presented here. Remember, there were total of 7 abstracts on liraglutide at EASD. That really – I think we get you here is the picture of how the liraglutide is being used and what its success pattern is, if you will in clinical medicine alone up not the first study that I’ll begin with.

The first study is actually an early phase study in pediatrics. Now there are two reasons for pursuing this, of course. One is, there is a regulatory requirement to look in a pediatric age population, both from EMA and the FDA. But more importantly, I think we have to recognize the type 2 diabetes in the pediatric age range. We’re not talking about age is 10% to 17%. Is increasing in frequency dramatically in the U.S., but also in some part of Europe, and there only two approved drugs for the treatment of diabetes in the [pioglitazone] and metformin and insulin. Metformin relatively easy to use as low medication, insulin not as easy to use certainly with preparations up until today.

But I think particularly in this age range in terms of compliance of (inaudible) and their effects. And also of course the issues of weight came with insulin and a population that is rather over weight to begin with, which is one of the causes of their or precipitance of their development of diabetes. So in any case there is a strong rational for looking at new drugs in this population and liraglutide is appealing for a number of reasons is glycaemic efficacy, a stability to promote weight loss along with that glycaemic efficacy and its very low risk of hypoglycemia.

So this was a five week study, a dose response study is really a pharmacokinetic study, but we were also were able to look at glycaemic efficacy over that period of time. It started with a 0.3 milligram dosing, incremented in the 0.3 milligram, increment up to 1.0 milligram, it actually went from 1.2 milligram to 1.8 milligram, but a little slower titration then we see in adults, because we wanted to capture the full pharmacokinetic profile in these individuals.

What I’m showing you here on the left is a slide of hemoglobin A1c, it’s a small study working individuals in the liraglutide exposed group, seven in the placebo, but you can see a clear difference even over five weeks with this gradual titration, remember the group precedes the highest dose of liraglutide only for one week and yes there was a reduction of hemoglobin A1c of nearly 0.9% over that period of time. It was well tolerated, the pharmacokinetic profile was not particularly different from adults even at the high dose of exposure was as expected; there are no differences in this age range.

And the tolerability was actually very good with no subjects dropping out for gastrointestinal side effects. There were two subjects who drop; one because they couldn’t get venous access to draw the blood and another one actually in the placebo arm. So we’re very, very satisfied with these outcomes, and we’re now undertaking a phase 3 trial in the pediatric age range, which of course is going to be a multicentre, multi-country trial with we assume some challenges in recruiting into this age range just because it’s a relatively infrequent disease despite its rather dramatic increase in frequency. So we’ll report out on that probably in a few years once the study is completed.

Now the other issue that’s become, I think very interesting to look at and this is an interesting study from a number of perspectives. One it’s actually a collaborative study between Amylin and Novo Nordisk is actually with their academic collaborators. But there has been the general perception and actually the (inaudible) that insulin is be most efficacious treatment of diabetes. Certainly in type I but also in type II diabetes, because ultimately the ability to lower blood glucose is limitless if you push in some part of. Now of course there are downsides of that, notably hypoglycemia. But in two large programs – two large studies, duration three which was looking at once weekly exenatide versus insulin glargine and in lead five which was looking at daily liraglutide versus glargine.

We had the opportunity to look not only at overall glycemic efficacy which as you know from those studies demonstrated actual benefit – greater benefit from the GLP-1 from insulin but also to look across the spectrum of A1c to see if there are differences there. And these data rather clearly show on the left you see the data with exenatide once weekly versus glargine. So exenatide in light blue, glargine in the open bars and on the right you see the data from lead five liraglutide in purple and glargine in this case in the open bars with the purple outline. And two things are obvious, one both GLP-1 preparations were able to promote a greater decrease in hemoglobin A1c than did insulin glargine or basal insulin.

Now, there are of course multiple reasons for that, one is glycemic efficacy and the other are the limitations imposed either on titrating insulin or the hypoglycemia that is intended to it, not to mention the weight gain that occurs as well. But the other thing that's interesting is that it doesn’t matter what you are starting A1c is. In all quartiles of A1c GLP-1 outperformed insulin glargine. Even while we are talking about the highest quartiles, even though when entering hemoglobin A1c levels that are 9.5 to 10.

I think this was a little bit unexpected actually in looking at this and demonstrate – this does not mean of course that these patients achieved their target A1c at less than 7%. Nonetheless, the ability of these agents to lower hemoglobin A1c was still greater than glargine. It's even more apparent or most apparent if you will at the lowest entry A1c.

Now, here of course the limitation of hypoglycemia is what prevents insulin producing the chronicle effect. So GLP-1 which I think most clinicians would agree is ultimately easier to use than insulin, both in terms of its titration but also in terms of the side effect profile, actually it can be more effective glycemic agent in terms of achieving glycemic control.

So the conclusions from this study were that, when we compare to the two of course you saw that we had numerically similar or superior hemoglobin A1c reduction together with weight loss which I haven’t shown you and of course together with a much lower rate – with a lower rate of hypoglycemia in the exenatide once weekly trial, a roughly comparable rate in the liraglutide trial, with the chosen trial but that was on a background of (inaudible) which was not present in the other and likely explain some of the hypoglycemia.

The agents were well tolerated with the expected adverse event profile for both GI side effects, well tolerated for the GLP-1, hypoglycemia and weight gain for the insulin. And the similar reductions really I think beings to think – allows us to think a little bit about change in the paradigm of diabetes even in individuals with slightly poor overall glycemia control.

Now, the final study that I’m going to present is actually one that also is a real world study (inaudible). This is an ABCD survey from the UK, so these are UK Endocrinologist who are looking at the real world effects if you will. Of liraglutide in patients with diabetes who in the UK buy nice guidelines tend to be more obese than they are in some other areas of the world in terms of indication of the use of this agent.

We know that GLP-1 agents not only are affected glycemia agents but they also tend to promote weight loss. In fact, about 75% to 78% of individuals treated with the drug actually lose weight if you look across the entire lead program. They develop and program for (inaudible). But this was an assessment to see what happened in the real world and to stratify them by initial court entry or initial treatment BMI.

Now there were individuals who excluded from this analysis. And those were those who will switch from exenatide, those who actually were on the highest dose of liraglutide, 1.8 milligrams. So you have to be on less than 1.8 to make into the survey those who are also using insulin or if you had a BMI of less than 25 or greater than 55. So the non-obese and the really morbidly obese would exclude. And what I’ll show you is data or our data on both hemoglobin A1c and weight reduction.

Lets us look first to the left which are Quintiles actually the (inaudible) of BMI. And you can see that the hemoglobin A1c reduction is roughly equivalent across these areas BMI parameter starting at 25 to 30 and going all the way up to 50 to 55. And not only were they roughly equivalent, but they were pretty dramatic in terms of their effect. I mean, the mean A1c reduction here, with the 1.2 milligram dose was 1.2 to 1.3 absolute hemoglobin A1c units.

To the right, are the weight profiles or weight loss profiles, if you will again looking across the spectrum. And not surprisingly as we saw in the lead program the more you weight when you come in the more you tend to loose on the Liraglutide and here it ranges from 1.7 kilos in the near normal weight individuals, normal weight they were 24 to 29, all the way up to 4 kilograms in the highest BMI range although the number of subjects in that group were in fact small.

So effective glycemic control across the spectrum of weight, greater weight loss with greater initial weight again not terribly surprising but very reassuring from this rather large survey. So the conclusion from this are that first of all, the use of Liraglutide is fairly common in the UK for individuals who have failed other methods of other glycemia control and are struggling with weight. After three months, 1.2 milligrams effectively reduced hemoglobin A1c and weight across a full spectrum of BMI categories. There was no significant reduction in the A1c based on BMI, absolute weight did increase with greater entry BMI. And on the other hand, the weight loss as a percentage of initial body weight which range from about 2.4 to 3.1 was about the same through each category. And that of course results in a greater absolute weight loss of (inaudible).

So we’re dealing with fortunately a drug in the real world in clinic practice that is essentially reaffirming again and again the findings from the lead program. And indeed in many cases the real world studies are even more effective in terms of glycemic reduction and that’s the function of some of the artificiality of the way the lead program was designed where some patients were using Liraglutide as true add on therapy to their background therapy and in others where they had one of their anti-hypoglycemic medications taken away as Liraglutide was added on. So they were disadvantage on that, and there was actually another abstract at this meeting demonstrating the greater effect when it’s added on as opposed to substitute.

So with that, I will turn it back over to Jesper, I think to have the Q&A.

Question-and-Answer Session

Jesper Brandgaard

I think I’ll do it from down here. We’ll now do a Q&A for approximately 30 minutes. I remind you that this is being webcast and we have microphone from two investment officers. So do wait for the mike when you ask questions. After the 30 minutes, there will be refreshments outside. I would suggest that we initially limit the questions to two per individual in order to give the dialogue going, but I think there will be multiple chances of asking questions and let’s start with Michael up here and please state your name.

Michael Novod – Nordea Markets

Yes, Michael Novod at Nordea Markets. Let’s turn the question to semaglutide looking at the (inaudible) sequence, it do resemble what we saw with taspoglutide. At least one of these institutions should make. So could you give us some flavor into that specific and why should not expect or not should be afraid of having a taspoglutide situation et cetera. And then the second question relating to the Japanese approval, could you give us some flavor into the Japanese label and also perhaps give some flavor. Approval process has been ongoing in terms of how much of the Japanese authorities maybe able to review of the data, not only based on the label but to actually give the entire approval (inaudible)?

Unidentified Company Representative

Thanks, Michael. Good questions. We have a Nova Taspo in our hand, so how does the immediate sequence different for CMEC compared to taspoglutide. And Mads if you would (inaudible) comment on the Japanese approval process?

Mads Krogsgaard Thomsen

Yeah, so to the first question, we don’t believe we have another Taspo in our hands, but you want today to see something that we will know about when it come to Phase III. That being said you’re right that the precision 8 in (inaudible). We’ve also seen taspoglutide, its pure degradation with and that was linked to the physician that was seen with Taspo and we got to say that we believe that’s a very, very minor modification to (inaudible). And we are confident that (inaudible).

Unidentified Company Representative

Remember that, taspoglutide was also a physical foundation so there was physical protection in this opportunity. This is a liquid and also distribute like any of our other in technical prolonged product. So there is a big difference between creating a physical (inaudible).

Mads Krogsgaard Thomsen

And to further highlight that, there were actually two ARB, two immune – is one in the interim based on (inaudible) but also in the terminals. And the one in the [compoxy] terminals has been shown to affect the (inaudible) sheet structure, i.e., the secondary restructure of taspoglutide that is not present in semaglutide and we have no change to the secondary structure whatsoever. After that that you would have like adjuvant-like effect of what Peter Kristensen describing this adulation of the vehicle that these are under the skin for longtime triggering the immune system. So no the short answer is we definitely would not anticipate to have a Sema, sorry a taspo...

Unidentified Company Representative

We do have…

Unidentified Company Representative

We do have Sema.

Unidentified Analyst

Thanks. Unless the Japanese process for...

Unidentified Company Representative

Yes, well Japanese NDA submitted as Jesper described December last year has been through a rigorous, but very systemic process according to some new Japanese guidelines where they actually expediting the way they at least will handle, you can argue parts that they concede outside. Some importance actually take us nine and a half months to get through the entire PMDA process ending up with the committee last month and then the official handover, the certificate last Friday, so it’s been a very good process, it’s not as if they haven’t asked hundreds of questions they have, ending up still with a, will be the fastest approval for a non-domestic company submitting a [numerous] entity to the PMDA. Beside all the data that was in the NDA was that, it is clinical, preclinical, CMC and so on so forth. The reason why Ryzodeg is still being assist by the PMDA is obviously that that also was submitted in March as opposed to December, but as the process also looks to be relatively explicit.

Unidentified Analyst

Was the difference for the gaining that the Japanese that that make the difference in that terms of brand?

Unidentified Company Representative

Okay the label in terms of, okay thank you for that. Two things, first of all Ryzodeg you need a different package also in terms of some CMC and stuff like that that call for a certain delay of that few months compared to the Tresiba. The label per se it is important what the PMDA actually does is they look at the totality for global data, but they will relatively clear piece of global data, but rather local Japanese data. So the hypoglycemia claims that we actually have in the packaging to, they are driven by the outcomes of Japanese – the Japanese once daily basal initiation trial that is a replica in the smallest scale of the one Peter just mentioned during his presentation that 3579 study. But the data were pretty much showing to seeing degrees the hyperglycemic benefit.

Now the reason why we did not get the ultimate flexibility claim in there, which we’d like is that the two flexibility studies have not that all being done in Japanese subjects, they can done implications. And hence I think the two instances why the Japanese are preferring from giving on that one being the population in question, the other being probably the notion that Japanese mentality is not to allow to erratic among the people or including in Tresiba people diabetes.

Unidentified Analyst

Okay thanks.

Unidentified Company Representative

Next one from Carsten.

Carsten Lønborg Madsen – Carnegie

Thank you very much Carsten Madsen from Carnegie. Just one more question to the Japanese processing when you (inaudible) safety. Could you elaborate a little bit on differences between FDA requirements and what is being required in Japan FDA has got this 1.8 milligrams, 95% of likelihood of success is that the same or similar in Japan? And then on the semaglutide, should we also consider semaglutide containing obesity or is that not an option?

Unidentified Company Representative

Thanks, Carsten. First on the Japanese approval and the requirements for the cardiovascular safety in Japan and where those differences between Japan and U.S, so see well there is something that could read across to the AdCom. That was question, I was diving. And I don’t know what Peter Kristensen answers on how or maybe both Peter Kristensen of course can comment on what are the plans for semaglutide in terms of indications?

Peter Kristensen

Well in Japan as such as you probably aware, Carsten there is not a specific CV requirement per se that obviously since as part of the and by the way in the U.S., there is actually obesity also not, because the CV guidelines for 2009 they do not the same at least as per the inclusion criteria in that guideline to injectable insulin products.

Now that also can of course change over time, as you start seeing you and had very long-acting agents and got no slot, and then you took it to of course be a part of the dialogue with the agencies. But per se, you are not held up against the CV guidelines that non-insulin products are. When that is said, you still adjudicate all your wins and then that being able to report the, and so on and that is also being the case for Japan. And if you had like statistical anomalies or significances then you can imagine having a very interesting meetings with the agency in that regard. And as I said, we got this approved in nine and a half months, so well that’s not a major hiccups in that regard.

Unidentified Analyst

Okay, (inaudible)?

Unidentified Company Representative

Yeah I think on the obesity, therefore with semaglutide I think that what were we maintaining in that project is actually how we were with Liraglutide 3.0 milligrams for obesity and this would probably launch major development activities on that but it’s an obvious opportunity because as Peter mentioned that as semaglutide dosed with the long half life actually it gives an even flatter profile than Liraglutide. So and therefore you can easily go high on GLP-1 occupancy without getting aggressive entity. It’s easier than the fewer peaks you have. So semaglutide from that point of view was a good, a good opportunity for obesity but I don’t think you would see as we move on that from a development point of view until we passed let’s say an AdCom on Liraglutide, 3.0 milligram for obesity which is yet to come.

Unidentified Analyst

Thanks, Peter.

Peter Kristensen

Sachin, next questioner.

Sachin Jain – Bank of America Merrill Lynch

Sachin Jain, Merrill Lynch. Semaglutide and titration on phase 3, any more color and more steps to the intervals and just what position, distance you think you have to complicated algorithms, and then second question, which monthly rose deal for CHMP, do you have any color whether are on the October meeting (inaudible). Thanks.

Peter Kristensen

I guess the second one, the second one I think I’ll actually deal with and I think missed the – the short answer will be that the regulatory process for our competitors, you will have to direct your questions to our competitors.

Sachin Jain – Bank of America Merrill Lynch

Degludec.

Jesper Brandgaard

Was Degludec? I’m sorry, then I will take it and the reply will be as I said in my introduction that the Tresiba approval or processing in EMEA will be on CHMP within the next couple of months. When it will specific, we’ll have to wait and see. And then the first question which was related to the being three trial for semaglutide. And I guess Peter that would be – in trip to the titration algorithm that we would be intending to use.

Peter Kristensen

What I can say Sachin is that, we are looking at prolonging the steps for products. But the of course there is always a challenge in how long should do that. So we will go through a four week interval at the low dose that will be used to the high dose, and from that we expect to have two different doses in Phase 3.

Jesper Brandgaard

And I think just to highlight what Peter is saying, it is you can say also a very aggressive situation. I think we underestimated potencies of semaglutide because 0.8 milligram dose actually did better than we Victoza. So at a high dose, that corresponds to do that without titration as we didn’t want our corresponds to giving the patients in excess of 2 milligrams of Victoza hit on, which of course you will never do, and if you look at (inaudible), that’s titrated with a 5 microgram dose for one month, and then you go to 10 micrograms, not one week.

I think Peter is in control of the titration scheme, then will not rule out, yeah, try to fix because this is an extremely efficacious deal to one agent, but that will also not give physician resistance or patient resistance for that matter, giving on boarding to the trial, I’m pretty convinced.

Jesper Brandgaard

All right, we will take next question from Brian.

Brian Bourdot - Barclays Capital

Thank you. It’s Brian Bourdot from Barclays. Two questions please, one on Ryzodeg and one on semaglutide please. For Ryzodeg Peter, quite interesting results from the Japanese population, so just want to ask you what your message is going to be, and Japan should a mix into an be used is that makes who ever should have basal into when we use, is that based in last your very periods. And second question on semaglutide actually is the oral version that you’ve advanced into Phase II development, just wondering what hopes you had for that so that drug, do you think you can show equivalent efficacy and safety, given that it looks like you got kind of similar doses that I would expect you to be using maybe to the injectable in Phase III and how much protein do you need to use to get to the improvement at least, thank you.

Unidentified Company Representative

All right, I guess Peter, additional comments on the positioning of Ryzodeg in Japan versus the first way of Tresiba approval and knowing that Japan has a significant combination mix market how will Novo Nordisk approach that, and then maybe on to Pete, I guess the old version of semaglutide [NN9535], how do we expect the efficacy will be compared to the subcutaneous injection version and approximately how much drug will be needed so we need to expand with the huge number of facilities et cetera?

Peter Kristensen

On the Ryzodeg what I presented to today was the once daily Ryzodeg study in Japanese subjects we also have a twice daily study in Japanese subjects and of course that it all depends on how you want to distribute your balance between basal and fast acting for the mill and that’s study you will start I remember presented at idea the twice daily, but having said that I think it’s important for the whole family of products building on (inaudible) that we first get an understanding in the market of the features of that insulin before we start complicating the message with Ryzodeg. So I think you will see that this is what we’ll also do in Japan.

Jesper Brandgaard

But Brian, you’re absolutely right in saying that Japan is so much been a twice daily premix initiation market. The company that changed that briefly was lends us to that now basal insulin initiation has actually become the number one option, and you’re absolutely right in saying that we can either than go big time found that route and then regained the loss share to speak in the basal segment but historically there has been a boost because of carbohydrate rich food, but also because at least of the notion the boost panto glucose are extremely incremental spike, this is lost relatively early on in the Asian subjects, that there is a need for plenty of position that could be either be twice daily or could even as Peter show be once daily so that’s a lot to think about.

Unidentified Company Representative

And I can go on with the old version of semaglutide, as some of you will know we are continuing those doses in Phase 1 clinical trials and the continuation of those doses to indicate that of course we were case with obese so fast. We do believe that if we get sufficient semaglutide into the blood stream, we will also have similar efficacy, because the majority of GLP-1 effect will be a systemic effect. However, you cannot exclude that an old version of GLP-1, analog relativity even more effective than a [GLP-1] because some biological data that points to some local effects of GLP-1 also is a cause as you will know indulge GLP-1 is actually secreted from the L-cells in the gut and some cells point to also (inaudible) with nervous system.

So we could hope for even greater things of the GLP-1 with given all. The challenge at the moment of course clearly is to have control over the two key parameters as you also alluded to one is, bioavailability and the other one is variability. Variability we believe we can very much control on the molecule like semaglutide type dosing orally once daily, not once weekly, that will ovearll gives a fairly best action profile despite basically variability. With respect to bioavailability, it’s too early to really give any conclusion remarks from that is clearly we are talking about much lower bioavailability than when we give semaglutide, as an injected drug. So we’re talking about probably building may be a new factory and so.

Unidentified Company Representative

But I think we can afford that at the current DPP-4 market, and how would say, DPP-4 inhibitor it should get an old version DPP-1 and all.

Unidentified Company Representative

Well, I think Brian, it’s likely that you will be looking at bioavailabilities below 10% and hence you will easily need 10 times as much of the actual molecule per patient and hence you won’t require a significant expansion of production capacity, if that would be the case.

Unidentified Company Representative

And obviously because the semaglutide such a good molecule that you are on a once weekly basis would never need more than 1 milligram or so. That even with what Jesper and Peter is saying, still means that we are in the low teens or tens of milligrams on a daily basis, and we are not talking like Aspirin doses of 500 mg.

Unidentified Company Representative

All right, next question, next.

Sam Fazeli - Bloomberg Industries

Hi, thanks for taking my question, it’s Sam from Bloomberg. Is there a limit on how many questions we can ask?.

Unidentified Company Representative

Two please.

Sam Fazeli - Bloomberg Industries

On semaglutide point on the slide that to club later on short. There was an origin in 34, 35 substitution too, although it was not actually substituted in the slide. Events are largely (inaudible). So can you explain what happened there, I’m not sure whether the slide was wrong or when there is actually a substitution that which is quite close to the same place that has substitution, that’s point one. Point two is, if you look at the FPG date of the degludec you have pretty similarly A1c drop versus glargine, you have a bigger FPG drop. I think it was [asking] in the conference too, but I’m too slow to pick up the answer. Does that automatically tell me that there is a disadvantage to degludec on a PPG basis or wider than or FPG has nothing to do with A1c which gives (inaudible).

Unidentified Company Representative

Okay thanks. The first one in terms of we’ll start again on semaglutide is in these resembles to taspoglutide and specific structure of the molecule and how the [Arg] substitution was done in the molecule. And I guess if we do want to take that Mads.

Mads Krogsgaard Thomsen

Yeah we can share it. Peter you want (inaudible).

Peter Kristensen

No I can just say Arg 34, is exactly the same substitution as we have in liraglutide, so the (inaudible) 34. But since then it’s also a vital increase precision 26 you can say that full. And it’s much easier for the chemist to do the escalation precision 26 we substitute modeling to precision 34. And that secular thing substitution as we prove and say for reconcile.

Unidentified Analyst

And unlike taspo the AIP change they have been (inaudible) does change the overall structure, so that’s the difference. This is just Victoza replica on the systems. The one that maybe, if I can try to respond to your degludec question, because this is frequently asked, we ought to comparisons has statistically significant differences in FPG and all five medical (inaudible) can that be when you get the same HbA1c that these areas around that. I like Peter Kristensen is very mainly four times literally ability that means that your fluctuation seems particular below that mean fasting glucoses are probably less such that you can actually end up from the same A1c with the low fasting glucose, if you have literally what you understand so to speak.

It extremely (inaudible) that would be that you have more hypoglycemia on glargine you spent more time on a per day basis in the hypoglycemic resume, that is actually going to help you A1c, but it’s not good to the patient. Okay, so you are going to have a fasting glucose that in the morning is improve for degludec, but because you have lift hypoglycemic episodes that that live without (inaudible), but that is the highly beneficial thing. That can probably be many other explanations, but one of them would not be post-prandial glucose, because as such the basal insulin shouldn't affect post-prandial glucose, if it does, it's actually because you have a big effect and we have hear from our colleagues that they don't have a big effect on the insulin.

Unidentified Analyst

This is Mark (inaudible). Two questions from me, then back to Brian’s question on Ryzodeg, because if I look at the figures, it look like that will be the same change, same level of hypos in Ryzodeg versus Tresiba, but then with in the data effect on HbA1c. Back to the question and pricing with the Ryzodeg been in Japan with product market Tresiba or like it was normally because it gives us very big difference between the parts on that. And then the same question we’ve got into (inaudible) if I look at the chart and look at 0.8 titrated very high level of an (inaudible) 0.8 was an upside titrate, it actually the same below the 1% titrated (inaudible).

Unidentified Company Representative

Okay, if I handle on the pricing level for Japan, I think we will basically await the approval process and the assessment of the label for Ryzodeg Japan before we make up our mind on this specific pricing and then product. Whereas, I think in Japan with (inaudible) on the market in Japan, we have relevant benchmark and then we have clearly more education start, we provide patient with significant lower hypoglycemia and we anticipate that will then call for a premium based on the current therapies and we don't anticipate at present that we will – I'd don't say we anticipate a present level we’ll take some element of that pricing on the basal segment into the pricing of the Ryzodeg, but it will also look in on the label and we’ll have to wait the label to conclude. But it is in reality, we have two components and you could basic and take the pricing between individual components and from that you can derive theoretical price for us.

Unidentified Company Representative

But within that (inaudible)

Unidentified Company Representative

That would be the higher price the norm makes again it will depend on what the specific legal would be for the product one semaglutide approved (inaudible).

Unidentified Company Representative

I think maybe we can allocate all basic, it will be very speculative, I think the main thing to the way up a little bit is that the numbers relatively small, so we have the 40 patients in each and if you have 5% difference between the two of the currency of the (Inaudible) that we thought more hypo in one arm than the other. So…

Unidentified Company Representative

Hypo.

Unidentified Company Representative

No, hypo. Any way it’s small, and then I think we can all have always speak with patient if you hit them hard in the beginning, well do then they relatively feel more relieved the following week because they just feel better or whatever, I think the major issue here is that the numbers are relatively small to compare between groups.

Unidentified Company Representative

And I think if we don't have that figure here, but if you still mind (inaudible) those who see that the majority at each of the levels of the insulin miles – so it's really down to 2 or 3 per patients we've got a live nausea in that, we cannot and so it is – it's too small numbers and we actually as much as 94% that are even (inaudible) reported by the circumstances.

Unidentified Company Representative

Alright next question, (inaudible) and you allow to the ones who restrain themselves to two questions and there is now an opportunity to…

Brian Bourdot - Barclays Capital

Thanks Brian Bourdot again. Another question on semaglutide actually see that on semaglutide please, that will quite interesting. The analysis that you showed it’s hard to nausea at a time, is that a completed analysis? Is that a raw analysis? And if it’s not a complete analysis, how much is the increase for the higher doses overtime driven by drop down, because I think you have like normal trivial portion of (inaudible) is dropping out hence the – I think the second equation might be that will broadly, your Chief Executive has on the call stated that Novo Nordisk daily people, not weekly people? Is that can you (inaudible).

Unidentified Company Representative

Just quick comment, yes, I’m a once a daily man, he did nothing we are once daily people, yeah I think he’s spoken his personal power.

Unidentified Company Representative

And I think he can say Brian on that one, let’s just clear that one first, and I think the view in management is that the proof is in the data and we'll have to see the Phase III trial to really be for conclusion. It is clear that the convenient matters and where the convenience and is going to come in terms of the very, very long half life in terms of semaglutide then being converted into a convenient once daily tablet, but using the long protracting life or whether it’s going to be the self good conversion.

I think (inaudible) is a little bit out on that one, but if we look at the uptick so far in the market from the once-weekly version of semaglutide. It is apparent to us that convenience has to be there both in terms of the delivery mechanism and in terms of the molecule if you want to go in that direction. So I think you have to think with the mindset of convenience, but I don't think that anything that moves out that once-weekly version or twice per month in theory could be possible or could be a feasible way for insulin or GLP-1 overtime, I think that is conceivable, but lets prove that we have very efficacious doctors, so you want to follow up on that.

Unidentified Company Representative

No, I actually have another question on the...

[Overlapping]

Brian Bourdot - Barclays Capital

You are referring to this the current way the nausea all time?

Unidentified Company Representative

That's what called the safety analysis that is just below, that’s all exposed basis, so the percentage you see is all the time the percent of all the patients who enter into that treatment on. So we don't – it's not like half of them have gone out and then it's percent of that that's not…

Unidentified Company Representative

And by the way you wasn’t (inaudible)...

[Overlapping]

Unidentified Company Representative

I think Brian I wouldn't extrapolate too much from the GI sort of profile in a phase 2 that was the designed this way. For sheer reasons of having under estimated the proof of this molecule, we got most bank for the buck than we would have expected those level and that of course (inaudible) how we think about titration.

Unidentified Company Representative

I think we had a follow-up question and then Martin you had final one on.

Brian Bourdot - Barclays Capital

Thank you. Sorry, this is my last question. Injection side reaction, I think (inaudible) injection side reaction. I know (inaudible) recently hard portion, but could you quantify and describe what would (inaudible). Thank you.

Unidentified Company Representative

Injection side, I think we are very low and you’d expect that because pH neutral solution and (inaudible) so it's a straightforward we should expect, would expect to meet....

Unidentified Company Representative

And Brian just to answer that you actually seeing the peak already out around 24 hours, so the site of protraction here, the section to circulation due to the strong (inaudible) this is not some strange people progression that this data around in this game.

Unidentified Company Representative

Actually you can say, I mean even though evaluating rare things like insecticide disorders, which are rare was escalated products, but we did have compared to it and there was no difference to liraglutide and we know that liraglutide is not ever is not effect over...

Unidentified Company Representative

Okay, then Martin?

Unidentified Analyst

Yes, Mark Mahan from (inaudible). Just with respect to the marketing business I guess there is a chance (inaudible) we know what mentions in the old days, it was just the once daily when you met the doctor, what would you say with the five seconds you have with the doctor on the seat?

Unidentified Company Representative

This is the insulin with the ultra long action profile that quickly use safety to target.

Unidentified Analyst

And you will not bring a hypo-simulator?

Unidentified Company Representative

I heard today that people actually don’t feel that the hypo-simulator adequacy reflects what's going on so maybe not.

Unidentified Company Representative

And that's of course the simple (Inaudible) that raises towards the TP but maybe I think we can also have the advantage of having (Inaudible) on the panel that maybe what would be a little bit more advanced message into all theses kind of diabetologist, while the outer lying insulin that provides safe efficacy but most specifically with very little variability dose-to-dose day-to-day and a very low rate of hypoglycemia best exemplified as eternal hypoglycemia which is the time period according with respect to see the effect from a basal insulin.

Jesper Brandgaard

Okay, with that, thank you for your interest in Novo Nordisk. There is refreshment outside. Thank you very much.

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Source: Novo Nordisk A/S's Management Discusses Investor and Analyst Meeting at EASD 2012 (Transcript)
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