MDCO
#Thanks very much for your question.
This is <UNK>.
Regarding ABP-700's market opportunity, there are 180 people who in the Europe and US alone who will undergo anesthesia sedation.
About 120 million of those we believe are conscious sedation patients.
Let's take the 60 million patients undergoing anesthesia.
A good number of those are high-risk.
That means to say that they have core mobilities or undergoing particularly difficult surgery where some form of cardiovascular or other complication could occur.
A second way of stratifying that risk is patients who have difficulty with intubation.
When we look at those anything from 10% to 40% of patients undergoing anesthesia can be classified in some way as high risk.
And a product that has relatively less ventilatory cardiovascular or other impact, a product that's very fast on and very fast off would be potentially suited for those high-risk groups where the advantages would be most evident versus propofol and/or etomidate.
So that's one way to think about that looking at 40% or so of those 60 million people and imagining a penetration into that market.
As far as pricing's concerned, it's a little early to tell.
We don't have all of the attributes of the drug yet mapped out with clinical data.
But it's not unreasonable in those high-risk patients to imagine a premium price relative to propofol.
On the conscious sedation side, I think the market is even more astonishing with 120 million people undergoing conscious sedation.
We know that the trend in the marketplace is forever more invasive conscious sedation procedures requiring ever deeper conscious sedation which with propofol and even with midazolam that really can't get you there, that runs the risk of driving respiratory depression.
So going deep in sedation without ventilatory suppression would be a very exciting prospect for anesthesiologists who supervise those procedures but also of course, for the non-anesthesiologists who are doing many of those procedures both in Europe and the US and who run the risk of having to get control of an airway without the necessary skills.
So that I think is a big opportunity for the product as well.
And again, we believe the safety advantages that may come from this product should be very valuable indeed.
I think that's the way to think of the market.
It's a large market, it's a premium priced opportunity we believe based on the attributes we've seen so far and it's worth remembering that propofol when it was not generic, at its peak was well north of $1 billion in sales.
The AHA data next week will be very important to us because it will determine whether we do or do not have a six-month durability of effect.
I won't try to pre-say the data today.
I think we'll wait for the results to be presented but obviously, a six-monthly dosing of a PCSK9 inhibitor, assuming that LDL knockdown stays at approximately the level it was at 140 days, would be quite affirmative of a differentiated profile versus the antibodies.
I think that's an important piece of information that should be revealed.
In addition, we will be showing the data on the full-blown lipid profile.
I think it is important to look at results in terms of total cholesterol, ACL and so on, and assuming those results are also favorable relative to PCSK9 antibodies, it will help us drive forward the phase 2 program quickly.
So those are two things to look out for, durability of effect and effect on other lipid profile.
<UNK>, it's <UNK>.
I think as <UNK> said, there's analysis that needs to be done.
So there's a number of factors that go into that.
How do you dispose of those assets.
Do you do it as one or a combination package.
That, obviously, will bring cash in.
Clearly, a programs that may be associated, resources that may be associated, that's what I think <UNK> is targeting in on, those are the things that will change.
All assets have ongoing commitments once their commercialized.
So things like: commercial spend, regulatory spend, post-approval research and development, and all those factors go into that basket.
And again, I just come back to what <UNK> had said, putting a number there today is maybe a little bit premature but these are the analysis that we are doing.
And the objective, I think, is most important that <UNK> outlined, is that we want to improve the liquidity of the Company and reduce the burn rate and reduce capital requirements.
<UNK>, I think we have accomplished a lot of that already.
If you look at SG&A specifically for the year on a cash basis, it's relatively flat.
In fact, Q2 to Q3 showed a downturn in the actual cash SG&A.
Now we're not going to save our way to success here because we haven launch products as well, but we're highly focused on that.
So specific areas like the redeployment of <UNK>iomax folks to support Kengreal is a good example of that.
So we're looking at that all the time and I think <UNK> and I in previous calls, have said the efficiencies that we can gain through optimizing the organization as we launch these products will continue to look.
I think what the numbers tell the story that we are very focused on trying to keep the cash burn in line, recognizing that we have both development programs as well as five launch products.
Hi, <UNK>.
So first of all, let me deal with the homozygous study.
That would be a comparative study against one or two of the antibodies, probably one of them.
Yes, it would be demonstrating non-inferiority for LDL lowering and obviously, would have a very different dosing profile and ease-of-use potential.
No, that would not be the only phase 2 study.
The major phase 2 study which we're kicking off right now is an LDL lowering study in the normal, should we say, broader population of patients who require LDL lowering, to another goal, who are not tolerant or maybe have heterozygous familial hypercholesterolemia.
So the homozygote population would be in addition to the main phase 2 study.
Can you repeat the first part of your question as well.
I'm sorry, <UNK>.
Yes, we would.
In fact, we think it's going to be about 450 patients and we're going to start enrolling those before the end of this year.
Yes, that might be a bit more than we'd care to share on a call.
I think we have great relationships with a lot of different companies and I think feel pretty confident that in this stage, the best way forward to maximize shareholder value is to outline and pursue the strategies that Dr.
<UNK> outlined.
I think our priority is to global deals if we can and therefore, we have not pushed the button on distributorships in Europe at this stage.
There are many available to us and there's some great companies in Europe that could help us in the very short-term.
But I think we have to get through the major choices first and then we'll see whether it makes sense to take local partners for specific products.
Certainly, the homozygous comparator agent is likely to be one that's already approved or approved at the time the trial is done.
So thank you for pointing that out.
On the other phase 2 program, we'll give the full details of the study next week.
But you may recall, that we were quite impressed with the 300 milligram dose in the phase 1 study.
That would likely be the centerpiece of dose expiration of phase 2 study, 300 milligrams.
And that in the current formulations, about 1.5 milliliters of injection volume but we anticipate that coming down in volume over time as we improve the formulation.
So we're talking about a 1 mil injection of the 300 milligrams, most likely.
Well, I think we still had a similar question a moment ago.
I don't know <UNK>, if you want to reiterate the response or elaborate on it further.
Just to add to that, I think clearly, on the back of an envelope, you can do evaluation for PCSK9 inhibitor which comes to values which could be very substantial.
I think most people have already done that and recognize that and even some people have published models on that.
So that's clearly a very high-value asset.
Carbavance, ApoA-1 Milano, ABP-700, as far as R&D assets are concerned, also I think relatively straight forward to model very high-value.
So certainly those four R&D projects would come out, I think, close to the top of anybody's modeling.
Yes, I think we have to be cautious there.
This is a new one for us, a generic market by calculation is a royalty off of gross profit.
The market for <UNK>iomax bivalirudin is evolving because it's a generic market.
So, don't want to come to any conclusions now.
We're very happy with our partner.
We think we have the strongest partner out there.
So if anybody's going to perform well, we will and they will.
But to put predictions on right now on a market that is changing, where price is changing, where the number of players are changing constantly; it's hard to put any certainty into a run rate
Yes, thanks <UNK>.
<UNK> here.
So first of all, IONSYS we've just got started with it.
We have got 78 formulary dates set up.
We're satisfied with that.
That's already 10% of the initial hospitals that we're shooting at.
So we're quite happy with that.
As for the training and education, you're absolutely right.
That's an arduous process.
We have to go through the education training of, particularly nurses as well as pharmacists, in all of the intensive care post-op care units in those hospitals.
So that's going to take some time.
But we have put together a team of nurse educators to help us with that and believe that that can be accomplished quite efficiently in the coming 6 to 24 months.
But as you know, these are not anticipated to be rocket launches.
They're rather slow steady builds over time.
We do think there's a great deal of interest in the product.
It's a very empowering product particularly for the nursing staff.
For Orbactiv, relative to single-dose Dalvance, I highlighted the excellent data that were presented at ICAAC and [ID] week, showing the relative bacteria's vital early kill qualities of Orbactiv which compare very favorably against all of the other gram-positive drugs that are out there.
I think the microbiology just gets better and better the more we study it.
The fact that Dalvance, we've expected for a long time that they would come with a single dose.
We believe that's the right way to dose these drugs and were glad that they agree with us.
The dosing convenience of, is it an hour, is it two hours, is it three hours infusion, I think that's a moving feast because we also are doing work to improve the duration of dosing.
So at the end of the day, I think people are going to choose the drug that is the most effective, the drug that actually has the best microbiological profile and of course, the drug that provides the greatest value.
So it will no doubt be an important choices people face and a competitive scenario that we anticipated.
Next question, please.
Well first of all, it's a shame for the Tetraphase program and the patients and their investors.
It's never great to see slip-ups of that nature.
I don't think there's any read through though at all.
As for TANGO 1 and 2, they're recruiting well.
We remain comfortable that we can get these two trials finished or get the NDA ready by early 2017 and get these trials pulled together by the second half of 2016.
And for the time being, we're going to stand with that estimate.
If it improves or looks earlier then we'll, obviously, let people know.
Thanks very much everybody.
With four potential blockbuster programs ongoing in R&D and five hospital launches, it's certainly a busy place.
Dr.
<UNK>'s arrival to help us with strategy I think has made a huge difference already and we're looking forward to executing on those plans in the coming weeks and months.
And of course, beyond that too.
So thanks very much for your attention.
We'll keep you updated on developments as they occur.
Bye for now.
