MDCO
#If you're looking for an analog in terms of sales and market, the obvious one which changed the game last time, was Diprivan.
First of all, we've already, I think, indicated our understanding of timing of this.
We've, I think, stated that we believe that the timing is a median of 2 1/2 months but a range of 1 to 6 months.
That's the only information we have, and we certainly don't have any updates for that.
As far as its impact on operating costs and expense, I think <UNK> has already covered that.
We'll take that step, when and if it happens.
Again, just to recap on prior discussions we've had in public, the study we're doing is an escalating dose, subcutaneous study with patients first getting a single dose, and then a second part of the study where they receive two doses.
The aim of this study is to demonstrate, first, the dose related reduction in PCSK9 protein expression and in LDL.
And we expect that to be the first part of the study.
Then as part of that observation, we should be able to estimate how long a single dose of PCSK9, if you like, last for.
What's the duration of LDL knock down.
What's the duration of PCSK9 protein knockdown.
From the second part of the study we should be also look at the effects of the second dose, and that will give us some pharmacokinetic and dynamic information about dosing periodicity.
Either way, I think we're going to be able to come out and say, we think the drug could be or couldn't be, but I think we're very optimistic, could be dosed much less frequently than currently planned antibodies maybe as infrequently as every three months.
We also will be able to make reasonable estimates of the volume of injection required to elicit these responses.
In general, we believe that will be less than 1 cc, which we think is also incredibly important for patient care.
Let me just clarify the last thing, <UNK>.
Orbactiv was launched in October, so this is actually our first, full quarter that we just reported.
And we feel very comfortable given the eight steps of hospital adoption that I read out earlier, which I did so deliberately, that we're marching along that adoption pathway in a very effective way.
I think our teams are engaging the right hospitals, are getting the right signals from a lot of formularies, winning a lot of formularies, putting protocols in place, and beginning to get drug utilization.
It is the nature of the launch of hospital drugs in the 21st century that you cannot just go to doctors and ask them to start writing prescriptions for your drug.
You've got to get the hospital system working with you in order to build a sustainable and growing business, and we're very pleased with the execution progress we're making.
It sounds a little bit odd for a CEO to say this, but I don't think we should be counting boxes as much as we should be counting relationships and processes at this stage, but the box sales will come I believe.
As far as the number of customer-facing people, the 400 number includes everyone in our Company who works with customers.
That includes about 340 people, field base, and about another 70 or 80 people who are working in the home office, if you like, on marketing, reimbursement and analytics programs.
So just to be clear on that.
That won't change with the initial launch of Ionsys, but at the numbers we gave out include everything and include the Ionsys launch planned.
Over time, could these numbers evolve.
Absolutely.
In each of our given areas, depending on developments of those drugs, the numbers may be titrated up, titrated down, depending on market responsiveness.
Obviously, as the fate of Angiomax is clear then our need to deploy against Angiomax may change.
However, on the growth side, Ionsys, if anything, will be increased in resources as it rolls out.
And that's the stepwise plan that we have.
In summary, it's more like 340 field based, of the 400, but there's a lot of shared services, marketing and home-office based people also included in the number that was quoted as 400.
They are not all reps, quote.
Then your first question which was PCSK9.
Will the results of this study be definitive.
Well, let me put it this way.
They'd be definitive in the sense that you'll know what a single injection of PCSK9 does to you and if a single-loading injection of a normal dose was to knock down your LDL, as it did in the primate studies, remember, for three months or more.
If that is associated with both LDL and PCSK9 reductions that are substantial and especially at the dose related, which they were in non-human primate studies, then I think we really do have an extremely exciting prospect for market, which is going to be, we believe, at blockbuster proportions.
And where the development pathway is very straightforward, because clearly the clinical proof of concept of LDL lowering is well known and others are helping us with that.
So I'm very excited about this one because I think it's ---+ we're working in a massive market opportunity with relatively simple development steps.
If I compare the development of a PCSK9 inhibitor with the development of cangrelor, frankly, it's a whole lot simpler.
Yes, I think, remember ---+ it's a good question, <UNK>.
Each product has to go through the same steps.
If you go to a large hospital system and let's say Orbactiv is already on the formulary, already in standing orders, already being used and increased, unfortunately that doesn't accelerate the Ionsys.
You still have to go all the way back to beginning of the process for Ionsys.
Now, because we know the hospital because there's a level of trust established, The Medicines Company people working with the hospital are probably going to have some advantage, but the hospital still has to go through its internal processes for each product.
We respect that, and I don't think we can anticipate any sort of leap-frogging moves through those eight steps.
<UNK>, that's because I didn't mention the price, my friend, and I'm not planning to right now.
We're working on that.
I think what I did say, and I'm very happy to reaffirm, is that we are getting extremely good feedback in our market research and pricing studies and we feel we can certainly launch this with a premium price, largely because the value beneath the product is easily to describe and we believe demonstrate.
So we are excited about the pricing opportunity here.
It's what we said on the call, so we hope it's true.
<UNK>.
<UNK>, we're looking at the numbers now and that's where the direction looks like it's going to be lower.
Don't forget, if a generic does enter, it would be mid June, so we've taken that into account, as well.
Then, really the activity by a generic would be very intensive probably beginning of June.
We know for a fact, now, that competitors out there are talking about entry of a generic.
Until we get the court case, we don't know if that's true or not true.
Our inventory levels are, as at the wholesalers, are decreasing and we would imagine that they're also decreasing at the hospitals.
It's probably premature to do that.
Obviously, we haven't got the results yet.
I think that the IV study that was important and published in the Lancet, clearly shows you the potential for this drug in humans.
Remember, we are on a different platform and we're subcutaneous, so the dose response might be different.
Let's wait and see that data.
But, I think the order of magnitude of effect and the order of magnitude effect in the non-human primate studies, I think, has been very consistent and definitely right up there with the antibodies.
And so I think we can look forward to a strong effect, if the results are what we anticipate.
If the what passes.
I didn't catch that.
Oh, the DISARM Act, we haven't ---+ let's put it this way.
Positive, however, we're used to watching legislators create new legislation.
In general, we'll be interested in analyzing that once the legislation is passed.
Difficult to say what the final decisions and structure of the bill will be.
Thanks, Michael.
We're not going to make any comments about Eagle Pharmaceuticals on this call.
Thank you.
With regard to the Orbactiv launch, we are very, very pleased with where we are, as I said earlier.
I think the engagement of hospitals, the process of formulary adoption, the initiation of protocols, the pull through that we're seeing, I think is very gratifying, and certainly, relative to competitors, has been really quite strong, we believe.
As far as your third question about single-dose Dalvance, we've always assumed in our modeling that that would be an important product as well.
I think the whole game plan for everybody right now is ---+ the problem here is vancomycin, not the new generation products.
And there's plenty of space in this marketplace to improve patient outcomes, improve the convenience of dosing and to deliver better economic results for hospitals and infusion centers.
So as far as we're concerned, we would congratulate the Dalvance team on their study, and anticipate continuing to educate the market in how to use these new products in the best way for patients.
Sorry, you felt squeezed in, <UNK>.
We always like to reserve plenty of time for you.
These questions are actually pretty straightforward, because I think at this stage, we are not going to comment on the core case.
I think there are three judges involved and a lot wiser in these matters than any of us are, so we'll leave that to them.
I don't know what you want to say about gross margins, <UNK>.
<UNK>, I'm not going to comment on whether or not I'm comfortable with the sell-side consensus estimates.
I think that's something for sell-side estimators to worry about.
Then, in terms of the sales of Orbactiv, we did already say them on this call, but just to repeat it, $1.2 million of sales and about $800,000 worth of sales of Minocin, which we are actually very comfortable with and feel is doing quite well competitively.
<UNK>, do you want to say anything about gross margins on anything.
Not today.
Okay.
Thanks, <UNK>.
We thank you for your interest in this matter as a Company, which is rotating into a whole set of new launches and which has some blockbuster products we believe in the pipeline.
And we're very excited to be investing in these.
We appreciate your interest in what we're doing, and thank you very much for your support.
Bye for now.
