MNTA
#Sure, absolutely.
So your first question was on appeal of IPR, and that would also go for appeal of any court case that we would have.
We would anticipate appeals here.
You would expect any company with a product that is as important as this to actually use appeals as a route to try to appeal a lost decision.
So that would fall in what is very typical and classic for generics, is looking at what do you think your chances are of winning that appeal, and that really depends upon the strength of the cases that actually were won.
So Sandoz is very experienced at this, and we expect that they will take a very close look at all the legal decisions when they're making a launch decision.
We do anticipate both a positive IPR as well as a positive outcome for us in our court case, and so therefore we expect it to be in a good position to be able to launch in the first quarter.
But we have to wait to see what the results of the court cases are.
On the CVS formulary, that's a place where I think I've been talking in the past about my belief that biosimilar penetration in the US will be helped by cost pressures and formularies actually picking up the programs.
And it's actually, I think, a very positive thing to see people starting to pick it up.
It should actually help penetration of biosimilars, in my view.
Sure.
Well, for the program overall, after Phase 3, we expect the program will have a very successful Phase 3 readout.
In terms of what Shire's going to do, we have not had formal conversations with Shire yet.
As I have said in the past, we think that the combination of Shire and Baxalta would be a good partner for us, but they have to make their own portfolio decisions.
And it may provide an opportunity for us to get the product back as well.
So we'll have to just to see what their decisions are.
I do anticipate that we will be having discussions with Shire in the relatively near future, and so we'll update you guys as appropriate.
Yes, I would say first, we can't really comment on our legal strategy, and second, it's a relatively new patent, so we're still really looking at all of our options.
There are several different ways that this patent could be gone after.
So I guess that my comment is you have to wait and see.
But we are pretty confident in our ability to actually challenge this patent.
We're just looking at the different options at this point.
I'm going to kick that question over to our Chef Medical Officer, <UNK> <UNK>.
<UNK>.
And I do want to give a shout-out to <UNK> and the team here, because the DSMB actually gave us these results at 9.30 last night.
So as you can imagine, it was a late night for many people here.
Sure.
So there were indeed some differences in the products.
I don't want to undermine the quality of the product that they made, but it's not to be expected that there would be some minor differences.
But I think what I was commenting on was, number one, Amgen's analytic work combined with their clinical work to show that those differences didn't matter structurally, as well as what I perceived as a very well-prepared FDA to actually take that analytic data and actually use that as a rationale for actually extrapolating.
One of my things that I was really surprised at is how well and strong in favor of this FDA came out.
They have been actually stating for a long time that they're going to actually use analytic data in combination with clinic data in making their judgment.
And in the earlier Advisory Committees, it tended to be a heavily clinical dominated discussion, and this one, it was a very different picture.
So that's where my comments came from.
Well, obviously, these antibodies, when you're trying to make them close, should be acting relatively similar to the original brand antibodies.
So if it's inherent in the antibody and you're trying to duplicate the structure, you'd expect to see it.
It's an interesting question.
My view has been in the biosimilar pathway, with the goal of making the same antibody, is that you're really working on trying to drive things which have the same effect.
And when you're starting to look at ADA, those are biologic effects that could have clinical effects that could have been in the original trials.
I do think that there are opportunities, as people do this, to actually look at making better molecules.
But my own view is that tends to shift you to a different pathway, because you actually have to show independent clinical evidence in terms of what you're actually creating.
<UNK>, I don't know if you have any thoughts on that.
Yes, I think you would be really judged primarily by having the same behavior as the parent molecule.
I think they wouldn't penalize you, is more the view I think we have.
So launching at risk here is Sandoz's decision under our contract.
We obviously were involved in all the discussions with Sandoz, but it really is ---+ so I really can't comment on Sandoz specifically.
What I can say is that in the generic world, when you're looking at patents, this patent is one that's going to rise or fall based on some pretty clear and simple standards of obviousness, et cetera.
So it's different than when you're looking at a complex issue of molecular weight measurement and things.
So we think this is going to be one that is going to be much clearer to understand the court's decision, and therefore it would be a much easier decision on launch, because of course, you will anticipate appeals.
But this is a much more common situation that is faced in generics, and Sandoz is a very sophisticated generic company.
So I anticipate that we will see pretty good logic here for launching.
And as I said in the call, we are preparing for first-quarter launch, and you should take that as we are all well aware that there will be appeals.
So first, obviously, we don't retain the ability to make that decision to launch at risk independently.
This product is partnered with Sandoz, and so I think the plan is really to work with Sandoz to figure out how to best get this product into the marketplace as quickly as possible.
On the novel drug programs, we have received several points of interest of our autoimmune candidates, and so I would say there is a fair amount of interest in what we're doing in the autoimmune space.
I can't give you more than that.
These are early programs, and so we will make our partnering decisions when we think we have the best opportunity for those programs.
But there is definite interest and attention being paid to these programs.
So we haven't given any specific guidance in terms of market penetration.
What I have said is that with the combination of the 20 and the 40, that we should have a more complete toolset to be able to deal with the contracting barriers that Teva has put up.
But I think our market penetration, the best way to look at it is to go back and think about what is the number of competitors in the market if we're first and we're only, what can we expect to see in share.
But the main point is that that market is a much larger market than the 20-milligram market.
So there are two issues there.
Let me try to get through them for you.
On the pricing side, it\
Well, formulation includes the concentration of the API, so that's why it's, by definition, a different formulation.
Yes.
Thank you very much.
I'd like to thank everybody for taking the time out of this beautiful day to join us on this earnings call, and we will keep you updated on all the things going on here and look forward to talking to you in the next quarter.
Take care, everybody.
