MNTA
#Sure.
I would say we are offering any help that is needed by either Sandoz or Pfizer in this process.
I guess we're standing by, ready to help wherever we can.
This is a more challenging one for us than the other things we have been able to jump in and resolve, because this is two steps removed, this a contract and a quality agreement between Sandoz and their fill/finish supplier, and so, we're working in partnership with Sandoz to be able to do anything we need to around our line, around the product, with the FDA, whatever is necessary.
Obviously, conversations have started across all three companies at this point, but it's very hard to say exactly who is going to be doing what, because I think it's still an assessment phase, and I'm sure there will be conversations with the FDA on Pfizer's part around this warning letter, as well, so, more to come on that.
In terms of communication from us, on the regulatory review, I don't expect there will be much, to be honest with you.
What we've said is we have no outstanding questions we think the regulatory review is basically ready or near ready to be approved.
The problem is until this issue is resolved in the fill/finish facility, there is not much they can tell us, they're going to tell us that our application is pending the resolution of the facility.
They usually don't call you up and say everything is great and everything if fine, and all you need is that, because that is just not how they typically work.
Unless we got some other major questions on the application, which I don't anticipate, then obviously we would come back and tell you that.
I think their communication is mostly going to be around resolution of this warning letter.
I think in terms of communication and updates on that, I think you will probably hear from us once ---+ and if we can get comfortable with giving you a better sense in terms of the time of resolution of that.
So that's going to have to be first figured out, and then negotiated with Pfizer and Sandoz in terms of what exactly we can talk about there.
But that would be my goal, is to be able to give you a sense of resolution time once we can, and that would help you and us get the clarity we need to understand what the market potential is for the product.
The simple answer is no.
I can't talk about general or specific pricing of the product.
That is basically Sandoz confidential.
The only thing I can say is that as in any generic market the pricing varies based upon the customers and market that get set into in the individual contracts that are negotiated.
Beyond that, we haven't really talked about the specifics of the pricing for the 20-milligram.
This is a personal opinion.
Obviously, Sandoz has the decision to launch, but I think the launch here could go faster.
I don't want to undersell the 20-milligram, because we are at basically between 40% and 45% of the market on the 20-milligram, which is where you would expect first generic to get to in that range, so we are not in a bad place in terms of penetration of the 20-milligram.
If you recall when we launched the 20-milligram, we were launching into a market where we were facing two years of counter-detailing by Teva before we launched the product.
We were facing contracts that tied contracting in place, we were facing a physician and patient market that didn't understand or weren't aware of all the patient services that Sandoz had in place at the hub, as well as co-pay assistance.
Sandoz, in conjunction with they were helped by the Novartis MS sales force, they have done a tremendous job, not just of the 20-milligram, but actually in working with the patient communities to make sure that people understand the product, are confident in the product, know the patient services, get the co-pay assistance they need.
So, when we launch the 40-milligram, we won't be launching into any of that headwind.
The accounts we are in are happy with the performance of the product, if you just say we could take the accounts would just switch us to the generic, then you could see some uptick right away.
I think there is a possibility of penetrating this market more quickly, based upon the confidence that the medical community has and the patient community has, and the experience they've had with the Glatopa product, and that really is a complement to what Sandoz has been able to do in launching the 20-milligram.
You are characterizing my comments correctly.
I will give you two perspectives on it.
I think there are things that are contemplated in terms of patent reform and what happens on both the IPRs, et cetera, it could simplify that.
The consideration by the court that looks at reasonable royalties as opposed to other methods of enforcing patents.
But I also think this process could over the long term get easier, because if you think about products that are out there now and people are putting 110 patents in place for something like a Humira.
Sometimes there is a bit of a scorched-earth policy to try to protect today's products, because they're putting so many patents in place, they're creating tremendous amounts of [prior art] for future attempts at manufacturing and formulation patents.
I think this is something that's going to be challenging and could get easier based upon some things that could happen in either the courts or in Congress, but it ultimately is going to create an opening, because people will have less room to patent as they create more prior art.
Thank you.
First, on the Pfizer facility, I don't know yet.
Typically, in a warning letter, to resolve all the issues in the warning letter, you would expect another inspection to come in.
However, it was very interesting in the warning letter, and I tried to highlight it in my text, that the FDA said they may restrict approval of new products in the plant, they didn't say they would.
We don't know what that means, and we are going to try to figure that out over the coming weeks and months, but it could mean a number of things, but we just don't know if it's going to require re-inspection or not, but typically, to fully close a warning letter, you would expect to see that.
On Humira, in terms of repartnering, there are a lot of Humiras out there, you're correct.
I can say that we have had [approaches] and are in active discussions with multiple partners at this point.
I think one of the reasons is that as I talked about in the clinical data as well as the analytic data we talked about before, we have a very high-quality product.
It has really come out spectacular in the clinical results, as well as in the analytic work that we had done.
I think people see a very good and viable biosimilar here, which bodes well for us, at least potentially repartnering the program.
I want to thank everybody for coming on to the call early today.
I hope we were able to give some clarity in terms of what we know so far, and we look forward to updating you as things progress.
