PGNX
#I, <UNK>, did not ask them that.
There was nothing in our interaction with them that would lead us to believe that that's not the case, that they're not committed to the SPA and to the 25% response rate endpoint.
You know, as I've mentioned many times, I think that you can't just do the math and say that we only need, say, one more responder, because we want to see that this drug works in our hands as well.
But I continue to believe this is highly de-risked.
And the regulators are standing behind the SPA, and so we have a clear target to hit.
Yes, we did not see any significant impact in the fourth quarter.
So that is what's leading us to feel that the issue may be behind us, but I'll just repeat my caution.
It's just one data point.
It could be.
It does seem consistent with the IMS data that we have seen, but again, just one data point.
Well, I'm not expecting that, <UNK>.
And I do think that RELISTOR is quite important to Valeant.
You know, obviously, they're going through their issues.
We know so many good people at Valeant, so definitely feel for them.
And I know that they're going to put the effort into this to make it a success.
We have tools as well.
So we are going to make sure that all the effort that can be is put behind it.
And as I mentioned earlier, the disease and awareness work that was done for the Movantik drug has created great momentum, I think.
So the timing is good.
And as we further our discussions with Valeant, and as their plans crystallize, we'll share with our shareholders the level of effort that we expect to see.
Yes, <UNK>, I don't have any data on that.
The anecdotal information that we're hearing ---+ when we ask, why do the RELISTOR Sub-Q sales look to be, continue to be strong in the face of oral competition.
The answers that we get when we ask that question tend to be more focused on the onset of action: that RELISTOR is maintaining usage because people like the quick onset of a bowel movement that comes from the Sub-Q RELISTOR.
So I don't think I can really give you more color into who is getting the drug.
We can see some of that from the doctors who are prescribing it but I think it's too soon to tell if that's made a big difference.
But clearly the mechanism of action of RELISTOR is top of mind when people think about that.
Yes, I ---+ again, I think we'll be learning this from Valeant as we interact with their commercial teams in the coming weeks.
I love that pain sales force that Valeant established for the promotion of RELISTOR.
And we do see, as we look at these subscribers ---+ the prescribers in the IMS data, some trends there.
But I'm kind of reluctant to overstate that, because we're reading some tea leaves there.
But we do see a widening of the types of prescribers, for example.
So that is good news.
Well, they announced that they had entered into a distributorship agreement with this company Sobi, a Swedish orphan company, for the distribution of the Sub-Q.
We are learning about that arrangement.
What we know about it is it's a distributorship-type arrangement.
It's relatively short-term.
And we expect to learn more from Valeant about what their long-range plans are.
And key will be to get the oral submission made in Europe, because I think that will be an excellent value creator.
We saw ---+ with respect to the Movantik drug, Nektar in AZ entering into a lucrative European arrangement with ProStrakan.
And so I continue to believe quite firmly that there is excellent opportunity in Europe for opioid-induced constipation treatments.
So I continue to have strong hopes that we'll see a strong collaboration in Europe for RELISTOR.
But still work to be done there, including on the regulatory side.
Well, we're not planning Super Bowl ads for pheochromocytoma.
And this would not be a drug that you would have a launch party in the Arizona desert for.
The key thing, I think, in promoting AZEDRA will be the connection with the patients.
And the clinical trial that we've, you know, just completed enrollment has given us great insight into those patients and what's important to them.
So we continue to believe quite firmly that the best way will be a focused, small sales force, really more MSL types.
<UNK> <UNK> comes to us from NPS, and so I think we've got the benefit of <UNK>'s background from a finance perspective in how you commercialize an ultra-orphan drug.
And we're not really seeing significant costs.
There could be, or there will be, some costs associated with the manufacture of the drug.
But because it's a radiopharmaceutical that's made to order, you won't see the kind of costs, for example, to build up inventory in advance of launch.
But to have the adequate capacity to manufacture the drug commercially could result in some expenses in 2017.
<UNK>, would you agree with my assessment of that.
Yes, I think we have ---+ looking at our options.
And we definitely could add some cash costs.
I'm not sure how it will flow through the P&L, because this is a capital item, <UNK>.
So we'll be looking at that 2016/2017.
Some impact on 2016, but I would think it's modest.
In 2017 ---+ you know, we're talking single-digit millions in 2017.
So on the latter question, the worldwide rights are held by Valeant.
And so they are responsible for exploiting the asset in other territories.
There are existing distributorship arrangements in place, for example, in Australia.
And I think that Japan is a good market for an opioid-induced constipation drug.
Of course, the Japanese people are not high consumers of opioids, but we do see changes in the Japanese market with respect to ---+ by the use of opioids by cancer patients.
So the Japanese market is really an advanced illness market, but I do feel that there would be strong potential there.
It will be for Valeant to do the licensing there.
And as I mentioned in the prior discussion, I see a really excellent opportunity in Europe, and that was just validated by the ProStrakan deal that was done for Movantik.
So we'll be discussing with Valeant that as a really prime topic, to make sure that we are getting the best value out of Europe.
Could other territories generate significant revenues.
Perhaps, but as you look at opioid usage, really it's the US and Europe that will be the value drivers.
And then, forgive me.
I've forgotten your first question.
So we're beginning to do the BD work, business development work, around ---+ and again, I think the focus is Europe; but also significant opportunity in pheochromocytoma and paraganglioma in Japan, where these are rare diseases of interest.
And I think that the value will be strongest in partnering into those territories when we have the data.
So the business development effort ---+ focused on identifying potential partners, talking with them about how they would want to participate.
Where the drug is manufactured is a really important issue, because we make it to order.
So deals in Europe and in Japan will also clearly involve the manufacturing side of the drug.
And we would hope that we'll be able to conclude those kind of arrangements as soon as we can, after we are able to show the data from the US trial.
Well, it is long been a hallmark of mine that I like to do separate deals in the Japanese market, because I think that it's a very substantial market.
There are unique regulatory requirements there.
And so local knowledge is critical, and I think that's even truer when you're talking about a radiopharmaceutical, where local manufacturing and distribution will be advisable.
So I would look at the Japanese market as stand-alone.
And Europe has long experience with radiopharmaceuticals, and there are many accomplished manufacturers in Europe.
So I don't think we would be looking to compete with them, and would be looking to partner with someone in Europe who was able to cover that entire territory.
So I think an ideal situation for me would be for us to commercialize here in the US on our own, to have a strong European partner, and a strong Japanese partner.
That would be our goal.
I think we have nothing further to say.
So I'll thank you all and wish you a wonderful day.
