ALXN
#Sure.
With respect to the fourth quarter of 2016 and the SG&A, I don't have all of the numbers in front of me but think of it as essentially all of that increase is associated with the investigation.
There's other as you no one time expenses typically that we have in the fourth quarter, there's items in both the second and fourth quarters as I mentioned earlier if you look at our typical pattern we can get that break out for you later but the significant item that influenced that would have been the investigation.
And then in terms of 1210 headwind duration as we talked about that will also be the annualized impact of the clinical study and the enrollment in those studies in 2018.
So I think there's always going to be some timing variability that's the nature of clinical trials, but for planning purposes, we would expect that headwind would continue through 2018.
Thanks, <UNK>.
Let me start with the view about our overall pipeline.
I mean, I think we've made a very strong commitment as an organization to extend our success and expect to extend our success in the complement franchise well into the next decade.
<UNK> mentioned our intellectual property expectations both are expected new intellectual property for Soliris along with the patents we have for 1210.
And so our goal is to continue to develop both 1210 and Soliris for new indications, there are other complement mediated diseases that go along with some of the other complement inhibitor projects that we have in the pipeline, and <UNK> can comment on those in a minute.
In addition to that it I think we plan to be very active from a business development perspective to identify opportunities that we think fit with our model and with our strategy and bring them in.
And so we aren't committed to a particular area, I think you know the complement franchise I think will continue to be a very important part of our future, we believe the metabolic franchise is positioned to grow for the next several years as well.
We have Samalizumab now under way which could represent yet another diversification of the pipeline and we're very active on the Business Development front looking at other opportunities.
<UNK> can you maybe put some more color on that.
Yes, thank you <UNK> and thanks for the question, <UNK>.
I'll take both questions, a follow-up to some of <UNK>'s comments and specifically on Myasthenia gravis <UNK>, you've mentioned some of the programs as well as having a metabolic franchise now with Strensiq and Kanuma.
We have a number of other programs that we're running outside of complement.
But I would say that it's really important that we continue to have this sharp focus on our complement pipeline not just C5 with obviously Eculizumab and ALXN 1210 but we have a number of other complement inhibitors pre clinically that we're looking to progress against a number of different indications.
So it's very much concentration out-compete ourselves on complement as well as diversifying into other areas such as Samalizumab and the metabolics.
In terms of our programs and preclinical we haven't spoken out they are all lined up against devastating diseases looking for transformative treatments and they go across multiple therapeutic areas.
And then in terms of your specific question on Myasthenia Gravis and the advisory panel, it's too early to say whether the FDA will consider an advisory panel but I would remind you, the decision to file in the US, Europe, and Japan was really based on very positive in person meetings with regulators and all of those authorities we reviewed all with perspectively defined endpoints.
As you know 18 out of 22 of the endpoints were pre-specified analysis and the P-values of less than 0.05 so very positive meetings with regulators we'll wait to hear back on from the FDA particularly in terms of an advisory panel.
Thanks for your question.
Thank you, <UNK>.
Great, why don't we take the first part of the question, <UNK> regarding PNH and future opportunities.
I think you stated we believe that got significant growth ahead of us.
Do you want to give us some color on that one.
<UNK>, thank you for the question.
As we have highlighted in the call, one metric we are looking at is how many patients are we finding in both in PNH as well as in HUS year-over-year, especially in our leading Markets the US and European Markets.
We continue to identify the same number of patients as previously.
And importantly, as it relates to their disease and severity of disease and conversion to treatment, we see a consistent number of patients initiating treatment and so this encourages us in our view that the majority of the opportunity for both PNH and HUS is in front of us.
Good <UNK> do you want to comment on the considerations that went into the impairment charge.
Yes, let me do that and I'll turn it over to <UNK> for the research and the technical side of this.
But it's really for us, obviously, annually, a review of all of our assets and in this case, based upon that evaluation, and driven by increases in both the development in commercial timelines as well as the updated cash flows, that really lead to the accounting and the decision from an accounting perspective to take the impairment.
And <UNK> over to you just in terms of anything you'd want to add from what you've already discussed on this subject.
Yes, thank you.
Thank you, <UNK> and really, <UNK> as part of your question, there in lies the answer.
We are continuing with a study with the patients that are currently on SBC103 and randomized either 5 milligrams or 10 milligrams very keen to look for this correlation between the Heparan sulfate reductions and benefits to neuro cognition and brain structure.
So we'll continue to look at those, but working with <UNK> and looking at just what he said no new patients into that particular study or additional trials until we really see those data.
I hope that makes it clearer <UNK>.
Thanks for your questions.
I think we're wrapped up here is that it.
Thank you all for participating.
We appreciate it.
