LLY
#Let me start with the sola question.
And make sure I hit all these, <UNK> as we go through, or <UNK>.
So on sola, we have a more standard data safety and monitoring board like we do with many large studies.
Their mission is really one of monitoring safety.
We have communicated on prior calls we have not chosen to go for an option to have an interim look specified by the company.
And we would not instruct them to conduct such a review.
I will say that data safety and monitoring boards, as we set them up, they're independent, their mission is to look at study data on behalf of the patients, and it's not unprecedented that they may call us and say we think you should stop the study.
But we have not asked them to do that, and we're under no obligation to follow their recommendation.
Based on our observations from EXPEDITION I and II, you would note it took till about 40 weeks to see a drug effect.
And based on the enrollment curve we have for this, we don't see a lot of value in looking at an interim because we enrolled the study very rapidly.
And most of the benefit will come in the final months if the study behaves like EXPEDITION I and II.
So unfortunately, we will be waiting until late next year, the latest part of next year before we have the answer, and I would expect the study to run until that time.
On US pricing, you're correct to point out our year to date is 3%.
I think that's more indicative of the underlying trend we see, which is list price gains net of gross to net reductions for all the various mandated and commercial reasons.
The one-time event in Q3 which <UNK> tried to answer earlier was a shipment to our authorized generics partner.
It's a large shipment.
The way that deal's set up is we book revenue under the terms of that deal for the bulk product that they then distribute, creating another option for patients, a low-cost option for generic raloxifene.
There's clearly demand for that in the market.
And we're help to supply Lilly-made raloxifene for our authorized generic partner.
The way that deal's set up, those shipments happen periodically.
' It just happened one occurred in Q3, and it was subsequent enough to shift down the Q3 reported price below our ongoing trend.
But I think the year-to-date numbers are more indicative of our trend.
I think your next question was on the base inhibitor, and what would trigger that into Phase III.
We've previously communicated that as well with our partner AstraZeneca.
We designed this as a Phase II-III program.
We are actively enrolling into the Phase II components.
The primary objective of the first interim analysis, which we expect to happen in Q1 of 2016 will be a look at safety.
Base inhibitors, while very promising in terms of genetic validation, and their pharmacokinetics and dynamics, many have gone down on off-target safety.
So this is a first look at sustained dosing in a reasonably large cohort of people with Alzheimer's.
And that will then trigger expansion of that study and perhaps triggering another study and movement into the Phase III component of Lilly's pipeline and advancing to patients.
Was there another question.
Okay great.
<UNK>, we're having a hard time hearing you.
I'm not sure if you can do anything on your end to improve audio quality.
Yes, it is.
I do not believe we did.
I think we have commented that the study designed for ACCELERATE was to have people come in on a variety of statins that they may have already been on on the maximum tolerated dose.
I will just qualitatively say the patients who entered the study had LDLs in line with guidelines.
And it was really already on best standard of care statin.
We further reduced LDL as <UNK> mentioned in the mid-30s on top of that, thus the quite surprising to us, and I'm sure the field lack of MACE effect.
We will be disclosing more data about ACCELERATE, everything we've learned and probably more data exposures after that sometime in 2016 in a major cardiovascular meeting.
Yes, you will have to remind me on the CSF1R question.
With regards to IO staff, we actually have a really, really good team of people in New York and in New Jersey who are focused on IO.
And Michael Kalos heads our research group there, he came from U Penn.
We also recently brought in some IO experience in the medical and the development area.
And we have in our IO hub that we announced in New York and New Jersey recently moved one of our very experienced drug developers from Lilly.
So we feel very good about the expertise we've got there, and we're going to continue to built that internal expertise as well as through the partnerships.
I think we announced over the last year, nine different partnerships related to IO.
So our view is that we will use the external expertise and the internal expertise to continue to drive our IO experience.
<UNK>, I don't know if you can comment on that.
I can't comment on that.
From a timing perspective, we have completed our Phase I dose study and now have a dose of one arm.
We just announced actually a collaboration with AstraZeneca to do a combination of the PDL-1 with our CSF1R.
So we think from a timing and from a development perspective, we're as competitive if not more competitive than other companies.
The specifics around the dimerization, we're going to have to get back to you on, okay.
We're excited about our CGRP antibodies for two different conditions.
We're studying first for cluster headache, we announced earlier in the year.
We proceeded into Phase III, and those studies are enrolling as we speak for both chronic and episodic cluster.
And then on migraine, we finished our Phase IIb study in the first half of the year and actually read out the results in June.
We need some robust reduction in headache days, et cetera, and we will be proceeding into Phase III imminently.
We're excited about this program.
We think it's a very competitive molecule in a largely underserved space.
In terms of the oral products, there's been a long history of researching and attempting to create an oral CGRP inhibitor.
That's proved to be difficult I think for many of our competitors.
We are in the list of people who also have our own program in this area.
We don't have anything to say about that today.
We observed the trade that happened and wish them all the luck in the world.
But right now, all the data in terms of what looks like drugable CGRP inhibition are antibodies, those are the late-stage projects, and of course we have one of those.
The ---+ you are right that it's a little on the pipeline.
It's the [biochaperone] that we licensed from Adocia.
I think so far the program is progressing extremely well.
We're very pleased with the results, and as we continue to get results, we will be sharing them.
Yes.
If you notice every ---+ each of our quarterly calls, we provide the absolute gross margin.
But then we also provide a slide in the packet where we illustrate what our gross margin would be without the effect of FX.
And if you're trying to get a sense of what the underlying run rate is, our gross margins are really running in that mid-70%s range.
So once all the FX noise is cleared out, which we expect to exhaust that once we move into 2016, you should expect we're going to be somewhere around that natural run rate of mid-70%s.
Thank, <UNK>.
We appreciate everyone's participation in today's call and your continuing interest in our company.
We hope you will take part on our call on November 11 to discuss the baricitinib data that will be presented at ACR as well as our investor event in Boston on Tuesday, December 8, where we will discuss in detail our Animal Health business and provide a comprehensive overview of our efforts in Alzheimer's disease.
We hope these updates allow you to more fully appreciate the myriad opportunities before us, and why we're bullish on our future.
Finally, if you have questions we didn't discuss during today's call, please contact our IR team.
They will be standing by.
Thank you and have a great day.
