CORT
#Yes, in fact, let me do that first.
It's a really interesting scientific rationale.
I think for those of you who follow prostate cancer, prostate cancer for many men is either a disease that will kill them when they get to be 130 or is easily treatable, but for younger men who end up with metastatic disease, it really is a very bad disease.
And unfortunately, until relatively recently there really weren't good treatments for when it became what was called castration resistant.
Enzalutamide, Medivation's drug, is an excellent drug in that regard, it is a potent androgen receptor antagonist.
But one of the things, the really important latch that Sloan Kettering showed, was that really, within hours of giving enzalutamide, you begin to select for colonies of cells for which androgen is no longer the growth factor, but cortisol is.
There is a real scientific underpinning now shown in transgenic animal models and so forth that the combination of either surgical or chemical castration with a drug like androgen deprivation, better said, with the drug like enzalutamide plus a GR antagonist like mifepristone, like CORT125134, can really enhance the treatment.
It's, I think, a very promising idea, we'll really find out what happens in this controlled study.
And to your first question that you asked a little while ago, we expect results of that study, again, it's an IST, but in 2018
Thank you.
Hey, just to spread the questions around a little bit, I'm going to give you to <UNK> <UNK>, our Chief Financial Officer, Ray.
Hi <UNK>, no, we didn't raise prices this quarter.
We had a price increase last quarter, February 1, nothing this quarter.
I am going to give that one back over to <UNK>.
Thanks <UNK>.
One of the challenges in orphan disease space and the nature of this condition is that these patients need support along the way.
It's taken a long time to get to a place of being diagnosed and treated and then helping them along their patient journey.
We have a patient advocate team here that offers support for patients from disease onset all the way through the lifecycle of their treatment and the ways of helping them manage side effects and manage the comorbidities associated with their disease.
It's an opt-in program, those patients have to consent to be involved in that, but our patient advocate team has grown over time and has become very involved with those patients.
Also, pharmacy side of course, there's a pharmacist with our specialty pharmacy and our case handlers that work very closely with those patients as well on a monthly basis as they are coming up for new shipments.
So they were closely with them if there are challenges or questions that they may have.
And <UNK>, the only color that I would really like to add to this, and it's something that really struck us from the beginning of our commercial on, is when we began to talk to patients, we found that these are often patients because it is a rare disease, that been bounced around, it had taken a long time to get to diagnosis, often felt as if they had not been treated well in the medical system.
And we really felt that by helping to guide their journey, we really could improve their medical care optimally.
And I actually think that our patient advocates are very large part of it, they are trained nurses and so forth and they really can help, of course with the patient's consent, their pathway through.
Additionally, and I will just point to this separately, from the time that we launched we actually stated and we have never violated, every patient who gets a prescription gets the medicine, and we work very, very hard to make sure that happens as that expeditiously as possible.
They can help with that as well.
Two questions.
We are now just beginning the phase 2 study for CORT125134 in Cushing's syndrome and we think that phase 2 study will take about a year.
So, I am hoping by the time we have this call next year, fingers crossed, we will have all of the results that we need to show you by that point in time.
Then as you know, in oncology studies, it is not like you have an eight week observation period.
We're going to run the study until patients have progressed.
This is, again, the Korlym and Eribulin study.
Now you know the nature of this disease, these are highly pretreated patients with metastatic illness, in many cases, unfortunately, that time is not long.
So, we expect to report those results at San Antonio breast cancer meeting, but we will report them as soon as we really possibly can and it's fully baked.
Patients are still on study.
Well, we presented the results, as I said, at ASCO, and I think that is really the last material update that we are going to provide for everybody.
But I really can still tell you that patients are on study and when they are not, we will have our final results.
Well I think there are really two things to look at, one is the overall response rate, as you have described.
And I think that this is a difficult disease, and the response rate really from any condition is, by standards in other diseases, pretty low.
I think what is really striking to us, and we'll have to see if it is also provable in a controlled study, is that there is a group of patients, and it's similar to what I think people see in immunotherapy, who seem to really respond for a much longer period of time than would otherwise have been expected.
About one-quarter of our patients are now beyond what was the 95% confidence level in a pretreated group of Eribulin only patients.
But again, I caution everybody that the previous study was an open label study, ours is an open label study, the real passive test is in the controlled study.
But it is a striking result that there really are, and I use this term with some trepidation, but it's just what some people say, some super responders.
I don't know really why that is the case, we cannot prove at this point that it's not just random, but it's really has been striking to everyone we have shown it to and I think really worthy of further exploration.
Yes.
I think I can really answer your question, but I really, again, want to provide a little context for this.
In our study for approval, our pivotal study, the median dose was about 750 mg and actually, the median dose was about 900 mg.
So, and in that sort of study, titration took place pretty quickly because it was part of the protocol, where is in the real world, titration takes a little slower because people don't come to the clinic every week or two weeks.
Now what's interesting that our average dose has increased over time but it still, rough for round numbers, around 600 mg and not 750 mg.
So we think that actually it could go further, because we think that patients optimized treatment is a little bit further.
I think that what we're really going for and what we're really helping our doctors with is that patients get to their optimal therapy, because we think at the optimal therapy pretty nearly every patient should see a substantial response.
That's true for some patients right now, but not all of them, but we hope to move the dial in that direction as time goes along.
And clearly, although it is a secondary thing, there is more economic benefit for getting people at the optimum dose.
Yes.
So we record the vast bulk of our sales, we sell, actually, directly to patients.
So we record sales upon delivery to the patients.
A very small portion of our sales is through a distributor who sells to hospital pharmacies, that's not really needs to be a material part of your calculation.
So the vast majority of sales directly to patients and it's upon delivery that they are recorded.
I think the reason you see receivables pop-up is that we had a very strong quarter and just we have not had time to collect everything yet.
But there's been no real change in the financial terms of our business over the quarter.
Thanks for taking my questions.
I have a couple of them.
Joe, you have a number of drugs that clearly impact metabolic markers, you have of Korlym and CORT125134 that have gone through or will go through a proof of concept on Cushing's Syndrome.
I share the excitement around CORT118335, what makes it so interesting from the [ammo models], what makes it so unique for metabolic syndrome.
What's interesting, and I have to be completely honest with you, <UNK>, we look at these things empirically, we would love to know what CORT118335 is so potent.
But I can tell you, it's about, even though Korlym really moves everything in the right metabolic direction, sometimes fairly substantially, on a per milligram basis CORT118335 is probably 60 times more potent.
And it seems to be particularly potent in diseases where the liver is very heavily involved, so fatty liver disease, antipsychotic induced weight gain, insert insulin sensitivity around those levels.
Now it's still fairly early in its pathway, it's just had animal studies, but the animal studies are being replicated in many different sites and there really is something going on with this medication that we don't fully understand, although I know you are sort of a scholar about these things, there was an interesting article published in PNAS about the cofactors which were involved with 118335 and they may give you some idea as to perhaps why this compound empirically is more effective.
We'll see if that translates to humans next year.
I have yet another question about sales for you and <UNK>, but hopefully it will be more of a conversation, I will try to give another tact on it.
Korlym is [typed] so high that new lives just have to account for very few new prescriptions a year for Corcept to generate profits.
At the same time you're getting past your first tier, your physicians and patients are getting increasingly dispersed.
And <UNK>, you talked about opening new areas organically, but if I read this right over time, even though you are opening organically, you really do not need a lot of patients in an area to signal the need for opening a new area.
Did I get the package right or could you provide some color on it.
I think I'm gong to hand it over to <UNK> in a second, but I think that the most important thing, and I know it is an unstated assumption for us, but I just want to make sure that everyone on the call gets it, is that Korlym is a very effective medication.
And in the pivotal trial, the overall percentage of people who had significant clinical improvement was 87% which really meant that it was pretty nearly 100% if it takes its dose correctly.
And I think that's a very important starting point.
We think that there are many patients in the country who have not found their way to optimal treatment and so we get, and we really noticed the early on and had to adjust for, these patients exist in medical practices in all 50 states and rural areas and urban areas and so forth.
So, that's the lay of the land.
Now, I will let <UNK> answer your specific question.
So back to reiterate the specific question was just around the incremental enrollments that come in and what is required from a headcount standpoint.
We really try to understand, what does it take to grow.
What does it take to add-on incrementally to grow our business.
And one of the things is this is a drug in the orphan space, we have patients across multiple etiologies, they have different retention factors associated, we have very [ectopic] patients that come in that are very, very sick and unfortunately they pass away on the product over time.
These are not ---+ we're not building upon the same base on a month by month basis, so we need to continually, obviously, add patients.
I think given the long sales cycle associated with this, we really need to make sure that it does make sense to put in additional headcount from a cost standpoint into a specific territory to grow the business or is that something that could be covered by an individual that is already there.
So, again, we are very careful about where we think it makes sense to add but, to your point, given the drug and the price of the drug, if we find an opportunity where we believe that there are patients were not being reached because of inadequate touch, then we will expand our field to reach those patients.
And <UNK>, it's something I said before, but I just want to repeat this, the controlling variable is really finding the right clinical specialist.
Because, we really do think that the right clinical specialist in a territory which has previously not been productive for us, where patients haven't been treated, will succeed.
So all of the things that <UNK> said are true and really this decision is very, very important, but what we really look is the front end, and we've learned what the front end really looks like.
Can we get the right person, can we train them correctly.
Because if we think that we can, we place them in the right territory they will be productive in the timeline that we have talked about.
I appreciate that.
Thanks.
Thank you very much, on a summer afternoon, late in a summer afternoon for all listening in.
We look forward to talking to you in another quarter.
Thanks very much.
