My name is Chris James. I'm a senior biotechnology analyst here at Ladenburg Thalmann. We're pleased to have Acadia Pharmaceuticals. We have a buy rating on the stock. Acadia is passionately focused on improving the lives of patients with CNS diseases.
The company commercializes a drug called NUPLAZID or pimavanserin, which is the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Speaking today, we have Stephen R. Davis, Acadia's President and Chief Executive Officer. He's a member of the Board. He joined in 2014 as the Executive Vice President, Chief Financial Officer and Chief Business Officer.
He was appointed to Interim Chief Executive Officer in March of twenty fifteen and President and Chief Executive Officer in September of twenty fifteen. I'll let Steve take it from here. Thank you.
Okay. Thanks, Chris. I'm going to move over here so I can I've got just a few slides. We'll as Chris mentioned, we'll spend about fifteen minutes. I'll just level set with everyone, I'll do a brief presentation, and then we'll go to Q and A.
I think everyone in the room is probably familiar with the fact that the pharmaceutical business has certain inherent risks and uncertainties. Please see a copy of our latest SEC filings for a description of these risks and uncertainties as they relate to our business. At Acadia, we are transforming the treatment of Parkinson's disease psychosis. The basis for this, as Chris mentioned, is NUPLAZID or pimavanserin, which represents an entirely new treatment paradigm in the treatment of PDP or Parkinson's disease psychosis. NUPLAZID the first and only drug approved by the FDA for hallucinations and delusions associated with PDP.
I mentioned it represents an entirely new treatment paradigm, but I just want to expand on that for a second. It's the first drug approved to treat hallucinations and delusions in these patients without impairing motor function. And the way that NUPLAZID achieves this is through its very novel mechanism of action. NUPLAZID is, in addition to being the first drug approved for the treatment of PDP, it's also the first selective serotonin inverse agonist approved by the FDA. So it preferentially targets five HT2A receptors.
Every other antipsychotic works through multiple mechanisms, but primarily by blocking dopamine or in particular, the D2 receptor. And there are pros and cons of blocking D2. You certainly get efficacy by blocking it, but you also get a whole host of side effects, including metabolic dysfunction, sedation, things like ekathisia, etcetera. In the case of Parkinson's patients, you have additional liabilities with blocking D2. And that is a consequence of the fact that Parkinson's, of course, is involves the deterioration of the part of the brain that produces dopamine.
And so to treat the motor symptoms of Parkinson's, we administer synthetic dopamine or dopamine agonist. By when patients develop psychosis, and about half of Parkinson's patients ultimately will during the course of the disease, if you give them a dopamine blocker, that drug has the potential to block the effects of the drugs used to treat the motor symptoms. So physicians make this compromise or they previously had to make this compromise in terms of whether they aggressively treat the motor symptoms or the psychosis, and they usually have to settle somewhere in between. With NUPLAZID, they no longer have to compromise. They can aggressively treat the motor symptoms with dopamine agonists or drugs that are increasing dopaminergic tone.
They can administer NUPLAZID, which doesn't touch dopamine, just blocks 5HT2A And as a consequence, have the potential to get much better outcomes for patients. I mentioned the some of the downsides of blocking dopamine D2. And one of them is we avoid the significant many of the significant safety and tolerability issues that you have with that. And with our very selective serotonin inverse agonist profile, we have a very favorable tolerability profile, which is really important in this frail and elderly population. I'm going to backtrack for just a second, just to share a few a couple of slides regarding the some of the results we achieved in clinical trials.
And what's represented here is the results we achieved in our 20 study. That was the single pivotal study that served as the basis of approval for NUPLAZID. And what we see here is a very significant improvement on the SAPSFIDI scale from baseline, With virtually all CNS drugs neuropsychiatric drugs, I should say, you get a placebo response, and we saw that here. But what we see beginning with week two is a very nice separation from placebo. In addition, importantly, what we see in this next slide is not only do we see a very strong, very clinically meaningful response, we see it across the spectrum.
So some patients improved exhibited a one point response, some at 3.5, seven, ten. And you can see in fourteen percent of the cases, we established a complete response. But the thing that I want to point out here that's really important even if a patient achieves only a one point response, a one point response can represent the difference between a patient having hallucinations or delusions on a daily basis versus a weekly basis. And so as you can imagine, many of these patients are cared for by their spouse. Many of them are in long term care facilities.
And just being able to reduce the frequency or severity or both of hallucinations and delusions can have a significant impact on their quality of life. We launched NUPLAZID a year ago, May thirty one of this year, so May thirty one of twenty sixteen. We're now a little past a year, almost one years point into the launch. And as I think many of you who followed our quarterly earnings reports are aware, we've had a very successful launch of the drug and getting really nice traction. We are targeting 12,000 neurologists and psychiatrists.
The vast majority of our targets are neurologists. We as many of you know, earlier this year, we expanded our sales force from 133 reps to approximately 155, primarily dedicated to increasing penetration in long term care. We are now on all Medicare Part D formularies and continue to expand our coverage on commercial formularies with over 90% of commercial lives now covered. More recently, in the last quarter or two, we've begun focusing on increasing awareness on the patient and caregiver side of the equation. So we feel like it's very important to establish a baseline with physicians.
They need to know about the drug. They need to have a good understanding of the advantages of the drug. And we're at a point now in the launch where, in addition to doing that, we're beginning to increase our attention with patient and caregivers. There's a very significant underappreciation disconnect between in the minds of patients and caregivers between psychosis and Parkinson's disease. Their awareness, until they actually present with those symptoms and their doctor tells them, makes the connection for them, yes, the psychosis, these hallucinations and booze that you're experiencing are linked to your disease progression.
The awareness otherwise is in the single digits. So there's a great opportunity for us to increase awareness and thereby increase the dialogue between patients and caregivers because many times, these patients suffer with these symptoms for a long period of time before they discuss them with their doctor. And a lot of it has to do with just the generational mindset. Many of them are concerned that now in addition to having Parkinson's disease, I'm beginning to hallucinate. I'm seeing things that aren't there, They may not be aware of delusions.
And they usually just imagine that it's just because I'm getting old, I'm getting C and I don't associate with the disease. They don't realize that they can actually be there's a treatment out there that can help them. So if we could increase that dialogue, I think it will be a great result for patients and very important medically as well as commercially. We're doing this through a very substantial campaign to get out to what events that are frequently on weekends or many times during the day for patient support groups. That's one of the big initiatives we've launched this year, and early returns are very, very promising.
In addition, we are at all major medical meetings. We have a KOL speakers program dedicated just to patient and caregivers. We also have one, of course, dedicated to physicians, but we have a speakers bureau that is now dedicated just to these patient and caregiver programs. And we have multimedia campaigns, including digital and some nondigital as well. I'm going to shift gears for a second now and just go to our mid- to late stage pipeline.
What's represented here is I think the take home message is really that in addition to Parkinson's disease psychosis, we're pursuing five other indications with this drug. I'm going to speak more to those on the next slide. And what we see here is, of course, we're approved in Parkinson's disease psychosis, where pimavanserin or NUPLAZID is administered as monotherapy. We announced in the fourth quarter of last year positive results in our Phase II Alzheimer's disease psychosis study. That's also a monotherapy approach.
I'll speak more to each of these indications in the coming slides. We also have a Phase II program ongoing in Alzheimer's disease agitation. And as we can see here, everything on this side of the slide is a monotherapy. Due to the very favorable tolerability profile of pimavanserin and its very unique pharmacology, we think there are also opportunities as adjunct therapy to improve results on top of baseline therapy. In schizophrenia, we have a large ongoing Phase III study in schizophrenia patients who achieve a response, but it's an inadequate response with traditional antipsychotics.
We also have a very large study ongoing in schizophrenia to treat the negative symptoms of schizophrenia. Today, there is no drug approved to treat negative symptoms of schizophrenia. And it is, for a few decades now, been one of the most significant unmet needs of these patients. The negative symptoms, by the way, are the more social withdrawal aspects of the disease as opposed to the psychosis represented by hallucinations and delusions primarily. And then we also have a Phase II program in major depressive disorder.
As many of you are probably aware, several of the existing antipsychotics are approved to also treat depression. In fact, the word antipsychotic is a little bit of a misnomer. These drugs are also approved to treat agitation in schizophrenia patients, and many of them are approved to treat major depressive disorder, some of them bipolar depression as well. And the one of the challenges in using these drugs, these traditional antipsychotics and major depressive disorder, is you get the whole host of side effects that I described earlier. And that results in physicians being a little bit tentative in how hard they push the dose of those drugs.
So we think with our very favorable tolerability profile and unique pharmacology, we have an opportunity to perhaps benefit those patients in a very different way. Spend just a couple of minutes now on Alzheimer's disease psychosis. I mentioned that we are we have positive results from our Phase II study that we reported in the fourth quarter. We will be advancing into Phase III later this year. There are five point four million Alzheimer's disease patients in The U.
S. Approximately half of them are diagnosed. Alzheimer's disease psychosis afflicts about twenty five percent to fifty percent of diagnosed patients. I should pause here for just a moment and note that the reason it's such a wide range is because we have to rely on literature surveys in this arena. We had to do that in Parkinson's disease psychosis as well because in neither of these disorders is there a diagnostic code for Parkinson's disease psychosis or, in this case, for Alzheimer's disease psychosis.
So we will ultimately do it's very substantial and tedious work to try to get a better fix on that. As we progress through clinical development, we'll ultimately do that in Alzheimer's disease psychosis in the way that we did in Parkinson's disease psychosis. But it's safe to say it's a very substantial unmet medical need. It's a significantly larger population than what we're pursuing currently in Parkinson's disease psychosis. There's no drug approved by the FDA for AD psychosis.
And I mentioned the side effects that these other drugs carry. Just one other very significant point to make as it relates to Alzheimer's disease psychosis, and you'll hear in a second, it also relates to Alzheimer's disease agitation. And that is in a similar way to Parkinson's disease psychosis, where traditional antipsychotics have the potential for worsening the motor symptoms. In this case, it's been well established that traditional antipsychotics are associated with worsening of cognitive function in Alzheimer's patients. So again, a similar situation where when these patients develop psychosis and you use traditional antipsychotics, they have the consequence of worsening the cognitive symptoms.
It's not insignificant, by the way. It's equivalent to about one year of disease progression. I mentioned our 19 results. This was a Phase II double blind placebo controlled study in one hundred and eighty one patients with AD psychosis. The primary endpoint was on the primary endpoint, we established statistically significant reduction in psychosis on the NPI Nursing Home Sarcoidosis scale at six weeks.
Pimavanserin improved the psychosis score by 3.76 points. That was from a 9.52 baseline versus a 1.94 improvement for placebo. Pimavanserin did not impair cognition as measured by the MMSE score over twelve weeks of treatment. Let me repeat that. We did not impair cognition.
The traditional antipsychotics, established that they do, we did not. So that's a very significant potential benefit that we have. Of course, we'll be following up on that in our Phase III development, but a very significant finding in this study. Of course, as we observed with Parkinson's disease psychosis, the advancement was very well tolerated. Safety profile was consistent with what had been observed in previous studies.
Most common adverse events were falls, UTI and agitation. And importantly, there was no difference in mortality between pimavanserin and placebo groups. And I should note that, that was despite the fact that the average age of patients in the Alzheimer's disease study were was 13 years older than in our Parkinson's disease study. So it's a very elderly, very frail population. We're very pleased to see such a favorable safety and tolerability profile.
And as I mentioned earlier, we're now advancing the program into Phase III, and we'll do that by the end of the year. Alzheimer's disease agitation. Many of the things I said about Alzheimer's disease psychosis also apply to Alzheimer's disease agitation. Same epidemiology, five point four million patients, approximately half diagnosed. In the case of agitation, again, relying on data in the literature, it appears that about forty percent to fifty percent of diagnosed patients with Alzheimer's suffer from Alzheimer's agitation.
I should also note that the type of agitation we're talking about here is not the type of agitation that we might experience if we try to take the subway at 05:30 this afternoon. It's a very pervasive, life altering type of agitation. Heretooth, there's no drug currently approved by the FDA for AD agitation. It is a chronic condition that leads to a very diminished quality of life, and it is frequently a precursor to nursing home placement. I mentioned schizophrenia inadequate response.
Schizophrenia afflicts about one percent of The U. S. Adult population. Actually, that's true globally as well. About thirty percent of patients with schizophrenia have an inadequate response to antipsychotics.
About onethree of them don't respond at all. About onethree, more or less, achieve an adequate response. And about onethree or thirty percent of them have a response, but they still have significant symptoms. So we think there's an opportunity to administer pimavanserin on top of these other therapies and get a better result. What's done today is many times patients receive multiple versions of the existing drugs.
And whether you get additional efficacy or not by administering very similar drugs on top of each other, you definitely get additional side effects. Same things I've said on inadequate symptoms, ultra on negative symptoms in terms of the epidemiology. Here, it's about forty percent to fifty percent of patients suffer from prominent negative symptoms. And hereto, this is an adjunct therapy approach where we believe by going on top of existing antipsychotics, we may be able to boost the signal on negative symptoms in order to achieve a better result. Existing antipsychotics show an improvement on negative symptoms, but it's not significant enough to warrant approval by the FDA.
So we're our hope and what we'll be exploring in this study is our ability to boost that signal in a way that would achieve approval for that indication. I've already talked a little bit about major depressive disorder and the challenge with existing therapies. So I'll just quickly note that MDD afflicts approximately sixteen million adults in The U. S. A very significant sadly, very significant portion of the population.
And we believe with our unique SSIA profile that we have the they have the ability to significantly help these patients. We are headquartered in San Diego. We have four twenty employees. Cash position at the end of the second quarter of this year was $417,000,000 Our key priorities for the year, I've spoken to most of these already, but just for the sake of completeness, are to advance continue building momentum in the commercialization of NUPLAZID to advance our Alzheimer's disease psychosis program into Phase III and to continue advancing the enrollment in these other indications. So with that, I'll stop my prepared remarks and turn it back over to Chris.
Thanks, Steve. Very nice presentation. Definitely appreciate your attendance today. Maybe I'll start off with one and then open it up for questions on the floor. If not, I'll come back with additional questions.
But just given the recent increase in the sales force, particularly in the long term care setting with pimavanserin, what can you tell us about the success and the penetration in this group? And if it's too early, when do you expect to see a significant uptick in this segment?
Yes. So when we launched, we I mentioned there's no diagnostic code. So it's a little bit challenging to get a good feel for just who's a PDP prescriber and how much do they prescribe. But we did a lot of work to look at the intersection of physicians that write drugs to treat Parkinson's and write antipsychotics. That gave us pretty good clarity with neurologists in terms of who's writing what.
With psychiatrists, much less so because they don't write Parkinson's meds, obviously. So it's more challenging. And in the long term care setting, also a little bit more opaque in terms of where to go. So when we launched the drug, we felt like the long term care setting would represent about 20% of the business. I think about six months in, we developed a view that whether it's going be substantially more than that or not, we'd have a difficult time just keeping up in long term care with the force that we have.
So we expanded the field force in April of this year.
What I can tell you
now is that it's about 30% of the business today. So it has grown more substantially than we would have projected when we launched the drug. And I feel like we're getting really good traction there. What I wouldn't wouldn't want to set the expectation that what you should expect to see is a sudden kick in the revenue curve. We're continuing to grow on all sectors and continuing to get really good traction.
But we were already in long term my point is we're already in long term care. We expanded it because we didn't want to get behind, and we are seeing it actually grow to be a bigger proportion of our business than we originally imagined. Yes, it's a great question. So there are many things that you typically would want to do and that we are doing when you get to post approval types of studies. And I don't want to comment specifically on that.
What I will say is that's a very long term assessment. And there are many things that we're looking at to try to just better understand disease progression, the impact of intervening earlier versus later, etcetera. And so whether we ultimately establish that kind of a benefit that is delayed institutionalization or not is something that's under consideration. But I can't speak specifically to that at this juncture.
Can you repeat the question?
Yes. I'm sorry. Could you repeat the question? Yes. So in those four studies, they all began very close in time in the fourth quarter of last year.
So it's a little bit too early in the enrollment of those trials to be able to predict exactly when we'll finish enrollment. But what we said at the time and remains true today is these kinds of studies in CNS and these size of studies typically take two to two point five years to run. So that's probably the best kind of ZIP code guidance we can give at this point in time. Yes. It's a great question.
I'll try to make this quick because I know we have limited time. I'll just say, in the with any Phase II study, your objective is to try to learn as much as you can to inform what to do next. Should I stop? Should I go? Etcetera.
And we came out of that study. What you don't always get is a really clear road map for what you would do in the next study or in Phase III development. We got that in the study. And as I mentioned earlier, we've now had an end of Phase II meeting with FDA. We went in with a plan.
We came out of that meeting with exactly the plan we went in with. And I think that just speaks to the clarity that we have in terms of how we proceed in the Phase III. So we'll see that sometime before the end of the year? You will see it before the end of the year. You will.
Yes, correct.
Steve. Thanks, Todd. Thanks, Chris.