Thanks for joining us. I am Tazeen Ahmad. I am the SMidCap biotech analyst here at Bank of America Merrill Lynch. It's my pleasure to introduce our next presenting company this afternoon, Acadia Pharmaceuticals. Taking the first portion of the presentation is President and CEO, Steve Davis.
We will have a few prepared slides, and then we will switch to a fireside chat format. And so if anybody has any questions as we discuss topics, feel free to raise your hand, and we'll bring someone over with a mic so that the Acadia team can take your questions. And with that, I will turn the podium over to Steve.
Great. Thanks so much, Tazeen. Very pleased to be here today, and thank you for coming out to learn a little bit more about Acadia and Neoplasma. As I think everyone in the audience is probably aware, there are certain inherent risks in the development and commercialization of pharmaceuticals. Please see our latest SEC filings for a description of these risks as they apply to our business.
One statement I'll make today that is not a forward looking statement is that NUPLAZID is now approved. NUPLAZID is the first and only drug approved by FDA for hallucinations and delusions associated with PD psychosis. It represents a new treatment paradigm. For the first time, physicians can treat the hallucinations and delusions in these patients without impairing motor function. This new paradigm is a consequence of the novel mechanism of action of NUPLAZID.
NUPLAZID is the first and only drug approved, which is a selective serotonin inverse agonist or an SSIA, preferentially targeting five HT2A receptors. In addition to not interfering with the motor therapies that Parkinson's patients are taking, NUPLAZID also demonstrated in our Phase III pivotal study a very favorable safety and tolerability profile in this elderly and frail population. I'm going to touch briefly on the PD population, PDP population. Then I'll go through a few slides that set kind of the groundwork for the commercial effort that we're now launching. And then I'll conclude with just a few brief remarks on some of the other indications that we're exploring with pimavanserin, which, again, is the generic name for Neoplasma.
So Parkinson's disease psychosis is a debilitating condition. It's characterized by hallucinations and delusions. It is a chronic condition. It worsens over time and severely impacts daily living of Parkinson's patients. It afflicts about forty percent of the one million Parkinson's patients in The United States, and it is a leading cause of nursing home placement of Parkinson's patients.
We believe NUPLAZID has a very significant potential to fill a very meaningful unmet need in treating hallucinations and delusions in PD psychosis. When we serve we've done a lot of work both with payers as well as physicians leading up to our imminent launch of NUPLAZID. And when we ask treating physicians what are they dissatisfied with in the use of atypical antipsychotics that are frequently used off label to treat PD psychosis today, What they most frequently cite is the fact that they impair motor function, they have safety and tolerability issues and the lack of an FDA approved indication. I just want to circle back up to the impact on motor function. This comes about due to the fact that Parkinson's patients, to treat the motor symptoms, the most prominent symptoms of their disease, take drugs that stimulate dopamine.
Parkinson's is caused by a neurodegeneration part of the brain that produces dopamine, so suffer from low dopamine levels. So they take therapies to boost the dopaminergic effects of that hormone. All antipsychotics on the market today work through multiple mechanisms, but one of the main mechanisms they work through is by blocking dopamine. So those two therapies work against each other and create what we frequently refer to as a dopamine dilemma. When we ask physicians what are the top ranked attributes for a PD psychosis product that they would like to see, the three most common attributes are: number one, does not negatively impair motor symptoms two, it resolves the psychosis fully and three, has a low incidence of side effects.
I'm going to skip through a little bit of the clinical data from our pivotal Phase III study, our 20 study, as we call it. What we saw here is that on the SAPS PD, the primary endpoint, we saw a significant and clinically meaningful effect through the six week treatment period. And as you can see here, at week two, placebo and drug treated groups are showing a numerical decrease in symptoms, and then the placebo effect tends to flatten out through weeks four and six, and the drug treated group continues to go down. What we see overall is a thirty seven percent improvement on drug treated patients. When we look at the data from the same study in a different way and we look at how many patients exhibited a one point response on the primary endpoint, three point response, five point, seven point, 10 or a complete response.
What we see is at every data point, we have very meaningful differences between placebo and drug with NUPLAZID. Perhaps most importantly or very interestingly, when we look at patients that achieve a complete response, so they a full remission of their symptoms, we see about fourteen percent of NUPLAZID patients get to that very high level of efficacy, and we only see one in the placebo group. Turning now to our preparations for the commercial launch, and we'll, I'm sure, spend a lot more time talking about this when we get to the fireside chat portion of presentation. We are now in the now approved promotional campaign. This includes significant multimedia and digital campaigns that we've launched, strong presence in major medical meetings post approval.
This will include the American Psychiatric Association Annual Meeting in the May, the International Congress of PD and Movement Disorders in June. And we've also launched New Plaza Connect, which we discussed in pretty significant detail on our two most recent calls. This is a network that we've established to assist both patients and physicians in with support services through and beyond the launch. We have now onboarded our neuroscience specialty reps. They are currently in training for June launch.
And we have also actively engaged and educated payers through our national accounts team. Our MSL team is actively engaged with the medical community. And we expect product to be shipped to specialty pharmacies and specialty distributors prior to our field launch in June. Just a couple of additional comments on New Plaza Connect. This is a multifaceted effort, but it includes, most importantly, access coordinators that are primarily dedicated to assisting physicians work through the reimbursement access and reimbursement aspects of dealing with payers.
It's a dedicate we have a dedicated team for each practice, so dedicated team for psychiatrists, for neurologists, for long term care. And again, as we frequently see with new drugs, we do expect some level of prior authorization, and we have specialists that are dedicated to working through those issues with physicians. In early days, before payers have fully established what they think would be appropriate reimbursement, you will have more letters of medical necessity, and we have access coordinators set up to deal with that as well. On the patient side, we have care coordinators established and an entire effort set up to help patients also navigate through this system and guide them to the right resources. And so the combined effort that we have with New Plaza Connect is a very substantial one.
And the of course, the primary objective is to make certain that patients who need the drug and for whom a physician has written an appropriate prescription have access to it. I touched on this earlier. We have hired now a very experienced neuroscience field team. It includes regional and account managers that we hired in March of twenty fifteen. So they've been on board for over a year and have had a very meaningful amount of time to prepare for and now execute on the launch.
We've recently onboarded 133 neuroscience specialty reps. Again, they are preparing for our June launch. They have a very strong CNS background, averaged eight years in CNS and 15 in total in the pharmaceutical industry. And we'll be targeting, as we've mentioned many times before, 11,000 PDP treating physicians. Neurologists comprise the largest portion of this group, approximately half psychiatrists are a little less than onethree and long term care physicians make up about 20% of the population by our market research estimates.
Each region will also have reps dedicated to health care professionals in these long term care facilities. I'm going to touch just very briefly, and then we'll open things up for Q and A. I'm going to touch just very briefly on a few of the other life cycle management opportunities that we're pursuing. These include, of course, Alzheimer's disease psychosis, where we have an ongoing Phase II study. There are five point three million Alzheimer's patients in The U.
S, approximately half of them have been diagnosed. ADP or AD psychosis afflicts twenty five percent to fifty percent of the diagnosed Alzheimer's patients. There is currently no drug approved by the FDA for ADP. Current antipsychotics, as they have been, and continue to be in PDP, are used off label. They, those drugs increase mortality, carry significant side effects and are associated with worsening cognitive decline.
And just digress for a second. It's not an insignificant cognitive impairment that those drugs have. They it's been estimated that they impair cognition in what would be equivalent to about one year of disease progression. So it's a pretty significant impact on what is the primary symptom that Alzheimer's patients suffer from. We believe the mechanism of action and the tolerability profile of pimavanserin would be very potentially attractive for ADP.
And as I mentioned, have an ongoing Phase II study, which should read out by the end of the year. Alzheimer's disease agitation is a related disorder. Again, there are five point three million Alzheimer's patients are diagnosed. In the case of agitation, it afflicts forty percent to fifty percent of the diagnosed population. And just to clarify, the agitation that we're talking about here is not the kind of agitation that you and I might feel if we if our flight's delayed.
But it's agitation that's really pervasive. It significantly impairs quality of life. There's currently no drug approved by the FDA for this symptom. And again, it is a chronic condition that leads to diminished quality of life and is frequently a precursor to nursing home placement. Here, too, we believe the mechanism of action and safety profile of pimavanserin could be very appealing.
I know I've mentioned this before, but I'll just mention briefly. When we look at in the literature, we see that animal models, in animal models, when animals are treated with five HT2A stimulators, they become more aggressive. When that mechanism is blocked, they become less aggressive. In addition, just the fact that a lot of these atypical antipsychotics are used off label to treat disorder. And most, if not all, those drugs have meaningful levels of five HT2 blockade.
We've got a number of indicators pointing in the right direction, and we're very excited about exploring this further. Our plans are to initiate a Phase II study in AD agitation in the first half, so that's coming up soon. Schizophrenia is an area where we've done some previous clinical work and continue to have a high degree of interest. It is a debilitating lifelong disease. It affects approximately one percent of the adult population globally.
This is a little bit different than PDP, ADP, ADA agitation. There's nothing approved prior to NUPLAZID to treat any of those. NUPLAZID now being approved for the treatment of hallucinations and delusions in PDP. Schizophrenia, the other hand, there are lot of drugs approved. Most of them are generic.
Despite that, there's some very significant unmet medical needs within schizophrenia that we remain very interested in, and we'll unveil more of our plans in this arena as we progress through the year. Just really briefly, I'll sum up. We're based in San Diego. We have three twenty employees. That includes the field force that we've recently brought on.
Our cash position at the end of the first quarter was $457,000,000 Key priorities for the year, of course. Number one, by wide margin, is to execute on the commercial launch of NUPLAZID in The United States. Second priority, also very important, is to complete enrollment around the middle of the year in our Alzheimer's disease psychosis study teaming up for results in the fourth quarter of twenty sixteen. And then as I alluded to earlier, we have other pimavanserin lifecycle management opportunities that will that you'll see more and more of. The first we'll be shedding more light on is our AD agitation study, which will commence very soon.
And then as we unveil more programs later in the year, you'll have a better clarity on the other kinds of things that we think are the other areas where we think pimavanserin could be very interesting. So with that, that concludes my prepared remarks. Give me a second to get back over to the other table, and we'll I'll turn things back over to Tazeen.
Okay. Thanks for that intro, Steve. So we're going to switch over to fireside chat now. And joining us for that portion is Teri Moore, who is Chief Commercial Officer at Acadia. And I'll also point out that Lisa Bartholomey from Investor Relations is also with us.
So Steve, congratulations on getting Nuplazid approved. We don't have to talk about the data anymore. We're now going to talk about commercial opportunities. So can you give us an update on things that have been underway since you got FDA's official approval? You said that you're preparing for a June launch.
Is your sales force fully hired, fully trained? What still needs to be done? And what are you expecting in terms of the first few months of the launch process?
So I'll give a very high level response, and then I'll let Terry respond to the sales force status, etcetera. So because we this predates my time at the company, so I can't take credit for it, but I think it was a very, very wise decision for the company a couple of years ago to bring on the commercial leadership of the organization. So Teri joined a little bit over two years ago, I guess, or about two years ago. I've been on board almost two years. And that put us in a position where we could really be very well prepared, understand the marketplace, understand the medical need, understand physicians' perceptions.
And so we've done a really exhaustive amount of work to be poised for this launch. So with that, I'll turn it over to Terry. He can speak a little bit more about where we stand with the field force etcetera.
Thanks, Steve. So as you can imagine, the approval triggered a multitude of activities for us, starting with getting our websites up and running, triggering our now approved launch program that Steve spoke about earlier through a variety of digital media and others. We also had hired our sales force on April 25, and so we've got a little bit of a jump start on their training. As we speak, they're halfway through their training, getting ready for the June launch. They're actually all sitting in San Diego today.
We also then were able to pull the trigger on all the manufacturing activities that need to take place in terms of putting labels on bottles and getting things ready to ship, making sure that our label read as we had hoped it would and make sure that, that's checked and ready to go. We also initiated our speaker training. Now that we know what our label is and what our messages are going to be, that has kicked off as well as getting everything stood up in the backroom in terms of all of our in house operations, data gathering systems as well as setting up our specialty pharmacies and our hubs. We launched our hub just recently, and it's called Duplass Connect. So those are just some of the things that I could probably go on for a long time, but we've got all the key activities that are getting us geared up for the official launch into the
field in June. Terry, I think you mentioned this on the call when you got the approval originally. But can you remind us the background of your sales force? How many of them have marketed CNS drugs in the past?
There is an average of eight years of CNS experience, 15 total. They're highly seasoned, a great track record of success. Just to give you an example of what we had to choose from, there were over 9,000 applications for 133 jobs. We actually went through 4,300 interviews and landed on really the top people in the country. And they come from very well known companies, and they have a great track record of success.
And we also have people that are highly experienced in long term care, which is about 20% of our market. So, we're very pleased to have that kind of mix.
I would just maybe echo Terry's comment and say, frankly, applies more broadly speaking, too. I think being part of a breakthrough designation, first in class, first in disease compound is extraordinarily attractive. So I think we've been highly successful in attracting some of the very best in the industry.
And so once your field force starts detailing to physicians, have you already identified targeted physicians who might be high prescribers? And how did you go through the process of identifying these docs? Right.
So this work was conducted over a year ago where we needed to find out who were the PDP prescribers. In doing the work, we discovered and we set up business rules for doing that. We had to look at claims data. We had to look at prescription data to figure out which patients were actually PD patients and then PDP patients and who are the physicians that are responsible for writing those prescriptions. As you can imagine, there are a lot of physicians that will touch a PD patient just in the general care of that patient, but we want to get to who the true decision makers were.
In doing that work, we determined there are approximately 11,000 plus PDP prescribers, a little more than half are neurologists, about thirty percent of psychiatrists, they get the referrals and the other about 20% are residing in the nursing home practice setting. And when we go to launch, we know that we have those tiered we have a top tier group that we'll be going to with high frequency. We're sampling those physicians as well as offering samples through the New Plastic Connect program. So at launch, we know who the prescribers are. We know who the very top prescribers are, and we know that we'll be getting our messages and education to those folks frequently.
And we also will have our speaker program set up so those physicians can attend those as well.
So how many of the targeted physicians that you've identified were also investigators And I ask that because they might just be familiar with the drug now and they might take less work to convert into actual scripts.
That's a good question. We were actually asked something similar earlier, and we estimated there was maybe 50 investigators. So out of the 11,000, we got to jump start with 50 maybe.
And do you know how many patients in total those 50 treat?
I in the entire universe of our trials, I don't have that number.
Okay. And then you talked about the breakout between neurologists and psychiatrists. Who do you think might be quicker to adopt Nuplizid, at least initially?
That's a good question. We've done a lot of research. We've now over the last two years, we've done market research with over 1,800 PDP treating physicians that are in our call targeting. And so if you're a PDP prescriber in psychiatry, we think that the adoption is going to be fairly quick. We know that there's a high unmet need in both practices.
We know neurologists, especially movement disorder specialists, have expressed high interest in getting started with this. So that's important. But you have to keep in mind that this is a paradigm shift, as Steve stated earlier. We have people that are going to be new to NUPLAZID. They're going to be new to this idea of a serotonin like drug working in hallucinations and delusions.
So even though we think we have people interested, we have a lot of education to do.
So keeping with the targeted approach, there's going to be some patients that are going to take your drug who are switching over from off label antipsychotics, and there might be some patients who are new to therapy. For the patients that you would want to get who are switching over from antipsychotics, even though they are off label and they have a lot of unwanted side effects, they are, in some cases, going to be much cheaper than NUPLAZID. So how do you make that case, especially to a doctor who might very well feel comfortable prescribing antipsychotics?
Well, again, I think this is a process where it will take time to get our message across and for them to really appreciate the benefits. Being able to better treat a Parkinson's disease patient is very important to prescribers. So it's not just the hallucinations and delusions, it's actually not interfering with motor symptoms. We know in all the research we've ever done, that is always one of the top attributes that they see in NUPLAZID that they don't see in any of the others. We'll never be able to discuss comparatively other agents use because they're off label and they're not approved.
But we can talk about what we don't have, which we don't bring the sedation or orthostatic hypotension as seen as our in our side effect profile. And those are things that are important to these physicians as frail elderly patients often can fall, get dizzy, they have a hard time with their gait as it is. So our product brings a very favorable side effect profile that will enable patients to function better and above the hallucinations and delusions being mediated.
I think just to echo what Terry said, and you see this with just about any drug launch. You've got physicians segment out or we often think of them as many different segments. You've got a certain number of physicians that are early adopters, and they're going to be more aggressive or progressive in adopting new therapies. There will be some physicians that are a little bit more cautious. There'll be some that will just they're never going to switch.
And so for us, as Terry mentioned, it is a paradigm shift. You never want to underestimate the time and effort that it takes to appropriately educate physicians so that they do something different than what they've been the habit of doing and have been doing for some period of time. And that's why we kind of caution people to think that this, as many launches are, particularly when they represent a potential paradigm shift, many times do start slowly. I want to be very clear that we think the opportunity for very attractive revenue growth over time is very significant. And so we think this is a significant medical advancement.
We think it represents a very important drug. And we think over time and it will take some time, but we think over time, it will be very meaningful in the medical community.
Okay. I have some questions. But does anyone have any questions from the floor? Okay. So let's talk about price.
So you announced your price last week as well. Can you tell us what elements went into the decision making process there in terms of maybe assumptions you might have made for discontinuation or compliance or how many patients might take both pills or things of that nature?
Yes. So I'll start. Jerry, feel free to chime in if you have additional color to add. So I think we probably have to start with the recognition that pricing of pharmaceutical is one part science and one part art. And the art really comes from the recognition that we really believe that the price of a pharmaceutical should reflect the value and the innovation that it's delivering.
So we took a lot of things into consideration, including the fact that there's no drug currently approved for the treatment of PDP, the fact that patients that are used off label interfere with the motor therapies and can impair motor function in these patients. And that's a very significant issue in these patients that are in more advanced stages of disease by the time they typically get Parkinson's. We took into account the tolerability profile of the product. And we also thought about the size of the PDP population. And we took did extensive work both with the medical community as well as payers.
And so what we wound up with is a multifaceted assessment of what we think the value of the drug should be. I will tell you we considered a wide range of prices. We considered some prices that were lower and some prices that were higher. And our where we settled on, we feel like is a price that is very well supported by the value that we're delivering. We didn't try to price the drug in where we would have the very lowest hurdles.
We didn't think that, that appropriately represented the value. And we also didn't price it where we thought maybe the value would support it, but there might be significant enough restrictions on the drug that, that wouldn't be the right result either. So what we settled on is a price that we think is very well supported. We're very confident in the price. We will get there will be some restrictions on the drug.
We would expect that to be the case. We think the most common restriction, most common type of prior authorization will be simply a confirmation of the diagnosis. But there will be some plans that will have more significant restrictions as well. So our entire we know that, and our entire commercialization strategy has been designed around making certain we have appropriate mechanisms in place to appropriately educate payers, educate the medical community. And those are the primary things that we took into consideration.
And then I guess lastly, can you talk about the program that you've put in place to help patients pay for the drug?
Yes. Gary? Sure. So as Steve mentioned, we have Neuplaza Connect. This is a call center that's really there to help both the physician and the patient navigate what sometimes can be a very complicated and lengthy process in getting your prescription adjudicated and delivered to the patient.
So we put this service together, and the idea is for physicians to be able to send the prescription in to the hub, where the Plaza Connect will then start the adjudication process and making sure that the patient is covered. In the meantime, that triggers a thirty day free trial for patients in the community that the physician would like to start on drug as soon as possible. We are dedicated to helping any patient receive the drug. And so we are providing co pay assistance and coinsurance assistance to those in the commercial community. And for those that are under government programs, we'll be making some meaningful donations to charitable organizations that support Parkinson's disease patients.
Okay. And then lastly, it's hard for you to talk about before you've actually launched the drug, but what are you expecting in terms of feedback from physicians? We talked about what physicians thought about your clinical data. But do you feel that there will be some additional insight that you'll get once the drug is fully commercial and accessible for paid use by physicians?
Well, there always are. So I'm sure we'll gain additional insights as we progress. I think we're starting from a position of, I think, very high support within the medical community. As Thierry mentioned, I think they're very eager to get access to the drug. And we have a very significant network within the medical community that will facilitate that kind of feedback.
I'm certain there will be some things as they often say about sales forecast, the one thing you know about it is it's wrong, right? So there will be some things that we will learn about the drug in practice that will be new to us. I think we're very well positioned and have a very good, very strong rapport with the medical community, and that I think that will be very helpful to us.
Okay. Great. So we're out of time. I'll leave it at that. Thanks, everybody, for attending, and thank you, Steve and Teri, for presenting today.
Thank
you. Thank you.