ACADIA Pharmaceuticals Inc (ACAD) 2013 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals third-quarter 2013 financial results conference call. My name is Erica, and I will be your coordinator for today.

At this time all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. (Operator Instructions).

I would now like to turn the presentation over to Lisa Barthelemy, Director of Investor Relations at ACADIA. Please proceed.

Good afternoon and welcome to ACADIA's third-quarter financial results conference call. This call is being recorded and an archived copy will be available on our website at www.acadia-pharm.com through November 20, 2013.

Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer; Tom Aasen, our Executive Vice President, Chief Financial and Chief Business Officer; and Dr. Roger Mills, our Executive Vice President of Development and Chief Medical Officer.

Uli will begin our call today with some introductory remarks, and then Tom will briefly comment on our third-quarter financial results. Following this, Roger and Uli will provide you with an update on our development programs and we will then open the floor to your questions.

Before we proceed I would first like to remind you that during our call today we will be making a number of forward-looking statements, including statements regarding our research and development programs and plans, including the timing, results or implications of clinical trials or CMC development; the benefits to be derived from future approval of and commercial potential for our product candidates, in each case including pimavanserin; the timing or likelihood of regulatory meetings, filings or approvals; future development and commercialization of pimavanserin; the expansion of the pimavanserin franchise; and our future expenses, cash position and usage, and growth potential.

These forward-looking statements are based on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors and other risks associated with our business can be found in our filings made with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2012 and other filings.

You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. ACADIA disclaims any obligation to update these forward-looking statements.

I will now turn the call over to Uli Hacksell, our Chief Executive Officer.

Thank you, Lisa, and good afternoon. Let me first take this opportunity to thank all of you for joining us on today's conference call. During the third quarter we continued to build on the strong momentum established in the first half of the year with another period of solid execution.

Following the positive outcome of our April FDA meeting, in which we established an expedited path to registration with our pimavanserin program for Parkinson's disease psychosis or PDP, we have continued to focus on completing the remaining elements of our program that are needed for submission of a new drug application or NDA.

I am pleased to report today that we have made excellent progress in advancing this program toward registration, and we remain on track for a targeted NDA submission near the end of 2014. I also wish to mention that the manuscript describing the stellar data from our pivotal Phase III PDP trial, the -020 Study, was recently published in the online issue of the prestigious journal, The Lancet.

While our primary focus is our PDP program, as Roger will share with you later, we have also moved forward with our lifecycle management program with pimavanserin. I am delighted to report that we have progressed well with preparations for our Phase II trial in Alzheimer's disease psychosis or ADP, and are scheduled to initiate the trial this month.

We are excited about the design of the study, which we believe will provide an excellent opportunity to explore the potential benefits of pimavanserin in treating the psychosis, as well as the related behavioral disturbances associated with Alzheimer's disease.

As is the case with PDP, no drug is currently approved in the US to treat ADP. Both disorders can have a devastating effect on patients and their caregivers, and each represents a large unmet medical need.

We believe that pimavanserin's unique clinical profile is ideal to address both of these large unmet medical needs. Initially, we are positioning pimavanserin to become the first drug approved in the US to treat patients with PDP. Our strategy is then to broaden our pimavanserin franchise to include ADP, as well as a range of other neurological and psychiatric disorders that are also poorly treated with currently available therapies.

On the commercial front, during the third quarter we appointed Terry Moore as Executive Vice President and Chief Commercial Officer. Terry has already started to build our initial commercial organization and has ramped up our precommercial efforts. His focus will be to position ACADIA for success in the planned launch of pimavanserin in PDP, and for effective lifecycle management.

While pimavanserin is the most advanced asset in our product pipeline, we have several additional programs in our R&D portfolio. Our pipeline also includes two clinical stage programs in the areas of chronic pain and glaucoma in collaboration with Allergan, and two programs in advanced preclinical stages directed at Parkinson's disease and other neurological disorders.

All our programs emanate from discoveries made at ACADIA, and offer what we believe are innovative approaches that may address large potential commercial market opportunities. Overall, our pipeline of product candidates, led by our Phase III PDP program with pimavanserin, positions ACADIA with multiple product and commercial opportunities, and significant growth potential.

Before we review our programs in a bit more detail, let me ask Tom to comment on our recent financial results.

Thank you, Uli. The third quarter financial results continue to reflect our strategy to increase our R&D investment in order to aggressively advance and build value in our pimavanserin franchise.

Our revenues totaled $240,000 for the third quarter compared to $3.5 million for the third quarter of 2012. The decrease was primarily due to the termination of our collaboration with Meiji Seika Pharma in July 2012, which resulted in recognition of the remaining $3 million in revenues from this agreement during the third quarter of 2012.

Our R&D expenses increased to $7.3 million for the third quarter from $4.4 million for the comparable quarter of 2012, primarily due to increased costs incurred in our Phase III program for pimavanserin. We expect our R&D expenses to increase in future periods as we continue to conduct the remaining activities in our PDP program and incur costs associated with a Phase II ADP trial that is scheduled for initiation this month.

G&A expenses increased to $3.8 million for the third quarter from $1.5 million for the comparable quarter of 2012, reflecting increased stock-based compensation and personnel costs as well as increased professional fees.

Finally, let's turn to our cash position and guidance. We continue to maintain a strong cash position which provides us with an important financial flexibility as we build value in our pimavanserin franchise.

We closed the third quarter with $196.2 million in cash and investment securities compared to $108 million at December 31, 2012. We used approximately $10 million in cash during the third quarter to fund our operating activities.

In future periods we expect our cash used in operating activities to increase as we advance our PDP program toward an NDA filing, conduct precommercial activities and execute on our lifecycle management program. We anticipate that our cash and investment securities will total at least $183 million at December 31, 2013, and that our cash usage will increase in 2014 relative to the current year.

Importantly, we have a strong cash runway that we believe will enable us to continue to advance and build value in our PDP program, while the same time strategically broadening the pimavanserin franchise.

Let me now turn the call over to Roger, who will provide you with an update on our pimavanserin program.

Thank you, Tom, and good afternoon. This continues to be busy an exciting time for all of us here at ACADIA. As Uli mentioned, we are very pleased to have had the -020 Study data featured along with an accompanying editorial in last week's online issue of the renowned peer-reviewed journal The Lancet.

As you know, based on these data we established an expedited path to registration earlier this year. Our team has been focused on completing the remaining activities in our pimavanserin PDP development program that are needed for submission of an NDA. This includes final aspects of CMC development, which is a rate limiting activity in our PDP program, including stability testing of pimavanserin registration batches.

I am pleased to report today that our CMC program activities have progressed according to plan. Following completion of the development and validation of the necessary analytical methods for the pimavanserin drug product during the third quarter, our three registration batches of pimavanserin were successfully manufactured at the commercial launch scale.

Importantly, the registration stability testing on these drug product batches was initiated in October. This registration stability program is designed to comply with ICH guidelines, and meet the regulatory filing requirements for major markets worldwide. Meanwhile, we are also underway with the remaining supportive studies, which include [customary], short-term drug-drug interaction studies and expect these activities be completed in advance of our planned NDA submission.

We're also continuing to conduct our Phase III PDP open label safety extension trial referred to as the -015 Study. You may recall that this study has allowed us to generate a large amount of valuable, long-term safety data regarding the use of pimavanserin in patients with PDP. This summer we presented interim data from the -015 Study at the 17th International Congress of Parkinson's Disease and Movement Disorders.

These interim data indicate that long-term administration of pimavanserin continues to be generally safe and well tolerated in this often elderly and fragile patient population. In addition, these data suggest that the duration of effect in PDP patients may be maintained for longer than the six weeks investigated in our pivotal -020 Study.

We have already far exceeded ICH guidelines for required one-year exposures, with over 200 patients having been treated for one year or longer. We also have well over 100 patients who have been treated with pimavanserin for at least two years. And through a similar extension study in connection with our earlier Phase II trial, our longest single patient exposure exceeds eight years.

Overall, our long-term safety data provide support for the potential of pimavanserin to offer significant advantages relative to current antipsychotics frequently used off-label for the treatment of PDP. We continue to be very pleased with the progress in our PDP development program, and remain on track for planned NDA submission near the end of 2014.

As we continue with the remaining PDP program activities, we plan to hold standard pre-NDA meetings with FDA to discuss our plans for the NDA submission. Given the progress in our CMC program, our plan is to have initial three-month stability testing data on our registration batches available for holding our separate CMC pre-NDA meeting. We expect to complete these FDA interactions by next spring, well in advance of our planned NDA submission.

In parallel we're also moving forward with efforts to define the path to registration in the EU. We expect to complete the series of interactions with regulatory representatives from several EU member states this fall, and to establish the requirements for the path to registration in the EU by mid-2014.

Let me now turn to our Alzheimer's disease psychosis or ADP program with pimavanserin. As Uli alluded to earlier, we are now completing the final stage of study startup activities, and are preparing to initiate our Phase II ADP trial this month. This trial, which we refer to as the -019 Study, is a randomized double-blind placebo-controlled study designed to examine the efficacy and safety of pimavanserin in about 200 patients with ADP.

I am delighted to announce that we will be conducting this study through a large network of research care facilities established as part of the Biomedical Research Centre for Mental Health at King's College, London. Our principal investigator is Dr. Clive Ballard, professor of age-related diseases at King's College and a renowned clinician in the field of Alzheimer's disease. We believe that conducting the -019 Study at this high-quality medical institution will provide several advantages in study execution.

Their unique clinical research infrastructure, including a geographically focused network of nursing care homes is expected to provide access to a pool of well-characterized ADP patients, and enable us to incorporate many design features from our successful PDP pivotal trial into the -019 Study design.

Following a screening period that includes brief psychosocial therapy, patients will be randomized on a one-to-one basis to receive either 40 milligrams of pimavanserin or a placebo once daily for 12 weeks. The -019 Study will assess several key efficacy endpoints, including the use of neuropsychiatric inventory at the nursing home, or NPI-NH scale, to measure psychosis, agitation, aggression and sleep nighttime behavior as well as additional exploratory endpoints.

The key efficacy endpoints will be based on the change at week six from baseline which is a standard duration for psychosis studies. The full 12-week treatment period will allow us to explore additional endpoints, including the cognitive status of patients. We will be looking to show that we do not worsen cognition relative to placebo-treated patients.

In contrast, currently marketed antipsychotics have been linked to cognitive decline in elderly patients with dementia-related psychosis. The 12-week treatment period will also provide the opportunity for a demonstration of durability response of pimavanserin beyond the six-week placebo-controlled period tested in our pivotal PDP efficacy trial.

We are very excited to move forward with the ADP study, and look forward to sharing more details when we initiate the study. We believe that this study positions us to thoroughly explore the potential benefits of pimavanserin in this patient population, and to inform us on design for future studies in this program.

Because of its selective mechanism of action and favorable safety profile observed to date in elderly patients with Parkinson's disease, we believe that pimavanserin's profile may be ideally suited to adjust the need for a novel ADP treatment that is safe, effective and well tolerated.

I will turn the call back over to Uli now.

Thank you, Roger. We are excited with the progress in our PDP program, which moves us closer to our ultimate goal of bringing innovative compounds like pimavanserin to the market to improve the lives of patients with neurological and related central nervous system disorders. PDP represents what we believe is an ideal lead indication and a specialty market opportunity for pimavanserin.

We believe that pimavanserin with its well-tolerated, non-dopaminergic profile has the opportunity to be a first-in-class therapy that will effectively treat psychosis in Parkinson's patients without compromising motor control. We also look forward to the initiation and execution of the -019 ADP Study as a key part of our lifecycle management program with pimavanserin.

ADP affects an estimated 25% to 50% of the more than 5 million Alzheimer's patients in the US. Similar to PDP there is currently no therapy approved to treat ADP in the United States, and as with PDP, physicians frequently resort to off-label use of antipsychotic medications to treat ADP. However, existing antipsychotics may exacerbate the cognitive disturbances associated with Alzheimer's disease, and are also associated with numerous side effects.

In fact, all existing antipsychotic medications have black box warning for use in elderly patients with dementia-related psychosis due to increased mortality and morbidity.

As we advance our PDP program and initiate our Phase II ADP trial, we will also continue to plan for additional studies with pimavanserin in schizophrenia that can build on our positive Phase II co-therapy trial data that we published last year.

Let me now touch briefly on the other programs in our pipeline. First, together with Allergan we have generated two clinical stage product candidates in the areas of chronic pain and glaucoma. Allergan also advanced an additional compound from our collaborative research into preclinical development as a potential new treatment for glaucoma earlier this spring.

In addition, our two advanced preclinical programs, our ER-beta and Nurr1 programs, may offer novel approaches to treating Parkinson's disease and other neurological disorders.

Preclinical studies in our ER-beta program as a novel pain treatment are supported by a grant from the National Institute of Neurological Disorders and Stroke. We are also collaborating with Dr. Rhonda Voskuhl of UCLA to evaluate our ER-beta compound in preclinical studies as an innovative approach to targeting neurodegeneration associated with multiple sclerosis.

Preclinical studies in our Nurr1 program directed at Parkinson's disease are supported by a grant from the Michael J. Fox Foundation.

Finally, before I close I would like to acknowledge several new members of the ACADIA team who have joined us during the year, and thank all of our employees for their dedication and significant contributions. In addition to Terry Moore, our Chief Commercial Officer, we have added a number of talented team members in several key areas including our medical affairs, development, regulatory and commercial functions, and have successfully expanded ACADIA to 48 employees.

This expansion has further strengthened ACADIA's organization, and positions us well for what we expect to be a busy and exciting road ahead.

Our priorities remain clear. We are focused on building additional value in our pimavanserin franchise. We believe that our pipeline of product candidates, led by our Phase III pimavanserin program, positions ACADIA with multiple attractive product and commercial opportunities and significant growth potential.

And, most importantly, all of us at ACADIA remain committed to advancing innovative therapies that will improve the lives of patients suffering from neurological and psychiatric disorders.

Operator, you may now proceed with the Q&A session.

(Operator Instructions). Jason Butler, JMP Securities.

First one, just on the pre-NDA meeting, you mentioned in spring of 2014. You mentioned having three-month stability data there. Do you expect that could be sufficient to file the NDA? Or do you think that you're going to need longer than three-month stability data?

Hi, Jason, this is Roger. We would expect to -- we actually plan for the 12-month stability data for the NDA as a standard, but we really want to go in with our best foot, as we have done all the way through with NDA -- with FDA and, obviously, position ourselves for success. So we want to really put that first three months data in that meeting and make a very strong case.

Great, thanks. And then on The Lancet publication last week, in the editorial that accompanied the publication, there was a mention of potential -- or speculation of potential pretreatment echocardiograms. Can you just comment on what your view is there on that potential?

So, actually, that was the -- I think she was -- mentioned an ECG in there. We have, obviously, described a small increase in QT as do many other agents. And certainly something that with any agent with the potential for QT, and there are many of them, then physicians should take this into account when they are prescribing the drug and ensure it is used safely. And that's usually covered in the labeling.

In terms of this population, this is a population who have multiple other agents, a mean of roundabout 12 other drugs that they are taking. And over the long period thereon, obviously those drugs change to meet various needs of the patients. We have not seen anything that has been troubling from a QT perspective there.

I think it is also worthwhile mentioning that when we had the meeting with FDA over this year, we gave a very comprehensive overview of not only our efficacy, but, importantly, of the safety profile of the drug, which we believe very clearly gives us an advantage over the atypicals. And that comprehensive meeting package included amongst the various safety aspects the data that we have on QT. And FDA reviewed that and, as you will remember, they came back and said they were very comfortable with us submitting an NDA based on the data we had.

That's really helpful, thanks. And then just the last question, could you maybe comment on some of the early work that Terry Moore is focused on in terms of pre-commercialization activities?

Yes, I can do that. So, first of all, he is clearly focused on building a small core infrastructure that will ensure that we have the capability to do all the pre-marketing activities. These include general traditional market research, education, research, outreach, branding, pricing work and other activities, which are really aimed to position us for a successful launch. And I think that we have the right person in place to ensure that we will do this in a very effective and successful way.

That's great. Thank you very much for taking the questions.

Thomas Wei, Jefferies.

Thanks for taking my question. I guess I had a couple of things, just on ADP and on the European front. On ADP, any better sense now that you have selected and finalized this network of centers, what they are projecting the enrollment timeline could be like?

And then on Europe I understand that you are just in the process of sitting down with different member states to talk about the potential for filing on a single trial. Any initial feedback or sense that you could provide there? Or I am sure you must have run this past European regulatory consultants. How much should we be betting on a single trial approval process in Europe? Thanks.

So thanks so much, and let me start by addressing the EU, the regulatory issue that you asked. We clearly believe that we have a very strong package, and that we have strong arguments why the current package that we will provide to the FDA should be sufficient also for Europe.

But I have to admit that Europe is still an unknown. Before we have tested it, we cannot really now give you a particular success chance or anything like that. We think that we have good arguments. That's what we can say.

And as we proceed with this process with the member state representatives, and we will learn next year what the ultimate path will be in Europe for European approval. And we will certainly be able to communicate that at that point in time.

So when it comes to the first question, can you repeat that?

Yes, Thomas, I think that was related to enrollment on the ADP. I think what we can say related to that is, obviously as we get rolling and get up and running with the study, we will start to get a much better sense of the timeframe. We are not estimating at this point how enrollment will come together.

We think -- and Roger can add to this -- we have a very, very nice infrastructure to facilitate doing the study, but we certainly need and will do this in a very controlled way to provide high quality. I can say studies of this nature can take up to two years to complete through to data. We will certainly take a good look and we will be able to be in a much stronger position at a later point.

And perhaps, Roger, you want to just add to that in terms of the infrastructure and ADP study.

Yes, thanks, Tom. I think the key thing for us, obviously, enrollment is always important, but as we start out through the various programs getting the quality -- our quality protocol and quality sites to perform the study, is absolutely critical in getting a successful outcome.

We're really pleased to be able to work with Professor Ballard and the site at King's. They have established a really excellent infrastructure through nursing homes where they have reached out and they partner with the homes, are able to characterize patients, identify them, and also these sites are well trained in clinical research. So all the staff involved in this are of high quality, and obviously as we run into the study we will get a better feel for enrollment.

Charles Duncan, Piper Jaffray.

Thanks for taking the question and congratulations on the recent Lancet article. So my first question is a follow-on to that last one regarding the ADP study. Seems to me that working with that type of group could perhaps reduce the variability in the patients enrolled, and perhaps decrease risk in terms of that as well as endpoint measurement. Am I thinking about that in the right way?

Exactly. I think it is important that -- when we did the PDP study, one of the key factors that we introduced in the -020 Study, prior to beginning that study was the brief psychosocial therapy. And this was actually developed by Professor Ballard originally from the ADP arena where it has shown utility.

So we have a very experienced investigator, who is also experienced, not only with our drug, but has been an integral part of many of the points we brought into the study to manage placebo response.

The other key factor within the study is because it's geographically limited, we can use a limited number of rate as very similar to the concept that we employed in PDP. And, in fact, we are going to use the same CRO we used for PDP for assessing the endpoints, [Metavante], to be able to train the raters in the manner that they train their own raters to be able to assess the patients in the study.

So it's really nice that we were able to bring in some of the key factors that led to success in the -020 Study into the -019.

Okay, and then not to jump too far ahead, and I know this is classic Phase II, but it seems to me that given that it is going to be a well-controlled study, could it prove to be one of two necessary to seek approval in that indication or does the geographic consideration limit its utility in that case?

The geography as such is not a particular issue in doing the studies that were done to, obviously, ICH requirements. But I think it is worthwhile to really understand that this is an exploratory study. We have not had the chance to look at the potential utility of the drug in this particular population.

Certainly the safety one would expect to be very similar to the Parkinson's patients we have seen. And clearly, given the very powerful antipsychotic activity that we saw in -020, we are expecting to be able to see an impact on the psychosis of these patients.

But, really, the utility of the drug may stretch beyond that in these patients where they often have a broader spectrum of issues, many of them behavioral, and pimavanserin has the potential to impact on those as well. So right now I think we need to complete the study, look at the data, and determine where the best bang for the buck will be with the drug and then look at doing another study to really enhance that and tease that out.

Thanks, Roger, and then one more question if I may regarding commercial ops or preparation. Have you given some thought to the potential size of the sales infrastructure, and what your preferred strategy is, Uli, with regard to the US? I think you have mentioned versus ex-US opportunities.

Yes, so let me start out by saying that clearly our strategy is very focused on establishing a commercial business in the US for pimavanserin and PDP. We believe that this is an ideal indication, because it doesn't require a large salesforce. We think that we can cover all the high prescribing neurologists in the US with about 75 reps, and do that really well.

So that's one of the reasons why we are so excited about PDP as an indication. We think it fits us perfectly.

When it comes to the potential outside of the US, as you know, we have worldwide rights for pimavanserin. We have all the options open to us, and we will -- currently we are focused on building value in pimavanserin. In the future we may or may not consider partnerships to help us commercialize pimavanserin in those regions.

Currently, what we are focused on is doing all the precommercial activities for a successful launch in the US, and building value in the pimavanserin franchise.

That's helpful, Uli. Thanks for the added color.

Bert Hazlett, ROTH Capital.

Thanks, mine is a follow-up to one that was asked a little bit earlier. This is with regard to QTc and the extent of pimavanserin's testing so far.

Could you just, either Uli or Roger, maybe characterize pimavanserin's potential for QTc prolongation and the methodologies that you have used to determine that? And if there is any prolongation, how long have you seen in terms of mean delays? And if there is any data in combination with other antipsychotic or other drugs that you can point to, to elucidate pimavanserin's safety in this specific regard. Thank you.

Roger, I am sure you can provide an exhaustive answer to that.

Sorry to delve into details, folks, but --.

Yes, with any drug, and there is obviously many drugs with potential for QT increases. Standardly you perform a thorough QT study, which we have done. It well characterized the QT potential. And, importantly, what we have seen is that has been in a healthy population, what we have -- and that's volunteers.

We've seen in real life patient data, and I explained the totality of our safety database earlier, it's a real -- this is a real patient population who, over a number of years, are treated with multiple, multiple other agents given the many challenges that these patients have, not only from their Parkinson's, but obviously many other factors that affect them at this age.

And what we have seen is that the QT is very, very predictable with just a small mean increase. And that has been reproduced study on study. So, really, it is not something that one simply dismisses, but at the same time it's not something which causes particular concerns.

And, once again, I must reiterate that all these data were supplied to FDA that they were able to consider that for the very clear yes that they gave us, in order for us to be able to submit the NDA.

Thanks, and in terms of those mean increases, are they single-digit or double-digit or can you characterize them any better?

It is about 7 to 9 milliseconds.

Okay, thank you.

Juan Sanchez, Ladenburg Thalmann.

With respect to the network of nursing homes associated with King's College, where are they located? Are they in the UK or in other countries?

And the second question on Europe is what is the current standard of care of PDP in Europe? How is it being treated differently than in the US?

So let me first (multiple speakers). Okay, yes, Roger you can take the nursing homes, and I can take the standard of care in Europe.

Yes, sure. So, on the nursing homes they are geographically co-located in southeast London. So it is sort of a radius around the site, which really enables us to be able to maintain the small group of highly trained raters to do the ratings.

And when it comes to the other question about European kind of standard of care, you are probably aware that clozapine is approved as a second line therapy for treatment of PDP in Europe. There is no first-line therapy approved.

And the reality that clozapine is rarely used in Europe because it's associated with a risk for a serious blood disorder. And, therefore, blood monitoring is required, something which is very complicated, and still doesn't remove the risk for agranulocystosis. So neurologists find it complicated and difficult to deal with clozapine.

So, just as in US, neurologists tend to prescribe Seroquel, also in Europe. And as you are aware, Seroquel, although it is tolerated at very low doses that are being used for PDP, it does not appear to have any efficacy on the psychosis in these patients. And, of course, in addition to that it is not a safe molecule to use either.

So we think that pimavanserin really will represent a major advance in the therapy of PDP, also in Europe, not only in the US.

And one final question about the long-term benefits of the drug. On the marketplace what's it going to take to, say, convince doctors that the drug has a long-term effect? Do you think the open label data that you have is enough, clinical practice or at some point you think additional work may require to demonstrate the long-term benefits of the drug?

Do you want to comment, Roger, on the long-term benefits of pimavanserin?

Yes, certainly. One of the -- the -015 Study was set up as a safety study. That was the original intent, to generate long-term safety data for the drug, because we believed it would be very favorable versus the atypicals. And so it's proven to be.

But, also, it does give you an opportunity -- they are not set up as an efficacy study. But it does give us the opportunity of looking at patients over time. And probably one of the key factors is that patients are on drug for a very long time, and if you look at the duration across the study that patients remain on drug, it's really, very, very, very different from the durations that you see with the atypical agents.

In fact, there is a recent study which was published out of the renowned group at UCSD, the [Geriatric Group], where they looked at the use of atypical agents in patients actually over 40, and so a slightly younger population than we have in our PDP studies. And the duration of these drugs, their usage in patients, any patient with any disease over 40 is really quite short. And, in fact, the quetiapine arm was stopped by the Data Safety Monitoring Board for safety reasons. So I think we have seen a very favorable durability of response in these patients.

Perfect, thank you, guys.

George Zavoico, MLV & Co.

Thanks for taking the questions. A couple quick ones, I think. With regard to CMC, it sounds like to me that you're pretty much completed all at least the logistical things that you need to do. You said you have made the three batches according to the standards you will use for the commercial lot, so you have the formulation.

And you have done -- you are going to have the three-month stability, so you have to wait another nine months for the rest of the stability for the one year. Is there anything else that you need to do in that regard? I know there's a whole lot of precommercial work that needs to be done in preparing for launch, but in terms of actually working with the drug itself is there anything else that needs to be done?

No, nothing else. It is very straightforward. We don't expect any problems at all, and we feel extremely confident about the way things are proceeding.

That's terrific. And the next question is with -- regarding to patient recruitment for the ADP trial. You have this little circle of nursing homes, but clearly I imagine the staff of the nursing homes will be able to identify patients who are perhaps most likely to have the right inclusion/exclusion criteria to go into the trial. So that will probably help in recruitment.

But because the patients themselves, they are pretty far along, they might not be able to really understand what they need to do or what they're going to into. Will you also need -- I suppose he will probably need the approval also for these patients to enter the trial by the family as -- in addition perhaps to the nurses? Or what exactly will you need to do in that regard to recruit the patients?

So we need to, obviously, ensure that responsible person for the patient is able to give consent for the study. This is pretty standard. One of the key factors --not only does the site offer us a potential to reproduce many of the factors that we had in the PDP study, but also importantly, it is a site which is also highly experienced in doing nursing homes studies. And that is one of the other attractive features of the site is this experience in performing these studies.

So we expect all that site will actually go very smoothly.

That's a clear advantage of using that kind of an organization -- like organization of nursing homes to recruit patients. It's a good idea. Okay, thank you very much and appreciate the opportunity.

Dr. Hacksell, proceed with closing remarks, please.

Okay, thanks again to everyone for joining us on today's call, and for your continued support. We look forward to updating you again in the future on our ongoing progress. Thank you.

Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect and have a great day.