ACADIA Pharmaceuticals' (ACAD) CEO Uli Hacksell On Q1 2014 Results - Earnings Call Transcript

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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q1 2014 Results Earnings Conference Call May 6, 2014 5:00 PM ET


Lisa Barthelemy - Director of Investor Relations

Uli Hacksell - CEO

Roger G. Mills - EVP, Development and Chief Medical Officer


Charles C. Duncan - Piper Jaffray & Company

Thomas Wei - Jefferies & Co. LLC

Alan Carr - Needham & Company

Jason N. Butler - JMP Securities LLC


Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' First Quarter 2014 Financial Results Conference Call. My name is Sy, and I will be your coordinator for today. At this time all participants are in 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.

Lisa Barthelemy

Good afternoon, and welcome to ACADIA's first quarter financial results conference call. This call is being recorded and an archived copy will be available on our website at through May 20, 2014.

Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer; Dr. Roger Mills, our Executive Vice President of Development and Chief Medical Officer; and Terry Moore, our Executive Vice President and Chief Commercial Officer.

We will begin our call today with some introductory remarks and brief comments regarding our recently announced financial results. Following this we will provide you with an update on our development program and business, 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 and our strategy including the timing, results or implications of clinical trials or CMC development; the benefits to be derived from, future approval of and the commercial potential for product candidates in each case, including pimavanserin, the timing, content or likelihood of regulatory meetings, filings or approvals, future development and commercialization of pimavanserin, the expansion of the pimavanserin franchise and its value; 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, 2013, 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'll now turn the call over to Uli Hacksell, our Chief Executive Officer.

Uli Hacksell

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. The first quarter of 2014 was another decent productive period for ACADIA helping to set the stage for what we expect to be a very exciting year. Most importantly, we have continued to make outstanding progress in advancing our Phase III Parkison's Disease Psychosis or PDP program toward registration.

With this progress I am delighted to report today that we remain on track for our planned submission of a new drug application or NDA near the end of this year. Currently, no drug is approved in the United States to treat the disease, a debilitating disorder that can have devastating effects on patients as well as their caregivers and families.

Pimavanserin offers an innovative non-dopaminergic therapy and has the potential to be the first safe and effective medicine to treat PDP without compromising motor control. From currently with advancing towards our NDA submission we have recruited additional professionals to round out our core commercial team during the first quarter. This highly experienced team is busy progressing with the wide range of pre-commercial activities designed to position ACADIA for success in the planned PDP launch.

Meanwhile, in parallel with completing our PDP program we are pursuing an aggressive life cycle management program to strategically broaden our pimavanserin franchise. Because of pimavanserin's selective mechanism of action and its efficacy and safety profile observed to date in elderly patients with PDP we believe that it also maybe ideally suited to address other major neurological and psychiatric disorders that are poorly served by currently available therapeutics.

Our initial focus in our life cycle program is Alzheimer's disease psychosis or ADP where we are conducting the Phase II trial that we initiated late last year. As is the case with PDP no drug is currently approved in the United States to treat ADP and the off-label use of existing anti-psychotics is linked to increased mortality, serious adverse events and cognitive decline in elderly patients with dementia related psychosis.

Behind ADP we are actively planning additional studies designed to further [inaudible] aspects of pimavanserin's clinical profile in our core neurological indication areas, and to expand to additional indications including schizophrenia. Roger will provide you with additional information on our life cycle management program later on in the call.

Before we review our programs in a bit more detail, let me highlight another very important first quarter event, the public stock offering that we completed in March. Through this financing we raised net proceeds of approximately $197 million, which significantly bolstered our financial position. This included proceeds from the underwriter's full exercise of the over allotment option.

Following the financing we closed the first quarter with $369.3 million in cash and investments securities. This positions ACADIA with a robust balance sheet as we pursue our strategy to be the leading U.S. Specialty neurology franchise using pimavanserin as a foundation.

We used a total of approximately $14.2 million in cash during the first quarter to fund our operating activities. In future periods we expect our cash used in operations to increase as we continue to advance our PDP program to an NDA, conduct commercial activities and execute on our pimavanserin lifecycle management program. Importantly we have a strong cash runway that we believe will enable us to expand and build additional value in our pimavanserin franchise and fund planned commercial activities.

We [commenced] with pre-commercial activities designed to optimize positioning for the current PDP launch as well as subsequent phase and marketing efforts too and beyond the projected timeframe of our market launch. We currently anticipate that our cash and investment securities will be greater than $300 million at December 31, 2014 and that our cash resources will be sufficient to fund our operations at least into 2017.

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

Roger G. Mills

Thank you Uli and good afternoon. As Uli mentioned we’re off to a great start to what we expect we’ll be in another good year for ACADIA. Our team has remained focused on completing the remaining activities in our pimavanserin PDP development program that are needed for submission of our NDA. This includes aspects of the CMC development, including stability testing of pimavanserin registration batches and supportive studies, including customary drug-drug interaction studies. Once again I'm pleased to report that we remain on track for planned NDA submission at the end of 2014.

Firstly we've made steady progress in our CMC program. You may recall that our three required registration batches of pimavanserin were successfully manufactured at the commercial launch scale, and registration stability testing on these drug product batches was initiated last October.

During the first quarter we completed an assessment on the initial three months of stability data from these registration lots and importantly confirmed that these data are consistent with historical data observed with our clinical trial formulations. Registration batches use the same manufacturing suppliers and general processes as our clinical trial formulation, for which we have previously established long-term stability of pimavanserin covering a three year period.

The initial three months stability data on our registration batches provides an important bridge between our regulatory and clinical formulations and increases our confidence in the performance and stability of our pimavanserin commercial scale batches. We are continuing to accumulate data in our registration stability program and expect to have six months stability data on our registration lots available this quarter. This program is designed to comply with ICH guidelines and meet the regulatory filing requirements for major markets worldwide.

Secondly, we’ve also made substantial progress with supportive studies which include customary short duration drug-drug interaction or DDR studies. I'm pleased to report that we’re now in the processing of finalizing our planned DDR program, the profile of pimavanserin appears consistent with what we have observed in our long-term PDP safety extension studies because patients with PDP are frequently on a number of concomitant medications.

We’ve had the opportunity to gain significant amount of real life clinical experience in this patient population through our clinical trials, in particular our open label extension studies. Importantly we have continued to observe that pimavanserin is generally safe and well tolerated in PDP patients.

Our Phase III PDP open label safety extension trial referred to the 015 Study is designed to continue until pimavanserin is commercially available. This ongoing study has allowed us to generate a large amount of valuable, long-term safety data regarding the use of pimavanserin in patients with PDP. We've already far exceeded the ICH guidelines for required one year exposures with well over 250 patients having been treated for one year or longer. In fact, through our 015 Study and a similar extension study tied to our earlier Phase II trial we have well over 100 patients who have been treated with pimavanserin for at least two years and our longest single patient's exposure exceeds eight years.

Our long-term safety data provides support for the potential of pimavanserin to offer significant advantages relative to current antipsychotics, frequently used off-label for the treatment of PDP.

In parallel with completing the remaining development activities, our regulatory team has made significant progress in preparation for the NDA. As part of this process we are scheduled to hold routine pre-NDA meetings with the FDA this quarter. These interactions will enable us to outline and discuss our planned submissions on how the NDA will be organized.

While our priority is clearly on our planned NDA submission we've also have moved forward with efforts to outline the path to registration in EU. We have completed an initial series of interactions with regulatory authorities from several EU member states. These initial interactions were very informative, we believe it's clear that the 020 study is seen as a strong study about the unmet medical needs of PDP is appreciated in the EU. I know there are significant concerns surrounding the current off label use of atypical in this patient population. We are continuing this process designed to clarify the pathway for registration in the EU.

Let me now turn to our life cycle management program for pimavanserin. As Uli mentioned earlier, our initial focus in this program is on an Alzheimer's disease psychosis or ADP, Phase II trial that we initiated last year. This is a double-blind placebo-controlled trial referred to as the 019 Study designed to examine the efficacy and safety of pimavanserin in about 200 patients with ADP.

We're conducting the study through a large network of research care facilities established as part of the National Institute for Health Research Biomedical Research Centre for Mental Health at King's College London. The 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 study at this high-quality medical institution with its network of nursing care homes and its experience in this patient population provides several advantages in study execution.

Firstly, we were able to incorporate many design features from our successful pivotal PDP trial into the 019 Study design. Importantly, the geographically focused network of care facilities enables the use of a small group of highly trained [raters], which we expect will enhance study precision.

Secondly, we believe this unique clinical research infrastructure and expertise provides access to a pool of well-characterized ADP patients and facilitates data management and monitoring. Let me take a moment to highlight key aspects of the 019 Study protocol. In this study patients are randomized on a one-to-one basis to receive either 40 milligrams of pimavanserin or placebo, once daily for 12 weeks, following an initial three-week screening period that includes brief psychosocial therapy. This brief pharmacologic therapy is designed to help patients advance to participate in the clinical trial setting, help manage symptoms during the screening phase and plot the placebo responses ahead of the baseline assessment.

The study is designed to assess several efficacy endpoints, including use of the Neuropsychiatric Inventory 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 were based on the change of 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 demonstration of durability of response to pimavanserin beyond the 6-week placebo-controlled period tested in our pivotal PDP efficacy trial and the key efficacy endpoints in the 019 Study. We're very excited with the 019 study and continue to believe that this study provides us with the unique opportunity to demonstrate potential benefits of pimavanserin in this patient population.

In addition to ADP we are actively planning additional studies in our life cycle management program designed to further characterize and highlight aspects of pimavanserin's clinical profile in our core neurological indication areas. One area of keen interest for us is sleep disturbance, which represents a frequent problem to patients with neurological disorders including both PD and AD patients.

Poor nighttime sleep quality and excessive daytime sleepiness are associated with the lower quality of life of PD subjects on that calculus. Benefit from sleep in this population are particularly important because sleep disturbance in PD can exacerbate psychosis, work in cognition lead more falls and increased [inaudible] burden. We have observed very intriguing long sedating sleep related benefits of pimavanserin clinical studies including our Pivotal Phase III 020 PDP study.

In the 020 study, pimavanserin demonstrated significant improvement in nighttime sleep and this improvement was not accompanied by any sedation or [hunger] effects. In fact pimavanserin produced a significant improvement in daytime wakefulness in PDP patients. Moreover, those patients in the 020 study with severe nighttime disturbances benefited the most from pimavanserin therapy and showed highly significant nighttime sleep improvements throughout the study.

Interestingly the positive effects of pimavanserin nighttime sleep and daytime wakefulness did not tolerate the psychosis measures, thus indicating that sleep and wakefulness improvement from pimavanserin may represent independent treatment benefit. We believe that additional studies in sleep disturbances area may allow us to further characterize and highlight these potentially important clinical benefits. We're also planning a health economic observational study involving patient-caregiver pass to demonstrate the economic and resource burden of PDP. This may complement important findings from our 020 in which we observed a significant reduction in caregiver burden.

Another key focus of our lifecycle program is to broaden the pimavanserin clinical program to major indications including schizophrenia. We have done considerable planning in this area and believe that pimavanserin's selective mechanism of action and attractive clinical profile may enable it to be used in multiple ways to improve the therapy for patients with schizophrenia.

Firstly as demonstrated in our earlier Phase II trial pimavanserin may be used as a co-therapy together with low doses of existing atypical antipsychotic drugs such as respiridone to enhance the clinical profile.

A second intriguing approach that we are very excited about is the potential to use pimavanserin as mono therapy in the maintenance phase of schizophrenia treatment. In this application, we believe that pimavanserin's selective 5-HT2A may allow for effective symptom control whilst avoiding interactions with dopamine and other receptors that are linked to many of the side effects caused by existing antipsychotics. We therefore believe that pimavanserin has the potential to provide a novel well-tolerated maintenance therapy that may result in better compliance of schizophrenia patients.

Our commercial assessment has reinforced our belief that this is an area of large unmet medical need for patients with schizophrenia and represents a considerable commercial opportunity. We’re now reviewing study designs of the schizophrenia program and look forward to sharing further details on this and other planned studies in our life cycle management program later this year. I’ll now turn the call back over to Uli.

Uli Hacksell

Thank you, Roger. We continue to be excited with the progress in our PDP program, which moves us closer to our ultimate goal of bringing innovative medicines like pimavanserin to 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 in our specialty market opportunity for pimavanserin. Our strategy is to commercialize pimavanserin for this indication in the U.S. by establishing a specialty sales force focused primarily on neurologists. During the first quarter our core commercial team continued to conduct pre-commercial activities in preparation for the planned future launch of pimavanserin in PDP.

These ongoing efforts are designed to ensure that a robust commercialization process and optimal strategy are in place to position ACADIA for success in the planned U.S. market launch. As part of these efforts we conducted extensive market research with over 700 PDP treating physicians including a through review of the market landscape to provide us with a deep understanding of the PDP patient journey.

Importantly this assessment of PDP patient journey has confirmed our prior insights into the market, highlighting the large unmet medical need and reinforcing our understanding that prescribers are in need of safe and effective alternatives to the off-label use of antipsychotics.

PDP substantially contributes to the burden of Parkinson's disease. As a result patients frequently suffer from limitations in daily activities, strained relationships with family members and social isolation. PDP is also recognized as a key contributor to nursing home admissions.

In addition to disturbing hallucinations and illusions our research indicates that over half of PDP patients also suffer from sleep disturbances, often including day time sedation. Caregivers also observed that the drug’s currently prescribed for psychosis exacerbated this problem often causing patients to sleep throughout the day.

The psychosis and other comorbid conditions often have a profound impact on PDP patients as well as their families and caregivers. One of our interviews with a professional PDP caregiver re-highlighted the challenges faced by caregivers and families. He noted and I quote, we generally call than the family can no longer court, they often describe the patient seeing things that are not there, of sleeping restless and up all night. The family doesn't know what to do to care for someone 24 hours a day can be totally draining.

Because no drugs are approved to treat PDP in the United States today physicians frequently resort to off label use of existing antipsychotics drugs, even though they carry black box warning fears in elderly patients with dementia-related psychosis due to increased mortality and morbidity. Many physicians have indicated that they will only consider initiating treatment with current therapies when the patient’s symptoms become disruptive to the caregiver and or the patient’s family.

Our market research uncovered that physicians currently devote considerable extra time and efforts related to prescribing and administrating existing atypical antipsychotics due to their pronounced safety concerns. In addition the physicians face a dilemma because current antipsychotics can worsen motor symptoms in PDP patients by contracting the customary dopamine replacement therapy for Parkinson's disease. The cost of this innovative non-dopaminergic mechanism of action pimavanserin avoids this dopamine dilemma and has the potential to be the first safe and effective medicine to treat PDP without compromising motor control, thereby significantly improving the quality of life for patients with Parkinson's disease.

The profile of pimavanserin has been well received by physicians in our market research. Among the themes we have heard from them was that if it were to be approved by the FDA for the treatment of PDP pimavanserin would provide them with an alternative that they would be more comfortable prescribing than the current antipsychotics.

Our market research also indicated that the ability to be able to use optimal doses of customary Parkinson's disease medications while maintaining motor function and treating the PDP symptoms would be factors in favor of the use of pimavanserin. Consequently with pimavanserin available physicians would have a treatment option that they could initiate at the onset of the PDP symptoms without the burden of safety concerns and off label use of currency available atypicals.

In early April we held an advisory board meeting involving several of the world's leading PDP experts. It was encouraging to hear the positive feedback on our pimavanserin PDP program. In addition, these leading clinicians clearly agree that an appropriate and proven treatment for PDP remains a large unmet medical need and suggested that there was a potential for pimavanserin to become a new therapy and to be widely adopted by neurologists and psychiatrists.

Overall the more our team examines the PDP market, the more excited we become with the potential for pimavanserin to improve the lives of people impacted by this disease. We believe that if approved pimavanserin has the profile to be a game changer in the treatment paradigm for PDP.

Let me now touch briefly on several other programs we have in our R&D portfolio behind pimavanserin. Together with Allergan we have clinical stage programs in the areas of chronic pain and glaucoma. Allergan also is pursuing preclinical development of an additional compound, which was advanced last year from our collaborative research as a potential new treatment for glaucoma. In addition, we have two advanced preclinical programs, our ER-beta and Nurr1 programs, which 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 on Neurological Disorders and Stroke. And we are also conducting preclinical studies with our ER-beta compound as an innovative approach to targeting neuro-degeneration associated with multiple sclerosis. Preclinical studies in our Nurr1 program directed at Parkinson's disease have been supported by a grant from the Michael J. Fox Foundation.

Finally before I close, I would once again like to acknowledge and thank our employees. ACADIA's extraordinary progress has been the direct result of the hard work, dedication and passion of our talented team. Looking forward, I'm confident that we have the right team and strategy in place to capitalize on the vast opportunities ahead. Our priorities remain clear. We are focused on building additional value in our pimavanserin franchise and establishing the transition to transform ACADIA into a successful development and commercial organization.

We believe that our pipeline of product candidates, led by our Phase III pimavanserin program, positions ACADIA with multiple attractive commercial opportunities and significant growth potential. And most importantly, all of us at ACADIA remain committed to advancing innovative medicines that will improve the lives of patients suffering from neurological and psychiatric disorders.

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

Question-and-Answer Session


(Operator Instructions). Your first question comes from the line of Charles Duncan, Piper Jaffray. Please go ahead.

Charles C. Duncan - Piper Jaffray & Company

Hi Uli, thanks for taking the question and thanks for the update today. My first question is on the European regulatory strategy. I appreciate that you've been meeting with member states, but I'm kind of wondering when they if you have like goals not date or timeframe but when do you think that you can provide additional clarity on steps forward for Europe?

Uli Hacksell

Well we have guided that we expect to have that clarity by the end of this year. We have initiated the process as we have talked about publicly by meeting with the country representatives and learned about their views. We have the interactions with our European advisors which are top advisors in the regulatory area. And as we have said they expect to have a care path forward established near the end of this year.

Charles C. Duncan - Piper Jaffray & Company

Okay, that's helpful. And then what is your perspective on Asia. We've never really talked about that, but it seems like there is an opportunity there as well.

Uli Hacksell

Yeah, it's good question Charles. Obviously Asia is a very different thing. We have not yet approached Asian regulatory authorities. It something that we intend to do probably together with a partner. Asia is a scenario where we don't expect ACADIA to have to play a commercial role in particular not in Japan. So eventually you will see that we will seek help to both go through the regulatory process in patient count for in Japan and also to get out from the commercial side. But I can't say it's also that obviously in Japan in particular, we will need to conduct a briefing program and that's another reason why we think we would benefit from having a partner that helps us with that.

Charles C. Duncan - Piper Jaffray & Company

Okay, and then finally my last question on Alzheimer's psychosis study, lots of information provided, but wondering how easy enrollment going in terms of patient the characterization of patients. Are you getting the kind of patients you thought you would do and any update in terms of number of patients if not number it just kind a timeline to that trial being fully enrolled. Thanks.

Roger G. Mills

Hi Charles this is Roger. Just to as you probably know we don't give guidance on enrollment in clinical studies. However we are really pleased with the way the study is you've going. We purposely placed the study in a center of excellence, and a center that is well versed in doing nursing home studies and also getting the view from NPI NH. And as we've kind a following before is important that we were able to build in a number of the factors that we believe really help with the success of 020 PDP study. It's with the -- I'm happy to say is that in working with the team at Kings, it's very clear that they understand nature and the exact patients that we want in the study and they are performing the study to a high level as we fully expect that they will do.

Charles C. Duncan - Piper Jaffray & Company

Okay. And with regard to that is it at all possible that could serve as a label expansion study or really just inform the next study on broader study.

Roger G. Mills

I think what now the important thing is well, this is the first time we've explored attention to pimavanserin in Alzheimer's patients. And I think you need to run the study and get the data look at it and then decide next steps.

Charles C. Duncan - Piper Jaffray & Company

Okay great. Thanks for the added color guys.


Thank you and your next question is from Thomas Wei, Jefferies. Please go ahead.

Thomas Wei - Jefferies & Co. LLC

Thanks on the U.S. filing strategy. I just wanted to clarify I know you had said you were last time in the midst as meeting with the agency about your filing. Have you had the discussions with the FDA on how much stability data would be required and we know now that the definitive answer is 12 months of stability data or are you still waiting to clarify or finalize that point?

Uli Hacksell

Yes we have -- Tom we have not yet had our NDA meetings with agencies we have scheduled them and have them later on this quarter and so we don’t have an answer for that question currently.

Thomas Wei - Jefferies & Co. LLC

Okay that’s helpful and then I wanted to ask about the QT prolongation profile just to double check we all know from the -- paper you have disclosed 7.3 millisecond increase in the QT interval but I can’t remember what you have said about your thorough QT study and whether or not you can share with us the specific on data of what happened at both the therapeutic dose and the super therapeutic dose that you tested? Thanks very much.

Uli Hacksell

I think we saw the QT signal what we saw in the 020 study we feel is very much in line with the drugs that are currently approved in the antipsychotic arena and certainly at the lower end of the QT signals in there. In terms of the QT study we did complete that, it was a group study and the study was done in healthy volunteers and the signal that we saw in patients was perfectly in line with what is expected from that study. So that really fits with the high predictability of the PK patients, with not a great deal of inter-patient or in intra-patient PK variability.

In terms of the implications of it and our meeting with FDA last year all are there to including the QT data were in the briefing package that we sent to FDA in order for them to make an informed decision around our request to submit an NDA for PDP and they were very clear in their response that they were comfortable in moving forward with that NDA submission in the light of all the data, both the short term, the long term and importantly the volunteer studies that we’ve done including QT.

Thomas Wei - Jefferies & Co. LLC

Can you share with us what the super therapeutic exposure was that you tested like what fold over the therapeutics dose does it represent?

Uli Hacksell

So in terms of the actual dosage we explored 80 milligrams on the top end and as I say we in terms of the modeling the data that we saw in the PDP population which by the way is an elderly very fragile population was perfectly in line and we’ve not seen any concerns from QT in our programs.

Thomas Wei - Jefferies & Co. LLC

Great thank you.


Thank you. And your next question comes from Alan Carr, Needham.

Alan Carr - Needham & Company

Hi, thanks for taking my questions. Wondering if you could I guess specify exactly what the next step is in dealing with the EU process there and then also are you considering with respect to business any bringing something into the company and what’s the timing for bringing those early stage pre-clinical programs into the clinic? Thanks.

Uli Hacksell

So let me start with the first part of your question Alan. So that was related to Europe and what we have said is that we currently are interacting with our European advisors to establish the next step and that we’re following, if we will follow that will lead to clarity later on this year. In accounts to other questions, so come back to the second part

Alan Carr - Needham & Company

Yeah well in terms of -- so you’ll submit a protocol to the EMA after you meet with -- after your discussions with the advisors or…?

Uli Hacksell

Well we have not yet decided exactly how we're going to proceed. So this is my process that we really want deal with very carefully in the best possible way. And so we will certainly over the rest of this year work through that process carefully. And the intention is to have that clarity on how can proceed in Europe over the end of this year.

Alan Carr - Needham & Company

Okay fair enough. The other question was around business development potential for inbound

Uli Hacksell

That's clearly something that we want to think about overtime. Obviously we think that in order to really keep our sales force busy we will need eventually something that will complement pimavanserin, that can be used with the same prescribers that prescribe pimavanserin daily. So this is something that we have started to try to look at. We are not in a rush to do anything because we are not on the market with pimavanserin yet. But obviously it becomes more and more interesting over time and long term it's a popular strategy to complement pimavanserin with additional assets.

And the other -- let me count through the programs that we have in our portfolio. Obviously Allergan has the rights to the glaucoma and the common pain programs. So we don't consider to commercialize those programs. But when it comes to the early stage programs they are still not yet in for full development. So it will take quite some time before we think about commercializing those programs. So I think in terms of bringing other programs to help pimavanserin on the market we will need to access such assets by other means.

Alan Carr - Needham & Company

One other question I have is around your plans for sleep. What sort of extra work would you need to do to in the label around improvements to sleep?

Uli Hacksell

Roger, you want to take that?

Roger G. Mills

Yes sure sleep will be run under a separate IND. The PDP and ADP are the same part of the psychosis position with FDA sleep is everything [inaudible]. And obviously as part of this process we will be interacting with that division to determine the part of sleep. But I think it feels the great we've seen really consistent benefits in these populations which confirm the improvements in sleep that we saw in our trial and much lower than in our healthy normal volunteer sleep study.

And what's nice now is that we've seen a very clear consistent benefit study-to- study in terms of improvements in sleep in a population for which sleep disturbance is not simply an annoyance, It is something which can really need to clinical outcomes patients that are not good. So I think it is a pretty good recognition certainly from the physicians and the experts in the area and quite -- it really is I think we are little bit excited that we are going to explore that area.

Alan Carr - Needham & Company

Is your thought at this point that any you would start with the population that with the some sort of disorder that also have sleep disturbance is that how are you approach to answering that question?

Roger G. Mills.

I think we not outlined the design of the study. But it is fair to say in parent with Parkinson's disease and actually with Alzheimer's disease as well sleep disturbances are pretty common through the patient populations. In fact in the studies we've done on PDP, there were no entry criteria that were embedded in protocols to enroll patients for sleep disturbances. The entry criteria rolled around psychosis. So the study is in no way enriched for sleep disturbance. So very clearly there are large numbers of patients in those studies that did exhibit disturbances and hence we were able to share that benefit.

So I think we would be really looking at one of these populations and that's likely going to be the PDP population.

Alan Carr - Needham & Company

Okay. Thanks very much.


Thank you. (Operator Instructions). And your next question comes from the line of Jason Butler of JMP Securities.

Jason N. Butler - JMP Securities LLC

Hi. Thanks for taking the question. Just wanted to follow up on the sleep disturbance work. So it makes sense that the drug might not have the same detrimental impact on sleep and wake that other instance like. But do you have any mechanistic rationale as to why there would actually be improvements in sleep and wake for example, is there any impact on circadian regulation?

Uli Hacksell

Perhaps I can take that. It's well known that molecules for the mechanism of action that we have with pimavanserin agonist mechanism, but we have an impact on architecture in such a way that increase the time spent in deep sleep and that you will decrease the time spent in superficial sleep. You do not affect REM sleep or other sleep parameters, you do not increase or speedup the onset of sleep and they don't patients at all. So the only thing is that to reset the sleep architectures so that you sleep more like a baby and less like an older person who frequently tends to wake up at night. This can be seen both in animal experiments and in clinical trials.

Jason N. Butler - JMP Securities LLC

Great. Thanks for the added color.

Uli Hacksell



Thank you. Dr. Hacksell please proceed with closing remarks.

Uli Hacksell

Well thanks again to everyone for joining us on today's call and for your continued support. We look forward to updating you 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. Good day.

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