Lisa Barthelemy – Director of Investor Relations Uli Hacksell – Chief Executive Officer Stephen Davis – Executive Vice President, Chief Financial Officer, Chief Business Officer Roger Mills – Executive Vice President, Development, Chief Medical Officer Terry Moore – Executive Vice President, Chief Commercial Officer.
Charles Duncan – Piper Jaffray Thomas Wei – Jefferies Ritu Baral – Cowen Robert Hazlett – Ladenburg Jason Butler – JMP Securities Mark Hurd – Needham.
Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Fourth Quarter and 2014 Financial Results Conference Call. My name is Joyce, 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 fourth quarter and 2014 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 March 12, 2015. Joining me on the call today from ACADIA are Dr.
Uli Hacksell, our Chief Executive Officer; Steve Davis, our Executive Vice President, Chief Financial Officer and Chief Business 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 NUPLAZID development program and commercial activities and then we will open the floor up 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 program and plans, our commercialization plans and our strategy, including the timing, results or implications of clinical trials or manufacturing development, the benefits or advantages to be derived from future approval of and the commercial potential for our product candidates, in each case, including NUPLAZID; the timing, content or likelihood of regulatory meetings, filings or approvals; future development, launch and commercialization of NUPLAZID; the expansion of pimavanserin into additional indications, and our future expenses, cash position and usage and growth potential.
During our call today, we may use words such as anticipate, believe, could, expect, intent, may, planned, potential, predict, project, should or the negative of those terms and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements.
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. You’re 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..
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. Our performance in 2014 was highlighted by a number of important achievements.
During 2014, we continue to advance our NUPLAZID program for the treatment of Parkinson’s disease psychosis or PDP towards registration and we remain on track to submit our FDA this quarter. We successfully completed our drug-drug interaction program and our stability program for registration batches.
We also have successful pre-NDA meetings with the FDA. Another important achievement this past year was receiving Breakthrough Therapy designation from the FDA for NUPLAZID. The designation reinforces the serious unmet medical need in PDP and the important of our NUPLAZID program.
As you are aware the FDA has not approved any drug for the treatment of PDP. As a selective 5-HT2A inverse agonist, NUPLAZID provides an innovative non-dopaminergic approach. We believe NUPLAZID has the potential to be the first safe and effective drug approved for the treatment of PDP.
In parallel with the advancement of our PDP program in the United States we also have outlined the path for registration for NUPLAZID in Europe. During 2015 we will be working on our marketing authorization application for NUPLAZID for submission in Europe.
Beyond PDP we also made important progress in the development of pimavanserin in other neurological and psychiatric areas we launch unmet medical needs. During 2014 we continue to enroll patients in our Phase II study with pimavanserin for Alzheimer’s disease psychosis.
Similar to PDP there is no drug approved by the FDA for Alzheimer’s disease psychosis. We also have been planning for studies where new therapies are greatly needed including schizophrenia and sleep disturbances in Parkinson’s patients. Roger will provide additional information on the studies on the call.
On the commercial front, Terry and his team continued to make significant stride in our commercial preparations for the planned launch of NUPLAZID in the United States. Terry will go into further details on the pre-commercial activities later on in the call.
Turning to our finances, we significantly strengthened our balance sheet in 2014 and are well capitalized to be able to build additional value in pimavanserin life cycle management program and also to investment in our commercial activities.
Our accomplishments in 2014 provide the strong foundation for what we believe will be a pivotal year for ACADIA in 2015. As we near the submission of our NDA, work with the FDA on the ready of the NDA and prepare for the commercial launch of NUPLAZID in the United States.
On that note, I will pass the call over to Steve, who will comment on our fourth quarter and full year 2014 financial results..
Thank you, Uli. Our financial results for the fourth quarter align with our strategy and that is to build a leading U.S. facility CNS franchise using pimavanserin as the foundation. This strategy translates into a near-term business plan and the investment associated with that our focused on two key objectives.
First is preparing the organization for the submission, the review and planned U.S. launch of NUPLAZID. And our second near-term objective is to building our medical and development capabilities to further leverage pimavanserin and its life cycle opportunities.
Turning now to the numbers, total operating expenses for the fourth quarter of 2014 were $28.6 million. R&D expenses for the quarter increased to $18.2 million, from $7.9 million for the comparable quarter of 2013. This was due primarily to three factors.
First, increased cost related to planned NDA submission for NUPLAZID and associated preparations for review and registration of the drug. Second, was cost associated with our ongoing Phase II study in Alzheimer’s disease psychosis or ADP as we refer to it, together with our ongoing open-label safety extension study.
And third, as noted in the release our R&D related stock-based compensation expenses increased by almost $1 million for the fourth quarter of 2014 over the fourth quarter of 2013.
G&A expenses increased to $10.4 million for the fourth quarter from $4.3 million for the comparable quarter of 2013, reflecting our continued investment in commercial preparations for the planned U.S. launch of NUPLAZID.
I should note as we noted in the release, G&A expenses for the just completed quarter include $2.9 million in stock-based compensation expense, which was an increase of about $1.5 million over the fourth quarter of 2013. Let’s turn to our cash position. As Uli mentioned, we significantly strengthen our balance sheet last year.
In 2014, we raised $197 million in net proceeds from our public offering of common stock and closed the year with $322.5 million. During 2014 after adjusting for changes in working capital and proceeds of stock option exercises, we burned approximately $77 million.
For the fourth quarter, using the same adjustments, we burned approximately $25 million. We expect our cash used in operations to continue to increase in future quarters and years, as we execute on our current business plan as described early on this call.
Importantly, we believe our strong cash runway positioned us to continue making the kinds of investments that we believe will leverage the full potential of pimavanserin. Under our current plant we anticipate our cash resources will be sufficient to fund our operations at least into the second half of 2016.
And importantly, should fund through an approval and launch of NUPLAZID for the treatment of PDP. Now let me turn the call over to Roger, who will provide you with an update on our NUPLAZD program..
Thank you, Steve, and good afternoon. Let me first start with an update of the NUPLAZID program for PDP and then I’ll discuss additional studies either ongoing or in the planning phase.
As Uli mentioned in the beginning of the call, we’re diligently completing preparations to support the FDA review of NUPLAZID, and remain on track to submit our NDA this quarter. During 2014, we advanced our PDP program towards registration, with the completion of our drug, drug interaction program and our stability program for registration batches.
In line with the recent [indiscernible] policy by the FDA our dose described in the NDA will be 34 milligrams and 40 milligrams, whereas 34 milligram of pimavanserin equates to 40 milligrams of pimavanserin tartrate. To be clear, the dose doesn’t change, it’s just a description of the dose that has changed.
During 2014, we also continued to conduct our ongoing Phase III open-label safety extension trial referred to as the -015 study. The study will continue to run until NUPLAZID is commercially available to study participants.
Through our -015 study and our Phase II extension study, we have exceeded the ICH guideline for requirement one exposures with well over 250 patients having been treated for one year or longer and our longest single patients exposure exceeds nine years.
Analysis of data from the open-label safety extension studies have shown that NUPLAZID has a favorable long-term safety and tolerability profile observed to 18 patients with PDP. This provides support for the potential pimavanserin to offer significant advantages relative to current antipsychotics used off label for the treatment of PDP.
During 2014, we also presented data from our PDP program a key medical conference. In December we presented caregiver burden data from our PDP program at the 10th Annual International Congress of Non-Motor Dysfunctions in Parkinson’s Diseases and Related Disorders.
Data from analysis of Phase III PDP studies showed the treatment with NUPLAZID demonstrated a significant reduction in caregiver burden compared to placebo. Research has shown that PDP is a significant cause of distress on caregiver and as leading course of nursing home placement among Parkinson’s patients.
A decrease in caregiver burden may translate into the patients being able to stay in the home environment for longer.
As we look to 2015, we plan to present data from our PDP program at a number of medical conferences during the year including the American Academy of Neurology Meeting April and the International Parkinson and Movement Disorder Society Congress in June.
As we have mentioned, one of the highlights for our team this past year is the FDA granting Breakthrough Therapy designation for NUPLAZID. The Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that are intended to treat serious or life threatening conditions.
For indications without unapproved therapy, drugs qualifying for this designation must show a substantial and clinically meaningful effect on an important outcome when compared to placebo. We’re pleased that NUPLAZID met these criteria.
We believe NUPLAZID may be one of the first drug candidates to receive Breakthrough Therapy designation from the Psychiatry Division of the FDA. During 2014, we also completed a series of interactions with the regulatory agencies from multiple EU members’ states.
These interactions are very informative and help shape our strategy for European submission. As a result, we will be working on a submission of a Marketing Authorization Application this year and planned to submit it to the EMA around six months to nine months following the submission of our NDA.
Let me now turn to our program with pimavanserin for Alzheimer’s disease psychosis or ADP. We continue to advance enrollment in the Phase II -019 Study, a randomized double-blind, placebo-controlled trial designed to examine the efficacy and safety of pimavanserin in about 200 patients with ADP. We are excited about the design of this study.
In addition to assessing our potential benefits to pimavanserin to treat psychosis we will also be assessing other key efficacy endpoints, including agitation, aggression sleep/nighttime behavior as well as additional explorer to the end points included in the cognitive status of patients.
The design of this trial will allow us to explore the potential benefits of pimavanserin in this patient population and to inform us on an optimal design for future studies in this program. We have also incorporated many study design concepts from our successful pivotal PDP trial in to the 019 ADP study design.
We planned to complete enrollment in the O19 study by the end of 2015. Beyond ADP we are planning additional studies in our pimavanserin lifecycle management program. Sleep disorders are major and frequent problem the patients with neurological disorders.
In fact there are major causes of disability in Parkinson’s disease and are associated with other symptoms including falls, psychosis, dementia and depression which have a substantial impact on quality of life. Study suggests that night time sleep disturbance is clearly almost 70% of Parkinson’s disease patients.
As you may recall, we observed significant non-sedating sleep related benefits of pimavanserin clinical studies including our pivotal Phase III O20PDP study. Pimavanserin demonstrated significant improvement on both night time sleep and daytime wakefulness on the scope of sleep scale compared to placebo.
We are currently planning to initiate the Phase II study with pimavanserin during the first half of this year to further explore the potential sleep benefits of pimavanserin in Parkinson’s disease patients. We will provide further information on trial design at initiation of the study.
Another area that represents a large unmet medical need and a tremendous commercial opportunity for pimavanserin is schizophrenia.
Study conducted by the National Institute of Mental Health which is published in New England Journal of Medicine founded 74% of patients with schizophrenia taking typical or atypical antipsychotics discontinued treatment within 18 months because of side effects or lack of efficacy.
There was a larger unmet medical need in new therapies that have improved side effects and efficacy profiles. We believe pimavanserin selective locate the 5-HT (2A) receptor may enable it to be use as a mono therapy for maintenance of patients with schizophrenia.
Pimavanserin avoid interactions with dopamine and other receptors which may be associated with many of the side effects caused by existing antipsychotic drugs. We are currently in the planning stages of this study and plan to initiate it during the second half of 2015. I will now turn the call over to Terry..
Great. Thanks, Roger and good afternoon, everyone. So looking back over last year the commercial team covered a lot of ground in preparing the market, the organization, and our lead product candidate NUPLAZID for launch.
Earlier last year, we complete the hiring our senior commercial team responsible for sales, marketing, managed markets and sales operations. Since then these senior’s leaders have done an excellent job in bringing on experiences and highly qualified commercial talent who have been very busy preparing for successful NUPLAZID launch.
I am pleased and excited to see the caliber of people we are brining into ACADIA many of whom have extensive commercial experience with successful CNS brands.
You may recall that during 2014 we conducted extensive market research with over 800 PDP treating neurologists, psychiatrists and long-term care clinicians to help us understand physicians current treatment approaches to diagnosis and treating PDP, the unmet needs as viewed by the physicians, what drives their prescribing behavior and NUPLAZID commit the needs of patients, caregivers and prescribers.
This research confirmed the high unmet need, medical need that exist for PDP patients and reinforced the prescribers are need of safe and effective treatment alternatives to the off label use of antipsychotics that they often resource to currently.
We also completed foundational access and reimbursement research, which was conducted with key decision makers for payers covering 168 million lives. Through this work, we were able to achieve even more thorough understanding of the payer landscape.
This research also provides us with insight regarding the perceived value of NUPLAZID in terms of price and formulary placement. And we are pleased to see payer’s response favorably to the target product profile of NUPLAZID.
Throughout 2014, we conducted national and regional scientific advisory boards with leading movement disorder specialist and PDP treating psychiatrist in order to gain insight and how to position NUPLAZID to best address the needs of patients, caregivers and physicians.
Because of the insights provided by these experts, we will be well prepared to launch to educate healthcare professionals regarding the potential clinical benefits of NUPLAZID.
We also made important headway in preparing commercial infrastructure and systems, including the supply chain distribution to ensure all channels the distribution are established at the time of commercial launch. In addition, to establishing internal processes and activities necessary for success, our team has worked diligently on sales force sizing.
Based on extensive research, we estimate that there are around 11000 PDP treating physicians with the largest segment being neurologist. There are also as an important role played by psychiatrist and physicians in the long term pure setting.
As we’ve stated previously, we plan to establish a specialty sales force of around 135 sales reps and plan to on-board them around the potential approval of NUPLAZID. Of note in January of this year, we initiated a PDP disease awareness campaign in the physician community with the launch of our website pdpsychosis.com.
This is one of several initiatives we will be implementing to better serve the education needs of healthcare professional regarding PDP. So moving forward, we’re continuing to execute all necessary preparations required to ensure we will have a successful commercial launch and are year excited about the year ahead.
And with that I’ll turn it back over to Uli..
Thank you, Terry. The [indiscernible] what I believe will be a very exciting year indicator and we’re off to a strong start in 2015. Our proactives are clear.
We plan to submit our NDA for NUPLAZID during the first quarter of 2015; continue to build out our commercial capabilities to prepare for the current launch of NUPLAZID and we will pursue the development [indiscernible] psychotic drugs. We also will prepare a submission for NUPLAZID in Europe.
As far as our organization, we’re expanding our existing infrastructure to support the plan launch and commercialization on NUPLAZID including adding to our commercial structure, commercial level manufacturing, medical affairs, quality control and compliance.
We had brought in highly qualified individuals with extensive experience in their functional domain and in CNS product. I am thrilled to see the high level of collaboration across functions. Finally, before we go to questions, I would like to take the time to acknowledge our employees for their significant contributions.
ACADIA’s achievements in 2014 were the direct result of my colleague’s hard work, deep knowledge and dedication. We have a bright future ahead of us as we look to build a leading in-house focus biopharmaceutical company that’s dedicated to bringing forward new therapist that can improve the lives of patients.
Operator, you may now proceed with the Q&A session..
[Operator Instructions] Your first question comes from the line of Charles Duncan of Piper Jaffray. Please proceed..
Hi, guys. Thanks for taking the question. Sorry for the background noise, hopefully it will stop in momentarily. Thanks for the update on the NDA timing, I had a question regarding EMEA or the European filings, I am wondering if you mentioned six to nine months, are there any synergies that you could see in the filing to the U.S.
agency or really what is directing the timelines of the six to nine months channels guidance there? Are there any really medic steps or data that you need to enable that European filings?.
I think Allergan committed to us yesterday..
Roger, I’ll take this. I think the package is essentially the package, the package that we submit to FDA, essentially the package that we submit to the Europeans. And therefore we’re comfortable, let’s say, robust – a robust package. There are certain Europeanization that need to be owned to meet the requirements of the EMA.
But obviously our focus – our initial focus and the principal focus appropriately so has been together robust NDA together, which will then leverage in the European theater..
Okay.
And then regarding the Breakthrough Therapy designation and I know you guys not have much experience with this nor does the rest of the industry or frankly anyone on Wall Street, but is there any chance for an accelerated review as a result of say that unmet medical need, could you invasion perhaps a review by the end of this year?.
So the press issue you talk about is the prior to review that is determine by FDA at the time that they filed the NDA itself. So we submit. They have to two week – two months to review that and then they file the NDA at that time. At the filing time that they determine whether a particular doc will get a policy review..
Okay. That’s helpful. Thanks for the added time color. Look forward to seeing that filing..
Thank you..
The next question comes from the line of Cory Kasimov of JPMorgan. Please proceed..
This is Whitney on for Corry.
Can you hear me okay?.
Yes, we can. Thank you..
Okay, perfect. Thanks for taking the questions.
First one, I just wondering how quickly post approval could you turn around and launch given you’re going to onboard approval?.
Well, we have a number of scenarios in place. We feel it’s important that we have the approval in our hands by the time that occurs and we had varying scenarios based on how much work will be required with our OPDP colleagues and processing the label. So it’s exactly hard to pin down at this point..
Got it. Okay and then one more question. Last quarter I think you guys provided and you review this quarter the larger research you did in the U.S.
Do you have any comparable data in the EU?.
Yes, we are actually conducting much of the same research as we speak and so we’re planning on having the degree of knowledge that we have in the U.S. and Europe as well..
Thanks for taking the questions..
The next question comes from the line of Thomas Wei of Jefferies. Please proceed..
Thanks. Just a few questions. First on the ADP timing I just wanted to make sure that I understood, does that mean the data is in the first half of 2016? I know you had previously talked about maybe it being available two years after you started this study, so that would have been more like the fourth quarter of 2015..
I think as we say, we would expect enrollment by the end of the year, which would put data – within the first half of next year around mid-year..
Okay. That’s helpful.
And then, I did want to get an update on what your latest thinking is about the black-box warning that exists on the atypical antipsychotics for using elderly patients with dementia and how you feel about that in relation to new placid following your pre-NDA meeting? And also if you do get a black-box warning what you think the commercial implications of that would be?.
I’ll take the first half and then the last question over to Terry. Regard black-box warning that is something that will be part of the review.
FDA will review our data for obviously efficacy and safety, clearly with the warnings in the current antipsychotics labels it will be something they will look at closely with regard to the specific safety of the drug.
However, in our review of the data and in completing that revenue for the NDA, we have not seen any signals that would suggest that we have the similar problems. The drug appears to have a very good safety profile in a particularly fragile population with multiple accommodate medications.
However, clearly we submit the NDA, FDA will review it and if they have some concerns on that, I come back to and we’ll discuss them during that release cycle..
Terry, do you want to add anything on the commercial implications..
Yeah. So, as you know the center for Medicare Medicaid services had an initiative that is targeting the inappropriate use of antipsychotics, especially dementia patients and nursing home setting. The keyword here is that it’s looking for inappropriate use.
The CMS initiative excludes patients with schizophrenia, Huntington are threats in their calculations.
And from our standpoint given the novelty of the molecule, the product profile, the demographics of the patients in our studies and that we anticipate the FDA approval in this indication, we’re actually very optimistic about this and that that for us we think all this is going to add up to a positive..
Now, and I think to add back two reasons we have certainly the extremely well differentiated clinical profile and we also have a completely different mechanics of actions with the NUPLAZID..
And then just....
I must just add -- I’m sorry, this is Steve Davis. I might just add to that while certainly it could happen. We think it would be a little bit odd for the FDA to give approval in an indication and then a black box warning for that same population.
So the fact that those drugs are not approved in PDP or for that matter for ADP has probably a bearing on that as well..
That’s helpful. And then just roughly on that CMS initiative, I’m glad you brought that out.
Do you know how many Parkinson patients are in a long-term care facility? And what percentage of those patients have psychosis?.
Well it’s hard to really nail it down, because as you know there is a not a diagnosis code, and the drugs that are used or used for other things other than parting this psychosis, so it’s really hard to nail it. We think about 20% of our business resides in the long term care of setting.
We think that many of them with Parkinson’s disease are likely to have psychosis given the fact it’s the key contributor to their institutionalization in the first place. So, in term of raw numbers, we estimate around 20% and we won’t know specifically how many until we get in there, but we anticipate a large majority, Will..
Very helpful. Thanks very much..
Thank you..
[Operator Instructions] Your next question comes from the line of Ritu Baral of Cowen. Please proceed..
Hi guys, thanks for taking the question.
Back to the market research, have you guys done any updated market research for the year especially if there have been any major changes in coverage plans, and have there been any major change in coverage plans that would affect NUPLAZID and it’s so – how would that change any sort of commercial strategy?.
All right. So, today we’ve continued to update our commercial access and revision of strategy. We have not seen any signals that things are changing that would affect us..
Right now, what do you – what are you assuming that the breakout in treatment is for PDP amongst the generic antipsychotics Seroquel and Quetiapine?.
I’m not sure I understand your question, could you -.
Well, how – yeah, just a breakout between how patients are treated right now, between the different treatment option currently approved?.
Yes..
And not through global, yeah..
Yeah. The most frequently used generic antipsychotics and quetiapine is barely used at all. It has – well less than 2% of the total scripts. We know that there is some use of Abilify which will become generic, I think very, very, soon..
I will just also add, we know that physicians through our market research are very dissatisfied and very conflictive when it comes to using the atypical antipsychotics they have available today.
So the research that we’ve done points to the fact that they are eager to have an alternative that will allow them to have the ability to treat the psychosis without impacting motor control..
Do you anticipate the -.
And obviously it’s very important to realize that although Seroquel is the frequently used generic antipsychotics for these patients. It has had a great problem to show any efficacy in controlled clinical trials. So that is of course a major problem with that drug, in addition to the problems related to in the black-box warning..
Do you anticipate with Abilify going generic that its use in PDP would increase and would you have to sort of detail against that drug differently versus the other two?.
No. The liabilities are the same, and so we feel that because we are so novel that we really don’t think there will be competition based on the proved indication and the benefits we bring to the patient..
Got it. And last question and I’ll hop back in the queue.
Any additional details that you can give us on the upcoming schizophrenia trial?.
Let us come back to that perhaps, what Roger related during in the introduction is basically what we want to say we – it’s going to be maintenance study. And we want to come back when we are closer to the initiation of the study with all the details..
We haven’t finalized designed yet. We’re obviously working through that process, but where we will be positioning that is in the management of patients in their outpatient status and where most schizophrenia patients are treated for most of the time.
But treated in adequately and treated in a way which many of them causes concern from toxicity from the available drugs. We believe the profile of pimavanserin offers a real opportunity to really be a game changer in the long-term management of schizophrenia patients and that’s what we wished to explore and exploit through the schizophrenia program..
Great.
Just one last question, I apologize someone just send me a request to follow-up on the SOX rule for a little more color on the new SOX rule and the dosing change?.
Yeah. So it’s something that FDA -- that is actually brought FDA in line with the Europeans. But when we started out the -- we using 40 milligrams of pimavanserin, but that was tartrate salt. So in line with the policy, you have to position that dosage in line with the free base [indiscernible] psoriasis, it’s a nice round number.
So it will be 34 milligrams instead of 40, but it’s a same thing. It’s the same tablet. It’s the same dose. And we would expect the same efficacy and the same safety..
So it’s essentially just the labeling change, no additional analysis or anything would need to be done?.
Absolutely..
Okay..
No difference. It’s exactly the same tablet. So we did not anticipate any changes..
Great. Thanks for taking all the questions. Appreciate your patience..
Thank you..
The next question comes from the line of Robert Hazlett of Ladenburg. Please proceed..
Yes. Thanks for taking the questions. Well, I have -- wanted to regarding ADP in the indications.
At this point, would you expect Phase II endpoints that you’re examining in terms of psychosis to be the Phase III endpoints that you consider in psychosis and the reason why I’m asking that is, is there an opportunity or is there a consideration at least for you to maybe pivot with the program more towards an agitation or aggression endpoint, as you consider optimum entrance used in that study?.
So, we’ve always position this, it’s a proof of concepts study we’ve not examined the utility of pimavanserin in this population to date.
The NPI prime – the primary endpoint we are looking at obviously relates to the psychosis naturally with the intent – the original intent would be molecule but also with the data that we’ve seen in other indications. So, hence why we are focused on psychosis however the NPI is well accepted and understood scale.
It offers the opportunity to look at different aspects of the consultation of symptoms that these patients have including aggression/agitation.
So yes, obviously at the end of this program – at the end of study we will look at the data when it comes out it may well be that we continue pursuing down the psychosis root or we continue down the psychosis root and also consider pursuing agitation/aggression as an indication for the drug.
But it will depend on the data we will look at carefully and obviously make appropriate judgment based on that and regulatory consultations in a accordance..
Thank you for that.
And just a question you talk about timing of that indication and data readout sometime in the first half of 2016, is – what type of turnaround of assuming success and again, I know we’re reaching in terms of timing because of there are lots of unknowns, but what type of turnaround should we expect from the end of Phase II in the data readout and your ability to clean information from that study until you might move into Phase III, is it six months, is it a year, how long can that take between Phase II and Phase III?.
I think you probably summarize in a way that it’s something variable, depends on the data, depends on a number of factors, depends on interactions with regulatory authorities. What I can say obviously with a good positive study will be pursuing the appropriate part as expeditiously as we can..
Okay. Thank you.
Any color in with regard to the -- a European authorities with regard to ADP, I know you’ve talked a lot about PDP with the EU, but have you had much discussion along the lines of what might acceptable with regard to ADP as well in the EU and the rest of the world?.
No. No to any extend. I think the need -- the unmet need is the same whether you are in the European theater or in the U.S. and its part of development. We will interact accordingly with the authorities appropriate timings..
Okay. Thank you..
Thank you..
The next question comes from the line of Jason Butler of JMP Securities. Please proceed..
Hi. Thanks for taking the question.
Just wanted to ask a question about the trial that you plan to run in sleep disturbances in PD patients, and acknowledging that you don’t want to go into too many details on trial design until you stop the trial, just wondering if you could maybe put into some broad perspectives, how you think about the end points for that trial relative to the sleep endpoints you assessed in the last Phase 3 PDP trial for pimavanserin?.
So in terms of sleep, we do know obviously that sleep is a major factor in patients with these genetic conditions in PDN and in AD. We showed an early Phase 2 study in [indiscernible] PSG that was a clear improvement.
These were slightly older healthy normal – complaining sleep problems, but got improved sleep with the drugs that is proceed a significant improvement. In the light of that – in the PDP studies, given the sleep is in inherent program associated with PD, we did incorporate the scope of sleep scale which was designed for Parkinson’s into those studies.
As you know we showed significant improvement in nighttime sleep and in the study, in fact we showed the corresponding improvements in terms of daytime, obviously you wake at night there is more change of you being sleepy during the day.
So it’s encouraging to see the night time sleep benefits were also accompanied by improvement in the amount of time or wake during the day. And obviously sleep in itself is not just like a sleep, but the impact it has on the patients in many other aspects, not the least including force.
So in moving forward and looking specifically at that area, all our PDP studies but we never – there was no enrollment criteria that related to sleep impairment. It was just taking all comers in effect with the PDP, and if they came with sleep and we looked at it.
But in fact, as we said many of these patients just sleep impairments, we are able to show benefits. But really given this consistent benefit we seen with the drug and given the problems that the patients have with sleep.
It does make sense for us to explore this further, what we want to do is in initial studies to really look at the more objective endpoint using PSG again. And but in the patient population of PD there is enrich sleep so it’s not the entry criteria we will not just be PD but it will be patient with PD, who have marked sleep disturbance.
So we will – this will be program targeted at a particular population of PD patients that have sleep impairment to come in. In terms of the detail, I think of we said earlier we will give you specific when we start the study but it’s something we’re actually quite really looking forward to doing..
Okay. Great.
And then, I guess following-on from then – from that, will you look at different aspects for sleep for example induction versus maintenance and will take in – will you assess circadian function as well?.
The drug is no sedative, so we wouldn’t expect patients – it’s not the drug that sends you to sleep better. There might be a benefit if you are sleeping, -- if you’re overall sleep cycles better than there is less concerns going to sleep you might get sleep better, but importantly, sleep maintenance.
One of the problem for PD patients is that wake up in the night.
They are not the most agile of people given the underline condition that they have especially those with psychosis have real problems on top of that, so they get up in the night and a start in sort of you can see where the full income from the services they can really harm themselves during the night. So it is actually maintenance.
And it’s really is in a way rebooting the sleep completed to get an improved profile through the night. And I think it’s something that may not just be a nice to have, but make a them for a benefit in the – in these patients..
Okay. Great. Thank you very much for taking my questions..
Thank you..
The next question comes from the line of Alan Carr of Needham. Please proceed..
Hi, guys. It’s actually Mark for Alan. Thanks for taking my questions. I was wondering if you could have to an unrelated, but I will just put them both out there.
If you can give us any details on what we might be seeing in various medical conferences, this year I think you have alluded to in the script and I was wondering if you had any updates on programs with Allergan? Thanks..
So I think – this is Roger.
Just in terms of conferences, we’ve been looking at a number of things really just additional slight stated that we have from the clinical trials, but also we will be presenting some data that really comes from some of the works that’s been in preparation for the commercial launch of the drug in terms of looking from the market research pulling out particular aspect of that, which is rather nice sense almost buy product of what it’s intended for.
But it really will help give flavors to the particular challenges that these patients have. For the data, there is nothing which is dramatically new from our own database, from our own studies.
But obviously we – as we combine the data for the NDA as it is required in the integrated summaries, there is some really nice data that just show the consistency of effect and also the consistency of the safety of the drug. So, we will be looking at slices of that in various meetings..
And Matt when it comes to the question related to the elegant [ph] programs, I just want to report that we have bound this two states program for chronic pain and we have a second program for glaucoma which is at Phase I stage. We think both of them are interesting programs.
It’s too early yet to – for us to speculate in what the outcome of the trial is in elegant discussions will be related to these programs. But it’s certainly something that we will keep a close eye on..
All right, thanks for taking my questions..
Thank you. I don’t think there are any additional questions. So, 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 very much..
Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Good day..