David Pitts - Argot Partners
Joe Oliveto - Interim CEO
Bill Schwieterman - Chief Medical Officer
Art Hewitt - Chief Scientific Officer
Liana Moussatos - Wedbush
Alan Carr - Needham
Scott Henry - Roth Capital
Chelsea Therapeutics International Ltd. (CHTP) Chelsea Therapeutics International Receives FDA Guidance for Northera (TM) (Droxidopa) NDA Resubmission With Study 306B Conference Call February 20, 2013 9:00 AM ET
Good day ladies and gentlemen and welcome to the Chelsea Therapeutics Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions). As a reminder, today's conference is being recorded.
I would now like to introduce your host for today's conference, Mr. David Pitts. Mr. Pitts, please begin.
Thank you and thanks to everyone on the call for joining us today to discuss developments in the Northera regulatory strategy, a subject for which we issued a press release this morning. On the call today are, Joe Oliveto, Interim Chief Executive Officer; Dr. Bill Schwieterman, Chief Medical Office; Dr. Art Hewitt, Chief Scientific Officer and Nick Riehle, Chief Financial Officer.
Before we begin, please note that some of the remarks you will hear today contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual future results could differ materially from those projected in these forward-looking statements due to known and unknown risks, uncertainties and other factors. Additional information concerning risks and uncertainties are contained in the company's filings with the Securities and Exchange Commission copies of which are available on our website at chelseatherapeutics.com or maybe requested directly from the company.
With that I will turn the call over to Joe Oliveto. Joe?
Thanks David and thank you everyone for joining the call today. Earlier this morning, we announced the receipt of guidance from the Director of the Office of New Drugs at FDA which provides Chelsea a new regulatory path forward for Northera. This guidance has led us to a decision to resubmit a New Drug Application for Northera for the treatment of symptomatic neurogenic orthostatic hypotension which in turn has the potential to yield an approval decision by year-end.
There is an urgent need for new therapies that help alleviate the potentially disabling symptoms of NOH and keep patients safer. Our goal remains to deliver such a therapy to these patients; one with a demonstrated record of safety and effectiveness spanning multiple studies.
Before I turn to have the announcement that sets our milestones for the remainder of the year and our cash runway for reaching these milestones, I would like to turn the call over to Dr. Schwieterman to discuss some of the details of FDA’s guidance and our regulatory and clinical path forward. Bill?
Thank you, Joe. As Joe mentioned, the Director’s guidance gives Chelsea a new regulatory path forward for Northera. Specifically, it provides written guidance stating that Study 306B, a recently completed randomized control Phase III Study in NOH may serve as the basis for resubmission for our Northera New Drug Application. In his guidance, the Director goes on to note that “data strongly demonstrating a short-term clinical benefit, for example, improvement in the symptoms or ability to function of Droxidopa in patients with NOH would be adequate for approval with a possible requirement to verify durable clinical benefit post approval.”
Clarification of this requirement is an important development for Chelsea as it provides for the use of short-term clinical benefit on approval of Northera as opposed to data showing durability of effect which would require an additional and well verse clinical trial. This is particularly salient given the statistically significant outcomes in Study 306B for what the primary endpoint at week one, improvements in dizziness, lightheadedness and in the secondary endpoint of week one as well, the increase in standing systolic blood pressure.
The guidance further notes that any decision regarding the outcome of FDA’s review of our submission will be based on the strength of Study 306B and it's ability to provide substantial evidence of effectiveness to support approval. This is a high bar which the guidance notes will include a review of the conduct and results of 306B, things such as clinical site inspections and then inspections of Chelsea and the CRO’s. It's also a bar which we believe can be backed.
Our Northera NDA will include the totality of our clinical experience to-date, an experience which now stands multiple Phase III efficacy study, Study 301, 302 and 306A and 306B. An integrated summary of that including Study 306 and expanded 650 patients 50 database including eight weeks of double-blind comparative data, two long-term open label extension studies dedicated to our QTc study and 24 ambulatory blood pressure monitoring safety study.
So as we plan to file a resubmission of the Northera NDA in the late second quarter of 2013, the application will be classified with Class II Resubmission, subject to a six month review period, which result in a potential approval by the end of this year.
This new path was defined following a meeting with senior FDA staff including the Director of the Office of New Drugs and top staff in the Office of Drug Evaluation One and Division of Cardiovascular and Renal products at the Center for Drug Evaluation and Research. It also included high ranking officials who had not been directly involved in the review of the Northera program until these recent interactions as well as officials at the office and division levels who were directly involved in the review of the NDA. The meeting included a detailed discussion of certain key aspects of the company’s NDA, including the agency’s prior guidance regarding Study 306B, the appropriateness of acute endpoint, studying NOH in trials and FDA criteria for determining approvability.
It’s also important to note that our path forward includes the initiation of a new clinical study something which we had previously anticipated doing. The focus of such a study would be to include durability endpoints that address guidance regarding Northera overtime in the post marketing study. The study will also include short-term clinical endpoints.
Following review of the NDA should the agency find that an additional study is required for the approval of Northera the inclusion of short-term endpoints combined with guidance on the acceptability of short-term endpoints would allow us to adjust the size of the trial thereby providing for the most efficient use of our time and resources. Our plan is to initiate this trial in the fourth quarter of 2013, however, the timing is highly dependent upon further discussion with the FDA.
I will now turn the call back over to Joe.
Thank you, Bill. So this guidance clearly changes our milestones and timelines for the balance of this year. As we noted in separate filings this morning, Chelsea is announcing that it ended 2012 with cash and cash equivalents of approximately $28.4 million. This higher than projected year-end cash balance along with the revised timelines for initiating a new clinical trial should allow us to fund operations into the third quarter of 2014 in extension of one quarter over our previous guidance.
In addition to the initial cost of a new trial, assumptions underlying this guidance cover costs related to the NDA resubmission. The current forecast does not include material activities related to our commercialization of Northera.
Clearly, we are pleased with this new regulatory path forward and the potential for an approval of Northera later this year. We look forward to updating you on our progress in submitting the new NDA over the coming weeks and months. And importantly, we appreciate the patience of our investors as we work through this sensitive and critically important process with the FDA.
We will now open up the line for questions. Operator?
(Operator Instructions) And the first question will come from Robyn Karnauskas of Deutsche Bank. Please go ahead.
Hey, this is [Lydia] here for Robyn and congrats on the encouraging news from agency, I just have two questions. One, on the longer term study what kind of endpoints in duration might be compelling to the agency and kind of, I guess what would be applicable and the short term endpoints will be used there, would they be different from the other studies? And then just also I am just curious around the feedback that you received from the new officials that haven't been involved and just kind of if can you give us a flavor for kind of how their thought process different maybe from the current group? Thanks.
Okay, Lydia, why don't I turn over the first question over to Bill with regard to the endpoints.
We have not formally finalized this particular product for design; this was something that we are actively doing, we have framework port, we have a synopsis ready to go, but I want to stress that we are not finalized with it. However, our every intention we have is to build upon our program and learn at least on; now OHSA 1, the item one of the OHQ, for the measures business is in fact the endpoint we’re almost certainly to use in this particular trial, it’s a validated endpoint, we’ve shown efficacy with this in the past and the agency has emphasized the importance of dizziness overall in this disease. For all those reasons we will probably pick that. As to your question as to how long this trial would go out and the actual duration, we have an eye towards looking at the European submission as well for this. This maybe something that satisfies them, probably on the order of eight to 12 weeks something like that in the final trial, like I said we haven't decided upon that.
As far as the acute endpoint goes, we again, we very much want to use an empirical approach here. This has been a difficult area. We've struggled as everyone knows with some of our designs but now that we have three different kinds of studies that inform us on this we are going to go with what we've seen works and that is the OHSA 1, probably a one-week for an acute endpoint, in the event say that the agency requires that study premarketing.
And I'll move on to the second question and obviously invite Bill to provide his caller on his view from the folks that had not been so close to the review and now are brought to review this information more critically. I have to say that we were very impressed with the level of detail that was reviewed and our understanding is that it was reviewed very carefully and the key issues were brought to the table. They offered some new drugs, they are bringing console from other areas of the agency that help lead them to this decision.
Finally, I will say before turning it over to Bill that this included obviously the division and the office level who obviously have the best understanding of our program to-date. So it was a collaborative effort in the sense that everyone was at the table as they reviewed all the information and participated in the meetings.
Yeah, all I'll add to that is this was a heavily attended meeting by the FDA from many different places. It was, we really appreciate the thoughtfulness, the care, the diligence that the FDA took into this appeal. It was very clear that they have had many discussions among themselves about looking forward. It was very clear that the agency was trying to work with us to find the path forward for dropsy but people recognize the benefits of this drug and it was very much of a collaborative effort I feel and there was much input, positive input like Joe said from people who had not reviewed the application before. So we are thankful for the meeting. We are encouraged by that and again we are appreciative of the agency offering us an opportunity here with our largest data center, in fact the largest trial ever conducted in this field.
Just quick one follow-up in on Europe, just kind of I know its little early but just kind of how are you thinking about your design for the US kind of complementing what could go in Europe there?
It’s a very astute question actually and we've been very clear that from early in the discussions with European regulatory agencies that they always had an interest in long-term comparative trials. The primary difference between their view and the FDA’s views early on in the program is that from a safety standpoint they are very interested in evaluating a comparative placebo controlled trials over the long-term for that two to three months.
So I think as we certainly look at this new trial, we have in our minds that this could be a design that could help us with European regulators as that was their basic concern going into the whole program.
The next question is from Liana Moussatos of Wedbush. Please go ahead.
Liana Moussatos - Wedbush
What changed their mind about focusing on eight weeks of durability versus short-term benefit during that meeting and will cardio renal be the reviewers for the resubmission?
Okay, well thanks a lot, Liana, of course a very good question. Always difficult for us to articulate what exactly in their mind change it there. You know, almost have to --- but I will say that again, we have the opportunity to go to a group who can look at this with a set of fresh eyes and the office of new drugs that come in and they took console from the Office of Scientific Investigation and in particular, the issue with regard to Study 306B as everyone knows was the potential or theoretical issue of [unblinding] and that issue was very thoroughly wedded by that group and they look in detail at all of the information that was provided to them by Chelsea and of course came to their assessment and exactly why they came to that assessment is based on I think their ability to look into detail and their expertise in these areas.
And just for those on the call that don’t know exactly what the Office of Scientific Investigation is, that’s the group, that sort of is primarily concerned with the quality of data and the oversight of studies. So again those experts came in and (inaudible) on it and thought that Study 306B and the potential unblinding issue that was on the table was not enough to disqualify it for a review. So that was basically just the answer that they provide and I will allow Bill to provide all further color on that.
I am just going to say, our appeal was actually an exhaustive one. It wasn’t just a few paragraphs. We put a lot of effort into outlining what we felt were all the relevant data, across the field across our study in our NDA about the benefits of this drug and so forth and I think the agency, and again I said this earlier, I think the agency really wants to find the path forward for this drug in a way that’s meaningful and through their interactions they believe that the key benefits looks something that others have used in the past with their clinical trials that we had also used in our past particularly 301 which was conducted under a special protocol assessment.
And I think conducting a durability study post marketing to that sounds like that requirement would really accomplish a number of things, the patients on that medical needs that exist was also recognized by the agencies. They acknowledged that there was a dearth of therapies for the treatment of neurogenic orthostatic hypotension and tend to move forward.
So I think it’s a combination of just then reviewing and taking a step back about this drug, about the unmet need, about their own previous history in this field and about finding a path forward.
Liana Moussatos - Wedbush
And will cardio renal be reviewing the resubmission?
Yes, yes I would say that. And that's an important point. This is a meeting that was held with the director of the office of new drug now the division of cardio renal products was certainly represented there and was participating in some of the discussions as well but they ultimately will get the resubmission from us and make a determination and we plan on working very closely and carefully with them all along the way with every aspect of this to get their input to make this as collaborative and productive as possible.
Liana Moussatos - Wedbush
And cardio renal change their mind about focusing on long-term durability versus short-term?
They were there at the meeting and did not distance from the view about long-term. This was a decision though as important to say that was coming from the office of the director. We have every, I would say that the division of cardio renal products is in sync and in concert with the division.
There is no indication at all that there is disagreement and so forth in fact it is our saying that (inaudible) that the agency really wants to work with us to make this path forward, but the official answer to your question Liana until they actually accept the application from us, we can't guarantee or say with the 100% certainty, but we think there is a very high likelihood that the subdivision will accept the short-term endpoint (inaudible).
The next question is from Alan Carr of Needham. Please proceed.
Alan Carr - Needham
Why didn't you go back to durability here item one has always is been, it sounds in (inaudible) eight to twelve weeks. I am wondering if you could talk a bit more about that in terms of the next trial contemplating (inaudible)?
Yeah, we discussed about it Alan. It’s a very good question about why is it so hard to measure durability with this drug and it goes back in essence to difficulty of studying this disease in general because we are using subjective outcome measures for these patients they tend to be older in their mid-70s, some of them going on 88-85 years old, and we talked to the patients ourselves about their scores and how well they are doing as they reflected on the OSHA 1.
This is something we had, when we designed the NDA we had every expectation that this drug is working given the anecdotes that we have heard, but the patients themselves reported difficulty in some instances and since actually coming up with the score and as time goes on, so you go from the week zero to week one and now you are at two months, the patients in all likelihood continue to have difficulty calibrating their time at week eight versus their time at week zero. It’s a well known effect in clinical trials. And we've discussed this with the agency and presented that to them as well. I think the good news is that we saw a key value of 0.077 in Study 306 when you combine the two studies together at week eight.
We nearly reached statistical significance with the overall analysis and thereby I think we can in fact demonstrate durable benefit. In the long term, its just going to take more patients and therefore longer time to approve them. And that's the reason why we are going to pick the OHSA 1 as our endpoint because of that data and because of reassurance.
We have no indication at all and this includes the blood pressure data as well that this drug is losing effect over time. In fact the patients are staying the same and often times when we talk to them, even they are experiencing benefit. So we remain confident that we can do that. It’s just the question of powering the study up Alan.
Alan Carr - Needham
Okay, thanks very much, on Europe financial guidance doesn't include expense of the trial, right.
Alan I'm having a little trouble hearing you but I think you asked if the guidance included the expense of the trial and it actually does. The difference between previous guidance was that we expect this trial, this new post marketing trial now to start in Q4 of 2013, whereas we had always planned on doing a trial and our last guidance was that we thought the trial would start in Q3 of 2013. So by pushing that trial start out by at least about a quarter we have a little further runway as a result of that.
The next question is from Scott Henry of Roth Capital.
Scott Henry - Roth Capital
I just had a couple of large picture questions, starting with the staff that the FDA that reviewed this drug, was there significant turnover in the staff that will be reviewing the new application versus the old application, just trying to understand perhaps why things change and how they changed.
There's been no change or turnover at the division that we are aware of. Certainly all the personnel we've been engaged with at the division at the senior level were there at the meeting, the office director was there as well. So its’ not a change in any personnel. I think what's happened here is that when we presented our case to them and again we spent a good deal of time assembling all the information from across a range of different angles and policies to appoint the staff and brought to them.
I think a pretty compelling argument for not only the need to find a way forward for this drug but to allow for 306b to also move forward. I think that when they saw that and recognized the value of that particular study, they agreed that we should be looking at the totality of the data overall with this particular NDA. So I'm just trying to get at your question a little bit about what changed there, but it’s mostly the application I think.
Scott Henry - Roth Capital
So was it they found the 306b data perhaps more compelling than they would have expected to find it or was it the 306b data strength that changed the tone in your opinion.
You are raising a good pint Scott, and it’s important to note they have not yet seen the 306b data per se. They are aware of the top line data that was issued in the press release. We communicated with them just briefly on 306b, but this appeal that we went forward with was not one that involved the 306b data. We went on the merits of what we felt were the dataset per from our NDA application and the complete response letter.
So what this represents then is the agency reevaluating some of the guidance that they had given us last year in response to our NDA and trying to find a path forward with 306b. But we still have to submit to them 306b. We still have to have the division review 306b and of course that involves a full review with an inspection and so forth that we discussed earlier.
Scott Henry - Roth Capital
And the final question which is very subjective, but as investors, the FDA process is always somewhat of a Blackbox and we see products refiled and sometimes management will say that the FDA has responded that you can resubmit, but this sounds a little more positive than just we will let you resubmit the application. This sounds more as if it you should resubmit and with a degree of confidence there.
I just want to get your subjective tone on how you believe the FDA feels about this resubmission and why do have that positive tone relative to simply a situation where the FDA is allowing you to resubmit but not in any way validating the process?
No, that’s an excellent question Scott and let me tell you why we believe that this is a very positive step forward. First of all, the data from 306b we think are compelling. We have a primary endpoint that reap statistical significance as well as an important secondary end point with blood pressure.
Even more importantly in my opinion then the blood pressure outcome that we're seeing improvement involved, involves related injuries. So that many more patients on placebo are having contusion, lacerations and fractures all consistent with the benefits we saw in the dizziness.
But your question has to with the FDA and why we believe that this is something that is a positive thing going forward, and let me first say that we do have to go back to the division let me say that that straight up. We have to go back to that and work with them and until we get full clarity with the division on their attitude (inaudible) there is a certain amount of risk involved with going back to them. But they were there in participating at the meeting with us at this meeting that we held with the director of the office of new drugs.
They accented to many of the things that we are discussing; they agreed to the totality of the data were there; and I can tell you the way the agency often times deals with complex issues such as ours and ours is a complex one, it’s actually look at new data that’s coming into them to actually affirm or not affirm the validity of the assumptions and conclusions that were made earlier.
So here we have the largest study every conducted in NOH and we have a positive primary endpoints, it’s consistent with the other data. The agency actually went out of their way in some respects to overturn some pretty significant guidance that they had issued last year as we reported.
The office director said that the study would not be useful and yet that is something that’s overturned and we are grateful for that and we believe that the FDA has given a lot of thought to this. So there is no guarantees with this going back to the division, but on the other hand this is the discussions we had coupled with our own data, coupled with what I think is the agencies wanting to actually find a path forward and citing the unmet medical need and the patient need for this drug. I think they all add up to what we believe as a pretty positive scenario for this getting approved potentially later this year.
(Operator Instructions) with Mr. Sanchez dialing with a connection he may re-queue. The next question will be from David Moskowitz of [Highland] Research. Please go ahead.
I just want to drill down on some granularity on the back of that question before on the sort of sentiment of the FDA. So you guys are kind of alluding to one week being the length of duration for the short term endpoints. We are not sure if that’s going to be (inaudible), lets assume that it is.
Going item one of the OHQ that you also talked about a like being the primary endpoints. Can you talk about the durability that you are seeing, the durability of affect that you’ve seen in the prior trails starting with 306b, and my question will be how sensitive is FDA to those prior short term results that you’ve shown so far?
So David this is Bill, I think I understood your question, I don't have the data on 306b directly in front of me, but when you look at the dizziness endpoint, I am going to let Dr. Art Hewitt I think speak maybe to the data, the granular question you have since he is the expert on the data here. But, in general the data from 306B and from the overall 306 Study are supportive of the endpoint and we have the biggest effect at week one it’s true but that then is then stabilized throughout the rest of the Study but Art why don't you walk David through that.
Sure, thanks for that. I mean, basically as we've indicated our ability to indicate it prior, we think this is largely an issue of larger numbers being required to overcome the inherent increase in the variability of the data over time. What we do see in 306B is that at the eight week time point we have a delta which is on the order of 0.6 and that is associated with a p-value of 0.18.
If you use the larger data set, the complicit data set which includes the 51 patients who were treated in the exact same fashion but handled under 306A then you see a delta of 0.8 and the statistical significance becomes a 0.077. So our feeling basically is that this becomes an issue of powering the study. It does become more challenging the further out you go but that this is something that can be achieved and we think the composite data from 306B and A combined give us a lot of confidence that we will be able to achieve a positive outcome as long as we power it and recruit an adequate number of patients.
Hey David this is Joe. Let me just add one other sort of components to Bill and Art’s thoughts on the data itself. And that's just the very practical understanding that we have more confidence that the week one data point because we have multiple studies that include week one worth of data. So 306A and Be are sort of a third study of seeing one week of data on the back of 302 withdrawal study and then Study 301 and induction study both having short-term endpoints. So 306 was the first study that actually showed data out to eight weeks and while its compelling information, it is one data point relative to the three data points that we have at the more short-term time points.
Okay, if my question is if you were to pool the data from all eight data sets that you have, is there a way to show that on a one week endpoint that this drug does achieve statistical significance in larger patient set?
Yes, David, the chief statistical significance even without pooling the studies together. When you pool the data together as we have done there are many, many zeros in front of the one from studies 301 and 306 together as that long-term endpoint and that's an analysis that we’ll supply to the FDA as part of the overall resubmission package. So it’s very compelling when you do that kind of a net analysis but I think more importantly we have two studies now which are replicative with regard to the final week endpoint.
So that discussion that we just had is that sort of the center point of resubmitting the NDA and trying to achieve approval is showing that you can achieve statistical significance based on the data that you have on Item 1 of OHQ which is dizziness?
Yes, that's correct. We're going to go in and fight the primary endpoint with Study 306b, which is a p=0.018. You remember we stopped that study early because the FDA had told us, this is back last quarter now, that the study was not going to be useful for a filing. So we had planned on recruiting an additional 50 patients for that study. We [emblided] nevertheless. We had a prospect of an analytic plan with that. The plan had been submitted with the FDA. It was consistent in many aspects with the plant that we've had originally with Study 306 and even though we didn’t complete the study, we showed statistical significant doubt at week 1.
And as you said David, that’s going to be the starting point of the new data. But I hate to emphasize that we have a lot more data than just week one dizziness scores. We have durability up to week 8 with a med analysis trying p=0.077. We have blood pressure data. The pulse state and injuries data are nearly statistically significant when you look at the injuries for example and the contusion and lacerations. There is a lot of data that altogether are consistent with each other and point to the benefit of (inaudible) but that we think is compelling.
And I have one final question. Did I read that Shire is going to withdraw midodrine from the market at the end of FDA? Is that really happening, and if so, does that include all the generics as well?
David, I am not aware of what reference what you are making to withdraw but Shire and the agency have reached an agreement. It's public record and Shire is in the process of running two trials that would be efficacy trials to support a symptomatic benefit of midodrine and they are in process of running those trials currently.
Okay, and what are the endpoints for those trials?
They are a combination of sort of dizziness, [pre-sinkebe] type endpoints associated with these use of [milagino] placebo.
Okay and did they specify the duration of dizziness within (inaudible)?
Yeah I won’t get too much into the Shire trials but what is public is that the relatively small trials and relatively short trials with regard to that comparative nature relative to placebo.
(Operator Instructions). I am showing no questions in the queue, and I would like to turn the conference back for any further remarks.
Thank you, operator and again thanks everyone for taking the time out this morning to participate and listen to the call and for the great questions provided. As stated before Chelsea is very excited about this regulatory path forward and the opportunity to interact with the division at the Cardiovascular Renal Products Group at FDA and we look forward to updating the investors as we move forward on this path. Thank you very much.
Ladies and gentlemen, thank you for participating in today’s program. This does conclude the conference and you may all disconnect. Everyone have a great day.
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