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Acorda Therapeutics, Inc. (ACOR)

February 27, 2013 1:30 pm ET

Executives

Ron Cohen - Founder, Chief Executive Officer, President and Director

Analysts

Yaron Werber - Citigroup Inc, Research Division

Yaron Werber - Citigroup Inc, Research Division

Good afternoon, everybody, and thank you once again for joining us at the Citi Health Global Healthcare Conference. It's a great pleasure to introduce Ron Cohen, who's the Chief Executive Officer at Acorda. So, Ron, thanks so much for joining us, we appreciate it. Ron has a little bit of laryngitis. He's definitely not going to sing for us, but we have a great microphone so that you can all hear him.

So let's start. We kind of want a few things to discuss. I want to talk about AMPYRA. Then I want to talk about pipeline, AMPYRA's pipeline and then the rest of the pipeline and then talk about diazepam.

So let's start with AMPYRA, and give us a little bit of a sense on -- I mean, you've given guidance, so we know what the outlook is for this year, but in terms of continuing to take action to stimulate demand and increase share, what's the biggest challenge facing in AMPYRA? Is it that -- it's already penetrated a good chunk of the patients who have an urgent need, or is it still a question of convincing docs to adopt the drug earlier?

Ron Cohen

I think it's both. But you touched on a great point, which is we've had over 75,000 people with that mass already trial the drug since launch. We think that of the population, about 200,000 are eligible, are labeled to try the drug in terms of their level of walking impairment. So as you continue to penetrate into that addressable population, by definition, the next level of patient is more challenging to get in than the earlier ones were, because if they weren't, you've gotten to them by now. And that's either because your efforts hadn't succeeded in reaching them yet through whatever outlets you're using or your messaging has not been touching them in the right way. So you do have to continue to evolve your promotional program to reach those people who haven't been reached yet and also, to adjust and tailor the messaging in ways that you've learned over time are going to be appropriate for those patients. So in that sense, that's really where the challenge is. So you do have to continue to invest to bring them in. That said, it still means we have, let's call it 125,000 patients. So the majority of the patients that should be trying the drug are still out there available to us. And it's really a question of how well we execute to get to them. I think we've -- the thing that encourages me is that since launch, I look at how we started out and where we are today almost 3 years later. We have a much more sophisticated and granular understanding of the marketplace than we did in the first year or even last year, and we're continuing to build on that, as well as build databases that allow us to penetrate further. Now the other thing you mentioned was persuading prescribers to go further down the curve. In other words, people who are more mildly affected where it's actually impairing their lives. But if they walk into the office, it's not obvious, they're not using an assisted device, they're not using a cane. But in fact, if you quiz them, you'll find out, well, I'm not picking up my kids at school anymore or I'm not taking them to the park. My husband does that or the nanny does that, and that's really upsetting to me in my life. Those people deserve a shot as well. And so, what we've been doing there -- but maybe the most effective thing we've done to persuade prescribers to do that is the First Step Program. First Step Program, we really -- we've piloted it in '11, but we put it out in full in January of '12, and that's a 2-month, free trial of drug. The drug is delivered by mail order. It's drop shipped from specialty pharmacy, so you can't pick it up at retail pharmacies. So we can track this very well. And one of the issues we found was that physicians were reluctant to prescribe what, in some cases, they perceive to be an expensive drug for an earlier stage disability. So it took on a feeling for them of, well, this is a big gun and it needs to have a big symptom complex to use it. Once we went out and said, look, this is all on us. It's on the system, it's not on insurance. You just -- if you write it, the patient will get the drug very shortly thereafter, and then you have 2 months to see whether it's benefiting them or not. And if it is benefiting them, then you're happy to have them continue to take it. And if it's not benefiting, no one's lost anything except Acorda. And that perhaps has been the single most effective thing we've done to get the goodwill of the prescribers to go ahead and try it. Because now, the attitude is, all right, well, we have nothing to lose here, let's try it and see if it works.

Yaron Werber - Citigroup Inc, Research Division

What percentage of new patient starts go through the First Step Program?

Ron Cohen

At this point, it's approximately half. It depends on the month, but it's fair to say it's approximately half.

Yaron Werber - Citigroup Inc, Research Division

And so as I'm thinking, why isn't it 100%? Because the docs, some new patients get 2 free months.

Ron Cohen

It's interesting, it is a different form that they fill out, and some of the physicians are very happy with the commercial prescription forms. They're actually very happy with the drug and they prescribe it without First Step. What we've also found that was we thought was really interesting is that those physicians who started using First Step also on average, increased their use of regular commercial prescriptions. Not sure exactly why, but there is some sort of virtuous circle going on there.

Yaron Werber - Citigroup Inc, Research Division

Were they the higher tiers of prescribers to begin with?

Ron Cohen

Not necessarily, no. And in fact, in some cases, they were lower tiers of prescribers.

Yaron Werber - Citigroup Inc, Research Division

Okay. And then can you share with us what's the retention? 2 months, 3?

Ron Cohen

We haven't changed our guidance on that for a while. The last guidance we gave is that at 6 months or so -- at 6 months, about 40% are taking the next refill, so they're taking the seventh month of the people who started. So if you have 100 people, let's say, who start, on average, 6 months later, 40 of them are still refilling.

Yaron Werber - Citigroup Inc, Research Division

Okay. And then I was going to ask, what's status or just give us a little bit of a sense of the 5 versus 10 milligram data and talking and discuss now with FDA.

Ron Cohen

We've submit it. We said we would submit it, we have submitted it to the FDA, and there are no updates beyond that, just reiterating our view based on the analysis of the data was that 5 milligrams was not as effective as 10. And in fact, it was, generally speaking, not effective. So that would be our interpretation. Now of course, if we hear something from the FDA, we'll let people know.

Yaron Werber - Citigroup Inc, Research Division

And the way this works is they can just get the data, review it and meet with you and tell you, okay, now you've fulfilled the criteria and we're finished?

Ron Cohen

Well, they could do anything that they think is appropriate. They could review it, put it away and not tell us anything. They can review it and call us up and say, can we have a meeting to discuss some points or they could go beyond that.

Yaron Werber - Citigroup Inc, Research Division

Well, if you feel that's it's not effective, let's just take a view that -- theoretical situation where the FDA views that it's effective. And they would like to include that in their labeling, is that the way this works? Or does the company needs to initiate the request to add this to the label and let the FDA initiate that request, too, for that discussion?

Ron Cohen

I don't absolutely know the answer. My assumption has been it could either way. The FDA certainly can initiate a request. But our view would be that we think that's unlikely, but if they came to that, we would have serious concerns about that interpretation of the data and we would ask to meet very deliberately with the FDA to discuss that.

Yaron Werber - Citigroup Inc, Research Division

Okay. Maybe just then commercial and talk about Europe. Our understanding is that the pricing negotiation between Biogen in Germany has concluded, but we don't know exactly what the price is, but it looks like the price was within that range, but maybe a little bit higher than the price that's been used to book sales in 2012. Is that [indiscernible]?

Ron Cohen

I have to apologize because I'm limited here by our agreement with Biogen. We have to follow their lead on anything that's in their territory. So if they haven't announced anything, we can't -- all we can do is reiterate what they've said, which is essentially what you just articulated. But they did say they expect to have a final price in the first quarter, and we have been booking sales since last August at the lowest possible price in the range and if the price turns out to be higher than that, we will make the adjustment on a go-forward basis.

Yaron Werber - Citigroup Inc, Research Division

It's going to maybe be a onetime catch-up historically and then the new...

Ron Cohen

Yes, I'm not sure how the accounting works, but obviously, it has to catch up somewhere.

Yaron Werber - Citigroup Inc, Research Division

And what's your understanding maybe based on what Biogen has said? Most of the sales, if we recall, have been coming from Germany.

Ron Cohen

Correct.

Yaron Werber - Citigroup Inc, Research Division

Has the drug been actually launched in the rest of Europe?

Ron Cohen

It's been launched in multiple countries. I don't actually have the number in my head and then they have a series of new launches planned this year and beyond. So that's really all I have in my head.

Yaron Werber - Citigroup Inc, Research Division

Has the price -- the lack of clarity on price in Germany impacted the method of the launch in other territories because of license pricing?

Ron Cohen

I don't know. I mean, I don't know it country by country. In some cases, not. In some cases, probably. I think that's the best we can say. It is true that the majority of sales right now are still coming out of Germany. On the plus side, the demand, the fundamental demand for the drug has been extremely robust and continues to be. So patients and doctors like the drug, they want it and the pricing is the issue.

Yaron Werber - Citigroup Inc, Research Division

Okay. Let's move -- if there are any questions at anytime, you can just raise your hand and we'll call on you. So we're going to move to stroke and talk about the ongoing Phase II. So maybe just, in a nutshell, give us a sense, the animal models have been provocative. I think one of them you've published, I think there's a second confirmatory model, which has been done.

Ron Cohen

Correct.

Yaron Werber - Citigroup Inc, Research Division

That has not been fully published but the understanding is that if confirmed, the first model, and the data looked as good as it can look in a mouse, the rat. The question is how could -- number one, how predictive is a rat model to a human? And then two what are you guys thinking -- what is reasonable to be able to show in the study just given the mechanism, just given how difficult this indication really is?

Ron Cohen

My answer to the first question is I don't know. We know that -- what you can say is that pathophysiologically, if you look at the anatomy and the mechanisms at a cellular level, the rat model of middle cerebral artery stroke closely resembles what you see in the human. Now having said that, no one's ever translated a functional outcome in a rat with a drug like AMPYRA or dalfampridine into a human trial because it's a first-in-class drug. So the reality is we can hand wave a lot of that, but if we're all being honest, we don't know. It is -- I think the word used is the best one. It's provocative, it's intriguing, and it gives some sense -- it certainly gives you a very rational underpinning for doing this clinical trial that we're doing. And some expectations that at a minimum, there is a biological activity in stroke patients. Now the real question is does that biological activity translate into meaningful functional benefit for these stroke patients to a degree that it's worth approving for the indication? And the only way that we're going to get an answer to that is when we unblind the study in the second quarter, and then we'll tell everyone about it. The reasonable expectation -- let's talk optimistically, let's assume that we see something meaningful, what would that look like? Well, on a basic level, look at the current indication, which is to improve walking in MS, that would be a very usable indication. If we can show that people with weakness or paralysis from stroke are able to walk better on a Timed 25-foot walk or what have you, that's very important. We're also looking at functional upper extremity measures. And as you know, people with strokes, particularly middle cerebral artery strokes, have compromise in their upper extremities, anywhere from total paralysis to severe weakness, inability to use their hands to feed themselves or to manipulate objects, to steer a wheel. So if we can show that there is a significant improvement in the various -- we have various tests that are validated in the field, like a block and box and grip strength and so forth. So we can show that there's a meaningful improvement in upward extremity function, that would also potentially be usable for registrations studies. That's about all we can honestly say. Now everything else will depend on what the data actually show.

Yaron Werber - Citigroup Inc, Research Division

And just remind us, the patients who are enrolled, these are stable stroke patients and...

Ron Cohen

At least -- no shorter than 6 months ago, but no upper limits. So it could be 10 years. But it has to be at least 6 months in the past because we wanted to allow the patient's recovery to have stabilized so that the deficits they have are extremely unlikely to improve absent some therapeutic effects.

Yaron Werber - Citigroup Inc, Research Division

What do we know about -- is there a difference between a patient who had a stroke 181 days ago and someone who had a stroke 10 years ago? Let's say, something identical deficit, just in a natural atrophy and deterioration that's been -- typically happens in a stroke?

Ron Cohen

Other than other things that happen to people over long periods of time, for example, getting older, and having various systems deteriorate a little bit more, there shouldn't be a substantive difference. For what we are concerned about, which is the impact of the drug on poorly myelinated segments of the white matter in the brain and spinal cord, in the brain, in this case, there really shouldn't be a difference based on all the available data. If you were to ask me the question, what about 1 month or 2 months after the stroke? The answer would be almost certainly yes. Because there is a level of natural plasticity and recovery that occurs in the few months after a neuro traumatic event, such as stroke where there is evolving improvement. But that -- by 6 months, almost no one is showing more improvement after that.

Yaron Werber - Citigroup Inc, Research Division

And the reason you guys think that dalfampridine potentially will have activity is why mechanistically?

Ron Cohen

Well, it starts with pathophysiology and the mechanism and then the underpinning is that we have proof-of-concept in an animal model that validates the original logic, which is pathophysiology and mechanism base. So we put those 2 together, and you say, well, that's really interesting. So on pathophysiology, what we know about dalfampridine is that it increases the excitability of the nervous system, and specifically, it increases conduction in poorly myelinated or poorly insulated segments of the white matter, which are the long tracks that conduct the signals from one nerve to another. And that's what happens in MS. There are other effects, there are presynaptic effects where it actually has been shown to stimulate more neuro transmitter release for a given action potential cascade. But overall, you have the general effect of generically more excitability, perhaps, through mechanisms like increasing the neuro transmitter release and then more specifically, restoring conductivity where it has been impaired by loss of the insulating myelin. So then you look and say, well, what other conditions are characterized or partly characterized at least by loss of myelin or impairment of myelin? And it turns out there are quite a few. The 2 that we selected were 2 that we felt had the most going for them. One was adults with cerebral palsy. Because cerebral palsy is a perinatal hypoxic insult to the brain that generally results in a large loss of myelinating capability around the ventricles in the brain and then you have weakness, all the things that you would see in stroke or other brain-impairing diseases. Post stroke, quite interestingly, most people think -- I think most people probably think of it as you have a clot in your artery that goes into some part of the brain and it wipes out a piece of the brain. It turns out it's more complicated than that. While it is true that you have cell bodies, neurons, gray matter that do get wiped out, very often, you get impairment of white matter tracts that flow through the area that is supplied by that artery, and to be very specific, we know that in humans, the middle cerebral artery, which is the one that is most frequently affected by strokes, the neurons for the corticospinal tracts, which allow motor functions in the lower extremities are actually found in the domain of the anterior cerebral artery. But the axons, which are the long tracts, the wirers, that transmit the information, cross into the middle cerebral artery area. So what you expect and find in the pathology studies in stroke is that in middle cerebral artery, you frequently get areas where the white matter for the lower extremities is demyelinated or poorly myelinated, but the cells are intact, so they're still initiating signals. That seems to be an ideal circumstance where a drug like dalfampridine or AMPYRA, because what you want to try to do is to amplify those signals so that they actually get through the demyelinated areas and get down to the legs where you want them to do something. Very similar to what we see in MS, just a different cause. So that was the logic for mechanism in pathophysiology, we tried it out in the rat model to see if it had any legs as it were. That can be funny, sort of, that wasn't funny.

Yaron Werber - Citigroup Inc, Research Division

We planned that actually.

Ron Cohen

Yes, it was -- and it turns out to be a highly reproducible improvement in function in the forelimbs and the high limbs in rats and its dose-dependent. So it does everything you would want to see to give you confidence without going through a human trial. The big caveat here is we don't know how well that translates to humans and we won't know until we unblind the study.

Yaron Werber - Citigroup Inc, Research Division

And just remind us in the Phase II, how long do you dose before you do a crossover?

Ron Cohen

I believe it's a week.

Yaron Werber - Citigroup Inc, Research Division

Is that a long enough to see an effect? And what did you learn from the MS study?

Ron Cohen

So we've done studies in spinal cord injury and MS. And we have years of experience looking at this. So the answer is that in some cases, it actually does take several weeks for people who are taking the drug to realize what they're getting out of it. But the actual effect on the nerves is instantaneous in every case. And we believe that that's a translational issue where people just haven't been using the muscles for a while and it takes a while for them, their bodies to actually realize, wait a minute, I'm getting signaling and the muscles get a little stronger and then all of a sudden, you see it. So ideally, you do a trial for a couple of months, right? But this is a proof-of-concept study and what we saw in our earlier studies is the majority of people that you put on drug within a week, you can -- if they're responding, you can show it. And so what we want to hear was not have excessive time or expense for proof-of-concept so we powered it based on everything we know to be able to show the effect, at least with a strong trend that would justify going into registrational studies.

Yaron Werber - Citigroup Inc, Research Division

Okay. And can I ask, in -- certainly in stroke -- I'm sorry, in CP, but I can't remember in stroke, do the patients have an underlying high risk of seizures and if so -- I'm mean, they're only going to dose this for a week, but is that something you guys, I would imagine monitoring pretty closely?

Ron Cohen

Yes.

Yaron Werber - Citigroup Inc, Research Division

How worried are you about potentiating new seizures?

Ron Cohen

So anyone with lesions in the brain, particularly subcortical lesions, can be at the higher risk of stroke -- of seizure because it disrupts the flow of electric connections and you can wind up getting apparent cascades. That's true in MS. So the baseline population has a multiple risk of seizure over their lifetime versus the rest of us who don't have MS. It's true of stroke. Based on the literature, we have -- no one's done a head to head, but based on the respective rates that are published, it looks like the risk of stroke -- of seizure in post-stroke patients is approximately the same or very similar to what you see in MS. So our initial expectation is that, that's what we should see, which is you do see some seizures in people with MS. But overall, the risk-benefit was judged to be appropriate for the MS indication, and if we had something similar in stroke, we would expect the same.

Yaron Werber - Citigroup Inc, Research Division

Okay. Any questions? Okay, question over here.

Unknown Analyst

I assume with your stroke study that you're using the same walking scales in adults that you use in MS. And so the question would be how validated is that in stroke? And then the upper extremity scale, have they been used in clinical trials before successfully? Because it seems to me my impression is that a lot of these scales have all kinds of issues being too coarse or having unpredictable behavior in trial and a lot of the stroke trial failures isn't because the drug isn't doing something, but that the scales just don't seem to quite measure it?

Ron Cohen

So it's an important question because it highlights something that everyone needs to differentiate. We, in the industry and people who follow the industry, have been conditioned by a series of spectacular stroke trial failures, each one costing on -- I guess, around $100 million, beginning in the 1990s and all the way through recent times. Those are all, without exception, been acute stroke neuroprotection trials. It is a completely different paradigm, you may as well be talking about 2 completely different diseases, why? Because in an acute stroke trial, you're bringing in people who just are having a stroke, you're intervening and you're hoping that when they recover, they will be better off than they would've been if you didn't have a drug. While there's no way to compare them to themselves in that case. So you have to have very large studies where you account for all the variability and you have to compare it to a very large placebo group to a very large drug group and then you have to have outcome measures that make sense, and the outcome measures that they typically use have been this global stroke scales that are not very specific. And that's one of the -- and they're very coarse, and sometimes, subjective. And that's been a big criticism of the whole field and with good reason. This is a completely different paradigm. In the sense, that here we have people who have the disability, that is their baseline, and you want to measure a change from that baseline. That's much easier to do because each person can serve as their own control as it were. So you can have smaller studies and then you're looking at not global recovery, you're looking for evidence of every specific functional recovery. Now let me say, that some of the leaders in this stroke field for years now, have been saying, that even in the acute stroke studies have gotten it all wrong, and what they should have been doing was going after this discrete functional measures that are more objective and more easy to quantify. And in fact, I believe that that's the way the acute stroke field is going to be moving into these kind of measures. And of course, the FDA has to agree to that. But I believe that's where we're going to wind up, because that's what matters to the patient and it's much better to quantify walking or a specific ability, to grip something with your hand or to be able to lift it and take to your mouth, that sort of thing.

Unknown Analyst

[indiscernible]

Ron Cohen

No, these are validated tools. Now having said that -- so let me give you the other side. Having said that, these are validated scales, they're not the ones that we used in the acute stroke trials. But having said that, because no drug has ever been approved to improve function in stroke, I don't believe these measures have been used to approve a drug. But that was true in MS for the Timed 25-foot walk, until we came along and got the drug approved with the Timed 25-foot walk. So I would stipulate to you or suggest to you that of all the groups out there, we're the best placed to know how to discuss that with FDA and came up with measures that they'll accept.

Yaron Werber - Citigroup Inc, Research Division

Okay. Diazapam nasal spray. Maybe let's talk kind of broadly, just give us a little bit of sense what else do you need to do in terms of one, completing the adults in case study; two, what do you need to -- what other clinical data do you need to submit; and three, CMC, I'm trying to just get some -- kind of what else needs to be done?

Ron Cohen

So we -- as a matter of course, we have never and don't discuss specifics about what's missing from a package or what are we waiting for and so on. What I can tell is that the clinical data are in. And what we are really waiting for now is a number of different CMC studies that have to be completed in order to file the package.

Yaron Werber - Citigroup Inc, Research Division

Okay. So sort of the equivalent, things like that?

Ron Cohen

CMC.

Yaron Werber - Citigroup Inc, Research Division

Okay. Do you have a sense -- do you need to do PK, PB studies in kids to get ultimately coverage for children or can you rely on the adults?

Ron Cohen

So that is something that is under discussion with FDA, so I can't say more about it now. What I can say is, if we do, we will. If we do need to do that, we will and we can do it quickly. And if we don't, we won't.

Yaron Werber - Citigroup Inc, Research Division

And if you have to do it, how long does it take normally?

Ron Cohen

I don't think there's a normally, but I don't think it would take very long because the 3 studies we have were done in adults. So that's what we're going to file with.

Yaron Werber - Citigroup Inc, Research Division

Okay. And what percentage of fails historically were in adults versus kids?

Ron Cohen

70% was pediatric. This is of the rectal gel. Now what's important to understand is that the majority of patients who are eligible for -- who experience cluster seizures, these breakthrough acute repetitive seizures, that the majority of the epilepsy community who experienced those are adults. But adults strongly tend not to use a rectal gel. They would rather call 911 and go to the emergency room and get treated there than to use it. Because remember, first of all, you can't give it to yourself. And if you've just had a seizure, you're certainly not going to give it to yourself. So you have to have a caregiver, a care partner, your spouse or someone else in the house or a parent. The reason it's given to little kids more than anyone is think about the same reason you use a rectal thermometer on little kids and no one else uses a rectal thermometer, even though the vast majority of people who have fevers are adults. So our view is that the -- one of the big opportunities here is not only switching over the people who are rectal gel to the nasal spray, but actually bringing in a sizable amount of the population that's currently going to emergency rooms and that's part of a value proposition to managed care.

Yaron Werber - Citigroup Inc, Research Division

And what are you -- give us a little bit of a sense on the market. Do you have any sense how many patients are on the U.S. suffering from cluster seizures?

Ron Cohen

Yes. It's up to about 175,000 are estimated, which is why we were able to get orphan status, about 175,000 in the U.S. We also have international rights. We have not addressed that portion yet. We're taking it one step at a time. Our view is to first, get the NDA in and meanwhile, we'll be scoping out the international situation. So it's about 175,000. And if you look at the peak sales of the rectal gel, when it was branded before it went generic about 1.5 years ago, they peaked at around 100 million a year, but again, we have a very sizable portion of the addressable market not using the rectal gel.

Yaron Werber - Citigroup Inc, Research Division

And what was the cost, do you remember?

Ron Cohen

Yes, it was -- as near as we can tell from the published filings, it was -- it came in -- it comes in a 2 pack, so there are 2 doses in each pack. And a 2 pack at peak was selling for about $358. So about $180 a piece per dose.

Yaron Werber - Citigroup Inc, Research Division

Okay. And typically these patients, 175,000 patients, how many cases, how many breakthroughs do they have per year, do we know?

Ron Cohen

It varies. I don't think we've given -- I mean, it's highly variable. There are people who are -- let's talk about the polls, right? So you have the worst cases, which are just terrible institutionalized people who are having more than one a day, or one a day or more. And then on the other side, you have people who might have 1 or 2 episodes a year. And then the middle, people who might have 1 a month, 1 every 2 months.

Yaron Werber - Citigroup Inc, Research Division

Okay. And then aside from you, any sense who else is working on a [indiscernible]?

Ron Cohen

Yes, so the most advanced program of which we're where is Upsher-Smith. They've been developing a different benzodiazepine, midazolam, as opposed to diazepam as a nasal spray. They have a couple of -- is it a couple of trials ongoing because they're not able to reference the DIASTAT label. We're doing a 505(b)(2) referencing the DIASTAT label because it's diazepam, so they have to actually do efficacy studies and they are doing those studies, you can find them on ClinicalTrials.gov.

Yaron Werber - Citigroup Inc, Research Division

And they're the only one or is there someone else?

Ron Cohen

There is another startup company called Neurelis in San Diego. They, to our knowledge, they are working on a direct competitor, which would be an intranasal diazepam spray. To our knowledge, they have not yet started their clinical program so we believe that all things being equal, that we would be considerably ahead. And then finally, you should be aware that Pfizer has a home administrable intramuscular injection of diazepam. Primarily, it's been used by the military. They have a contract with the military, but I don't believe they have an approval yet. They've said that they are going to file this year, I think they've even said early this year. But it's a very different animal, this is something where -- it's a big needle, you can't inject it through clothing. So you have to take off the clothing, stab it into the muscle and then hold it there for 10 seconds and our view is that we have a very strong story to tell parents and care partners about the virtues that a nasal spray versus that.

Yaron Werber - Citigroup Inc, Research Division

Okay. Final question.

Unknown Analyst

[indiscernible] I don't know about cluster seizures and how long do you last. I know you're a neurologist so you'll tell me but...

Ron Cohen

I'm actually an internist. I pretend, but I don't play one on TV.

Unknown Analyst

Okay. But I mean, a lot of seizures, as you well know, lack a minute or 2, and by the time you fumble around, realize there's a seizure, start scrapping around for whatever you need, it's over with.

Ron Cohen

Yes.

Unknown Analyst

Are these longer lived such that you'll be able to treat more?

Ron Cohen

Yes, that's why they're called cluster seizures. So they're actually bouts of seizures. This is not simply, I'm on medication and I see a flashing red light, and I have a single seizure and it's over in a minute. These are people who have repetitive seizures, acute repetitive seizures, so they have one seizure and then they go and have another one, then have another one, then they have another one. So they actually get into a cycle of seizures and what you're trying to do is not stop the first ones, you're preventing the next few.

Yaron Werber - Citigroup Inc, Research Division

Which happens minutes or hours later, I guess?

Ron Cohen

Yes.

Yaron Werber - Citigroup Inc, Research Division

So again, this is not -- the thought is this is not going to be self-administered. Most likely, it's going to be by a caregiver.

Ron Cohen

Most likely it's going to be by a care partner.

Yaron Werber - Citigroup Inc, Research Division

Okay. One of the things that I think is sort of a boilerplate, sort of template in your -- or language, I should say, in your earnings release is that you guys are always -- the current guidance is to not take into account potential in-licensing or acquisition of products. Is that a boilerplate language or is it that you guys in sort of looking at things late stage currently?

Ron Cohen

Everything we put in is meaningful. So yes, we want people to be aware that we -- that part of our strategy for building value in the company involves corporate development -- business's development. So last year, we brought in this Diazapam nasal spray opportunity. We sifted through several dozen potential opportunities before we settled on that one and we're continuing to do that, right? What I hope that transmits is that we're disciplined and that we're looking for value and we're not looking just to make a deal so that we can go to everyone and say, look, we're doing deals. We're looking for things that have leverage. They have to leverage our expertise, which in seeing opportunities in the neurology space that maybe other people haven't seen or haven't seen quite the same way. And adding our expertise to that, to develop it would add value. And leveraging our commercial capabilities, which are getting to be, I'd say, elite now in the specialty neurology space, where we have the relationships, we have the infrastructure, we have experience to put something in the bag next to AMPYRA and hopefully, Diazapam nasal spray and build our revenue line in that way by adding value. So we are looking, we are still sifting through multiple opportunities and when we find one that fits, we'll bring it in.

Yaron Werber - Citigroup Inc, Research Division

Does it make sense to you to co-market someone else's drugs?

Ron Cohen

It could. That's always a possibility and that could be a part of it.

Yaron Werber - Citigroup Inc, Research Division

Okay. Well, great. Ron, thanks so much for coming, I really appreciate it.

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