Keith Katkin - President and CEO
Randall Kaye - CMO
AVANIR Pharmaceuticals (AVNR) Wall Street Analyst Forum September 10, 2008 11:10 AM ET
Good morning ladies and gentlemen. In our ongoing attempt to adhere to the public schedule, I would like to introduce the next company in this morning's Biotech and Specialty Pharmaceutical program. AVANIR Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing novel, therapeutic products for the treatment of central nervous system disorders.
AVANIR's lead product candidate Zenvia is in the late stage of development for two different diseases states. Without giving an overly lengthy introduction to the company, I'll let them do their PowerPoint presentation themselves, I would like to introduce the management of the company Keith Katkin, President and Chief Executive Officer. He is accompanied today by Randall Kaye, Chief Medical Officer and Eric Benevich, Vice President of Communications.
Thank you and good morning everyone. My name is Keith Katkin, I am President and CEO of AVANIR Pharmaceuticals. As Joe mentioned joining me here today is Dr. Randall Kaye, our Chief Medical Officer; and Eric Benevich, our Vice President of our Investor Relations and Corporate Communications.
I'd like to start with our forward-looking statements as I will be making comments pertaining to future events, which may or may not occur for AVANIR. As we are a publicly traded company I would encourage everyone to visit either our website or the SEC's website to look at our public filings, Annual 10-K and Quarterly 10-Q filings.
AVANIR Pharmaceuticals is in late stage CNS development company with our lead assets Zenvia, which has demonstrated efficacy in two neurologic diseases states. The first is pseudobulbar affect or PBA and the second is diabetic peripheral neuropathic pain. I will provide a greater explanation of both of those disease states a little bit later in the presentation.
Earlier this year AVANIR Pharmaceuticals completed a capital raise of $40 million attracting four very well know blue-chip venture investors. That money provides us sufficient funding to get through our anticipated FDA approval date for Zenvia in pseudobulbar affect or PBA. We are on the verge of some real large milestones and the company will up a little bit approximately the next 12 months including a release of our pivotal Phase III data in approximately one year from today.
I would like to start with a little bit of background on Zenvia. Zenvia is a unique combination, it's the combination of dextromethorphan and quinidine, and you maybe familiar with dextromethorphan as it is available in many over-the-counter cost methods. That said when you are taking dextromethorphan over-the-counter, you are not really taking dextromethorphan, your body rapidly metabolizes dextromethorphan into its metabolite called dextrorphan and what provides the benefit is the dextrorphan.
Dextromethorphan on the other hand has long been believed to have a lot of therapeutic benefits related to the central nervous systems. Unfortunately because the body so rapidly metabolizes dextromethorphan into its metabolite, dextromethorphan is unable to reach significant levels enough in the plasma to pass the blood brain barrier.
What we have done is recognized that you can inhibit ones ability to metabolize dextromethorphan by adding quinidine, which is a therapeutic. That's been available for a number of years, but we can deliver that quinidine in extremely low doses as low as 10 milligrams, which will inhibit ones ability to metabolize dextromethorphan into its metabolite allowing dextromethorphan to achieve appropriate levels in the plasma to confirm therapeutic benefits.
That's best illustrated by this next slide and on the slide you can see in either gold or gray if you were to take 30 milligrams or 60 milligrams of dextromethorphan by itself it doesn't reach very high plasma concentrations in the body. However if you add as little as 10 milligrams of quinidine to 30 milligrams of dextromethorphan you can see the 25-fold increase of dextromethorphan in the plasma. It's that amount of dextromethorphan, which allows it to confirm a therapeutic benefit.
Now I would like to spend a few minutes mechanistically talking about how dextromethorphan works and how it actually has these therapeutic benefits. Dextromethorphan is a glutamate regulator and works in two separate ways, first as an NMDA receptor and agonist.
Second as a sigma-1 agonist and what you can see here is a depiction of a neuron and you can see dextromethorphan working at the sigma-1 level both pre and post synoptically. You can see that they are on the top right of the screen as well as the bottom left of the picture and what the other mechanism for dextromethorphan is as an NMDA receptor antagonist and then you can see right in the middle as it blocks the ability of the receptors to bind NMDA.
So through this combination this mechanism of action we have seen dextromethorphan and Zenvia be able to demonstrate efficacy in two separate diseases states pseudobulbar affect, and diabetic peripheral neuropathic pain. We believe there are a number of other applications for which Zenvia could be effective.
Now I would like to talk about our first clinical development program for Zenvia and that is pseudobulbar affect or PBA. PBA is a disease, a disorder that not many people are familiar with. It's characterized by sudden unpredictable emotional out-burst and they typically manifest as laughing or crying episodes and some clinicians believe that anger, irritability and frustration is also as part of the disorder.
It's estimated that at least 1.8 million Americans suffer from PBA and PBA has to occur secondary to neurologic injury or damage and when I say secondary to neurologic injury or damage, I'm referring to patient that have ALS, MS, stroke, to mention including Alzheimer as well as traumatic brain injury and other neurologic conditions.
If you think that that there are roughly 20 million American that suffered from those underlying trigger conditions, that means somewhere between 5% and 10% of those patients surfer from PBA and we've been able to confirm that through medical literature as well as through our own market research.
If you are not familiar with PBA, if you put yourself in the place of these patients imagine sitting in this room and starting to laugh uncontrollably or cry uncontrollably, imagine the disruption that may cause to your life causing you to leave the room and ultimate in family settings separate from your family and it leads to a high level of social isolation.
So this a very serious diseases and it's basically a burden for the people already afflicted with this devastating disease as well as the family members who are taking care of these patients. There currently are no approved therapies for PBA and this makes a very attractive market for a company like AVANIR where we can specially commercialize Zenvia for PBA with a small specialty sales force.
Let's spend a few minutes now talking about Zenvia's development history in PBA. AVANIR completed two successful Phase III studies in PBA, the first study was in ALF patients, it included a 140 ALF patients. The second study was a 150 MS patient study with all patients obviously having PBA. In both studies, Zenvia met its primary as well as all of its secondary end points with p-value of less than 0.001 across all end points and p less than 0.0001 for the primary end points. The most common adverse events observed were nausea and dizziness and you could see the discontinuation rates in the two different studies.
In addition to those two double blind studies we also performed a very large open label study and that study included over 300 patients who have been on therapy for greater than six months. Over 200 patients on therapy for more than one year and 100 patients on therapy for over two years, so this was the package that was filed, this was the data that's recorded and I will talk about the FDA's comments on that package in a few slides.
So this is some of the efficacy analysis of the MS study and the ALF study had very similar efficacy, the MS study being a 12 week study and the ALF study being a four week study. Here you can see Zenvia in the red having a rapid and sustained response and same response as early as one week of therapy. On the left you have the number of episodes suffered by patients per week and on the bottom axis you see the number of weeks the patients were involved in the clinical study.
So you see patients having around 19 episodes per week at baseline. So these 19 episodes of uncontrolled laughing or crying and that goes from 19 per week down to less than one per week at the end of the 12 weeks. So you can see that Zenvia is highly efficacious and really has a major impact for these patients.
Just taking a look at a few other end points that were involved in the clinical studies, on the left you see episode-free days, so this is of the 86 days the patients are in the study. What percent of those days were episode-free? You can see that 94% of the days were episode-free in the Zenvia treatment arm compared to just about half of the episodes in the placebo arm.
On the right, you can see that in our studies we measured quality of life and quality of relationships and on both of those endpoints we achieved statistically significant results. Few just are showing quality of life improvements measured by a visual analog scale and you can see that Zenvia treatment arm performing about that twice as well as the placebo arms.
I mentioned a little bit earlier that we filed our new drug application with the FDA for Zenvia in PBA. We did receive an approvable letter, this is back in October of 2006 and the approval letter contained questions, which principally focused on cardiovascular risk that the combination as well as adverse events in what the FDA called a vulnerable population really referring to the ALS patient population.
On the cardiovascular risk front, the primary concern the agency had was regarding potential changes in the QT interval. Although we had not seen any unexpected changes in the QT intervals in our clinical studies, the FDA did have concern that doctors may prescribe the drug off label where the patients may accidentally take more pills than are prescribed per day, which could have the effect of increasing the QT beyond what the agency was comfortable with. On the adverse events side the agency primarily focused around episodes of falling that could be caused by nausea and dizziness.
So in our discussions with the FDA we came to an agreement where we would reformulate Zenvia and the original combination had 30 milligrams of dextromethorphan and 30 milligrams of quinidine. We agreed with the agency that we would reformulate keeping dextromethorphan the same at 30 milligrams, but reducing the quinidine component from 30 milligrams down to 10 milligrams.
With that agreement to reformulate to that new dose we are also able to obtain a special protocol adjustment with the FDA to conduct one single confirmatory Phase III study at that new dose. If the new dose demonstrates the appropriate safety and efficacy profile that should be sufficient to obtain FDA approval.
Why do we reduce the amount of quinidine down from 30 milligrams to 10 milligrams? Really it has a two-fold impact. First, it addresses the cardiovascular as concerned in the agency by reducing the component of the combination, which caused the change in the QT interval and by reducing quinidine by 67% from 30 milligrams down to 10 milligrams respectively dramatically reduced the change in the QT interval and in addition by lowering the quinidine from 30 milligrams down to 10 milligrams.
We also lowered peak dextromethorphan exposure and by lowering peak dextromethorphan exposure, we should see an improvement in the overall adverse event profile of which the agency had some concern. Now the question you are probably asking yourselves is what does this do to the efficacy of product if you lower your dextromethorphan levels. We conducted that significant pharmacokinetic and thermodynamic modeling to determine that there will only be a modest impact on the reduction of efficacy and I will walk through some of those assumptions on the next few slides.
So first I am talking about the change on the QT. As I mentioned earlier the FDA had a concern regarding the QT change of Zenvia and its original formulation. On this slide you can see modeling of what the new formulation should look like from a QT change perspective. These are data on the left side of the purple bar and the middle red bar from our actual thorough QT study of mean changes in the QT study phase and you can see that as a 60/60 dose, that the approximate change is 12 milliseconds. If you cut the dose of quinidine in half down to 30 milligrams of quinidine you see almost a 50% reduction going from 12 millisecond change to a 6.2 millisecond change.
So based on some previous research that has been done outside of the company we know that the impact on QT study [Technical Difficulty] there will be a dose of quinidine for 30 milligrams to 10 milligrams, we expect to see the change in QT reduce from 6.2 milliseconds down to 2.3 milliseconds. That would be below and then as a level that is acceptable to the agency.
In our discussions with the FDA they did similar modeling in this slide we use the mean study sake QT changes. The FDA used a different approach called max mean changes and they came up with an estimated max mean change of three milliseconds. So we were very comfortable that both the FDA and AVANIR did independent modeling and came up with numbers that are below the five millisecond threshold.
Next I would like to move on to efficacy, and what this chart depicts is the result of the PK and PD modeling that I spoke about earlier and what it shows is on the right side you have the original 30/30 dose of Zenvia and on the purple in the middle you have the new dose formulation that includes 30 milligrams of dextromethorphan and 10 milligrams of quinidine.
What we found is that when we reduce quinidine by 67%, we only reduced the dextromethorphan levels in the plasma by approximately one-third and what that led to is an approximate 20% to 25% reduction in efficacy. If you think about the two Phase III studies that we did we had almost 300 patients in those studies, and we had a full PK database.
So we had each patient their dextromethorphan and plasma levels at all the different time points that we measured in the primary and secondary end points. So from that database we could create this line which was essentially a dose response curve and we could project out what the change in efficacy should be as caused by the approximate one-third reduction in dextromethorphan levels in the plasma.
Perhaps a better way to look at that is on the next slide, which is the original Phase III study in MS that I had shown just a few minutes ago with the Zenvia treatment arm in red and the placebo in green, and what you see is in the attached purple line there our projection of what the new dose formulation of 30/10 should produce in terms of efficacy. So you see there essentially a 25% reduction in efficacy but something that still would demonstrate and should demonstrate a very clinically meaningful and statistically significant improvement for these patients.
Now I'd like to talk a little bit about the clinical study that we are conducting we are calling it the STAR Trial, and as I mentioned it is under a special protocol assessment with the FDA. The trial will have approximately 300 patients, 120 patients with MS and 180 patients with ALS. The primary end point will be episodes of laughing and crying and you can see a number of secondary endpoints on the slide as well that we would be looking at to explore the clinical utility of Zenvia in this study.
They will be performed at approximately 50 sites in the US and Latin America and has 90% power to detect a 36% deferential versus placebo. The study will be conducted for 12 weeks in a blinded portion and then there will be a 12 week open label portion of the study after the (inaudible) component is complete.
One other thing I would like to comment on is, I talked about the 30/10 dose and we looked at the anticipated efficacy and safety of the 30/10 dose on the previous slide. In addition the FDA asked us to explore an additional lower dose formulation of Zenvia. So on the slide here you see a 20 milligram of dextromethorphan and 10 milligram of quinidine dose arm as well.
That's because the FDA in their modeling believes that 30/10 will likely and almost certainly be efficacious, but they think that there could be the opportunity to use a lower dose formulation that being 20 milligrams of dextromethorphan minus 10 milligrams of quinidine, they would still demonstrate efficacy. So this has a benefit of either demonstrating the minimally effective dose, if it's not effective or identifying a dose combination, which will likely have an improved safety profile even beyond 30/10 if it is successful.
Through the next steps in the PBA study, we expect that we will have our last patient enrolled in a clinical study by the end of the first quarter, so by March of next year we have all our sites in the US up and running and last month we passed a 50% mark in terms of enrollment, so over a 150 patients enrolled as of the end of last month.
That will lead to top line data being available by the end of the third quarter 2009, so just about within 12 months from right now. That would lead to a complete response of the approvable letter by the first half of 2010 and we expect we'd have a six month review time so approval some time in the second half of 2010.
Next I'd like to spend a few minutes talking about Zenvia program in diabetic peripheral neuropathic pain. Most people are familiar with diabetic peripheral neuropathic pain, it has affected about 3.5 million patients within the US and there are number of approved therapies out there including Lyric and Cymbalta.
The issue with those approved therapies are that it is well known that only about half the patients receive benefit from the available therapies. So it still leaves a very unsatisfied market with a high unmet medical need. If Zenvia is approved within this indication it would be the first NMDA receptor antagonist and sigma-1 antagonist to market for the treatment of DPN pain.
We completed one Phase III clinical study in DPN pain and the study design is here and we tested two different doses of Zenvia in this study, a high dose arm with 45 milligrams of dextromethorphan and the same dose that we tested in PBA studies containing 30 milligrams of dextromethorphan. You can see the primary and secondary endpoints listed on the left side and this was conducted under a special protocol test with FDA.
In total we enrolled 379 patients into this study and we announced the results in the first half of last year. I am happy to report that Zenvia performed very well within the DPN pain indication. You see the primary endpoint are listed first as the pain rating scale with some very robust P values associated with achievement of the primary endpoint. As well Zenvia performed very well on most of secondary endpoints including the quality of life instrument for which the study was not powered to demonstrate a benefit. Although we didn't quite achieve statistical significance there, we certainly saw some very strong trends within the quality of life.
So this left the company in somewhat of a conundrum because we had just received an approvable letter for Zenvia in PBA using 30 milligrams of quinidine. So at this time the company had a choice. The choice was we could either try and pursue with a different division of the FDA, the Pain Division, the Anesthesia Division, getting Zenvia approved for DPN pain using 30 milligrams of quinidine, or we could try and figure out if there was a way to create a new combination of dextromethorphan and quinidine that would yield the same plasma levels as the original formulations, but with a lower exposure to quinidine.
So we opted to perform a very large PK study, and the goal of that PK study was to identify a new dose combination of Zenvia that would yield the same dextromethorphan plasma levels as we tested in our pain study, but with lower exposure to quinidine. Given we believe the FDA will likely act on precedence, we thought this was a prudent approach to see if we can identify this and potentially head off concerns that the Anesthesia Division of the FDA might have.
So what we did here is test a number of different combinations of dextromethorphan and quinidine from the 45/30 dose which was the reference dose and the dose that performed it very will within our first Phase III study in DPN pain. We just tested the 30/10 BID dose which is the dose that we're currently using in our PBA study.
Our 30/10 three-times-a-day dose, which we thought we may have some utility within the pain indications, as well as two different formulations of 60 milligrams of dextromethorphan and 15 milligrams of quinidine either given once or twice daily. Again, the goal here was to try and create a dextromethorphan plasma concentration profile similar to that top dose, the 45/30 Zenvia dose.
I'm happy to report that we did have a positive outcome to that PK study, and we were able to identify a new dose formulation, which would reduce the exposure to quinidine but provide dextromethorphan plasma levels near the 45/30 dose and we believe they will actually be somewhere between the 30/30 dose and the 45/30 dose, both of which demonstrated typically significant efficacy in our first pain study.
Now we are not able to list the actual dextromethorphan plasma concentration numbers here on this slide, because we do believe that information is patentable information. So in the process right now is incorporating it into our IP portfolio so that we can further enhance the IP portfolio for Zenvia.
In addition to the 30/10 dose administered three times a day we also believe that the 30/10 dose given twice a day, the same dose that we are currently using in our PBA studies may also be in effect a dose without pain. Part of that reason is that the adverse event profile of the 30/10 dose given twice daily was looking very good. In pain studies if you can minimize dropouts within the study and many dropouts are due to adverse events, it can greatly increase the power of the study and increase the likelihood that you can demonstrate efficacy. So these are the two doses that we plan on proposing with the FDA to move forward into our next Phase-III program in DPN pain.
So I'll talk a little bit about adverse events on the last slide and what I would like to do is explain on a little bit greater detail and what you can see here all of the different doses that we tested in our large PK study and the top adverse events which were observed in the clinical studies. First I would like to draw your attention to the last two rows the 30/10 BID or 30/10 twice a day which is the PBA dose versus placebo. Here what we observed is an adverse event profile that we believe has much improved versus the original 30/30 dose.
So when I talked earlier about some of the FDAs concerns related to adverse events and the FDAs belief that if you reduce the level of dextromethorphan you can improve the overall adverse event profile it does look like the FDAs belief on that was correct and that we should see an improved adverse event profile.
Second I would like to draw your attention to the top row the 45/30 milligram twice a day dose versus the fourth row which is the 30/10 BID a three times a day, and if you take a look at the adverse event profiles of both those you can see that by reducing the exposure of quinidine and only slightly lowering the total dextromethorphan plasma level concentrations, we do see an improved safety profile of the 30/10 three times a day versus the 45/30.
So we are very excited by these results because we believe we now identified a new dosing combination, which will be more acceptable to the FDA. So although we look forward to working with the agency to define exactly what our next clinical study looks like.
So as I mentioned our next step in the pain program. First is an update to our intellectual patents, and our intellectual property portfolio with our new information. Second we will submit under the special protocol assessment process or next clinical study to the FDA and we plan on submitting that by the end of this calendar year and that will really align us very well, typical review times for the FDA to actually reach a binding agreement on a special protocol assessment in the 9 to 12 months and at a minimum sometimes longer.
So if you think about that relative to our PBA data, we would be looking at in the second half of 2009, ideally announcing the top line data from our PBA clinical program and then shortly around the same time line announcing that we have reached an agreement of special protocol assessment with the FDA for our next pain study. So we believe that combination of events will hopefully give us a number of strategic options relating to the development DPN pain either raising additional capital to fund the development ourselves or potentially increasing partnership interest for people that have an interest large pharma companies in particular that can appropriately gain the right share of voice within the competitors DPN pain space.
I would like to spend the last few minutes just talking about AVANIR's resources and some of our milestones. As I mentioned at the introduction, we recently completed $40 million financing earlier this year and that financing will give us sufficient capital to fund the company through our anticipated FDA approval date in the second half of 2010.
We had a cash balance of approximately $48 million on June 30, 2008. I mentioned some blue-chip investors who participated in that financing, financing was led by ProQuest Investments and they were joined by Clarus, Vivo Ventures, and also OrbiMed Advisors who had been a large shareholder before the most recent financing on a double deposition through the financing.
For our fiscal year 2008, which ends at the end of this month we expect a cash burn of $20 million to $22 million and that is a reduction from our original estimates for this year of $23 million to $25 million. So what we have been trying to do this year is manage our expenses very carefully, we have been able to do that, but we also had the ability to accelerate our timelines and that the PBA timelines that you saw earlier are actually faster then we had committed to at the beginning of the year.
AVANIR's primary focus as I mentioned is on Zenvia for PBA and DPN pain. We do have some other assets though; one is Abreva, which you may be familiar from your local grocery store or drug store. It is an over the counter cold sore medicine. The company out-licensed it to GlaxoSmithKline a number of years ago, but we do still receive some trailing royalties. This year we received approximately $1 million in royalties and we expect the number to be similar for the next many years.
In addition we have a Macrophage Inhibitory Factor program or MIF program, it is partnered with Novartis. This is a pre-clinical asset that is essentially an oral formulation of TNF inhibitor. So we think about that Humira or Enbrel, this would be an oral formulation that works upstream from TNF. That licensing agreement titles AVANIR to approximately $200 million in potential milestones as well as a nice royalty on the product.
Our final asset is Xenerex, its antibody platform particular focused as an anthrax antibody. We recently outlicensed that to Emergent BioSolutions, they are a leader in government contracts, and just last week they announced that they were able to secure a $24 million grant from the government to spend on the continued funding of Xenerex and its anthrax antibody.
Looking ahead at the key milestones for the remainder of 2008, we expect that we will submit our protocol to the FDA under the special protocol session process by end of the year. We have some additional pre-clinical work that the FDA requested in the approvable letter that we will also complete by the end of the year, but that really leads to a pivotal and what we believe to be a transformational year for AVANIR 2009 with completing enrollment in the study by the end of the first quarter and then as I mentioned at the onset on unbinding our top line data for our STAR Trail by the end of the third quarter next year.
So in summary, we believe that Zenvia is a very promising drug candidate we have fantastic data supporting both indications from the two positive Phase III studies in PBA to the one positive study in diabetic peripheral neuropathic pain. We have got sufficient capital to get through our anticipated FDA approval decision date for PBA and a number of milestones over the next 12 months accommodating with the availability of top line data by the end of the third quarter. So that leads us to and hope you will agree that our attractive growth stock and right now at our current valuation of just under $75 million we think that we have a large opportunity for growth
With that, I would like to thank you for your time and attention, and I will be more than happy to take any questions from the floor.
Unidentified Audience Member
I will let our Chief Medical Officer, Dr. Randall Kaye comment on that. I will say that your point in regards to alternative delivery systems is well taken, and we are looking into other controlled release formulations. That said, as it relates to quinidine, we do believe that we have addressed the problem and so far as the new dose formulation significantly reduces the overall exposure to quinidine and that we believe based on our models and the FDA's models that through minimizing the exposure of quinidine, we have brought a change in the QT to a level that the FDA can be comfortable with and we are certainly comfortable with. I will let Dr. Randall comment as well.
Unidentified Audience Member
I think your question was a general drug development question, why did you select quinidine versus other potential inhibitors. Is that not right?
Unidentified Audience Member
Okay so quinidines half life is in the 4 to 6 hour range it's relatively short. It metabolizes fairly rapidly by say 3 or 4, even increasing the dosing as you would expect of quinidine would maintain the same desired half life whether you go up or down. Some of the options to consider in new formulations in the future are providing quinidine at a very low level throughout in order to keep the 2D6 down. What we do not know yet, something we are trying to learn more about what level of quinidine you would need to maintain onboard in order to keep 2D6 down.
Unidentified Audience Member
Absolutely, so it's where we are in terms of potential future development and new delivery systems.
Unidentified Audience Member
From a current development standpoint there is a lot of different potential options that one could consider. You could consider changing the way you are delivering quinidine which is your 2D6 inhibitor, you could consider looking at other 2D6 inhibitors that might produce the same thing or you might just want to develop a new [analong] for dextromethorphan. Those are as we think into the future over the course of decades or so that is when we would be approaching it.
Thank you. Are there any other questions? Great well thank you for your participation and we will be available if you have any follow up questions. Thank you.
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