Avanir Pharmaceuticals CEO Presents At Bank Of America Merrill Lynch Health Care Conference (Transcript)

Avanir Pharmaceuticals, Inc. (AVNR)

Bank of America Merrill Lynch Health Care Conference

May 17, 2012 01:00 PM ET

Executives

Keith Katkin - CEO

Greg Flesher - CBO

Analysts

Presentation

Unidentified Analyst

(inaudible) one of the biotech analysts here at Bank of America Merrill Lynch. It's my pleasure to introduce Avanir Pharmaceuticals who's got Keith Katkin, CEO to give us the latest presentation.

Keith Katkin

Thanks Rachel and good morning everyone. Thank you for joining us for the Avanir corporate presentation. I'm joined here today with Dr. Ian Clements, our Head of Investor Relations and Greg Flesher, our Chief Business Officer. I'd like to start with our forward looking statement as I will be making statements that are forward looking in nature. We encourage everyone to look at our publicly available documents either on the Avanir website or on the SEC's website.

Avanir is a specialty biopharmaceutical company focused on CNS therapies and our lead product, NUEDEXTA launched a little over a year ago and has met with very nice market acceptance and growth over the past year as the first and only FDA approved product for the treatment of pseudobulbar affect or PBA. Pseudobulbar affect is a very large market with a high unmet medical need and now that we have a marketed product we start to look to develop NUEDEXTA for other potential indications and if you look at NUEDEXTA from a mechanistic perspective, it is an NMDA receptor antagonist and a sigma-1 agonist and because of that mechanism there is a potential for numerous follow on indications, some of which are listed here on this slide and currently are soon to be under developed by Avanir.

First is Central Neuropathic Pain in Multiple Sclerosis, second Behavioral Disturbances in Alzheimer's disease, specifically agitation, and then also Diabetic Peripheral Neuropathic Pain. From a corporate perspective we've got a growing revenue line, a strong balance and also we've retained global rights to NUEDEXTA and are currently in discussions with the EMA for approval of NUEDEXTA in Europe.

Taking a quick look at our pipeline, you can see NUEDEXTA approved for the treatment of pseudobulbar affect and then NUEDEXTA, when it's in the clinic, we refer to it as AVP923. You can see our Central Neuropathic Pain in Multiple Sclerosis study which is currently enrolling and in Phase II. Behavioral Disturbances in Alzheimer's study, we're getting ready to file that IND and then we'll initiate a Phase II study by the end of the third quarter. So by the end of September we expect to start enrolling patients in that study.

And then finally a Diabetic Peripheral Neuropathic Pain study, this is a successful program which had that positive Phase III data a number of years ago. We put that program on hold pending the outcome of the Central Neuropathic Pain in Multiple Sclerosis study. And then finally, recently we in-licensed deuterated dextromethorphan and deuterated dextromethorphan is at currently a pre-clinical state but we plan on getting that into humans by the end of this calendar year.

So now I'd like to spend a few minutes on NUEDEXTA which is an innovative combination of dextromethorphan and quinidine and as I mentioned at the onset NUEDEXTA is a known NMDA receptor antagonist and sigma-1 agonist. So this is a fairly well known and understood mechanism and there also are some approved products out there. You may be familiar with pours (ph) product, Namenda or Memantine just doing over $1 billion a year in sales. Mementine's mechanism of action is similar. So it's just a NMDA receptor antagonist. So here we have the receptor, you can see NMDA on the bottom, put synaptically there. What NUEDEXTA does that's different is it works on both sigma-1 and NMDA and sigma-1 working both pre and post synaptically. So given this mechanism we think that there are a number of potential indications for NUEDEXTA.

Some of those indications are listed here on this page and as I mentioned at the onset many of them we're currently investigating with the approval of PBA. We're currently enrolling the Neuropathic Pain study. Soon we'll enroll the Behavioral Disturbances in Alzheimer's study but when you look at NMDA and sigma-1, there is potential in Korea, (inaudible) depression, autism and also sigma-1 is believed to play an important role in memory and cognition. So a number of areas that we can explore the therapeutic utility of NUEDEXTA or deuterated dextromethorphan over time.

So as I mentioned, NUEDEXTA is a combination of dextromethorphan and quinidine and dextromethorphan when taken by itself is rapidly metabolized by the human body and you can see that in the chart here down below, that’s 45 milligrams of dextromethorphan and you get very little dextromethorphan in the plasma at steady state. So the addition of just 10 milligrams of quinidine, what we do is we dramatically increase the bioavailability of dextromethorphan and significantly raise the levels of dextromethorphan in the plasma and that’s demonstrated in the line at the top there and you can see a many folds higher amount of dextromethorphan available in the plasma. This allows dextromethorphan to pass the blood brain barrier and confer therapeutic benefits in PBA and as I mentioned we think many other potential indications as well.

So PBA is something that not many people are familiar with unless you have family or friends that have suffered from some type of neurologic disease or injury. So if PBA must occur secondary to neurologic disease or injury. This includes Alzheimer's disease, ALS or Lou Gehrig's disease, multiple sclerosis, Parkinson's disease, stroke or traumatic brain injury and the hallmarks of PBA are uncontrolled episodes of laughing and/or crying.

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