Avanir Pharmaceuticals' Presents At Deutsche Bank Securities Annual Health Care Conference (Transcript)

Avanir Pharmaceuticals, Inc. (AVNR)

Deutsche Bank Securities Annual Health Care Conference Call

May 8, 2012 2:50 pm ET

Executives

Keith A. Katkin – President and Chief Executive Officer

Analysts

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Presentation

Robyn Karnauskas – Deutsche Bank Securities, Inc.

Good afternoon, thanks for joining us this afternoon. Next, we have Avanir. And speaking for Avanir, we have Keith Katkin, the President and CEO. For those of you listening on the webcast, if you have questions, we’d like to ask them anonymously, you can go to our website [viorn.com/hz] and ask questions anonymously we will read them here.

With that, I will turn it over to Keith.

Keith A. Katkin

Thanks, Robyn. And good afternoon everyone. Thank you for joining us for the Avanir corporate presentation. I would like to start with the forward-looking statements, as I will be making statements that are forward-looking in nature. I’d encourage everyone to visit our publically available documents on the SEC website or on the Avanir website as well.

So Avanir is a specialty biopharmaceutical company focused on CNS therapies. And our lead product is NUEDEXTA, as the first and only FDA approved therapy for the treatment of pseudobulbar affect. Pseudobulbar affect is a very large market with a high unmet medical need, and I go into a little more detail on PBA later in the presentation.

And importantly from a mechanistic perspective, NUEDEXTA is an NMDA receptor antagonist and a sigma-1 agonist, a very well known and well understood mechanism of action, which we believe supports the potential use of NUEDEXTA in a number of other additional indications.

And you can see some of those additional follow on indications on the slide there, including central neuropathic pain in multiple sclerosis, behavioral disturbances and Alzheimer's disease, as well as Diabetic Peripheral Neuropathic Pain.

Taking a look at our pipeline, NUEDEXTA, as I mentioned, is approved for the treatment of pseudobulbar affect. Looking at our central neuropathic pain study in multiple sclerosis, that’s a Phase II study, now underway, that I’ll go into a more detail little later in the presentation.

Our behavioral disturbances in Alzheimer's program, that will be filing the IND before the end of this quarter, and expect to enroll the first quarter patient into our Phase II study by the end of the third calendar quarter. And then our Diabetic Peripheral Neuropathic Pain program is on hold pending the outcome of our central neuropathic pain in multiple sclerosis. And on the bottom, you can see some additional legacy programs that we have some of which are currently generating revenue and some of which are the potential to generate revenue in the future.

So I’d like to start with an overview of NUEDEXTA, which is an innovative combination of the dextromethorphan and quinidine. And as I mentioned, if you look on a mechanistic level of NUEDEXTA works in the brain, it is an NMDA receptor antagonist and a sigma-1 agonist. So we think about some commercially available products like Memantine or Namenda.

We have a very similar mechanism of action. Whereas however, whereas Memantine just works on NMDA. We have the additional benefit of sigma-1, so we believe that we can modulate glutamate both pre and post-synaptically, unlike a product like Memantine, which only modulates glutamate at the NMDA level.

And because of this well-known and well understood mechanism of action, this really allows us to think about the potential uses of NUEDEXTA quite broadly. And as I mentioned, we’re approved for PBA, but additionally, you’ve got neuropathic pain which studies are underway, behavioral disturbances, also we have studies underway, and then a host of other potential applications everything from Huntington's Chorea to Parkinson’s dyskinesia, depression, autism and memory and cognition just a name a few really falling in the three major areas.

Movement disorders, pain and then also behavioral disturbances. And if you take a look at how NUEDEXTA works in the pharmokinetic and pharmacology basis, you can see that the quinidine is acting as a metabolic inhibitor allowing or actually stopping the body from metabolizing dextromethorphan.

So as you can see here on the graph on the left, if you just were to take say 45 milligrams of dextromethorphan by itself, you get very little dextromethorphan in the plasma as indicated by the dark blue line on the bottom.

However if you give just a small amount of quinidine in the case of NUEDEXTA, only 10 milligrams of quinidine, you can see the very large increase in the availability of dextromethorphan within the plasma, and then on the right, you can see the receptor binding both the sigma-1 and NMDA that occurs with NUEDEXTA.

Now I will spend a little bit of time talking about the PBA market for those of you not familiar with PBA, PBA is an underlying neurologic condition that must occur secondary to some type of neurologic disease or injury.

So it affects patients with stroke, Alzheimer’s disease and other forms of dementia, traumatic brain injury, ALS, MS and Parkinson’s, as well as a number of other neurologic disorders. In the way PBA manifest is as uncontrolled emotional outburst in our studies, we studied laughing and crying. So these PBA patients have a disconnect between the front and the back of the brain, and that disconnect causes a lack in ability to control once emotional effect, leading to these episodes of laughing and crying, and as we’ve heard in our clinical studies, the average patient was having roughly 40 to 50 episodes a week.

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