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TheStreet Open House

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

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.

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