Chelsea Therapeutics International Ltd. (CHTP)

2012 Wedbush PacGrow Life Sciences Management Access Conference Call

August 14, 2012 2:30 pm ET


Joseph G. Oliveto – Interim Chief Executive Officer


Liana Moussatos – Wedbush Securities Inc


Liana Moussatos – Wedbush Securities Inc

Okay, we are going to get started. I’m Liana Moussatos from Wedbush, and it’s our pleasure to have Joe Oliveto, CEO of Chelsea Therapeutics to give us a corporate update. Joe?

Joseph G. Oliveto

Thank you, Liana, and thanks to the Wedbush folks for inviting us today. Let’s see, great. First, just to remind you that we’ll be making the forward-looking statements I’ll direct you to the website where you can get our SEC filings, and we’ll get into the Northera droxidopa pitch. This slide, I’d like to remind people that well, the vast majority whatever we’ll be speaking about today is on our lead indication of neurogenic orthostatic hypotension and the company is very focused on neurogenic orthostatic hypotension. There’s a lot of legs behind droxidopa Northera for other indications, it’s on the market in Japan for Parkinson’s disease and intradialytic hypotension and (inaudible) studies at for fibromyalgia, ADHD and Parkinson’s Disease. So just want to leave you with the idea that there is a lot of opportunity for Northera once we get past the first hurdle for our lead indication.

Okay. So where is Northera? Northera is a prodrug of norepinephrine, it’s directly metabolized into norepinephrine, and it’s got a mechanism very similar or exactly similar to the way levodopa is converted, it’s a dopamine and that natural mechanism converting into norepinephrine the same endogenous of norepinephrine that you and I have in our bodies, so it lends itself to some safety advantages that you’ll see later on and it’s also the beneficiary of well documented safety and efficacy profile from being the market leader in Japan for the last couple of decades.

So what is neurogenic OH or neurogenic orthostatic hypotension? I think many of you in the room might be familiar with orthostatic hypertension, again a drop in blood pressure when going quickly from supine or bending over to standing up, some of us may have even experience this occasionally, but neurogenic orthostatic hypotension is really a result of depleted norepinephrine levels, and Northera treats the root cause of that neurogenic OH and these patients are really pretty severely impacted by this disease, I mean unlike us maybe after some dehydration or naiad out have that fleeting dizziness. These people can’t stand for more than a couple of minutes a few times a day, many of them, so it’s really debilitating, it’s impactful on their quality of life and with dizziness and lightheadedness comes falls and really major events. So we are pretty proud to be offering these people an opportunity to improve their lives.

Now the Neurogenic OH patient comes from clattery of underlying neurological diseases I have a few listed here. Neurogenic OH is orphan at less than 200,000 patients in the U.S. and clearly the largest population that makes up the disease pay for us is Parkinson's disease.

The therapeutic options for Neurogenic OH are limited there is only one approved drug for this indication and that’s mitogen and it’s been on the market for some time now and it was approved based on accelerated pathway and demonstrating improvements in blood pressures is a surrogate marker for symptoms. The drug was never able to show an impact on symptoms even though that was a post approval commitment the company is still trying to do that.

Combined with that inability to show impact on symptoms, the drug is a very potent base of constrictor and increases blood pressure quite dramatically and these patients with neurological disease is not only of hypotension or low blood pressure upon standing, they also experience hypertension or high blood pressure when they’re lying down, so a very potent base of constricted that is indiscriminate is really not the ideal therapy for these patients.

As a result of their hypotension and that inability to approve benefit on symptoms mitogen is settled with blood box has tolerability issues. The other sort of disheartening thing about this drug is that Shire really never spent the time educating the Parkinson’s Disease decisions about this drug, so there is really poor penetration into the largest market.

So we feel that neurogenic OH remains a very significant unmet medical need and again we’re really proud to be working in this area to provide Droxidopa. Now we’ve been working in the area for a while six years, we’ve learned a lot, we’ve learned that there is no successful trials in this area, whether they will be done by Shire or anyone else and some of the key challenges are listed here and anyone who has followed the story has heard a lot about these.

We’re dealing with different patient populations of underlying disease or so, heterogeneity creates issues, we’re dealing with an elderly population with potential issues of recall and being able to define their symptoms and we’re dealing with this lack of standardized studies and standardized end points.

But we’ve come a long way. We’ve had successful trials now, which I’m going to share with you, we’ve learned a lot from the fail trials and the latest issue that we are dealing with and interacting with the FDA on is the duration of these studies and the difficulty in doing long-term double-blind randomized trials. Clearly, these patients frequently dropped out for non-drug effects, they have treadmill effects where it’s hard to remember the impact of your symptoms or how you’re feeling relative to two months ago, where you were base lined and in general investigators are very reluctant to place these trial and (Inaudible) patients into long-term placebo control trials for the fear falls and the fear of all the rigors that come with the clinical trial. So when you think about long-term trials that are placebo control, do you have to think about not being able to get the most severe patients. And these are topics that we’re in process of interacting with the FDA on and having a full flow scientific dialog on.

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