Neurocrine Biosciences (
Citi 2012 Global Health Care Conference Call
February 29, 2012 11:00 AM ET
Kevin Gorman – President and CEO
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Thank you very much and thank you to Citibank of giving us the opportunity to present here today. Before I get started, I put up our safe harbor statement here and I direct you to our recent SEC filings, our 10-K, we'll be making forward-looking statements throughout this presentation and that would show you a detailed level of the risk factors for the company.
2012 is going to be a very event driven year for us. We're going to have four Phase II clinical trials reading out, three of them are going to be in our two lead programs. There's going to be a Phase II reading out at the end of the year and our uterine fibroids program and then in about three weeks we anticipate releasing the results of our Phase II clinical trial in VMAT2 in schizophrenic patients. That's a two week long study. We'll then be starting up two Phase IIB studies this year in our VMAT2. We'll then be starting up two Phase II b studies this in our VMAT2 program large Phase IIB I one schizophrenic patients that will start up mid-year and we'll also read out at year end a second Phase II will be starting up in Tardive Dyskinesia but this time in bipolar and depressed patients, that will read out in approximately Q1 of next year. And then next year we will then have our Phase II meeting with the FDA and start our Phase III program in Tardive Dyskinesia.
In addition, this year we plan on having the data from our Phase II euro court in two programs in acute congestive heart failure that's with our collaborators in New Zealand. If that program turns out to be very positive, it's an area of focus for us in the longer, we will then look for a partner and out license that to acute cardiovascular program and then in addition this year we plan on having ready for an IND new novel molecule from one of our internal research programs. Our research has been very productive this past year and we look forward to bringing a new compound into the clinic having nothing to do with any of the other programs that we have ongoing right now.
So today I'd like to briefly talk about our lead program Elagolix. Again, a first clap opportunity with a number of advantages over the drugs that currently exist for endometriosis and I won't go into all of those advantages, this is truly first in class opportunity and this is also a pipeline within a program. You'll see that theme a bit more as I go on in these primary indications that our partner is taking us into endometriosis and then they have it in Phase IIs and Uterine and Fibroid. There is a number of other women's health opportunities here anywhere from assistive reproduction therapy to polishes stickle viracle variance germ and is only listed about six or seven on this slide that there's a couple of dozen that can be taken into. And we have a robust follow on that are in that Abbott tense that can be taken into men's health or into oncology indications and women health.
The current activities is what Abbott is doing right now is they have a series of very successful types of meetings with the FDA culminated ended December last year and at that point Abbott and as we've announced the Abbott and the FDA that there would be a filing of an SPA in order to basically memorialize all the agreements that were reached through those meetings. And so that SPA was filed with the Abbott with the FDA there is a 45 day clock on that. So mid-March is when we anticipate hearing back from the FDA. Abbott is currently poised to then submit that final protocol to the IRBs in all the clinical trial sites that have been identified and contracted and ready to start in the Phase III program.
So moving on from our Elagolix program which is moving forward, I'd like to spend the rest of this time talking about our VMAT2 program. This is wholly owned by Neurocrine, I'll state right from the beginning that we plan on keeping this program to ourselves and commercializing ourselves in the United States at the appropriate time. We'll look for an ex-US partner.
Now here again, is a program, a pipeline within a program. VMAT2 is a very attractive target for a number of moments to sort. The first one we're going after is Tardive Dyskinesia. Tardive Dyskinesia is an irreversible movement disorder by and large that is caused by the anti-psychotic drug both typical and atypical antipsychotics.
Our next program that we hope to have our first demand studies this year is Tourette's syndrome and this is yet another movement disorder primarily in adolescence that this found. And something that I am going to touch on at the end of this talk is some work that we've been doing that further bolsters the promise that perhaps while we're treating schizophrenics for their Tardive Dyskinesia with our drug, that we may also be able to be an effective treatment for the underlying symptoms of schizophrenia itself which should be a very nice upside for this drug and for the patient population.