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This is delectating, this affects young women. These are women who are in the prime of their carriers or their family life and it not only affects them, it affects everyone who interacts with that women and we have a fairly startling image here of a women that has barbed wire around her mid-section and we utilize this image because in the hundreds, if not thousands of women that have spoken to with endometriosis that is a recurrent thing that comes up from them. This is how the feel. This what this disease does to them.I’m very pleased to say here today that the Phase III protocol that Abbott has designed has now been locked at Abbott. They’ve held the investigators meeting last week with all the investigators in this very large Phase III program. And in the coming days they will begin patient screening, which is the beginning of this trail drug has been shipped to all the sides. So this trail will be launching in just the next few days. The Phase III protocol, the end points are the ones that we defined at the end of our Phase II program that is two co-primary end points, non-menstrual pelvic pain, and dysmenorrhea, dysmenorrhea being the intense pain that is felt during menstruation. As with our Phase II program, the statistical analysis is going to be a responder analysis that’s been agreed to with the FDA and this trial will be six months in duration and then a safety extension out to one year. Shortly after the trial kicks off Abbott will be putting it up on clintrials.gov with far more detail and that’s when we will be able to talk about that detail, but very pleased that this trial is getting started and Abbott is putting considerable resources behind this entire program of endometriosis.
Also quite a bit of work has been done and continues to be done by Abbott and some of ourselves doing on market research getting this product ready for commercialization, pharmacogenomics and both qualitative and quantitative market research. Now the second half of this program is even a larger market opportunity than endometriosis and that’s uterine fibroids.We did not treat any uterine fibroid patients in our large Phase II program that Neurocrine ran. That’s because we had the resources only to concentrate on one program at a time. Abbott, one of the main reasons we selected them amongst the competitive partners that we were looking at, at the time that we partnered us with them is that they were dedicated to develop this drug simultaneously in both indications; endometriosis and uterine fibroids. So Abbott started up last year a proof-of-concept trial, a large proof-of-concept trial in uterine fibroids. They take patients in and get a baseline measurement of the disease for two months. This baseline measurement is bleeding, it’s interesting in endometriosis the primary problem or complaint and what the primary end point has to deal with is pain. In endometriosis secondarily is bleeding, our drug takes care of both of those problems in endometriosis. In uterine fibroids, the primary problem and which leads to the primary end point is bleeding excessive, unpredictable, throughout the month bleed especially, heavy bleeding during menstruation. Secondarily they do suffer from pain and discomfort from mechanistic aspect of antagonizing the GnRH receptor our drug should work in uterine fibroids just as it works in endometriosis. In endometriosis, the primary growth factor of these endometrial explants is Estradiol in uterine fibroids, the growth factors for the fibroid collisions and causing the bleeding is both Estradiol and Progesterone by antagonizing centrally the GnRH receptor we lower in a dose dependent fashion both Estradiol and Progesterone.
After two months of getting baseline bleeding, the patients get randomized into different cohorts and they are characterized by having in each cohort a placebo arm and then a dose of elagolix. Abbott does not disclose and request that we not disclose in this proof-of-concept study, what the doses they’re looking at here, suffice to say, it’s a broad dose range, that Abbott is doing in this proof-of-concept trial and then happy end of that three months of treatment, where the primary end point which is bleeding is taken and compared to the baseline, they then will follow these patients upon a safety basis for three months after that.Read the rest of this transcript for free on seekingalpha.com