Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from Ian Sanderson of Cowen and Company.
Ian Sanderson – Cowen and Company
Good morning, thank you for taking the question. First on ENTEREG, if you get further into the process, the formulary negotiation process with hospitals what has been I guess the most consistent pushback you have received on a sort of therapeutic review basis? And secondly, on the ADL5859 and 5747 have those been reformulated in any way to deal with the food effect as you go into the phase 2a trials and maybe if you can provide a bit more color on exactly what the end point and what you are getting at in those trials?
Mike Dougherty
Sure. Thanks, Ian, good morning. I will take the first question. This is Mike and then, I will ask Eliseo to make some comments on the delta compound. You know we have grown to say around here that when you know everything there is to know about one hospital, a hospital formulary, everything there is to know about one hospital so that the issues, the successes are varied among institutions. Having said that, if I were to look for the most common theme it may simply be that hospital institutions often have some period of time that must last before they consider a new product for inclusion on formulary. Sometimes that is a year, we have seen a few cases where that may even be a bit longer than that but in a rather diverse area I would say that is probably the most consistent area of pushback that they want to see the product on the marketplace for a period of time, perhaps sound experience from other institutions and then they are going to make an assessment. And with that, maybe Eliseo you can make some comments on the delta compound.
Eliseo Salinas
Yes, good morning, Ian. We did reformulate both 5859 and 5747 and the intention is to maximize the dissolution. So when you suspect that the absorption might be challenging, what you want to do is that your drug has the maximum, the best possible dissolution so that does not contribute to the problem. With it there still is a food effect with the dissolution and today we are going to be further characterizing that during the coming – in parallel with the pivotal council [ph] studies. You cannot necessarily expect that you are going to handle that exclusively with the formulation. But we will further characterize the different type of food, different timing with respect to the drug absorption, etc during the pivotal council. You mentioned the question regarding study in point, these studies will be in both compounds in osteoarthritis and what we mentioned would be pain in the short-term trials, the two-week trial, measuring pain and the second would be a study on postherpetic neuralgia of course with pain as the primary combinable where we will assess 5747.
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