Male
Bill, could you go back to the pricing argument, you said lower than generic cost? Can you define…
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
For betrixaban?
Male
Yes.
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
Right now, Mark, what is the generic? We are on $20 something for a 40 mg injection of Lovenox which is normally given for somewhere between six to ten days in acute medically ill patient. It is in the $20 range. That is the generic. The branded is still higher than this in the United States. In Europe, it is somewhere in the $6 to $12 range. We expect to price betrixaban at an equivalent to the other oral factor Xa inhibitors, which right now is with AWP 850 and then you can say you can figure price increases somewhere north of that. We are in a pretty good position from a pricing standpoint.
At that price that we say it is an addressable $3 to $4 billion market. Whether we will have more pricing leverage, we will wait to see where the market plays out, how far ahead we are of the competition and what our clinical data looks like. Yeah, Jason?
Jason
Yes. Can we talk a little bit about the futility analysis and what exactly are you looking at and what can you tell us about what we can learn or infer if we get the announcement, trial continues as planned? What have we learned?
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
Yes. That is exactly what you are going to get. Well, there is one of three outcomes. Continued trial as plan, stop trial due to futility or something in the middle which says, you might want to consider or some indications of increasing the sample size. Because there are statisticians that are taking a look at the probability of success. We set a bar and our guidance to the folks that are going to look at this is that we want to see activity. We want to see activity and a probability that we can succeed.
Alex is our head of clinical research here, Alex Gold. Alex, do you want to maybe give a comment just at a high level from a precedent standpoint and how this is similar to or what has been done?
Alexander Gold, Senior Vice President, Clinical Development, Portola Pharmaceuticals, Inc.
Yes, Bill. As Bill mentioned, this is something,[that cap] is commonly in the clinical trial, as you know. We have planned that into the design and the purpose is really to ensure that there is not a high probability that there is not efficacy. We do not think that this will happen because we have previously established that the drug works in Phase 2, etcetera. As Bill mentioned, there is indication that the trial design has worked so we are treating the right patients.
Bill told you about what the scenarios are and how we would interpret it. It looks very positive based on the indicators that we are able to follow. The only negative scenario is when they see no activity which appears unlikely based on everything we know about the drug and also we have no so far indication of unexpected safety signals. We look forward to the result, which will tell us to either move on or will give us some useful information if that is not the case, but we are positive about the outcome.
This is not an interim analysis so it does not have a pre-specified stopping rule, so what actually is used is a conditional probability as a concept. Really again, the purpose here is to not continue the trial if there is clearly a very low chance of success. In that case, we would get guidance not to continue. I think it is low probability based on everything we know and they indicated so far but those are kind of the scenarios, just to be differentiated.
