None of the other agents have demonstrated in these areas what we have demonstrated, not this [per sphere] compound and certainly not 4-Factor PCCs. As far as we know, the companies are not even running trials with 4-Factor PCCs, the company that manufactures this. What we do know as our colleagues, the manufacturers of the factor Xa inhibitors are conducting some things, trying to look for some things here. What is important is if you look at 4-Factor PCCs, there is a poor biological rationale for why this could reverse factor Xa inhibitors if you use these parameters. There is clear in the label, warning for the downside of using factor replacement to restore hemostasis. That is the blackbox warning for strokes and myocardial infarction. What was interesting is it was just data presented on the ability of this drug or this drug not to reverse anti-factor Xa inhibitors and that was just done at ASH in December.
What they found is there was no measurable effect on anti-factor Xa inhibitor activity. When they looked at normalization of thrombin generation, it did some, but it did not achieve the statistical significance or the primary endpoints that were defined by the company who ran the trial. I believe BMS run the trial. There is some information out there in a press release and other that is a little bit misleading because it suggests that there was normalization of thrombin generation. There was, but it did not achieve statistical significance and it did not do it early. It did it late, mostly when the drug was starting to be eliminated.
We just want to clear the air and make sure you folks understand that the 4-Factor PCCs, they not only have a poor biological rationale but the data that is coming out does not meet the criteria that we have started to establish with the FDA that would grant this or definitive demonstration of activity or a reversal because people use the word reversal interchangeably. We think this is what defines reversal, not what we have seen with 4-Factor PCC in the reversal of Eliquis. We will continue to educate around that fact.
We have been asked a lot of about when are you going to give us more information and more data? It is going to continue to come out. It is moving forward at a pretty significant pace. I know everybody want to know is more clinical data and more importantly manufacturing data and then commercial data pricing, cost of goods.
This slide is what we promise to you and it is kind of a timeline of when we are going to present this information. We just gave you Phase 4 study design, we gave you Phase 3 data in the last few weeks. In the first half of 2015, what other data are you going to have? Bolus plus infusion longer duration from both the Xarelto and Eliquis trials; Phase 2 betrixaban data, which is important to us; and then very important, a larger scale and advanced scale production of andexanet at the Lonza facility which is our long-term commercial supplier. That is very important. That is what will give you in the first half of 2015.
What about the second half of 2015? Very, very important. This is the 2500 leader validation of what we are doing at CMC Biologics. This is the first commercial product for the BLA. That is what you have in the second half of 2015. All important, how much supply and what is the productivity at Lonza’s 10,000 liter tanks and facility that will produce commercial products? These are very important because this is your launched product and that is your long-term solution, so that is important.
What about our commercial strategies, specifically how are you going to target this, what is your label going to look like? What is your cost of goods? What is your supply? What is your pricing? When is that going to come? It is going to come in the first half of 2016. There are a lot of factors that factor into this. Our supply, what the market looks like, and what our data looks like and our discussions are with the FDA. That is what we promise to you and that is the timeline.
