today Elan talked about how the new drug Tysabri is seeing wide use, they talked about the future...!!!!!!!!
READ THIS ......CAREFULLY ...YOU TELL ME WHAT YOU THINK ....
Q. You touched on the Alzheimer’s program a little earlier. I am wondering if you can give us an update on the timing and the enrollment of the vaccine trial? When should we expect to see some of that data and then anything you might have going on small molecules?
Kelly Martin ELAN CEO: O.K., I’ll frame that and Lars can go through where we are with the vaccine. We have four programs. Three of them are in pre-clinical: gamma and beta secretase and the active [vaccine – ACC 001] program are all in pre-clinical. We are making progress on all three. And the AAB program, Lars, perhaps you could go through those?
Dr. Lars Ekman ELAN: Yeah, we're about to finish the extended Phase I study. You have to remember that in Alzheimer’s disease you do not do Phase I studies as you would do in other diseases. You do it in patients. So there, we will finish that study which has been ongoing for now almost 18 months. We have 18 months of data in patients. We will start the Phase II in the first quarter of the coming year [he means 2005]. That will actually be two studies, one with 180 patients, and one with 30 patients in which we will study the image of the brain with the binding of the antibody to the plaques in the brain, which we are doing together with General Electric. So there will be altogether 210 patients in the study at the start. That will be an 18 month study with a one year interim look.
Question: [unclear] Is that ’05?
KM: Yes.
Question: Just a follow-up: is it reasonable to think that that may be sufficient for a regulatory filing or are you looking at having to do a full-blown Phase III?
KM: I’ll scare Lars by answering this. You know, it’s clearly an area that has enormous pressure: political [and] patient pressure. It’s also an area, however, – unlike other areas in the FDA like oncology and other things – where the perception of risk, or the willingness to take risk is almost zero. It will depend on the data, number one. And it will depend on where the Agency is vis-à-vis risk. It’s going to be improper to speculate, but clearly our job to deliver what we think is going to be very, very strong data. And then work with the Agency on the best path forward, as we have done with Tysabri and Prialt. But clearly, you know, the dimensions of this disease are geometrically growing. And the pressure on all of us to get “there” is very significant. I think that that pressure is not going to subside; it is going to go up. I don’t know Lars if you want to …
Q. When is the immunoconjugate [ACC-001] going to start Phase I?
KM: Sometime, we’re hoping sometime within the first six months of this year. We have done a lot of work on that and we are progressing that through the process, again getting all the “t”s crossed and the “i”s dotted. But, sometime in the first six months of this year.
// If you listen carefully to KM's remarks, and Lars' important comment about the one-year interim look, you see a path laid out before you
READ THIS ......CAREFULLY ...YOU TELL ME WHAT YOU THINK ....
Q. You touched on the Alzheimer’s program a little earlier. I am wondering if you can give us an update on the timing and the enrollment of the vaccine trial? When should we expect to see some of that data and then anything you might have going on small molecules?
Kelly Martin ELAN CEO: O.K., I’ll frame that and Lars can go through where we are with the vaccine. We have four programs. Three of them are in pre-clinical: gamma and beta secretase and the active [vaccine – ACC 001] program are all in pre-clinical. We are making progress on all three. And the AAB program, Lars, perhaps you could go through those?
Dr. Lars Ekman ELAN: Yeah, we're about to finish the extended Phase I study. You have to remember that in Alzheimer’s disease you do not do Phase I studies as you would do in other diseases. You do it in patients. So there, we will finish that study which has been ongoing for now almost 18 months. We have 18 months of data in patients. We will start the Phase II in the first quarter of the coming year [he means 2005]. That will actually be two studies, one with 180 patients, and one with 30 patients in which we will study the image of the brain with the binding of the antibody to the plaques in the brain, which we are doing together with General Electric. So there will be altogether 210 patients in the study at the start. That will be an 18 month study with a one year interim look.
Question: [unclear] Is that ’05?
KM: Yes.
Question: Just a follow-up: is it reasonable to think that that may be sufficient for a regulatory filing or are you looking at having to do a full-blown Phase III?
KM: I’ll scare Lars by answering this. You know, it’s clearly an area that has enormous pressure: political [and] patient pressure. It’s also an area, however, – unlike other areas in the FDA like oncology and other things – where the perception of risk, or the willingness to take risk is almost zero. It will depend on the data, number one. And it will depend on where the Agency is vis-à-vis risk. It’s going to be improper to speculate, but clearly our job to deliver what we think is going to be very, very strong data. And then work with the Agency on the best path forward, as we have done with Tysabri and Prialt. But clearly, you know, the dimensions of this disease are geometrically growing. And the pressure on all of us to get “there” is very significant. I think that that pressure is not going to subside; it is going to go up. I don’t know Lars if you want to …
Q. When is the immunoconjugate [ACC-001] going to start Phase I?
KM: Sometime, we’re hoping sometime within the first six months of this year. We have done a lot of work on that and we are progressing that through the process, again getting all the “t”s crossed and the “i”s dotted. But, sometime in the first six months of this year.
// If you listen carefully to KM's remarks, and Lars' important comment about the one-year interim look, you see a path laid out before you
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