Earnings call transcript excerpt c/o SeekingAlpha.
We're making progress with our mid-stage pipeline as well and also the important work of keeping the sustainability of the pipeline going. We expect data readouts for daclizumab in 2014, TYSABRI and SPMS in 2015 and potentially SMNRx in 2016.
We're making progress with our mid-stage pipeline as well and also the important work of keeping the sustainability of the pipeline going. We expect data readouts for daclizumab in 2014, TYSABRI and SPMS in 2015 and potentially SMNRx in 2016.
So first of all, on SMNRX, I'm wondering if you can give us some sense as to the timeline for this and whether you -- and how aggressive you'll be in going after Type 2, 3 patients, which I think is the larger patient group.
And with respect to SMNRx, again, our working assumption right now is that, if the trials were to proceed as we envision them today, and this would be 2 -- Phase II, III type studies that we'd be looking at, data readout is probably in a 2016 time frame, as George alluded to in his comments. We will be looking at Type 2 and 3 patients. And in fact, the data that we presented thus far, Isis presented at the AAN meeting, is a combination of both the Type 2 and Type 3 patients. We're obviously interested in the Type 1 patients as well where, as you can imagine, the sort of medical need is the greatest. We -- Isis just announced that they'll be starting an infantile study, which will be patients with Type 1 disease, the most severe form of the disease. And that's largely a PK study to confirm that the sort of exposure in these neonates is very similar to what we see in the older patients that we treated in the studies that have been ongoing to date. So the program is moving quickly. We're having a lot of dialogue with the regulatory agencies because this is somewhat uncharted territory with respect to end points and study design issues. But we've had good dialogue back and forth, and our anticipated timeline would be to actually have data that we could file, assuming its positive, in a broad cross-section of Type 1, 2 and 3 patients in the 2016 time frame.
And with respect to SMNRx, again, our working assumption right now is that, if the trials were to proceed as we envision them today, and this would be 2 -- Phase II, III type studies that we'd be looking at, data readout is probably in a 2016 time frame, as George alluded to in his comments. We will be looking at Type 2 and 3 patients. And in fact, the data that we presented thus far, Isis presented at the AAN meeting, is a combination of both the Type 2 and Type 3 patients. We're obviously interested in the Type 1 patients as well where, as you can imagine, the sort of medical need is the greatest. We -- Isis just announced that they'll be starting an infantile study, which will be patients with Type 1 disease, the most severe form of the disease. And that's largely a PK study to confirm that the sort of exposure in these neonates is very similar to what we see in the older patients that we treated in the studies that have been ongoing to date. So the program is moving quickly. We're having a lot of dialogue with the regulatory agencies because this is somewhat uncharted territory with respect to end points and study design issues. But we've had good dialogue back and forth, and our anticipated timeline would be to actually have data that we could file, assuming its positive, in a broad cross-section of Type 1, 2 and 3 patients in the 2016 time frame.
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