Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Eric Schmidt with Cowen And Company.
Eric Schmidt - Cowen And Company
My question is on the opportunistic infections that Al mentioned regarding Ocrelizumab. I am just looking for a little bit more information. What type of infections did you see, have you observed these in the past with RITUXAN and why isn’t the ongoing MS trial impacted?
Al Sandrock, MD
That is a lot of questions. We are not commenting on the types of opportunistic infections. I can say that we saw a lot of these predominantly in Asia and the reason for the imbalance right now is unknown.
In terms of the Ocrelizumab our MS trial, while it is a different indication, you know the unmet need is different and that trial is actually over in terms of the efficacy read out portion, and in fact we plan to be looking at some data later this year.
Operator
Your next question comes from Joel Sendek with Lazard Capital Markets
Joel Sendek - Lazard Capital Markets
I have a question about Fampridine-SR. It looks to me that you are targeting a little bit earlier filing time than you previously stated and I am wondering what is left on the critical path to that filing, and if you could tell us at all about what kind of meetings you have had with the European regulators about the one point that the Company had.
Al Sandrock, MD
I think the main issue that we had to grapple with was the requirement for a pediatric plan which we have had some verbal interactions with the MEA, and we have a verbal agreement on a plan forward. That was the main issue that we dealt with, and yes we are planning to file in early 2010.
Operator
Your next question comes from May-Kin Ho with Goldman Sachs.
May-Kin Ho - Goldman Sachs
You mentioned that you have been talking with the FDA about changing the label on TYSABRI in terms of the higher risk of PML when you have long duration of therapy. Will you be specifying how long patients should be treated and what kind of changes are you thinking about?
Al Sandrock, MD
We are not specifying how long they should be treated, in fact there is not going to be any mention of terminating treatment. The overall risks are still within the rate implied in the label currently. The main reason that we are implementing this label change is predominantly so that our labels worldwide are roughly harmonized in terms of what it says about duration. In some locales our label stated that the link with duration was unknown and clearly that is not compatible with our current thinking, so that was the main reason for asking for a label change. In terms of the overall risk benefit we believe it remains favorable and nothing major has changes. In fact we think that the risk is basically the same as that implied in the label currently.
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