Question-and-Answer Session
Operator
(Operator instructions). And we have our first question from Gary Nachman. Please go ahead.
Gary Nachman – Leerink Swann
Hi, thank you. First, for Sylvie, a few on REPLAGAL. What is your share of the market been in Europe? And how has that improved since Genzyme had its issues with Fabrazyme? What data will you be including in the U.S. filing? And then how much supply do you have at this time for REPLAGAL and how's that going to improve in the near-term?
Sylvie Gregoire
Maybe I will start with your last question first, Gary. We have sufficient REPLAGAL to meet any anticipated need that we see in the marketplace for this product. So we don't see any supply constraint for this product at all. In terms of market share, we've been competing with Fabrazyme for many years now in Europe, and it ranges between 40% and 50%. But, of course, these are all numbers, there is no IMS data, so these are self-reported numbers or assessment numbers by ourselves and it depends a bit country by country as well.
And then your third question was what will we be filing in the U.S. with REPLAGAL. We'll be filing with long-term observational data from our Fabrazyme outcome survey study as well as the data that comes from our extension trial. And so it's not on a new trial, it is really on the ongoing long-term experience of the product that we will be filing.
Gary Nachman – Leerink Swann
Okay, great. And then a quick one for, Mike, on VYVANSE. How has formulary acceptance been? Has it improved? We actually heard that you got a big win at Express Scripts. And how has GSK been helping your penetration in the market? Has it really been all for adults or are you getting some benefit (inaudible) as well? Thanks.
Mike Cola
Yes, first question, on the formulary, we generally don't comment on our individual big wins. But again, our goal with VYVANSE was to replicate the AXR coverage and we've done that and more, and it continues to improve as the drug performs. I think it's performed quite well for most of these managed care organizations.
As far as GSK's performance, I think they've really done a good job so far, particularly in the areas where they are targeting GSK only physicians. Again, we said this was really predicated on a very long-term relationship. We look for the ultimate benefits from this in the out years, we're still in the relatively early stages of this relationship.
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