Question-and-Answer Session
Operator
(Operator Instructions) And your first question comes from the line of Gene Mack of HSBC Securities. Please proceed.
Gene Mack - HSBC
Thanks for taking the question. I apologize for the bad connection, but that actually your fault for having this during prime trick-or-treating hours.
Patrick Mahaffy
I want to apologize to all of you with young kids, or all of you wanting to go to a party. So sorry about that.
Gene Mack - HSBC
Can you just give us an idea, in terms of market share, in terms of patients, share, where Vidaza is at this point?
Patrick Mahaffy
Yeah, the patient share for Vidaza in the United States is about 60% Vidaza, 40% Dacogen, maybe 59%, 41%, but that's the patient share.
Gene Mack - HSBC
Okay, great And then on Satraplatin, can you say definitively at this point, with what you know right now, whether or not you're going to file or not for that drug in EMEA?
Patrick Mahaffy
Well, I can say definitively we're going to file, because we already have. I cannot say definitively what I think the outcome will be. Maybe Andrew or Gillian can spend a moment on, Andrew; do you want to talk a little bit about what you think the clinical data mean, and Gillian a little bit about just the regulatory process? Because I think we'll have some interactions with the agencies certainly by the end of the year. Andrew?
Andrew Allen
Okay. So, the SPARC trial, remember, had two coprimary endpoints. One was progression-free survival and the other was overall survival. As you know, it met the primary endpoint of progression-free survival and failed to meet overall survival.
Now, as we've discussed previously, the progression-free survival endpoint is a composite, and it includes various measures of disease progression, and the major one is pain, which is as you know the major symptom of men with hormone-refractory prostate cancer that has metastasized to the bone.
So, we believe that the PFS benefit is related to a direct clinical benefit because of the impact upon pain. That's obviously a discussion that we're having with the regulatory authorities in Europe. Clearly, it didn't meet the overall survival endpoint, but the study was complicated by the introduction of the approval of Taxotere midway through the conduct of the SPARC study.
So, if you recall, SPARC began, the first patient came in September of 2003. Taxotere was approved in the European countries that were part of the EU at that point in November 2004 and would have rolled out during the year thereafter, as reinvestment took place in various countries.
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