Question-and-Answer Session
Operator
(Operator instructions) Your first question from Analyst for May-Kin Ho – Goldman Sachs.
Analyst for May-Kin Ho – Goldman Sachs
Just quickly, how different is your filing package for skin infections to the FDA versus to the European regulatory agency?
Rick E. Winningham
Yes, this is Rick Winningham. The primary difference between the two submissions is that the US application now contains all of the safety information and some summary of efficacy information from an additional 1503 patients that were in the hospital-acquired pneumonia program. We submitted that data in January of 2008 to the FDA as part of our complete response to the approval letter. In Europe, the hospital-acquired pneumonia data was not submitted as a part of the complicated skin and skin structure package.
Operator
Your next question comes from Rachel McMinn – Cowen & Co.
Rachel McMinn – Cowen & Co.
Just going back to FDA panel, at this point do you have a sense of what will be discussed? Do you have briefing documents for the panel?
Rick E. Winningham
No, we do not have the briefing documents at this point in time. The only indication that we have of what might be discussed is sort of what was potentially on the docket earlier this year. My expectations would be that we discuss the overall benefit risk profile of Telavancin, we would discuss the profile of renal profile of the drug as well as QT and pregnancy category but there could be other subjects that the FDA wants to address and we will not know what. We will have an idea of that until we receive the briefing document.
Rachel McMinn – Cowen & Co.
And I guess just on the topic of risk benefit, based on data that you have presented. You have clearly an increase in renal events relative to vancomycin that overall a low number despite that the EMEA still or is CHMP still could not find it I guess in their hearts to recommend approval? What is I guess, what gives you confidence that FDA would have a different opinion? HAP data is great perhaps but that indication is totally different than CHMP?
Rick E. Winningham
Yes, it is totally different. Clearly an additional 1503 patients would accept roughly 750 on Telavancin in a more serious infection setting with a more serious illness, an important additional piece of information to understand how the drug works. And in the Telavancin skin program, about 12% of the patients in that program have moderate to severe renal insufficiency at baseline. In the HAP program about 33% of the patients in the hospital-acquired pneumonia program had moderate to severe renal insufficiency at baseline. The overall difference of a couple of percent renal adverse events was rough, it was about the same between the two studies but I think clearly the information of the HAP program does in fact shed a light on how the drug works in patients with moderate to severe renal insufficiency at baseline and how to identify, really amplifies how to identify those patients who might be at most risk for a renal adverse events. Mike, you want to add to that?
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