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» Idenix Pharmaceuticals, Inc. Q2 2010 Earnings Call Transcript
Additional information concerning these factors is contained in our filings with the SEC today, which are available on our investor section of our website.While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so even if our assumptions change. You should not rely on these forward-looking statements as representing our assumptions as of any date subsequent to today. We issued a press release this morning and on today’s call, Ron will discuss the partial clinical hold based on IDX 184, and then we will open up the call up for Q&A. I'll now turn the call over to Ron. Ron Renaud Thanks Daniella. We were verbally notified by the FDA late yesterday afternoon that our clinical candidate IDX184 has been placed on partial clinical hold. We believe this is a result of the recent occurrence of a serious cardiac-related adverse event with Bristol-Myers BMS094 which is that company’s nucleotide pro-drug for the treatment of HCV. The FDA has expressed an interest in further reviewing the safety of IDX184 and therefore it has placed IDX184 on partial clinical hold. In previous clinical trials as well as the ongoing Phase IIb clinical trial of IDX184 dosed in combination with pegylated interferon and ribavirin, there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 and pegylated interferon and ribavirin, beyond that seeing with pegylated interferon and ribavirin alone. I should also add that there are no -- there are currently no patients receiving IDX184 worldwide. We believe and we assert that there are significant differences between IDX184 and BMS094, including an entirely different pro-drug approach. In our view there at least three components of BMS094 and its metabolites that are not present in IDX184 and which could have contributed to the reported toxicity of BMS094.
In addition BMS094 distribution appears to be far less liver targeted than IDX184. Finally in pre-clinical testing performed by Idenix, BMS094 exhibited significant cytotoxicity across a wide variety of cell types in sharp contrast to IDX184. The FDA has requested that Idenix perform additional cardiac testing of patients in the ongoing study.This is a priority to us, as Idenix has always committed to ensuring the safety of our patients, Specifically we are initiating echocardiograms on nine patients with reported dyspnea in the ongoing Phase IIb study. These included one case of grade 3 dyspnea and 8 cases of cases of grade 1 dyspnea. Of note dyspnea is a well known side effect of pegylated interferon and ribavirin. We expect to submit the data to the FDA in the coming weeks. Idenix also intends to engage in an ongoing dialog with the FDA and to seek the FDA's feedback on the necessary steps to remove the partial clinical hold. At this point our timelines for advancing IDX184 are expected to be impacted by the partial clinical hold. Until we gain additional clarity from the FDA, we cannot predict potential delays in our clinical timelines with more certainty at this time. Patient safety is our main concern and we work quickly and diligently to address the FDA's concerns, but remain confident in the safety profile of IDX184. Idenix remains strongly committed to advancing (inaudible) or oral combination of direct acting antivirals to change the treatment paradigm of patients infected with HCV. With that I will now turn the call back to the operator to open the question-and-answer session. Question-and-Answer Session Operator (Operator Instructions) Our first question is from Geoff Meacham with JPMorgan. Geoff Meacham - JPMorgan Just got a couple here. Is it your sense from talking to FDA as the hold related to the fact that you have a somewhat similar structure, somewhat similar active metabolite or is it more to do with fact that you don’t have as many patients as say some other nucs in the space? Ron Renaud Read the rest of this transcript for free on seekingalpha.com