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The agenda for our call today will be brief. Bill Heiden, our CEO will provide a review of the Phase III registration program for Feraheme. Lee Allen, our Chief Medical Officer will review the preliminary data from the study reported today, and Bill will close the prepared remarks and we’ll open the call for Q&A. Frank Thomas, our Chief Operating Officer, is also with us today. With that I’ll now turn the call over to Bill.Bill Heiden Thank you, Amy, and thanks to all of you for joining us here this morning. Before we jump into the data I thought it would be helpful to outline the scope of our Feraheme Phase III program and some of the history behind the design of the clinical program. The final design of this registration program emerged after detailed discussions regarding endpoints, comparators, and sizing of the trials among other things with both US and EU regulatory authorities. The program consists of two Phase III trials, trials that we call IDA-301 and IDA-302, and an extension study called IDA-303 which evaluates repeat dosing. We initiated the program in 2010 and completed enrollment earlier this year. The data from IDA-301 and IDA-302 will be the basis of our SNDA submission to the FDA for a broad IDA indication which we plan to submit by the end of the year. Takeda is responsible for filing the broad indication in their territories and we expect that they will be filling in the EU sometime in 2013. So with that brief background I’m now going to turn it over to Lee who’s going to review the data. Lee? Lee Allen, MD Thank you, Bill, and thank you to those of you who have joined us this morning on the call. As Bill mentioned, today we reported preliminary top-line results from the IDA-301 study, the second of two Phase III studies that make up our global registrational program for Feraheme for the treatment of iron deficiency anemia regardless of the underlying cause. In this program, we have now treated more than 1000 broad iron deficiency anemia patients who had a history of unsatisfactory response to oral iron with Feraheme. As we’ll discuss today we are very pleased with the results that have been achieved.
The 301 study compared treatment with Feraheme to treatment with placebo. The study was robust, enrolling 808 at 136 sites in the United States, Canada, India, Latvia, Hungary, and Poland. The patients enrolled in this study, as I mentioned, had a history of unsatisfactory response to oral iron or could not otherwise tolerate oral iron, and therefore they never achieved the desired clinical benefit from oral iron treatment. As in IDA-302, the patients enrolled in this study had iron deficiency anemia associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.Patients in this study were randomized 3:1 to receive a 1.0 gram intravenous course of Feraheme or placebo with 608 patients randomized through the Feraheme treatment arm and 200 patients randomized through the placebo treatment arm. This study was designed to demonstrate superiority on efficacy. The demographics and baseline parameters were found to be well balanced between the two treatment groups with a mean baseline hemoglobin level of 8.9 g/dL in the Feraheme arm and 8.8 g/dL in the placebo arm. As in the IDA-302 Phase II study previously reported, the primary efficacy endpoints for this study differs depending upon the regulatory body. For European regulatory authorities, we are measuring the mean change in hemoglobin from baseline to week five. For the FDA, the proportion of patients who achieved a ≥2.0 g/dL increase in hemoglobin at any time from baseline to week five is the primary endpoint of this study. Read the rest of this transcript for free on seekingalpha.com