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.
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, MDThank 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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV