Chelsea Therapeutics International Ltd. ( CHTP) Special Call February 23, 2012 5:30 pm ET Executives Kathryn McNeil – Head-Investor & Media Relations Simon Pedder – President & Chief Executive Officer William D. Schwieterman – Chief Medical Officer
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Before I turn the call over to Dr. Pedder, let me note that some of the remarks you’ll hear today may contain forward-looking statements about the company’s performance. Actual future results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause actual results to materially differ from those in these forward-looking statements is contained in our SEC filings and periodic reports under the Securities and Exchange Act of 1934 as amended, copies of which, of course, are available on our website or may be requested directly from the company.And with that said, I’m going to turn the call over to Dr. Pedder. Go ahead, Pedder. Simon Pedder Thanks, Kate, and thanks to everybody for joining the call today. As we announced earlier today, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 7-4 with 1 abstain and 1 non-voting to recommend approval of NORTHERA, also known as droxidopa, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, a group of diseases that include Parkinson’s disease, multiple systems atrophy and pure autonomic failure. All pivotal studies showed that NORTHERA improved a broad range of Neurogenic OH symptoms, including dizziness, standing systolic blood pressure, and ability to perform activities of daily living. And clinical studies have shown that NORTHERA is safe and well tolerated in this chronically ill population. So, we were pleased to have this discussion with the FDA. We believe we had a thoughtful, fruitful discussion on key issues. For those who could not attend or listen to the meeting, we had a good discussion on endpoints to characterize the treatment effect. We appreciated the type and scope of the questions from the panel, especially how to capture symptomatic benefit in this patient population. Certainly, we have a lot to learn in accepting symptomatic benefit in these patients. The panel was similarly interested in understanding the clinical benefits seen in our clinical trials. The unmet medical need weighed heavily on their discussions as did the lack of effective treatment alternatives and severity of the underlying condition. All of you can appreciate the challenges going into this meeting given the emphasis placed on safety concerns in the FDA briefing document.
We are particularly proud of Bill and the clinical team along with Dr. White, Dr, Stacy, Dr. Factor and Dr. Kaufmann. They did a great job on the specific safety concerns raised by the Agency. The panelists were clearly interested in understanding the potential risks of wide use.We also appreciate the input of doctors Temple, Unger and Stockbridge whose input was key on a number of issues. We certainly look forward to working with the Agency as we move forward. All in all, we felt it was a very good discussion. The committee’s recommendation will be considered by the FDA in its assessment of NORTHERA NDA. A PDUFA action date for NORTHERA NDA has been scheduled for March 28, 2012. I’d like to acknowledge and thank the patients, especially the particular ones who came today, and the investigators for their participation in NORTHERA trial and for their unwavering support for NORTHERA and Chelsea Therapeutics over the years. Chelsea is excited by the opportunity to play a role in changing the everyday life of these patients. We look forward to continue interaction with the FDA over the coming weeks as it completes its review of NORTHERA. We will now open up the line for questions. Operator? Questions-and-Answers Session Operator: Thank you. (Operator Instruction) Our first question comes from Robyn Karnauskas from Deutsche Bank. Robyn Karnauskas – Deutsche Bank Securities, Inc. Thanks for taking my question. I know it’s been a very long day for you. I guess the first thing that comes to mind is that the panel sort of unanimously suggested that you should do another trial to support approval and comments on maybe looking at longer duration of therapy, and given that if you were to still use that endpoint, 306 trial really didn’t work if you used the OHQ endpoint in the specific way you looked at it and the specific patient population. So what do you think – when you go to the FDA, what kind of trial might you suggest to support approval? Is it the fall trial that you are doing or are there other options on the table? Read the rest of this transcript for free on seekingalpha.com