Acorda Therapeutics, Inc. (ACOR)
April 15, 2013 8:30 am ET
Ron Cohen - Founder, Chief Executive Officer, President and Director
Andrew R. Blight - Chief Scientific Officer
Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division
Michael J. Yee - RBC Capital Markets, LLC, Research Division
Mark J. Schoenebaum - ISI Group Inc., Research Division
Christopher J. Raymond - Robert W. Baird & Co. Incorporated, Research Division
Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division
Philip Nadeau - Cowen and Company, LLC, Research Division
Marko K. Kozul - Leerink Swann LLC, Research Division
Raghuram Selvaraju - Aegis Capital Corporation, Research Division
Previous Statements by ACOR
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Good morning, everyone, and welcome. With me today are Dr. Ron Cohen, our President and Chief Executive Officer; and Dr. Andrew Blight, our Chief Scientific Officer.
Before we begin, let me remind you that the presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ from -- materially including our ability to successfully market and sell AMPYRA in the U.S.; third-party payers, including governmental agencies, may not reimburse the use of AMPYRA or our other products at acceptable rates, or at all, and may impose restrictive prior authorization requirements that limit or block prescription; the risks of unfavorable results from future studies on -- of AMPYRA or our other research and development programs, including Diazepam Nasal Spray or any other acquired or in-license programs; we may not be able to complete development of, obtain regulatory approval for or successfully market Diazepam Nasal Spray or other products under development; the occurrence of adverse safety events with our products, delays in obtaining or failure to obtain regulatory approval of, or successfully market FAMPYRA outside the U.S. and our dependence on our collaboration partner, Biogen Idec, in connection therewith; competition including the impact of generic competition on ZANAFLEX CAPSULES revenues; failure to protect our intellectual property or to defend against the intellectual property claims of others or to obtain third-party intellectual-property licenses needed to -- for the commercialization of our products; failure to comply with regulatory requirements could result in adverse action by regulatory agencies and the ability to obtain additional financing to support our operations. These and other risks are described in greater detail in Acorda Therapeutics' filings with the SEC. Acorda may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this presentation are made only as of the date hereof, and Acorda disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation. I'll now turn the call over to our CEO, Ron Cohen
Thanks, Jeff. Good morning, everyone. This morning, we announced the top line results from 2 proof-of-concept studies, which exploit the uses of dalfampridine extended release tablets, also known as AMPYRA in treating people with respectfully, post-stroke deficits and cerebral palsy. I'm going to summarize the key findings, and then Andy Blight, our Chief Scientific Officer, will provide you with more detail and then we'll open the call for your questions. The primary endpoint of both of these studies was safety and tolerability. The safety profile in both studies was consistent with what we saw in the MS clinical trials and in our post-marketing experience in MS. We saw promising efficacy signals in the post-stroke deficits trial. I'm pleased to report that after we completed the analysis, we plan to proceed to design a clinical development program for dalfampridine ER in this patient population and to discuss this with the FDA.
With respect to the CP study, efficacy data suggested potential treatment activity on measures of walking and hand strength. However, these are still being analyzed to determine if they are sufficiently robust to warrant further clinical studies. Given that this study was smaller than in the post-stroke study with just 20 participants, we'll need to wait for these analyses before we can draw further conclusions. Once we've had a chance to fully analyze the data from both trials, we'll be disclosing additional information at medical meetings and in publications.
Now I'm going to turn the call over to Andy, so he can take us through the studies, beginning with post-stroke deficits. Andy?
Andrew R. Blight
Thanks, Ron. As a reminder, this was a double-blind randomized crossover study, in which the participants received 14 days of dalfampridine extended release, 10 milligrams twice a day and 14 days of placebo, with 1 week washout period in between, where everyone was treated with placebo. There were 2 groups, one which started on dalfampridine-ER and then went to placebo, and the second that started on placebo and then received dalfampridine-ER. This was designed as a proof-of-concept study, first to confirm that the drug is well tolerated and safe in the study population, and second, to examine the number -- a number of potential efficacy measures. The focus of the efficacy measures was on walking as measured by the Timed 25-Foot Walk, which was also the primary measurement tool used in the MS development program. In addition to walking, we also looked at other measures of upper and lower extremity function, as well as more global measures. Our initial look at the data has focus on safety and the Timed Walk data, and we will need more time to look at the full extent of the data set.