Acorda Therapeutics, Inc. (ACOR) recently reported an analysis of data on Ampyra (dalfampridine) at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. The analysis demonstrated improvements in walking ability of patients on Ampyra as measured by patient self-report on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12).
The analysis comprised data from a phase II trial and two phase III trials of Ampyra. These data were a part of Acorda’s new drug application (NDA) submission to the US Food and Drug Administration (FDA) for the approval of the drug.
At the CMSC meeting, another set of study data on Ampyra called – UTI (urinary tract infection) Incidence among MS Patients Treated with Dalfampridine 10 mg Twice Daily – was also presented. As the name suggests, the study evaluated the incidence of UTI reported by multiple sclerosis (MS) patients treated with Ampyra in clinical trials, extension studies, and post-marketing safety reports.
We note that about 80% of newly diagnosed MS patients and up to 96% of patients who have had MS for 10 years or more normally experience some bladder dysfunction, and UTI is a frequent complication of this dysfunction.
The data from mid-stage and late-stage clinical trials demonstrated that 14.5% of the patients treated with Ampyra (total 400 patients) experienced a UTI compared with 9.2% of patients on placebo (total 238 patients), over periods of 9–14 weeks.
The incidence of serious UTIs was similar across the Ampyra and placebo groups. Additionally, among the 483 patients who were enrolled in Ampyra’s extension studies, 33.1% reported a UTI, over an observation period of 1–182 weeks.
Ampyra, which is yet to receive approval outside the US, is available in the US as a treatment for improving walking in MS patients.
Acorda has a licensing agreement with Biogen Idec Inc. (BIIB) for the development and commercialization of Ampyra outside the US, under the trade name Fampyra. Biogen is currently seeking regulatory approval for Ampyra in the European Union (EU). Last month, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion regarding the conditional approval of Fampyra (fampridine). Biogen is seeking approval for the use of Fampyra for improving walking ability in adult patients with MS.
In addition to the licensing agreement with Biogen, Acorda has a supply agreement with Elan Corporation plc (ELN) for manufacturing Ampyra.
Neutral on Acorda
We currently have a long-term Neutral recommendation on Acorda, which carries a Zacks #3 Rank (short-term Hold rating). We expect investors focus to remain on the sales ramp-up of Ampyra and its approval in the EU.
Meanwhile, Acorda is looking to expand its portfolio by in-licensing products.
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