Positive Data on Acorda's Ampyra - Analyst Blog

Acorda Therapeutics Inc. (ACOR) recently published late-stage data on its multiple sclerosis (MS) treatment Ampyra (dalfampridine) in Annals of Neurology. The trial data demonstrated that a significant proportion (42.9%) of MS patients on Ampyra experienced an improvement in walking speed as compared to patients receiving placebo (9.3%).

The phase III trial, which was the second of two pivotal trials being conducted by Acorda, enrolled 239 patients at about 39 centers in the United States and Canada. The company added that the results of this study were consistent with the first one.

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.  Biogen is currently seeking regulatory approval for Ampyra in Canada and the European Union (EU), with a response expected in the first half of 2011. Acorda has a supply agreement with Elan Corporation plc (ELN) for manufacturing Ampyra.

The company recently reported better-than-expected third-quarter fiscal 2010 financial results on the back of Ampyra sales. The drug should continue seeing significant uptake going forward.

Neutral on Acorda

We currently have a long-term Neutral recommendation on Acorda, which is supported by a Zacks #3 Rank (short-term Hold rating). We expect investors to remain focused on the sales ramp-up of Ampyra and its approval in the EU.

Meanwhile, Acorda is looking to expand its portfolio by in-licensing a development or commercialization stage neurology product.

 
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