Acorda Therapeutics, Inc. (NASDAQ: ACOR) is taking it right on the chin this morning. The company announced that it has received a “refuse to file letter” from the FDA regarding its New Drug Application for AMPRYA (Fampridine-SR). Unfortunately, this is supposed to be for a novel therapy being developed to improve walking ability in people with multiple sclerosis.
The FDA raised “format issues” regarding the electronic submission, and it also requested that some of the data in the application be reformatted and that some additional supporting information be included in the filing. The good news is that the FDA did not request or recommend additional clinical or other studies.
Acorda’s CEO said it plans to address the issues raised in the FDA letter. He also noted that the company believes Fampridine-SR “is potentially an important, first in class treatment option for people suffering with MS.”
The company plans to request a meeting with FDA as soon as possible to discuss its comments on the NDA filing.
As with most actions, there is a reaction elsewhere. Biogen Idec Inc. (NASDAQ: BIIB) is the TYSABRI play for MS, and its shares are up by 0.8% at $52.95 this morning. These treatments may be a bit different in the fight against MS, and TYSABRI has had its own PML issues that has arguably kept the drug from being more widely used.
Acorda was expected to see total company revenues of about $60 million in 2009 and about $137 million in 2010. It is a safe bet that this filing acceptance may push back at least some of the expected revenue. The company had revenue of $47.8 million in 2008 and $39.4 million in 2007. Shares are down 18% at $20.50 in early trading on almost 4-times volume. Its 52-week trading range is $14.42 to $35.65..........................story in 24/7 Wall St.