"I am pleased that we were able to work quickly to address the comments from the FDA and resubmit our NDA, approximately three weeks from having received the Refuse to File letter on our initial NDA submission, and that the FDA accepted the filing two weeks later," said Ron Cohen, M.D., Acorda Therapeutics' President and CEO. "We are also encouraged that the FDA has elected to assign Priority Review status to the Fampridine-SR NDA. Our focus in the coming months is to work with the FDA during the regulatory review of Fampridine-SR, to prepare for its launch in the U.S., if approved, and to continue discussions with potential Fampridine-SR commercialization partners for ex-U.S. markets."

Financial Results and Product Update

Zanaflex Capsules® (tizanidine hydrochloride) and Zanaflex® (tizanidine hydrochloride) Tablets gross sales - For the quarter ended March 31, 2009, the Company reported combined gross sales of Zanaflex Capsules and Zanaflex tablets of $14.6 million, compared to combined gross sales of $12.7 million for the same quarter in 2008. Gross sales are recognized using a deferred revenue recognition model, meaning Zanaflex Capsules and Zanaflex tablet shipments to wholesalers are recorded as deferred revenue and only recognized as revenue when end-user prescriptions of Zanaflex Capsules and Zanaflex tablets are reported.

Zanaflex Capsules and Zanaflex Tablets shipments - Total Zanaflex Capsules and Zanaflex tablet shipments for the quarter ended March 31, 2009 were $16.3 million, compared to total shipments of $14.8 million for the same quarter in 2008.

Research and development expenses for the quarter ended March 31, 2009 were $7.9 million, including $0.8 million of share-based compensation, compared to $9.6 million including $0.4 million of share-based compensation for the same quarter in 2008. Research and development expense increases for the quarter ended March 31, 2009 included costs related to our Fampridine-SR long-term extension studies, costs related to our NDA preparation and filing for Fampridine-SR and development of our preclinical pipeline products. The decrease in R&D costs in the first quarter of 2009 compared to the first quarter of 2008 is primarily due to the Company's acquisition of certain in-process research and development assets from NRI, which resulted in a non-cash expense of approximately $2.7 million during the quarter ended March 31, 2008.

Sales, general and administrative expenses for the quarter ended March 31, 2009 were $20.0 million, including $1.9 million of share-based compensation, compared to $15.3 million including $1.5 million of share-based compensation for the same quarter in 2008. This increase in expenses was primarily due to increases in Fampridine-SR pre-launch activities and SG&A staff and compensation. Sales, general and administrative expenses are expected to increase in 2009 compared to 2008, primarily due to an increase in our expected pre-launch costs.

Other expense for the quarter ended March 31, 2009 was $0.7 million compared to $0.1 million for the same quarter in 2008.

The Company reported a net loss of $18.7 million for the quarter ended March 31, 2009, or $0.50 per diluted common share, compared to a net loss of $16.4 million, or $0.54 per diluted common share, for the same quarter in 2008.

As of March 31, 2009, Acorda held cash, cash equivalents and short-term investments of $226.0 million, which are expected to be sufficient to fund the Company's operations through 2010.

Fampridine-SR Update

Acorda submitted the Fampridine-SR NDA to the FDA on January 30, 2009. On March 30, the Company received a Refuse to File (RTF) letter from the FDA, which cited the need to correct "format issues" and requested additional supporting information before the NDA could be accepted for review. Based on subsequent discussions with the FDA, Acorda resubmitted the Fampridine-SR NDA on April 22, 2009. On May 5, 2009, the FDA accepted the Fampridine-SR NDA for filing and assigned it Priority Review with a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009.

The Company is continuing discussions with potential Fampridine-SR commercialization partners for ex-U.S. markets.