Fampridine-SR: PRESS RELEASE...NEW DRUG IN PIPELINE
"...I was pleased to report in September that the Company achieved positive results from its Phase 3 clinical trial of Fampridine-SR on walking ability in people with multiple sclerosis," stated Ron Cohen, M.D., President and CEO.

"We believe that Fampridine-SR, if approved, could be a first-in-class product, as no existing therapies are indicated to improve walking or other function for people with MS. We also have had continued growth in our Zanaflex Capsules franchise, and recently announced the expansion of our commercial sales force from 32 to 65. This sales organization will provide the commercial foundation for the launch of Fampridine-SR, if approved."

Fampridine-SR Highlights

-- The Company reported positive data from the Phase 3 clinical trial of Fampridine-SR on September 25, 2006. Following are the top-line results from that trial:

-- Statistical significance was achieved on all three efficacy criteria defined in the Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). A significantly greater proportion of Fampridine-SR responders had a consistent improvement in walking speed, the study's primary outcome, compared to people taking placebo (34.8 percent vs. 8.3 percent) as measured by the Timed 25-Foot Walk (p less than 0.001). In addition, the effect was maintained in this study throughout the 14-week treatment period (p less than 0.001) and there was a statistically significant improvement in the 12-Item MS Walking Scale (MSWS-12) for walking responders vs. non-responders (p less than 0.001).

-- The average increase in walking speed over the treatment period for this Phase 3 study compared to baseline was 25.2 percent for the drug responder group vs. 4.7 percent for the placebo group.

-- Additionally, increased response rate on the Timed 25-Foot Walk was seen across all four major types of MS.

-- The Company has requested a meeting with the FDA to discuss next steps for the Fampridine-SR program, and expects that meeting to occur before year end.

-- The Company intends to present comprehensive data from this trial at an upcoming medical meeting.

-- As of October 31, 2006, over 1,150 people had been exposed to Fampridine-SR in clinical trials, including over 300 individuals with MS who have been exposed for greater than six months, over 140 for greater than a year, and over 125 for greater than two years....MORE