Acorda Therapeutics Announces Positive Results of Phase 3 Study of 
Fampridine-SR on Walking in People with Multiple Sclerosis


-Statistical significance achieved on all three efficacy criteria set 
forth in SPA- HAWTHORNE, NY -- September 25, 2006 -- Acorda 
Therapeutics, Inc. today announced positive results from its Phase 3 
clinical trial of Fampridine-SR on walking in people with multiple 
sclerosis (MS). 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 people taking Fampridine-SR had a consistent 
improvement in walking speed, the study's primary outcome, compared 
to people taking placebo (34.8% vs. 8.3%) as measured by the Timed 25-
Foot Walk (P <.001). In addition, the effect was maintained in this 
study throughout the 14-week treatment period (P <.001) and there was 
a statistically significant improvement in the 12-Item MS Walking 
Scale (MSWS-12) for walking responders vs. non-responders (P <.001). 
The average increase in walking speed over the treatment period 
compared to baseline was 25.2% for the drug group vs. 4.7% for the 
placebo group. Increased response rate on the Timed 25-Foot Walk was 
seen across all four major types of MS. In addition, statistically 
significant increases in leg strength were seen in both the 
Fampridine-SR Timed Walk responders (P <.001) and the Fampridine-SR 
Timed Walk non-responders (P =.046) compared to placebo. The Company 
intends to present comprehensive data at an upcoming medical meeting. 
"We are delighted with the results from this trial, which are 
consistent with Acorda's prior Phase 2 study in people with MS. We 
will request a meeting with the FDA as soon as possible to discuss 
next steps for the Fampridine-SR program," said Ron Cohen, MD, 
President and CEO. "Acorda is committed to the development of 
therapies that will improve the function and lives of people with MS, 
and we wish to thank the physicians and people with MS who 
participated in this trial." "Many people with MS experience nerve 
damage that eventually impairs walking. Currently, no therapies are 
indicated to improve neurological function, such as loss of mobility, 
in MS," said Andrew Goodman, MD, Director of the Multiple Sclerosis 
Center at the University of Rochester. "Based on the results of this 
trial, Fampridine-SR could represent a new way to treat people with 
MS. In this study, a significantly higher proportion of subjects 
experienced a consistent improvement in walking speed with Fampridine-
SR than with placebo, and this was accompanied by a reduction in the 
degree of disability that the subjects reported in their daily 
activities related to mobility." Special Protocol Assessment (SPA) 
This clinical trial was conducted under an SPA from the FDA. The 
efficacy criteria set forth in the SPA included three elements: --To 
show that there were significantly more responders in the Fampridine-
SR treated group than in the placebo group, as measured by the Timed 
25-Foot Walk, a standard neurological test. A responder was defined 
as someone whose walking speed on the Timed 25-Foot Walk was 
consistently greater during at least three of four on-drug visits 
than the person's fastest speed on any of the five off-drug visits. --
To demonstrate statistically significant improvement in walking speed 
on the last on-drug visit for the Fampridine-SR-treated responders 
compared to the placebo group. --To show that responders reported a 
significantly greater improvement than non-responders on the MSWS-12, 
a self-rated assessment of walking disability. This step was meant to 
validate the clinical meaningfulness of consistent improvement on the 
Timed 25-Foot Walk. Study Design The double-blind, placebo-controlled 
trial was designed to evaluate the safety and efficacy of Fampridine-
SR in improving walking ability in people with MS. The trial, which 
enrolled 301 individuals at 33 MS centers in the United States and 
Canada, recruited patients between 18 and 70 years old with a 
definite diagnosis of MS and some degree of walking disability. The 
study was open to people with all types of MS, including primary-
progressive, secondary-progressive, relapsing-remitting and 
progressive-relapsing. Participants were permitted to remain on a 
stable regimen of their current medications, including interferons. 
Secondary endpoints for the trial included measurements of leg 
strength. Subjects were randomized to 14 weeks of treatment with 
Fampridine-SR (n=229) or placebo (n=72), a 3:1 ratio of drug to 
placebo. Safety Statement In this study, adverse events were largely 
consistent with the safety profile observed in previous studies of 
Fampridine-SR in people with MS, including an increased risk of 
seizures that appears to be dose related. Following is a list of the 
most common adverse events reported in the study, with percentages 
representing the Fampridine-SR treatment group vs. the placebo group: 
falls (15.8% vs.15.3%), urinary tract infection (13.6% vs.13.9%), 
dizziness (8.3% vs. 5.6%), insomnia (8.3% vs. 4.2%), fatigue (6.1% 
vs. 2.8%), nausea (6.1% vs. 4.2%), upper respiratory tract infection 
(6.1% vs. 9.7%), asthenia (5.7% vs. 6.9%), back pain (5.7% vs. 0%), 
balance disorder (5.7% vs. 2.8%) and headache (5.7% vs. 5.6%). Two 
serious adverse events that were judged potentially related to 
treatment and led to discontinuation were anxiety in one subject and 
a seizure in another subject that was observed during an occurrence 
of sepsis associated with a urinary tract infection. No deaths 
occurred during the study. One death was reported for a subject five 
weeks after the last on-drug study visit. This death occurred outside 
of the protocol time window for reporting adverse reactions and the 
cause of death is not known at this time. About MS Multiple sclerosis 
is a chronic, usually progressive disease of the central nervous 
system in which the immune system attacks and destroys the structure, 
and therefore degrades the function, of nerve cells. Approximately 
400,000 Americans have MS, and every week about 200 people are newly 
diagnosed. Most are between the ages of 20 and 50, and women are 
affected two to three times as much as men. Worldwide, MS may affect 
2.5 million individuals. According to the National Multiple Sclerosis 
Society (NMSS), the direct costs of medical care for MS patients in 
the United States exceed $6 billion annually. Additionally, a recent 
NMSS analysis estimated the total cost of MS, including medical and 
non-medical care, production losses, and informal care, at more than 
$47,000 per U.S. patient per year. Complications from MS may make it 
harder for people to work and may interfere with their ability to 
perform common, daily activities. For most people with MS, the 
disease slowly progresses with a series of unpredictable flare-ups, 
also called relapses or exacerbations. But for some, the progression 
of the disease is rapid. Each relapse tends to lead to increasing 
disabilities such as walking impairment, muscle weakness or speech or 
vision impairments. Approximately 80% of people with MS experience 
some form of walking disability. Within 15 years of an MS diagnosis, 
50% of patients often require assistance walking and in later stages, 
about a third of patients are unable to walk. About Fampridine-SR 
Fampridine-SR is a sustained-release tablet formulation of the 
investigational drug fampridine (4-aminopyridine, or 4-AP). Data 
collected in laboratory studies found that fampridine can improve the 
communication between damaged nerves, which may result in increased 
neurological function. Fampridine-SR Mechanism of Action A nerve cell 
has one extension, called an axon, which it uses to communicate via 
electrical signals to other nerve cells. All but the smallest axons 
have a special covering of a fatty substance called myelin that acts 
as insulation to preserve and speed these nerve signals, much like 
the insulating cover of an electrical cord helps preserve the 
transmission of electricity. In MS, the myelin becomes damaged and 
the axon cannot effectively transmit electrical impulses. 
Specifically, the damaged myelin exposes channels in the membrane of 
the axon, which allow potassium ions to leak from the axon, 
dissipating the electrical current. Fampridine-SR blocks these 
exposed channels, and helps the electrical signals to pass through 
areas of damage. SOURCE: Acorda Therapeutics, Inc.