Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR

* Reuters is not responsible for the content in this press release.

Wed Oct 14, 2009 7:22pm EDT

* Committee Views Fampridine-SR as Safe, Effective and Clinically Meaningful for
Improving Walking in People with Multiple Sclerosis 
* Conference Call Scheduled for Thursday, October 15 at 8:00 a.m. Eastern Time

HAWTHORNE, N.Y.--(Business Wire)--
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the U.S. Food and Drug
Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD)
Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice
daily demonstrated substantial evidence of effectiveness as a treatment to
improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1
abstention) that it is clinically meaningful and can be safe for use. 

"We are pleased with the outcome of today`s Advisory Committee meeting. People
with MS have an urgent need for therapies to improve their walking, which is
essential to conducting their activities of daily life. If approved,
Fampridine-SR would be the first medicine to improve walking in people with MS,"
said Ron Cohen, M.D., Acorda Therapeutics President and CEO. "This Advisory
Committee meeting is an important milestone in the development of Fampridine-SR,
and we look forward to working with the FDA as it completes its review of
Acorda`s New Drug Application." 

The Committee also recommended by a vote of 12 to 1 that Acorda be required to
evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2
vote (1 abstention) that these studies not be required prior to approval. 

At the request of the FDA, the Committee discussed possible conditions for use,
including for patients with renal impairment or history of seizure. Acorda has
proposed a Risk Evaluation and Mitigation Strategy (REMS) program, which could
include healthcare professional and patient education around appropriate use of
Fampridine-SR. 

The FDA seeks the advice of an advisory committee such as the PCNSD when
evaluating a potential new treatment, but is not required to follow its
recommendation. The current Fampridine-SR Prescription Drug User Fee Act (PDUFA)
date set by the FDA is October 22, 2009; the PDUFA date is the target date for
the FDA to complete its review of Fampridine-SR. 

Conference Call

Acorda will hold a conference call and audio webcast on Thursday, October 15,
2009 at 8:00 a.m. ET to discuss the outcome of the Advisory Committee meeting.
To participate in the conference call, please dial 866-700-6979 (domestic) or
617-213-8836(international) and reference the access code 85689772. The
presentation will be available via a live audio webcast at: 

http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=2484252

A replay of the call will be available from 11:00 a.m. ET on October 15, 2009
until midnight on November 14, 2009. To access the replay, please dial
888-286-8010(domestic) or 617-801-6888 (international) and reference the access
code 45457470. The archived webcast will be available for 30 days in the
Investor Relations section of the Acorda website at http://www.acorda.com. 

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational
drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has
been found to improve impulse conduction in nerve fibers in which the insulating
layer, called myelin, has been damaged. Fampridine-SR is being developed by
Acorda Therapeutics and manufactured by Elan Corporation plc. 

About MS

Multiple sclerosis is a chronic, usually progressive disease in which the immune
system attacks and degrades the function of nerve fibers in the brain and spinal
cord. More than 400,000 Americans have MS, most between the ages of 20 and 50,
with women affected two to three times more than men. Worldwide, MS may affect
2.5 million individuals. 

Research indicates 64%-85% of people with MS have difficulty walking, and 70%
report walking to be the most challenging aspect of their MS. Within 15 years of
an MS diagnosis, 50 percent of patients often require assistance walking and, in
later stages, up to a third of patients are unable to walk. 

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal
cord injury, multiple sclerosis and related nervous system disorders. The
Company's marketed products include Zanaflex Capsules (tizanidine
hydrochloride), a short-acting drug for the management of spasticity. The
Company's pipeline includes a number of products in development for the
treatment, regeneration and repair of the spinal cord and brain. 

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements, other than
statements of historical facts, regarding management's expectations, beliefs,
goals, plans or prospects should be considered forward-looking. These statements
are subject to risks and uncertainties that could cause actual results to differ
materially, including delays in obtaining or failure to obtain FDA approval of
Fampridine-SR, the risk of unfavorable results from future studies of
Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell
Fampridine-SR, if approved, and Zanaflex Capsules, competition, failure to
protect its intellectual property or to defend against the intellectual property
claims of others, the ability to obtain additional financing to support Acorda
Therapeutics' operations, and unfavorable results from its preclinical programs.
These and other risks are described in greater detail in Acorda Therapeutics'
filings with the Securities and Exchange Commission. Acorda Therapeutics may not
actually achieve the goals or plans described in its forward-looking statements,
and investors should not place undue reliance on these statements. Acorda
Therapeutics disclaims any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of this press
release.

Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com



Copyright Business Wire 2009

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