HAWTHORNE, N.Y.--(BUSINESS WIRE)--Dec. 8, 2006--Acorda
Therapeutics, Inc.(R) (Nasdaq: ACOR) today confirmed that, based on
feedback it received in a meeting with the U.S. Food and Drug
Administration (FDA), it will design and conduct an additional Phase 3
trial of Fampridine-SR in people with MS. Consistent with that
meeting, the company expects to discuss with the FDA a study of the
same or shorter duration as its MS-F203 study with a single criterion
for efficacy, a consistent response on the Timed 25 Foot Walk.
In September 2006, the Company announced the results of its recent
Phase 3 study, MS-F203, which was based on a Special Protocol
Assessment (SPA) from the FDA. The FDA indicated that, while this
would require confirmation in a New Drug Application (NDA) filing, the
criteria for the SPA appear to have been met. Typically, the FDA
requires two adequate and well-controlled studies, each convincing on
its own, to establish substantial evidence of effectiveness.
Based on the discussion, Acorda also plans to execute a QT study
in accordance with the FDA's October 2005 guidance, "Clinical
Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
for Non-Antiarrhythmic Drugs". The Company will continue to consult
with the FDA on protocol development for both of these studies and any
additional requirements that might be needed.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing
therapies for SCI, MS and related nervous system disorders. The
Company's marketed products include Zanaflex Capsules(TM) (tizanidine
hydrochloride), a short-acting drug for the management of spasticity.
For full prescribing information, please go to
www.zanaflexcapsules.com. Acorda's lead clinical stage product,
Fampridine-SR, recently completed a Phase 3 study in people with MS.
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 Acorda Therapeutics' ability to successfully
market and sell Zanaflex Capsules, the risk of unfavorable results
from future studies of Fampridine-SR, delays in obtaining or failure
to obtain FDA approval of Fampridine-SR, competition, the ability to
obtain additional financing to support Acorda Therapeutics'
operations, unfavorable results from its preclinical programs, and
failure to protect its intellectual property or to defend against the
intellectual property claims of others. 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.
CONTACT: Acorda Therapeutics
Tierney Saccavino, 914-347-4300 ext. 104
tsaccavino@acorda.com
SOURCE: Acorda Therapeutics, Inc.