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Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for
Improvement of Walking Ability in People with Multiple Sclerosis
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Apr. 23, 2009-- Acorda Therapeutics, Inc. (Nasdaq:
ACOR) today announced the resubmission of its New Drug Application (NDA) for
Fampridine-SR to the U.S. Food and Drug Administration (FDA). Fampridine-SR is a
novel therapy being developed to improve walking ability in people with multiple
sclerosis (MS).
Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March
30, 2009, 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 has resubmitted the
Fampridine-SR NDA and believes that all of the Agency’s comments related to the
RTF have been addressed.
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.
Source: Acorda Therapeutics, Inc.
Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
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