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Acorda Therapeutics Submits New Drug Application for Fampridine-SR for
Improvement of Walking Ability in People with Multiple Sclerosis
* Acorda Submitted New Drug Application (NDA) for Fampridine-SR on January
30, 2009
* No Current Therapies Indicated to Improve Walking Ability in People with MS
HAWTHORNE, N.Y.--(BUSINESS WIRE)--)--February 02, 2009-- Acorda Therapeutics,
Inc. (Nasdaq: ACOR) today announced the submission of a New Drug Application to
the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR,
a novel therapy being developed to improve walking ability in people with
multiple sclerosis (MS). The Company expects that the NDA filing, if accepted,
will be subject to standard review, which would provide a target for the FDA to
complete its review within ten months from receipt of the submission.
“This NDA filing is a major milestone for Acorda and our Fampridine-SR
development program,” said Acorda Therapeutics President and CEO Ron Cohen, M.D.
“Walking impairment is one of the most pervasive and alarming aspects of MS for
patients, their families and their health care providers. There are no medicines
currently indicated to improve walking ability in people with MS, and Fampridine-SR
therefore may represent an important new approach to MS therapy. We are excited
to have taken this major step toward potentially making Fampridine-SR available
to help people with MS.”
Approximately 400,000-500,000 people in the Unites States have MS, and recent
studies indicate that between 64-85% of people with MS have walking
disability1,2. Fully 70% of people with MS who have walking disability report it
to be the most challenging aspect of their disease1.
The Fampridine-SR NDA submission is based on data from a comprehensive
development program assessing the safety and efficacy of Fampridine-SR,
including two Phase 3 trials that involved 540 people with MS and were conducted
under Special Protocol Assessments (SPAs) from the FDA. The safety and efficacy
profile of Fampridine-SR was consistent across Phase 2 and Phase 3 trials.
Overall, the NDA filing included more that 50 clinical studies of Fampridine-SR.
The total exposure to Fampridine-SR in MS studies filed as part of the NDA was
over 1,200 patient-years. Additionally, more than 450 people are currently
enrolled in Fampridine-SR extension trials, with treatment duration ranging from
seven months to almost five years.
The Company also has discussed Fampridine-SR with regulatory authorities in
Europe and believes that the current data are sufficient to file a centralized
Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA).
The Company plans to file the MAA when it has determined the commercialization
pathway that maximizes the value of Fampridine-SR outside the U.S.
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. As of June 2008, the Company completed
two successful Phase 3 clinical trials to evaluate the safety and efficacy of
Fampridine-SR in improving walking ability in people with MS.
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. In June
2008, Acorda's lead clinical product, Fampridine-SR, completed a second Phase 3
clinical trial to evaluate its safety and efficacy in improving walking ability
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 Statement
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.
1 Harris Interactive poll, April 2008
2 NARCOMS patient database
Source: Acorda Therapeutics, Inc.
Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
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