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Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug
Application for Filing FDA Assigns Priority Review and PDUFA Date of October 22,
2009 No Current Therapies Indicated to Improve Walking Ability in People with MS
HAWTHORNE, N.Y.--(BUSINESS WIRE)--May. 6, 2009-- Acorda Therapeutics, Inc. (Nasdaq:
ACOR) today announced that the U.S. Food and Drug Administration (FDA) has
accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning
Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22,
2009. The PDUFA date is the target date for the FDA to complete its review of
the Fampridine-SR NDA.
“I am pleased that we were able to work quickly to address the comments from the
FDA and resubmit our NDA approximately three weeks from having received the
Refuse to File letter on our initial NDA submission, and that the FDA accepted
the filing less than two weeks later,” said Ron Cohen, M.D., Acorda
Therapeutics’ President and CEO. “We are also encouraged that the FDA has
elected to assign Priority Review status to the Fampridine-SR NDA.”
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 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.
About Elan Drug Technologies
Elan Drug Technologies (EDT) is the world’s leading drug delivery company and is
a business unit of Elan (NYSE: ELN). EDT developed Fampridine-SR, using one of
their proprietary Oral Controlled Release Technologies, the MXDAS® (MatriX Drug
Absorption System) Technology. Products developed by EDT aim to deliver
clinically meaningful benefits to patients by using their extensive experience
and proprietary delivery technologies in partnership with pharmaceutical
companies. More information is available at
www.elandrugtechnologies.com
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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