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
