Acorda Therapeutics Presents GGF2 Preclinical Stroke Data at International Stroke Conference

  Acorda Therapeutics Presents GGF2 Preclinical Stroke Data at International
  Stroke Conference

Business Wire

ARDSLEY, N.Y. -- February 7, 2013

Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced data from studies showing
that Glial Growth Factor 2 (GGF2) can enhance recovery of sensorimotor
function in a preclinical model of stroke. The studies expand on an existing
body of preclinical work examining GGF2 in stroke, and specifically explored
various doses and frequency of administration to assess optimal treatment
regimens. The data were featured as a late-breaking poster presentation at the
American Heart Association/American Stroke Association International Stroke
Conference in Honolulu, HI.

“These data confirm earlier preclinical study results showing that GGF2 can
improve recovery of function following stroke. They also provide valuable
information about varying dosing regimens that will contribute to the further
development of GGF2,” said Anthony Caggiano, M.D., Ph.D., Acorda’s Vice
President of Research and Development. “Previous studies have shown that GGF2
can be effective in restoring function when initiating therapy as long as
seven days following a stroke. Currently approved stroke interventions need to
be administered within a few hours of an event, which limits therapy to a
small minority of people who experience a stroke. Early data on GGF2 suggest a
longer time window to administer treatment, which represents a potentially
critical advance.”

The poster, entitled “Optimized Dosing of Glial Growth Factor 2 in a Middle
Cerebral Artery Occlusion Model Increases GAP43 Expression,” reviewed data
from study groups receiving differing doses of GGF2 to determine which dose
was most effective in enhancing recovery of sensorimotor function after
stroke. This was measured by several sensorimotor function tests, including
limb placement. Treatment was initiated 24 hours after the stroke. The study
showed significant improvements in sensorimotor recovery with GGF2 that were
related to dose and frequency of treatment. As was seen in previous studies,
improvements were not associated with reduced lesion volume, but in this study
were shown to be associated with increased expression of the growth associated
protein, GAP43, within the brain, both close to and distant from the area of
injury.

GGF2 is the leading development candidate from the Company’s neuregulin
program. Neuregulins are a class of naturally occurring protein growth factors
that have multiple effects on the nervous and cardiovascular systems. Acorda
is conducting a clinical program for GGF2 in heart failure and preclinical
development in a number of neurological indications, including peripheral
nerve injury and stroke. The first clinical trial of GGF2, a Phase 1 study of
GGF2 in patients with heart failure, was completed in late 2012.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company focused on developing therapies
that restore function and improve the lives of people with MS, spinal cord
injury and other neurological conditions.

Acorda markets AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg, in
the United States as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an improvement in walking speed.
AMPYRA is marketed outside the United States as FAMPYRA^® (prolonged-release
fampridine tablets) by Biogen Idec under a licensing agreement from Acorda.
AMPYRA and FAMPYRA are manufactured under license from Alkermes Pharma Ireland
Limited.

The Company also markets ZANAFLEX CAPSULES^® (tizanidine hydrochloride) and
Zanaflex tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride capsules, an
authorized generic version of ZANAFLEX CAPSULES distributed by Watson
Pharmaceutics, Inc. under its agreement with Acorda.

Acorda has an industry-leading pipeline of novel neurological therapies. The
Company is developing Diazepam Nasal Spray for treatment of certain epileptic
seizures. It is also studying AMPYRA to improve a range of functional
impairments caused by MS, as well as its potential for use in other
neurological conditions, including cerebral palsy and post-stroke deficits. In
addition, Acorda is developing clinical stage compounds AC105 for acute
treatment of spinal cord injury, GGF2 for treatment of heart failure and
rHIgM22, a remyelinating monoclonal antibody, for the treatment of MS.GGF2 is
also being investigated in preclinical studies as a treatment for neurological
conditions such as stroke and spinal cord injury. Chondroitinase, an enzyme
that encourages nerve plasticity in spinal cord injury, is in preclinical
development.

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 our ability to successfully market and
sell Ampyra in the U.S.; third party payers (including governmental agencies)
may not reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization requirements
that limit or block prescriptions; the risk of unfavorable results from future
studies of Ampyra or from our other research and development programs,
including Diazepam Nasal Spray or any other acquired or in-licensed programs;
we may not be able to complete development of, obtain regulatory approval for,
or successfully market Diazepam Nasal Spray or other products under
development; the occurrence of adverse safety events with our products; delays
in obtaining or failure to obtain regulatory approval of or to successfully
market Fampyra outside of the U.S. and our dependence on our collaboration
partnerBiogen Idecin connection therewith; competition, including the impact
of generic competition on Zanaflex Capsules revenues; failure to protect our
intellectual property, to defend against the intellectual property claims of
others or to obtain third party intellectual property licenses needed for the
commercialization of our products; failure to comply with regulatory
requirements could result in adverse action by regulatory agencies; and the
ability to obtain additional financing to support our operations. These and
other risks are described in greater detail inAcorda Therapeutics'filings
with the Securities & Exchange Commission.Acordamay not actually achieve the
goals or plans described in its forward-looking statements, and investors
should not place undue reliance on these statements. Forward-looking
statements made in this release are made only as of the date hereof, and
Acorda disclaims any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of this
release.

Contact:

Acorda Therapeutics
Jeff Macdonald, 914-326-5232
jmacdonald@acorda.com
 
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