Acorda Therapeutics Announces Positive AMPYRA® (dalfampridine) Phase 2 Data in People with Post-Stroke Deficits

Mon Apr 15, 2013 6:00am EDT

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* Company Plans to Continue Clinical Development in Post-Stroke Deficits 
* Safety Findings Consistent with Previous Clinical Trials and Post-Marketing
Experience in Multiple Sclerosis 
* Separate Proof-of-Concept Study in Cerebral Palsy Confirms Safety; Efficacy
Measures Require Further Analysis 
* Webcast at 8:30 am Today to Review Study Findings

ARDSLEY, N.Y.--(Business Wire)--
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that a proof-of-concept
trial found dalfampridine extended release (ER) tablets, marketed as AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, improved walking in people with
post-stroke deficits. Post-stroke deficits refer to chronic neurological
deficits, such as impaired walking, motor and sensory function and manual
dexterity that persist in people who have had a stroke. 

"There were clear efficacy signals in the dalfampridine-ER post-stroke deficits
trial and we therefore plan to proceed with a clinical development program for
this indication. A top-line analysis of the data found dalfampridine-ER improved
walking for people with mobility impairment resulting from ischemic stroke.
Dalfampridine-ER treatment was also associated with a positive change versus
placebo on a scale of functional independence in this study," said Ron Cohen,
M.D., Acorda`s President and Chief Executive Officer. "We are analyzing the data
further to better understand the entirety of the results. After we complete the
analysis, we plan to discuss the development program with the FDA. There are
more than seven million stroke survivors in the United States, and approximately
half of them have some lasting mobility impairment. There are no medications
currently available for these patients, so new therapies are desperately
needed." 

This study included 83 participants who had experienced an ischemic stroke at
least six months prior to enrollment and had chronic motor deficits. As part of
the crossover design, participants received both dalfampridine-ER 10 mg and
placebo for 14 days twice daily, with a wash-out period in between during which
participants received placebo. The primary goals of the study were to assess
safety and tolerability, as well as to explore various efficacy measures. 

Key Safety Findings from Post-Stroke Deficits Trial

The safety findings in this study were consistent with previous clinical trials
and post-marketing experience of AMPYRA in multiple sclerosis (MS). 

The most common adverse events reported in the study were dizziness (10.4%
dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo),
fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER,
2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo). 

Three participants experienced a seizure during the study. One occurred while
the participant was taking placebo (without prior exposure to dalfampridine-ER),
one occurred while the participant was taking dalfampridine-ER, and one occurred
due to an intentional overdose of dalfampridine-ER. The overdose was judged by
the study investigator to be a suicide attempt related to a recent family
tragedy. All three participants recovered fully. 

Key Efficacy Findings from Post-Stroke Deficits Trial

Improvement in walking was measured by the Timed 25-Foot Walk (T25FW). Using the
full crossover design, walking speed increased while participants were taking
dalfampridine-ER compared to placebo (p < 0.05). 

Participants also showed a positive change on the Functional Independence
Measurement (FIM) scale while taking dalfampridine-ER compared to placebo. The
FIM scale assesses an individual`s ability to perform daily tasks such as
bathing, grooming, eating, and walking independently. 

Other exploratory efficacy measures in the study are currently being analyzed. 

Cerebral Palsy Study Update

A separate proof-of-concept trial including 24 participants explored the use of
dalfampridine-ER 10 mg dosed twice daily in adults with cerebral palsy (CP). 

The safety findings in this study were consistent with previous clinical trials
and post-marketing experience of AMPYRA in MS. The most commonly reported
adverse events were headache (12.5% dalfampridine-ER, 4.2% placebo), fatigue
(12.5% dalfampridine-ER, 0% placebo), insomnia (8.3% dalfampridine-ER, 4.2%
placebo), diarrhea (4.2% dalfampridine-ER, 4.2% placebo) and nausea (4.2%
dalfampridine-ER, 4.2% placebo). There were no serious adverse events reported. 

Efficacy data from this study suggested potential treatment activity on measures
of walking and hand strength; however, these data are still being analyzed to
determine if they are sufficiently robust to warrant further clinical studies. 

The Company plans to present data from the post-stroke deficits and CP trials in
appropriate medical forums following additional analysis of the data. 

AMPYRA is approved by the U.S. Food and Drug Administration (FDA) for the
improvement of walking in people with MS. This was demonstrated by an increase
in walking speed. The findings in post-stroke deficits and CP do not impact
AMPYRA`s proven safety and efficacy profile in people with MS. 

Webcast and Conference Call

Ron Cohen, M.D., President and Chief Executive Officer, and Andrew Blight,
Ph.D., Chief Scientific Officer, will host a conference call today at 8:30 a.m.
ET to review the study findings. 

To participate in the conference call, please dial 800-510-0219 (domestic) or
617-614-3451 (international) and reference the access code 93715573. The
presentation will be available via a live webcast on the Investor section of
www.acorda.com. 

A replay of the call will be available from 10:30 a.m. ET on April 15, 2013
until midnight on May 15, 2013. To access the replay, please dial 888-286-8010
(domestic) or 617-801-6888 (international) and reference the access code
18022123. The archived webcast will be available for 30 days in the Investor
Relations section of the Acorda website at www.acorda.com. 

Important Safety Information

Do not take AMPYRA if you have ever had a seizure or have certain types of
kidney problems. 

Take AMPYRA exactly as prescribed by your doctor. 

You could have a seizure even if you never had a seizure before. Your chance of
having a seizure is higher if you take too much AMPYRA or if your kidneys have a
mild decrease of function, which is common after age 50. 

Your doctor may do a blood test to check how well your kidneys are working, if
that is not known before you start taking AMPYRA. 

AMPYRA may cause serious allergic reactions, including rare occurrence of
anaphylaxis. 

AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same. 

The most common adverse events for AMPYRA in MS patients were urinary tract
infection, trouble sleeping, dizziness, headache, nausea, weakness, back pain,
and problems with balance. 

Before taking AMPYRA tell your doctor if you are pregnant or plan to become
pregnant. It is not known if AMPYRA will harm your unborn baby. 

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not
known if AMPYRA passes into your breast milk. You and your doctor should decide
if you will take AMPYRA or breast-feed. You should not do both. 

You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 

About AMPYRA (dalfampridine)

AMPYRA is a potassium channel blocker approved as a treatment to improve walking
in patients with multiple sclerosis (MS). This was demonstrated by an increase
in walking speed. AMPYRA, which was previously referred to as Fampridine-SR, is
an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP),
and is known as prolonged-, modified, or sustained-release fampridine (FAMPYRA®)
in some countries outside the United States (U.S.). 

In laboratory studies, dalfampridine extended release tablets has been found to
improve impulse conduction in nerve fibers in which the insulating layer, called
myelin, has been damaged. 

AMPYRA is being developed and commercialized in the U.S. by Acorda Therapeutics;
FAMPYRA is being developed and commercialized by Biogen Idec in markets outside
the U.S. based on a licensing agreement with Acorda. AMPYRA and FAMPYRA are
manufactured globally by Alkermes Pharma Ireland Limited, a subsidiary of
Alkermes plc, based on a supply agreement with Acorda. 

AMPYRA is available by prescription in the United States. For more information
about AMPYRA, including patient assistance and co-pay programs, healthcare
professionals and people with MS can contact AMPYRA Patient Support Services at
888-881-1918. AMPYRA Patient Support Services is available Monday through
Friday, from 8:00 a.m. to 8:00 p.m. Eastern Time. For full U.S. Prescribing
Information and Medication Guide, please visit: www.AMPYRA.com. 

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 Actavis, Inc.
under its agreement with Acorda. 

Acorda has one of the leading pipelines in the industry 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. 

Acorda 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 partner Biogen Idec in 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 in Acorda
Therapeutics' filings with the Securities & Exchange Commission. Acorda may 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.

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

Copyright Business Wire 2013

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