Acorda Therapeutics Announces Department of Defense Contract to Support Study of AC105 in Acute Spinal Cord Injury

Thu Jan 24, 2013 7:00am EST

* Reuters is not responsible for the content in this press release.

http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130124:nBw245366a

ARDSLEY, N.Y.--(Business Wire)--
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Army
Medical Research and Material Command (USAMRMC) has awarded the Company a $2.67
million research contract to support development of AC105, a propriety magnesium
formulation being studied as a treatment for acute spinal cord injury (SCI). 

The contract will help support a Phase 2 clinical trial designed primarily to
assess the safety and tolerability of AC105 in people with acute SCI. The
Company plans to open enrollment for this study in the first half of 2013. 

"Spinal cord injuries often result in severe, lifelong disability, and primarily
occur in young people. This leads to long-term care and quality of life issues
for the person with the injury, as well as for their family and the healthcare
system as a whole," said Anthony Caggiano, M.D., Ph.D., Acorda`s Vice President
of Research and Development. "We are pleased to be collaborating with the U.S.
Army on this project to determine if AC105 can improve outcomes in SCI. It is
also a privilege for us to be working on a therapy that may help those who have
been injured in the line of duty." 

In preclinical studies, AC105 demonstrated neuroprotective properties and
improvement of locomotor function in SCI when therapy was initiated within
several hours of injury. The U.S. Food and Drug Administration (FDA) granted
Fast Track designation for AC105 to improve functional recovery of acute SCI
patients. Acorda expects to apply for FDA orphan drug designation for the acute
treatment of SCI and will explore orphan drug designations in Europe and in
other parts of the world. 

About Spinal Cord Injury (SCI)

Spinal cord injury (SCI) refers to any injury to the spinal cord that is caused
by trauma, such as a motor vehicle accident, fall or sports injury. According to
the National Spinal Cord Injury Statistical Center (NSCISC), there are
approximately 270,000 people in the United States living with a spinal cord
injury. Each year, there are approximately 12,000 new injuries reported in the
United States, the majority of which are males. Spinal cord injuries primarily
affect young people, with 50-70% occurring in those aged 15-35. 

The costs of living with SCI can be considerable and can vary greatly with the
severity of injury. Long-term complications from SCI can include neurologic
impairments in any body system controlled by the affected nerves. Average annual
medical cost for an SCI patient ranges from $40,000-$178,000 depending on the
extent of the injury. There are currently no FDA-approved therapies indicated to
treat, mitigate, or reverse SCI. 

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
("DZNS") or any other acquired or in-licensed programs; we may not be able to
complete development of, obtain regulatory approval for, or successfully market
DZNS 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

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.