Acorda expects to seek approval for drug

January 12, 2009

Acorda Therapeutics Inc., a Hawthorne-based biotech company, said that it is pushing ahead with plans to seek regulatory approval for its most promising product, Fampridine-SR, a drug to help people with multiple sclerosis walk.

The company said that it remains on schedule to file a new drug application for the medication with the U.S. Food and Drug Administration during the first quarter. It also expects to submit applications for the medication to regulators in Europe and Canada.

“We are also beginning discussions with potential marketing partners to explore commercialization options in Europe and the rest of world excluding the U.S.,” Chief Executive Officer Ron Cohen said in a written statement. “Achieving these milestones will bring us closer to our goal of making Fampridine-SR available to the many people with MS who may benefit from it.”

Acorda Therapeutics Presents Additional Data from Second Positive Phase 3 Study of Fampridine-SR at World Congress on Treatment and Research in Multip

- Similar Response Rates Seen Across Different MS Subtypes and Background Therapies -

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Sept. 20, 2008--Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced additional data from its second Phase 3 clinical trial of Fampridine-SR (MS-F204) on walking ability in people with multiple sclerosis (MS) at the late breaking news session of the World Congress on Treatment and Research in Multiple Sclerosis, being held in Montreal, Canada. Previously, the Company announced the trial met its primary endpoint with a significantly greater proportion of people taking Fampridine-SR having a consistent improvement in walking speed compared to people taking placebo (42.9% vs. 9.3%), as measured by the Timed 25-Foot Walk (p less than 0.001). The study also met its secondary outcome measure, leg strength, showing a statistically significant increase in the Fampridine-SR Timed Walk responders compared to placebo (p = 0.028).

New findings and information presented at the meeting from the study included:

-- The response rate for Fampridine-SR treated patients was
higher than placebo across all MS subtypes. Response rates for
the four major MS subtypes in the study were:
relapsing-remitting: 37.2%; secondary-progressive: 45.9%;
primary-progressive: 50.0%; and progressive-remitting: 40.0%.

-- Response rates were similar between study participants who
were being treated with immunomodulators and those who were
not.

-- The Fampridine-SR treated group showed improvement in the
Ashworth Score (a physician-reported measure of spasticity),
which was significant in an unplanned analysis.

-- Baseline demographic and disease characteristics of study
participants were also presented, including the percentage of
Fampridine-SR treated patients with each subtype of MS
(relapsing-remitting: 35.8%; primary-progressive: 8.3%;
secondary-progressive: 51.7%; and progressive-relapsing: 4.2%)
and the mean duration of disease in Fampridine-SR treatment
patients (14.43 years).

"People with MS often cite walking disability as one of the most challenging aspects of their disease, and there are no therapies currently indicated for improving walking in MS," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester, who presented the data. "The results of this study, which were consistent with the first Phase 3 Fampridine-SR trial, show that Fampridine-SR may provide benefit to people with walking difficulties."

Study Design

The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The primary endpoint of the study was response on the Timed 25-Foot Walk. A Fampridine-SR Timed Walk responder was defined as a study participant whose walking speed was faster during at least three of the four on-drug visits than any speed measured during the five off-drug visits. This Timed Walk Response was validated for clinical meaningfulness in previous trials by showing that the response was associated with significant improvements in day-to-day disability, as measured by the 12-item MS Walking Scale (MSWS-12), and was also associated with significant improvements in both Subject and Clinician Global Impression scores. The trial, which enrolled 240 individuals at 39 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. Subjects were randomized to treatment with Fampridine-SR (n=120), at a dose of 10mg twice a day, or placebo (n=119), and the study was open to people with all four major types of MS: primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including immunomodulators.

Safety Statement

In this study, adverse events were generally mild to moderate and largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS. The most common adverse events reported in the Fampridine-SR treatment group compared to the placebo group included: urinary tract infection (17.5% vs. 8.4%), falls (11.7% vs. 16.8%), insomnia (10.0% vs. 1.7%), headache (9.2% vs. 0.8%), asthenia (8.3% vs. 4.2%), dizziness (8.3% vs. 0.8%), nausea (8.3% vs. 0.8%), back pain (5.8% vs. 2.5%), balance disorder (5.8% vs. 1.7%), upper respiratory tract infection (5.8% vs. 6.7%), arthralgia (5.0% vs. 4.2%), nasopharyngitis (5.0% vs. 4.2%) and paraesthesia (5.0% vs. 1.7%).

There were three serious adverse events (SAEs) that led to discontinuation: two in the placebo group and one in the Fampridine-SR group. In the placebo group, one participant experienced a possible complex partial seizure and another experienced a combination of chest tightness and gastric reflux. Both of these events were judged by investigators, who were blinded at the time, to be possibly related to treatment. In the Fampridine-SR group, one participant had a patellar fracture, which was judged not to be treatment related. In addition, one participant treated with Fampridine-SR experienced an episode of syncope (fainting) one day after completing the treatment phase of the study. This was judged to be possibly related to treatment, but the participant was not discontinued from the trial. Follow-up assessment by the clinical investigators determined that these SAEs resolved completely with no residual effects. No deaths occurred during the study.

As of August 5, 2008, the total exposure in our MS studies to Fampridine-SR at 10mg twice a day, including both double-blind and open-label studies, is approximately 1,200 patient years. The incidence of seizures in these studies at the 10mg dose has been within the rates reported for placebo-treated groups in long-term controlled studies of immunomodulator drugs in MS patients. These rates have ranged up to two percent of patients in a two-year study, or one seizure per 100 patient years. The overall incidence of seizure appears to be dose-related.

About MS

Multiple sclerosis is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. Over 400,000 Americans have MS, and someone is newly diagnosed with MS every hour in the United States. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments. Research indicates 64% -85% of people with MS have difficulty walking, and 70% of people with MS who have difficulty walking report it to be the most challenging aspect of their MS. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and, in later stages, up to a third of patients are unable to walk.

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 completed a second Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS in June 2008.

Fampridine-SR and MS

A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity.

In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. In published studies, fampridine has been shown to block these exposed channels and help the electrical signals to pass through areas of damage.

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(R) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, recently completed a second Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

Forward-Looking Statement

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.

CONTACT: Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
Cell: 917-371-0940
jmacdonald@acorda.com
or
Tierney Saccavino, 914-347-4300 ext. 104
Cell: 917-783-0251
tsaccavino@acorda.com

SOURCE: Acorda Therapeutics, Inc.

New Drugs in late-stage trials offer promise for sufferers of the chronic and crushing disease multiple sclerosis

Two Steps Forward

New drugs in late-stage trials offer promise for sufferers of the chronic and crushing disease multiple sclerosis

Mary Ellen Egan 08.07.08, 6:00 PM ET
Forbes Magazine dated September 01, 2008




Robin and Clifford Giese, with Kevin Giese at right.


Robin Giese, 59, kicks off each day by getting out of her wheelchair for a half-hour ride on a stationary bike followed by 30 minutes of stretching exercises. Most afternoons she visits friends or one of of her five grandchildren, and in the evenings she and her husband, Clifford, entertain guests or go out to dinner.

Giese hasn't always been so active. She has multiple sclerosis, the degenerative disease of the central nervous system that afflicts 400,000 Americans. In MS the immune system attacks myelin, a fatty substance that protects nerve fibers much the way insulation protects electrical wires. When the unprotected nerve fibers, or axons, are damaged, signals are blocked or delayed traveling to and from the brain. This causes a variety of symptoms that can include blurred vision, incontinence, difficulty walking and paralysis.

Over three decades multiple sclerosis has slowly robbed Giese of her mobility and weakened her muscles, and without treatment she would be all but immobilized in her wheelchair. But an experimental drug has changed the course of her disease--and her husband's career path.

The compound, called dirucotide, is a chain of 17 amino acids that mimics a portion of the protein in myelin. It works by acting as a decoy to divert the attacking immune cells. It has had such a profound impact on Robin's condition that her husband has started a company, BioMS Medical, to bring it to market. Today dirucotide is one of two novel MS drugs in late-stage clinical trials. The other, from a small firm called Acorda, improves muscle strength.

There are four kinds of MS. Most sufferers are first given a diagnosis of a mild relapsing form of the disease marked by occasional flare-ups followed by months or years without symptoms. Ninety percent of patients with this condition eventually develop a progressive MS characterized by continuous deterioration. The two remaining types of MS, less common, entail a rapid decline.

Most existing MS therapies work by suppressing the immune system, and they're generally effective only when the disease is at an early stage. They include Biogen Idec (nasdaq: BIIB - news - people )'s monoclonal antibody Tysabri, beta interferons and anticancer drugs. They can be helpful (there is no cure), but their side effects can range from flu-like symptoms to fatal viral infections of the brain.

Dirucotide began with research conducted at the University of Alberta by doctors Kenneth Warren and Ingrid Catz. In 1989 Warren developed a synthetic peptide that mimics myelin protein. He began testing his compound on MS patients in 1994, and Robin Giese, who became a patient of his that same year, received her first infusion in 1996. Three weeks later, she says, her energy level had increased dramatically, and her head, which had felt "fuzzy" for years, was suddenly "clear." "It was the best I'd felt in years," she says.

Even though the drug didn't allow her to throw away her wheelchair, she credits it with restoring her zest in life. "Before I started taking it, I couldn't predict how I'd feel or what I could do each day. Now I wake up feeling great and have energy for the entire day." She gets dirucotide infusions twice a year.

The university lacked money for clinical trials, so Clifford, who had made a fortune with a chain of Canadian oil-change stores, stepped in to help. He and his brother, Kevin, licensed the drug from the university and founded BioMS in September 2000. The following year they started selling shares to the public, and they've raised $180 million so far on top of the $1 million that they estimate they invested themselves at the outset. Kevin took the role of chief executive, and Clifford became chairman.

BioMS moved to late-stage clinical trials of dirucotide in January 2005 and has done them with 611 patients with the progressive form of MS. Testing should wrap up in mid-2010.

The results so far have been very promising. Patients with either of two genes associated with autoimmune disorders, HLA-DR2 and HLA-DR4, have gone five years without any progression of the disease. Those genes are found in 65% to 75% of all MS patients, and because of that analysts estimate that the potential market for drugs like dirucotide, effective for patients at later stages of the disease, could reach $10 billion a year. The current market for all existing MS drugs is $6 billion.

Acorda's drug, Fampridine-SR, works differently from dirucotide and specifically addresses one of the most devastating symptoms of the disease, loss of muscle strength. Its key compound, 4-aminopyridine, has been around for 100 years. Academic researchers originally used the synthesized chemical to study nerve cell conduction. Not until the 1980s did they figure out how it works and how it might help with MS.

In MS the damage to myelin exposes channels on the surface of the axon, allowing potassium ions to leak out and thus dissipate the electrical current that carries nerve signals. The 4-aminopyridine molecule patches the exposed channels so the current can pass through.

But, early on, using the compound in humans proved to be tricky. Dosages were hard to control, and patients given too much had seizures. The drug languished until the mid-1980s, when Elan Corp. (nyse: ELN - news - people ), an Irish firm, began looking for ways to reformulate it.

In 1994, after a decade of tinkering, Elan began testing a sustained-release version in patients with MS. A year later Acorda, then privately held, approached Elan for permission to test Fampridine-SR, as the new version was named, in spinal cord injury patients. Acorda began clinical trials in 1998 and, five years later, when Elan was struggling, secured the rights for Fampridine-SR for all applications.

Acorda started its tests of Fampridine-SR in MS patients in late 1999, and in June this year the now public company completed late-stage trials in 540 patients with all four types of MS. The results are impressive: 43% of the patients showed consistent improvement in walking speed, as against 9% of patients on a placebo.

"One of the first questions patients ask is if they'll be in an wheelchair. Anything that helps to keep them out of a wheelchair longer is very important," says Dr. Hillel Panitch, one of the drug's clinical investigators and director of the University of Vermont's Multiple Sclerosis Center. Acorda plans to submit its data to the FDA early next year and ask the agency for fast-track approval.

"One of the first questions patients ask is if they'll be in an wheelchair. Anything that helps to keep them out of a wheelchair longer is very important," says Dr. Hillel Panitch, one of the drug's clinical investigators and director of the University of Vermont's Multiple Sclerosis Center. Acorda plans to submit its data to the FDA early next year and ask the agency for fast-track approval.

Acorda Therapeutics Announces Positive Data from Second Phase 3 Study of Fampridine-SR on Walking Ability in People with Multiple Sclerosis

Company Plans to File New Drug Application (NDA) in First Quarter of 2009

Investor Conference Call and Webcast Today at 8:30 A.M. ET
HAWTHORNE, N.Y.--(BUSINESS WIRE)--June 2, 2008--Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced positive results from its second Phase 3 clinical trial of Fampridine-SR (MS-F204) on walking ability in people with multiple sclerosis (MS). A significantly greater proportion of people taking Fampridine-SR in the trial had a consistent improvement in walking speed compared to people taking placebo (42.9% vs. 9.3%), as measured by the Timed 25-Foot Walk (p less than 0.001). Consistent improvement in walking speed was the primary endpoint of the study as outlined in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA).

"With the success of this trial, we have achieved a critical milestone for Fampridine-SR. We have now completed two successful Phase 3 trials demonstrating improved walking ability in people with MS," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "We believe that, subject to FDA review, the results of our two Phase 3 trials are adequate to support an NDA. We expect to submit this application in the first quarter of 2009 and plan to request priority review."

The study's only prospectively defined secondary outcome measure, leg strength, showed a statistically significant increase in the Fampridine-SR Timed Walk responders compared to placebo (p = 0.028). There was a small improvement in leg strength for Fampridine-SR Timed Walk non-responders compared to placebo that was not statistically significant.

Additional measures in this study were consistent with the results of the first Phase 3 Fampridine-SR trial. The average increase in walking speed over eight weeks of treatment compared to baseline was 24.7 percent for the Fampridine-SR Timed Walk responders compared to 7.7 percent for the placebo group. The 12-Item Walking Scale (MSWS-12), a self-rated assessment of walking disability, was improved in Timed Walk responders compared to non-responders. Also, an increased response rate on the Timed 25-Foot Walk was seen across all four types of MS. The Company intends to present comprehensive data from this trial at an upcoming medical meeting.

"Difficulties with walking are among the most pervasive and debilitating problems faced by people with MS. Walking disability affects their ability to accomplish daily tasks and limits their independence," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "Because there are currently no therapies indicated to improve walking impairment in MS, clinicians are limited in their ability to address this aspect of the disease. The results of this study indicate that Fampridine-SR could represent an important new way to treat people with MS."

Study Design

The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The primary endpoint of the study was response on the Timed 25-Foot Walk. A Fampridine-SR Timed Walk responder was defined as a study participant whose walking speed was faster at a majority of the four on-drug visits than any speed measured during the five off-drug visits. The trial, which enrolled 240 individuals at 39 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. Subjects were randomized to treatment with Fampridine-SR (n=120), at a dose of 10mg twice a day, or placebo (n=119), and the study was open to people with all four major types of MS: primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including immunomodulators.

Safety Statement

In this study, adverse events were generally mild to moderate and largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS. The most common adverse events reported in the Fampridine-SR treatment group compared to the placebo group included: urinary tract infection (17.5% vs. 8.4%), falls (11.7% vs. 16.8%), insomnia (10.0% vs. 1.7%), headache (9.2% vs. 0.8%), asthenia (8.3% vs. 4.2%), dizziness (8.3% vs. 0.8%), nausea (8.3% vs. 0.8%), back pain (5.8% vs. 2.5%), balance disorder (5.8% vs. 1.7%), upper respiratory tract infection (5.8% vs. 6.7%), arthralgia (5.0% vs. 4.2%), nasopharyngitis (5.0% vs. 4.2%) and paraesthesia (5.0% vs. 1.7%).

There were three serious adverse events (SAEs) that led to discontinuation: two in the placebo group and one in the Fampridine-SR group. In the placebo group, one participant experienced a possible complex partial seizure and another experienced a combination of chest tightness and gastric reflux. Both of these events were judged by investigators, who were blinded at the time, to be possibly related to treatment. In the Fampridine-SR group, one participant had a patellar fracture, which was judged not to be treatment related. In addition, one participant treated with Fampridine-SR experienced an episode of syncope (fainting) one day after completing the treatment phase of the study. This was judged to be possibly related to treatment, but the participant was not discontinued from the trial. Follow-up assessment by the clinical investigators determined that these SAEs resolved completely with no residual effects. No deaths occurred during the study.

As of June 2, 2008, the total exposure in our MS studies to Fampridine-SR at 10mg twice a day, including both double-blind and open-label studies, is approximately 1,100 patient years. The incidence of seizures in these studies at the 10mg dose has been within the rates reported for placebo-treated groups in long-term controlled studies of immunomodulator drugs in MS patients. These rates have ranged up to two percent of patients in a two-year study, or one seizure per 100 patient years. The overall incidence of seizure appears to be dose-related.

About MS

Multiple sclerosis is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. Over 400,000 Americans have MS, and someone is newly diagnosed with MS every hour in the United States. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments. Approximately 85 percent of people with MS experience some form of walking impairment. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and, in later stages, up to a third of patients are unable to walk.

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.

Fampridine-SR and MS

A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity.

In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. In published studies, fampridine has been shown to block these exposed channels and help the electrical signals to pass through areas of damage.

Conference Call and Audio Webcast

Acorda will hold a conference call and audio webcast today at 8:30 a.m. ET to discuss the top-line results from the trial. To access the call, please dial 866-578-5801(domestic) or 617-213-8058 (international) and provide the access code 57594133. To access the audio webcast, please go to the Investor Relations "Calendar of Events" section of the Acorda website at www.acorda.com, or you may use the link: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=1866966 . (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

A replay of the call will be available from 10:30 a.m. ET on June 2, 2008 until 11:59 p.m. ET on July 2, 2008. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 37448849. An archived version of the webcast will be available for 90 days on the Acorda website in the Investor Relations section.

Patient Information Line

Patients with questions regarding the results of this study or who want to join Acorda's mailing list to be kept informed of future company news may call 877-617-2494, toll-free, weekdays from 10:00 a.m. to 5:00 p.m. ET.

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(R) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, has completed two Phase 3 clinical trials to evaluate its safety and efficacy to improve walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the nervous system.

About Elan Drug Technologies

Elan's Drug Technologies group has developed Fampridine-SR tablets using one of its proprietary Oral Controlled Release Technologies, the MXDAS(TM) (MatriX Drug Absorption System) Technology. Elan Drug Technologies (EDT) is an established, profitable and growing specialty pharmaceutical business unit of Elan Corporation plc. For nearly 40 years, EDT has been applying its skills and knowledge to enhance the performance of dozens of drugs that have been marketed worldwide. EDT is focused on using its extensive experience, proprietary drug delivery technologies and licensing capabilities to develop innovative products that deliver clinically meaningful benefits to patients. More information about EDT's broad range of technologies including their Oral Controlled Release and NanoCrystal(R) Technology Platforms, their patent estate and range of services is available at www.elan.com/EDT.

Acorda Therapeutics, Inc. 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 Zanaflex Capsules(R), 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.

CONTACT:
Acorda Therapeutics
Media:
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
or
Investor Relations:
Molly Newton, 914-347-4300 ext. 203
mnewton@acorda.com

SOURCE: Acorda Therapeutics, Inc.

MS Patients Say Mobility Is Top Problem

But Surveys Show Many Multiple Sclerosis Patients Don't Discuss Walking Trouble With Doctors

By Denise Mann

WebMD Medical News Reviewed by Louise Chang, MD

April 10, 2008 (New York) -- The majority of people with multiple sclerosis (MS) say that trouble walking significantly affects their overall quality of life, yet many do not discuss their mobility issues with their doctors, according to two surveys.

The polls were conducted by Harris Interactive on behalf of Acorda Therapeutics Inc. and the National MS Society.

"We didn't expect to see that people who have mobility issues are not discussing them with their doctors because there are so many possibilities in terms of addressing mobility problems," Nicholas LaRocca, PhD, tells WebMD. LaRocca is the vice president of health care delivery and policy research at the National MS Society, based in New York City.

MS affects the central nervous system (the brain, spinal cord, and optic nerves). It results in loss of muscle control, vision, balance, and sensation. In MS, the body's own immune system attacks myelin, a fatty substance that surrounds and protects the nerve fibers in the central nervous system. Symptoms can range from mild, such as numbness in the limbs, to severe, such as paralysis.

The new polls comprised 1,011 U.S. adults with MS and 317 of their care partners. The participants were surveyed online between Jan. 28 and Feb. 25.

Almost two-thirds of people with MS experience trouble walking, the inability to walk, or the loss of balance at least twice a week; 94% of people with MS who have trouble walking say they find it at least somewhat disruptive to their daily life, with 63% percent finding it very disruptive or disruptive.

While 70% of people with MS who have difficulty walking say that it is the most challenging aspect of their disease, 39% of people with MS and almost 50% of their caregivers say that they rarely or never discuss this with their doctor.

Loss of mobility spills over into many aspects of the lives of people with MS and their caregivers. In the surveys, 21% of people with MS who experienced mobility loss said they changed their plans to have children because of it and nearly three of five people with MS who have mobility issues said they had missed out on personal events due to these issues.

Close to 70% of people with MS who have mobility problems say it affects their emotional health; about half say their mobility issues affect their ability to work and increase their daily expenditures.

Fatigue was also a very common symptom among survey respondents; 76% of people with MS said that they experience fatigue at least twice a week. Fatigue is known to affect mobility and balance.

Speak Up, Help Is Available
The onus may fall on the person with MS or a caregiver to broach mobility loss with a doctor, LaRocca tells WebMD. "The person with MS and their partner need to be proactive in terms of raising the issues that are concerning to them," he says.

In terms of mobility issues, "there are so many different areas to pursue," he says. Several mobility aids -- including canes, walkers, and electronic wheelchairs -- are available to help people with MS, he says. According to the surveys, 32% of people with MS do use some type of mobility aid to get around. Of these, 37% said they are embarrassed by their use of such aids.

"The tendency to underuse mobility devices is something we really want to address in the future," LaRocca says.

The first step is to evaluate the walking problem and identify the best strategies to improve it, he says. In addition to mobility aids, other tools are available depending on the problem. Exercise braces or electrical stimulation can help foot-drop (a compensatory technique that involves raising the heel on the stronger leg to make it easier to swing the weaker leg through); time and energy management can help curb MS-related fatigue, and there are drugs that can slow the disease course as well as treat spasticity and fatigue, he says.

Exercise can also help improve mobility problems among people with MS. "Seek out advice for a physical or occupational specialist to help develop an exercise program," says Brian Hutchinson, PT, MSCS, president of the Heuga Center for Multiple Sclerosis in Edward, Colo.

"People with MS can see the same benefits of regular exercise as people without MS," he says.

Acorda is investigating a drug called Fampridine-SR, which may improve walking ability in people with MS.

Acorda Therapeutics Announces Successful Thorough QT Study of Fampridine-SR

Fampridine-SR Not Associated with QT Changes

Company to Host Conference Call at 8:30 am Eastern Time Today

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jan. 28, 2008--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced results from a thorough QT study of Fampridine-SR. This study evaluated the potential to cause an increase in the electrocardiographic QT interval. Fampridine-SR, at both therapeutic and supratherapeutic doses, was found to be no different than placebo. The U.S. Food and Drug Administration requires thorough QT studies for all new drugs seeking regulatory approval, as increases in the QT interval (corrected for changes in heart rate, or QTc) may signify an increased risk of developing malignant cardiac arrhythmias.

This double-blind trial compared the electrocardiographic effects of Fampridine-SR, given at a therapeutic (10 mg twice daily) and supratherapeutic dose (30 mg twice daily), to placebo and moxifloxacin in 208 healthy subjects. Moxifloxacin is a positive control known to increase the QT interval.

The placebo-corrected QTc mean change from baseline (using the individual correction method for heart rate, or QTci) for the therapeutic and supratherapeutic doses of Fampridine-SR were 0 and 1 milliseconds, respectively. Moxifloxacin demonstrated QT prolongation consistent with previous clinical experience. In addition to no changes in the mean QTci interval, none of the subjects in the Fampridine-SR cohort showed increases in the QTci of greater than 30 milliseconds, nor did any of the Fampridine-SR subjects display a QTci interval that exceeded 480 milliseconds at any time.

Ron Cohen, Acorda's President and Chief Executive Officer, commented, "We are delighted with the results of this QT study, and are looking forward to completing our second Phase 3 trial of Fampridine-SR in multiple sclerosis patients in the second quarter of this year."

The company will host a conference call Monday, January 28, 2008 at 8:30 a.m. Eastern Time. To participate, please dial 866-800-8652 (domestic) or 617-614-2705 (international) and reference the access code 87165145. A replay of the call will be available from 11:00 a.m. Eastern Time on January 28, 2008 until February 28, 2008. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 18388394. The archived teleconference will be available for 30 days in the Investor Relations section of the Acorda website at http://www.acorda.com.

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine

(4-aminopyridine or 4-AP). Laboratory studies have shown that fampridine can improve the communication between damaged nerves, which may result in increased neurological function. Fampridine-SR is currently being studied in a Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with multiple sclerosis (MS).

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(R) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, is in a Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

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 Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, 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.

CONTACT: Acorda Therapeutics
MEDIA:
Jeff Macdonald, 914-347-4300 ext. 232
jmacdonald@acorda.com
or
INVESTOR RELATIONS:
Molly Newton, 914-347-4300 ext. 203
mnewton@acorda.com

SOURCE: Acorda Therapeutics, Inc.

Scientists Show Monoclonal Antibody Leads to Repair of Myelin Sheath in Laboratory Study of Multiple Sclerosis

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Oct. 16, 2007--Researchers at Mayo Clinic have presented details from a preclinical study showing that a recombinant human monoclonal antibody, administered in a single low dose in a laboratory mouse model of multiple sclerosis, can repair myelin, the insulating covering over nerve fibers in the central nervous system.

The study was presented on October 9, 2007 at the American Neurological Association meeting in Washington, D.C.

"We are excited to be collaborating with Mayo on the development of this therapy," noted Andrew R. Blight, Ph.D., Chief Scientific Officer at Acorda. "The options for treatment of MS are still quite limited, and a new approach that could repair damage to the central nervous system would represent an important advance for the individuals who live with this disease."

In multiple sclerosis and some other disorders of the central nervous system, the immune system attacks and destroys the myelin sheath, causing the nerve to lose its ability to conduct electrical impulses from the brain to the body, resulting in the disabilities associated with those conditions.

The antibody, which was genetically engineered for large-scale production, binds to myelin and the surface of cells in the brain and spinal cord, triggering the cells to begin the repair process called remyelination. The study was conducted using a laboratory mouse model of chronic progressive multiple sclerosis in humans. The antibody was delivered alone and in combination with the steroid methylprednisolone; remyelination was detected in both instances.

The antibody is being developed by Mayo Clinic and Acorda Therapeutics. Under a license agreement between Acorda and Mayo Clinic, Acorda holds exclusive worldwide rights to certain patents and other intellectual property for this antibody related to use and treatment of central nervous system disorders, including multiple sclerosis. Both Acorda and Mayo will be working on the steps leading to a future Investigational New Drug Application (IND) and a Phase 1 clinical trial.

About Multiple Sclerosis

Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. According to the National Multiple Sclerosis Society, approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

The NMSS estimates the direct costs of medical care for MS patients in the United States to exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments.

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(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, is in a Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

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 Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, 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.

CONTACT: Acorda Therapeutics
Media:
Erica Wishner, 914-347-4300 ext. 162
ewishner@acorda.com
or
Investor:
Tierney Saccavino, 914-347-4300 ext. 104
tsaccavino@acorda.com

SOURCE: Acorda Therapeutics

Acorda Therapeutics Presents Data from its Phase 3 Study of Fampridine-SR in Multiple Sclerosis at the American Academy of Neurology Meeting

BOSTON--(BUSINESS WIRE)--May 2, 2007--Acorda Therapeutics, Inc.® (Nasdaq: ACOR) today presented data from a Phase 3 clinical trial of Fampridine-SR in people with multiple sclerosis (MS) at the American Academy of Neurology meeting. Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester, presented top-line results on walking ability, leg strength, spasticity and clinician and subject global impressions. Dr. Goodman also presented a review of safety data.

Presentation Highlights

The prospectively-designed analysis plan for the study was based on a responder criterion, defined as a consistent improvement in walking speed, as measured with the Timed 25 Foot Walk. A significantly greater proportion of people taking Fampridine-SR were Timed Walk Responders compared to people taking placebo (34.8 percent vs. 8.3 percent, p less than 0.0001). Increased response rate with treatment was seen across all four major (relapsing and progressive) types of MS.

The mean increase in walking speed, compared to pre-treatment, for Fampridine-SR treated Timed Walk Responders was significantly greater at every visit during the treatment period, compared to both Fampridine-SR Timed Walk Non-Responders and placebo treated patients (p less than 0.0001). The average increase in walking speed over the treatment period, compared to baseline, was 25.2 percent for the drug treated Timed Walk Responders vs. 4.7 percent for the placebo group. In follow-up visits, at two and four weeks after the end of the treatment period, Responder and Non-responder groups returned to their baseline walking speeds.

The clinical significance of the consistent response on the timed walk was validated in the trial primarily by the 12-Item Multiple Sclerosis Walking Scale (MSWS-12), a patient self-assessment of walking disability. There was a statistically significant improvement in the MSWS-12 score for walking Responders compared to Non-responders (p less than 0.001). In addition, the mean scores on all 12 questions in the MSWS-12 were better for the Responder group than the Non-responder group.

Subject Global Impression and Clinician Global Impression scales were used as secondary validators of clinical meaningfulness. Both measures also showed statistically significant improvement among Responders compared to Non-responders (p = 0.0010 and p less than 0.0001, respectively).

Statistically significant increases in leg strength, as measured by the Lower Extremity Manual Muscle Test (LEMMT), were seen in both the drug-treated Timed Walk Responders (p = 0.0002) and the drug-treated Non-responders (p = 0.046), compared to placebo-treated patients.

In an unplanned, direct comparison of Fampridine-SR vs. placebo-treated groups, the following measures were significantly improved in the Fampridine-SR-treated group: mean change in walking speed (p = 0.0004), mean change in the Lower Extremity Manual Muscle Test (p = 0.0029), and mean change in the Ashworth score for spasticity (p = 0.021).

Andrew Blight, Ph.D, Chief Scientific Officer of Acorda Therapeutics, commented, "Walking impairment is one of the most pervasive and serious disabilities afflicting people with MS, and there are no currently approved therapies that are indicated to improve walking in this population. Fampridine-SR, if approved, may offer a novel treatment for improving walking ability in people with MS, one that may be complementary to currently available therapies. In this study, we also saw improvements in measures of leg strength and spasticity compared to the placebo group. In particular, even the Fampridine-SR group that did not show a consistent walking improvement still showed a statistically significant improvement in leg strength compared to the placebo group. Further clinical studies would be required to determine whether such additional improvements may be clinically significant."

Study discontinuations due to adverse events occurred in 11 (4.8%) of the 229 Fampridine-SR-treated patients, and none of the 72 patient placebo group. Three of these events were considered serious: influenza, sepsis and anxiety. The anxiety was considered probably related to treatment. A focal seizure, observed during the sepsis, was considered possibly related to treatment. An additional 13 patients in the Fampridine-SR-treated group experienced various serious adverse events but none of these led to discontinuation from treatment and none was considered related to treatment. Most non-serious adverse events were rated as mild to moderate in intensity and observed at similar rates in Fampridine-SR and placebo groups. Some events were seen more frequently in the Fampridine-SR group (insomnia, fatigue, back pain, balance disorder) while upper respiratory infection was more common in the placebo group. Overall, the safety data were consistent with previous experience.

Study Design

The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The trial, which enrolled 301 individuals at 33 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. The study was open to people with all types of MS, including primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including immunomodulators. Secondary endpoints for the trial included the Lower Extremity Manual Muscle Test, the Ashworth Score for spasticity, and Subject and Clinician Global Impressions. Subjects were randomized to 14 weeks of treatment with Fampridine-SR (n=229) or placebo (n=72), a 3:1 ratio of drug to placebo. The safety measures in this trial included a physical examination and vital signs at each study visit, ECG, laboratory tests, and tests of drug plasma concentration in addition to adverse event monitoring.

Key inclusion criteria for the study included the ability to complete the Timed 25 Foot Walk twice at screening with times averaging between 8 and 45 seconds, having a confirmed diagnosis of MS and having a stable condition. Key exclusion criteria included a history of seizures, having previous treatment with fampridine or having an MS exacerbation within 60 days of screening.

About MS

Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

Over time, MS tends to lead to increasing disabilities such as walking impairment, muscle weakness, problems with cognition, speech or vision impairments. Approximately 80 percent of people with MS experience some form of walking disability. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and in later stages, about a third of patients are unable to walk. These complications may make it harder for people to work and may interfere with their ability to perform common, daily activities.

According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year.

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP). Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.

Fampridine-SR Mechanism of Action

A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity.

In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. Fampridine-SR blocks these exposed channels, and helps the electrical signals to pass through areas of damage.

Webcast

Acorda will hold a webcast this evening at 7 p.m. Eastern Time. Study data will be presented and members of the Acorda management team will be available for a question and answer session. To access the webcast please log on to http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=1529938

(Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
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 Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. 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.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda's lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

CONTACT: Acorda Therapeutics, Inc.
Erica Wishner
Director, Corporate Communications
Cell: 914-282-0836
ewishner@acorda.com
or
Media:
Rooney and Associates Communications
Sean Leous
Cell: 917-715-3765
sleous@rooneyco.com

SOURCE: Acorda Therapeutics, Inc.