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Acorda Therapeutics

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Industry Drug Manufacturers - Specialty & Generic
Employees 201-500
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FY2009 Annual Report · Acorda Therapeutics
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Changing TomorrowsTM

The early part of 2009 was consumed by preparation, submission, 
and subsequent re-submission of our New Drug Application (NDA) 
for AMPYRA. Our team did an outstanding job of responding to the 
FDA Refuse to File letter we received in March, and we re-filed in 
record time. Upon accepting the NDA, the FDA granted us 
Priority Review. 

“

Never doubt that a small 

group of thoughtful, committed 
citizens can change the world. 
Indeed, it is the only thing that 
ever has. 

“

-Margaret Mead

Immediately following the acceptance of our NDA, we turned to 
preparing for the FDA Advisory Committee meeting on October 14, 
2009. Following months of intensive preparation, our team 
presented a compelling case for the medical need for AMPYRA. 
One of the most moving experiences I’ve had during the development 
of AMPYRA came during the public comment session of the meeting, 
when people with MS and their caregivers spoke about the impact 
that their walking disability has had on their lives. At meeting’s end, 
the Advisory Committee voted overwhelmingly that efficacy of 
AMPYRA to improve walking in MS had been demonstrated and 
that this was clinically meaningful for people with MS.

Last year we also conducted a rigorous selection process and 
announced a collaboration with Biogen Idec to market dalfampridine 
outside the U.S., where it is known as Fampridine prolonged-release 
tablets. Under the terms of our agreement, Biogen Idec has assumed 
responsibility for development and commercialization activities in all 
markets except the U.S. We are delighted to be working with them to 
make this therapy available to patients around the world. 
In January 2010, Biogen Idec announced regulatory filings in 
Europe and Canada; these filings are under review by the respective 
health authorities.

Our top priority in 2010 is the launch of AMPYRA. At the same 
time, we are tending to Acorda’s future growth in three key areas: 
life cycle management for AMPYRA; advancement of our preclinical 
pipeline to clinical development stage; and acquisition of new 
clinical stage assets.

Dear Members of the Acorda Community:

AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg 
was approved on January 22, 2010 by the U.S. Food and Drug 
Administration (FDA) and is now available by prescription to 
people with multiple sclerosis (MS).

When I founded Acorda in 1995, it was with the purpose of 
someday taking discoveries from the lab and delivering them as 
novel medicines to people with neurological diseases. At the time, 
and many times over the past 15 years, it seemed that goal was 
a very distant star on the horizon.  

Having now developed our first new medicine successfully, 
I can tell you that there are few human endeavors more complex, 
risky and demanding. That we have done so is a tribute to 
the enormous collective talent and perseverance of Acorda’s 
associates. Great recognition is due also to our clinical 
investigators, study coordinators and clinical trial volunteers for 
their many contributions – without the participation of these 
individuals, medical progress would not be possible. In addition, 
our shareholders have been essential contributors to our success, 
in being willing to provide at risk the large amounts of capital 
necessary to pursue Acorda’s work.

AMPYRA is the first orally administered drug approved for MS. It 
represents an important advance in the care of people with this 
affliction. As we continually hear from people with MS, walking 
impairment, particularly in walking speed, is one of the most 
devastating consequences of their disease. With the approval 
of AMPYRA, we are poised to make a real difference for many 
thousands of people with MS and their families. 

Now that AMPYRA is approved, we are focusing on commercializing 
the drug in the U.S. The launch is being supported by our expanded 
sales team, which now includes approximately 100 in-field sales 
representatives. In addition, our teams of Regional Scientific 
Managers and Managed Markets professionals are educating 
physicians and payors about AMPYRA. 

Several critical regulatory and business events in 2009 helped lay 
the groundwork for the launch of AMPYRA and the growth of 
Acorda. It was a very successful year, and I am pleased to briefly 
review some of the highlights.

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AMPYRA Life Cycle Management
Acorda’s life cycle management team is exploring the potential 
for extending the exclusivity period for the AMPYRA franchise. 
AMPYRA has orphan drug status, which provides for seven 
years of exclusivity from the January 22, 2010 date of 
approval. In March 2010, we applied to extend two AMPYRA 
patents listed in the FDA Orange Book based on provisions in 
the Hatch-Waxman Act that allow for up to five additional years 
of patent protection based on the development timeline of a drug. 
These patents currently expire on December 6, 2011 and July 30, 
2013. If both applications are granted, the Company will need to 
select one patent for extension. 

In addition, we are prosecuting pending AMPYRA patents that 
were filed in late 2004 and early 2005, which, if issued, could 
provide additional patent protection. 

Our team is also working on potential new formulations of 
AMPYRA and is exploring whether it would be valuable to 
study other clinical indications in neurology.

Advancement of Preclinical Programs
Our lead preclinical product, Glial Growth Factor 2 (GGF2), 
has been shown to be pharmacologically active in a number 
of cardiovascular and central nervous system conditions. In the 
first quarter of 2010, the Company filed an Investigational New 
Drug (IND) application for treatment of heart failure which was 
subsequently accepted by the FDA. We expect to initiate a 
Phase 1 single ascending dose clinical trial in heart failure 
patients in mid-2010. GGF2 acts directly on heart muscle cells, 
or cardiomyocytes. It is believed to improve the heart’s ability to 
contract by promoting the repair of tissue damage resulting from 
heart disease or injury. Existing medications for heart failure 
primarily aim to modify the workload of the heart, rather than 
promote ventricular repair. If we are able to establish a proof of 
concept in human heart failure trials, we believe this will enhance 
the value of this asset and our ability to continue to examine 
potential neurological indications for GGF2 and related neuregulin 
growth factors. 

Our remyelinating antibody program, led by rHIgM22, is moving 
through pre-IND toxicology studies and manufacturing scale-up. 
There currently is no therapy that repairs lost or damaged myelin 
in diseases such as MS, so that a successful remyelinating 
therapy would represent a novel advance in the treatment of 
such diseases.

We also are continuing to develop our chondroitinase product, 
which in preclinical models has shown the ability to enhance 
plasticity, and functional recovery, in the damaged brain or 
spinal cord.

The U.S. Food and Drug Administration 
approved AMPYRA on January 22, 2010. 
AMPYRA is indicated to improve walking in 
patients with MS. This was demonstrated 
by an improvement in walking speed.

AMPYRA was previously referred to 
as Fampridine-SR, and is an extended 
release tablet formulation of Dalfampridine 
(4-aminopyridine, 4-AP), which was 
previously called Fampridine.

Acorda’s partner, Biogen Idec, filed 
regulatory applications in Europe and 
Canada for Fampridine prolonged-release 
tablets. There are more than 630,000 
people living with MS in Europe, and 
approximately 50,000-75,000 
in Canada. 

Asset Acquisition
We are exploring the acquisition of clinical stage compounds in the 
neurology space. I believe that Acorda has demonstrated its ability 
to unlock both the scientific and commercial potential of neurological 
medications – first with the ZANAFLEX franchise, and more recently 
with AMPYRA. We intend to identify and look to acquire additional 
assets in neurology where we are enthusiastic about both the caliber 
of the science and the potential to address unmet medical needs.

The approval of AMPYRA was a transformational event for Acorda. 
With the achievement of this milestone, Acorda has taken a giant 
step toward realizing its potential to become a leading innovator in 
the development and commercialization of neurological therapies. 
On behalf of all my associates at Acorda, I extend my thanks to you, 
our shareholders, for your support of this important enterprise. 
I look forward to updating you on Acorda’s continued progress.

Ron Cohen, M.D.

President and Chief Executive Officer

3

Leadership

Management

Ron Cohen, M.D.
President and Chief Executive Officer

Andrew R. Blight, Ph.D.
Chief Scientific Officer

Anthony O. Caggiano, M.D., Ph.D.
Vice President, Preclinical Development

Denise Duca, Ed.M.
Senior Vice President, Human Resources

Herbert Raymond Henney III, Pharm.D.
Vice President, Medical Affairs

Ruhi Khan
Vice President, Business Development

David Lawrence, M.B.A.
Chief Financial Officer

Adrian L. Rabinowicz, M.D., FAAN
Senior Vice President and Head,  
Medical Affairs

Lauren Sabella
Executive Vice President,  
Commercial Development

Tierney Saccavino
Senior Vice President,  
Corporate Communications

Jane Wasman, J.D.
Executive Vice President, General  
Counsel and Corporate Secretary

Thomas C. Wessel M.D., Ph.D.
Chief Medical Officer

Board of Directors

Ron Cohen, M.D.

Barry Greene

John Kelley

Sandra Panem, Ph.D.

Lorin J. Randall

Steven M. Rauscher

Ian F. Smith

Wise Young, Ph.D., M.D.

15 Skyline Drive
Hawthorne, NY 10532

www.acorda.com