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Acorda Therapeutics

acor · NASDAQ Healthcare
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Ticker acor
Exchange NASDAQ
Sector Healthcare
Industry Drug Manufacturers - Specialty & Generic
Employees 201-500
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FY2007 Annual Report · Acorda Therapeutics
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2 0 0 7   A N N U A L   R E P O R T

15 Skyl in e Dri ve

Hawthorne, N Y 10532

w w w. a c o r d a . c o m

D E A R   M E M B E R S   O F   T H E   A C O R D A   C O M M U N I T Y,

Over the past year, we made significant advances on 

In anticipation of filing Investigational New Drug (IND) 

three levels essential to Acorda’s ongoing success 

applications with the FDA in late 2009, we began the 

and long-term shareholder value: progress in the 

manufacturing scale-up process for our remyelinating 

clinical development of Fampridine-SR; advancing 

monoclonal antibody and neuregulin programs. 

our preclinical pipeline assets; and expanding our 

commercial capabilities in preparation for the launch 

of Fampridine-SR, if it is approved by the U.S. Food 

and Drug Administration (FDA).

Commercially, we exceeded our goal of doubling 

annual gross sales of Zanaflex Capsules® (tizanidine 

hydrochloride), which rose 115% over 2006. I am 

encouraged by the performance of our marketing 

We obtained a Special Protocol Assessment (SPA) 

and sales organization, as it demonstrates our 

and completed enrollment for a second Phase 3 trial 

understanding of the neurology marketplace and 

of Fampridine-SR to assess walking improvement in 

our ability to successfully launch and drive product 

people with multiple sclerosis (MS); top-line data are 

growth in this therapeutic category. 

expected in the latter part of the second quarter of 

2008. If this trial is successful, we believe we will have 

met pre-specified efficacy requirements outlined by 

the FDA and will move forward with a New Drug 

Application (NDA) filing. In early 2008, we completed 

a successful Thorough QT study, which is required to 

These accomplishments underscore the Company’s 

ability to deliver on its promises, and they point to the 

potential for greater success and growth in the future. 

BUILDING A FOUNDATION FOR LONG TERM SUCCESS 

evaluate cardiac safety of any new drug candidate. 

Over the last 13 years, we have developed deep 

We also acquired patents and intellectual property 

expertise and insight into the needs of the neurology 

rights that will enable us to explore additional 

community,  integrating scientific,  clinical and 

therapeutic indications for Fampridine-SR in the  

commercial disciplines to create a company with an 

area of peripheral neuropathy.  

While we maintained intense focus on Fampridine-SR 

as a key driver of Acorda’s near-term growth, we also 

continued to advance promising new compounds in 

our pipeline toward the clinic. 

Acorda is actively partnering with people with MS, 

advocates and healthcare providers. For example, 

we are pursuing a multifaceted educational program 

in collaboration with the National Multiple Sclerosis 

Society. This program, which focuses on the impact 

of walking disability, includes our sponsoring twenty 

of the top Walk MS events across the country in 2008. 

uncommon breadth of knowledge in the area of 

neurological recovery and repair. We have built 

relationships with world-renowned scientists and 

clinicians who serve as trusted advisors, and with  

all of the major patient advocacy organizations who 

serve the same patients we do. As a result, we 

believe we have established the capabilities and 

expertise necessary to bring novel neurological 

therapies from the lab to the clinic, through 

regulatory approval to commercial launch. 

We also capitalized on an opportunity to build an 

exceptional sales organization by securing marketing 

rights to Zanaflex Capsules, a product prescribed by 

many of the same specialists who would prescribe  

products developed from our pipeline. This strategic  

acquisition has been key to establishing our 

commercial capabilities in neurology prior to the 

launch of Fampridine-SR, if approved. 

 
For over a decade, Acorda has pursued its mission with passion and purpose: developing 

treatments that can improve function in people with multiple sclerosis, spinal cord injury and  

other serious disorders, thereby giving them greater options and opportunities. 

Marketing Zanaflex Capsules has enabled us to gain 

Our organization has developed this expertise over 

valuable experience and strengthen our relationships 

several years, as demonstrated by such achievements 

with relevant patient organizations, prescibers, payors 

as our successful initial Phase 3 trial of Fampridine-SR 

and key opinion leaders. This strategy is already 

and the outstanding performance of our commercial 

paying dividends – we expect Zanaflex commercial 

group in growing our Zanaflex franchise over the past 

operations to be cash-flow positive in 2008. Based on 

three years. By engaging with potential customers 

this success, our sales force has expanded more than  

through our work on Zanaflex, our commercial group 

fourfold in two years, from 14 to 65 professionals. Most 

has gained insights into patient needs from constit-

importantly, we have the elements in place to be a  

uents who will impact the market performance of 

world-class neurology marketing and sales organization. 

Fampridine-SR, if approved.

Gross sales of Zanaflex Capsules increased  
from $2.5 million in 2005 to $38.8 million in 2007. 
Despite the availability of generic tizanidine tablets, 
our sales and marketing organization has been  
able to help healthcare providers and payors 
understand the unique value of Zanaflex Capsules.  
The same team driving this success will develop  
and execute the commercial strategy for the  
launch of Fampridine-SR, if approved. 

We still have important milestones ahead of us – 

including the need to complete a second successful 

Phase 3 trial in mobility and submit an NDA to the 

FDA. If Fampridine-SR is approved, I believe we are 

well positioned for success in the commercial arena.

If approved, Fampridine-SR would offer patients 

and healthcare providers a new tool which, 

by improving the key neurological function of 

ambulation, may complement existing therapies 

SETTING ThE STAGE FOR FAMPRIDINE-SR

that attempt to slow the progress of MS. 

We believe that Fampridine-SR, if approved,  

could represent a fundamental shift in the treatment 

ADvANCING OUR PIPELINE ASSETS

of people with MS because it is designed to improve 

ambulation, a key neurological function, rather than 

treating the symptoms or slowing the progression 

of disease, as current treatments do. However, 

what makes Fampridine-SR novel also makes its 

progression from the clinic to the marketplace 

uniquely demanding. We have leveraged the multi-

disciplinary knowledge within our organization to 

design outcome measures that, based on our SPA, 

we believe appropriately evaluate the efficacy of  

this compound and provide the data necessary  

for regulatory review. 

We are keenly aware of our short-term need to 

focus resources on bringing Fampridine-SR to the 

finish line. At the same time, we also have kept our 

preclinical pipeline moving forward because we 

believe our most impactful therapies may be yet to 

come. Published data from both our own studies and 

multiple external academic groups indicate that our 

three lead preclinical products have the potential to 

significantly advance treatment of MS, spinal cord 

injury and other serious disorders. We believe that 

they represent exceptional opportunities in medicine 

that have significant commercial potential.

To introduce and successfully market a new 

treatment option of this kind will require a 

specialized understanding of the market.  

We are conducting our remyelinating monoclonal 

antibody program in partnership with the Mayo 

Clinic. In preclinical studies, these antibodies have 

 
Multiple sclerosis is a debilitating disease that destroys the insulating myelin around nerve 

fibers, thus impairing nerve function. It affects over 400,000 people in the U.S. and  

an estimated 2.5 million people worldwide – often in the prime of life. 

been shown to regenerate myelin on damaged 

ThE RIGhT APPROACh TO CREATING vALUE 

nerves, a unique approach to reversing MS-related 

nerve damage. We expect to complete manufacturing 

scale-up for this program in 2008, and pending initial 

toxicology results, plan to file an IND application with 

the FDA in late 2009, in order to begin clinical trials.

Our neuregulin molecules have demonstrated 

extensive neurological protection in a number  

of indications, including preclinical models of MS 

and stroke. In addition, the neuregulins have shown 

the ability to reduce and even reverse dysfunction 

resulting from congestive heart failure by directly 

strengthening and protecting heart muscle cells. We 

are scaling up manufacture of our lead neuregulin 

candidate and aim to submit an IND in late 2009. If 

we pursue a cardiovascular indication, we may seek 

a partner with expertise in that area to complete 

development and commercialization. In turn, this 

could provide resources for Acorda to further 

develop our pipeline programs. 

While no company can capture the entirety of its 

culture, outlook and promise in a few paragraphs, 

I hope this letter has conveyed the excitement we 

have about our future and why we believe this is a 

company that will continue both to serve the needs 

of patient and to reward shareholders. 

I also want to thank each of Acorda’s growing 

number of associates, as well as our shareholders 

and partners, for believing in the Company’s  

vision and participating in its growth.

“I wonder if I’ll be able to walk down  
the aisle with my children when  
they get married.”

Tobi Rogowsky, person living with MS, 
Westchester, NY 

In preclinical studies, chondroitinase has been 

As we work to achieve significant milestones in  

shown to enable repair of nerve connections and 

2008 and beyond, we will continue to nurture your 

recovery of function after injuries to the spinal cord  

Company with a sense of purpose and constant 

or brain. While at an earlier stage of development 

attention to the quality and integrity of everything  

than our other two preclinical programs, in my 

we do. We are intent on improving the lives of 

opinion this ultimately may be the most exciting.  

people affected by multiple sclerosis, spinal cord 

I look forward to keeping you informed about  

injuries and other serious disorders, and thereby 

future milestones in its development.

delivering significant shareholder value. 

I look forward to reporting on our further  

progress next year.

Ron Cohen, M.D. 

President and Chief Executive Officer