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Acorda Therapeutics

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Industry Drug Manufacturers - Specialty & Generic
Employees 201-500
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FY2010 Annual Report · Acorda Therapeutics
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A path forward.

ACORDA THERAPEUTICS, INC. 2010 ANNUAL REPORT

Dear Members of the Acorda Community:
In last year’s letter, I noted that the approval of AMPYRA® 
was a transformational event for our Company. As the year 
unfolded, it became clear just how transformational it was.

On March 1, 2010, our team implemented the commercial launch 
of AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg 
following U.S. Food and Drug Administration (FDA) approval on 
January 22. AMPYRA addresses a critical unmet need 
for people with multiple sclerosis (MS): improving their walking. 
We therefore expected an enthusiastic response from both 
healthcare professionals and MS patients and their families. 
In fact, the response far exceeded our own projections, as well 
as those of Wall Street, making 
AMPYRA one of the most successful 
product launches in the MS space.

In the fi rst 10 months of availability, 
approximately 40,000 people—
roughly 10% of all MS patients in the 
United States—fi lled a prescription 
for AMPYRA. During that same 
period, more than 7,000 healthcare 
professionals wrote at least one 
prescription for AMPYRA and, based on this, we expanded 
our original call list of about 5,500 prescribers to approximately 
10,000. Our commercial and medical affairs teams did an 
outstanding job of educating physicians and other healthcare 
professionals about the product’s labeled indication, safety profi le 
and managed care requirements, and also addressing logistical 
issues that arose due to the huge pent up demand for AMPYRA.

Studies have shown that approximately 65% of people with MS 
suffer from walking impairment at a given time; even with 10% of 
all U.S. MS patients having tried AMPYRA in 2010, a large unmet 
need remains to be addressed. We have now established a 
strong base of consumers and healthcare providers who have 
positive views of the AMPYRA and Acorda brands. In 2011, we 
plan to build on that success by presenting new data analyses 
and expanding our education to prescribers about the broad 
range of appropriate patients who could potentially benefi t from 

AMPYRA. We are also launching new live and online programs 
to increase consumer awareness of AMPYRA and 
encourage appropriate patients to discuss initiating therapy 
with their physician. 

We experienced some growing pains in our fi rst year on the 
market. The pent up demand for AMPYRA among early-adopting 
physicians and patients was substantially larger than we 

Approximately 40,000 
people with MS tried 
AMPYRA in 2010, which 
represents about 10% 
of MS patients in the 
United States.

anticipated. While that contributed to a 
very successful launch, the volume of 
prescriptions initially outstripped our ability 
to process requests, resulting in delays in 
fi lling and shipping prescriptions. 
We met this challenge, and also took it 
as an opportunity to improve the overall 
customer experience for healthcare 
professionals and patients in fi lling 
AMPYRA prescriptions. I was pleased with 
the rapid and innovative responses of 

our commercial team—from adding more resources at our 
customer support center to identifying new ways to expedite 
processing and shipping prescriptions. By early September, 
we were able to resolve the prescription backlog generated by 
the pent up demand, and the process improvements we 
implemented have contributed to high customer satisfaction 
with our support services. There were also expected 
challenges related to reimbursement, and we were pleased 
with AMPYRA’s overall reimbursement status at year end. 
Thanks to an excellent job by our managed markets team 
in educating healthcare plans about the benefi ts of AMPYRA for 
their subscribers with MS, approximately 75% of covered lives 
had minimal to no restrictions, and several of the largest 
plans in the U.S. put AMPYRA on Tier 2 formulary status. About 
25% of covered lives had restrictive prior authorizations. Our team 
continues to meet with managed care organizations to provide 
further education and additional data from the marketplace. 

Susan

Age 65

Primary-progressive MS

Diagnosed in 2000

AMPYRA patient since 2010

December 2010. This milestone was especially noteworthy 
because GGF2 is the fi rst compound that Acorda has successfully 
shepherded through the preclinical process and into human 
trials. In animal studies, GGF2 has shown the ability to improve 
the heart’s function to relieve heart failure. These effects are 
believed to be related to GGF2’s ability to promote the repair of 
heart muscle tissue damage resulting from heart disease or injury. 
Existing medications for heart failure primarily aim to modify 
the workload of the heart, rather than to promote repair of the 
injured tissue itself; GGF2 therefore represents a novel approach 
to treatment. We also published data showing that GGF2 can 
restore function in animal models of stroke, even when the 
treatment is administered up to seven days after the actual event. 
An accompanying editorial noted that this long treatment window 
is unique in the stroke literature and potentially represents an 
exciting opportunity for clinical development.

rHIgM22, our remyelinating antibody being developed in 
partnership with the Mayo Clinic, completed the majority of 
required preclinical studies, including cGMP (Good Manufacturing 
Process) manufacturing testing and pilot toxicology studies. 
Our R&D team is currently working on GLP (Good Laboratory 
Practice) toxicology studies. If the GLP toxicology results are 
acceptable, we plan to fi le an Investigational New Drug (IND) 
application with the FDA to begin clinical trials studying the ability 
of rHIgM22 to stimulate remyelination in people with MS. 
Currently there is no therapy that repairs myelin in people with MS. 
rHIgM22 represents a novel approach, and potentially a signifi cant 
advance, in the treatment of this terrible disease. 

My belief in the intrinsic value of Acorda remains fi rm; however, as 
a fellow shareholder, I have shared your disappointment that our 
stock price did not always refl ect our performance over the course 
of 2010, particularly with regard to the highly successful launch 
of AMPYRA. Nevertheless, as we move into 2011, I see signifi cant 
opportunities for Acorda to create value for shareholders. Acorda’s 
Board of Directors and management team have identifi ed three 
priorities that we believe position us to do so: 

1. Maximizing the AMPYRA opportunity
2. Advancing our existing pipeline into the clinic
3. Pursuing accretive product acquisition opportunities

Our top priority is to maximize the AMPRYA opportunity. First, this 
means that we must drive demand in the United States, so that 
as many appropriate patients as possible have the opportunity to 
try AMPYRA. Our commercial team is rolling out new campaigns 
directed toward healthcare professionals and consumers. One 
feature of this campaign is a focus on AMPYRA data that showed 
clinically meaningful improvements in walking across the entire 
spectrum of walking impairment that was studied, from the 
least to the most impaired, indicating that even patients who are 
relatively early in their disease course may benefi t from AMPYRA. 
At the same time, our scientifi c team continues to develop and 
present new data analyses from our clinical trials that highlight the 
unique benefi ts that people may experience when taking AMPYRA 
regardless of their clinical sub-type of MS. 

While the launch of AMPYRA® was the most signifi cant 
event for Acorda in 2010, several additional accomplishments 
deserve to be highlighted as well.

The Zanafl ex franchise again provided a meaningful fi nancial 
contribution to our Company, with $48.5 million in net sales for 
the year. We have brought patent infringement litigation against 
a generic manufacturer who has fi led an abbreviated New 
Drug Application (ANDA) to enter the market prior to expiration 
of our patent in 2021. 

We made signifi cant progress on developing our pipeline, 
including the initiation of a Phase 1 clinical trial of Glial 
Growth Factor 2 (GGF2) for patients with heart failure in 

Leah

Age 37

Progressive-relapsing MS

Diagnosed in 2000
AMPYRA patient since 2010

In January 2011, the European Medicines Agency’s (EMA) 
Committee for Medicinal Products for Human Use (CHMP) issued 
a negative opinion to our partner, 
Biogen Idec, recommending 
against the approval of FAMPYRA 
(the proposed trade name for 
AMPYRA® in Europe). We were 
disappointed by this decision and 
are working closely with Biogen Idec on a formal appeal. We are 
also working with Biogen Idec to respond to a Notice of Defi ciency 
that was issued by Health Canada. 

Approximately 7,000 healthcare 
professionals wrote at least one 
AMPYRA prescription in 2010.

The success of the AMPYRA launch in the U.S. resulted in 
$133 million in net AMYRA sales for the 10 months of commercial 
availability in 2010, approximately 
double the consensus Wall Street 
projections at the time of launch. 
Together with net Zanafl ex 
Capsules® and Zanafl ex® sales of 
$48.5 million, this resulted 

in Acorda’s fi rst quarterly profi t in the third quarter. Year-end cash, 
cash equivalents and short-term investments were approximately 
$240 million, a result of appropriate management of our resources, 
even in a launch year requiring signifi cant investments. 

 
 
 
Our third priority for growth is business development. We are 
seeking to leverage the key assets of the company in these 
endeavors. From my perspective these assets are, fi rst, a team 
that has been highly successful in identifying non-obvious 
neurology opportunities and developing them creatively through 
clinical and regulatory challenges. To leverage this asset, we 
are seeking product opportunities that we view as having high 
therapeutic potential and that are undervalued relative to 

In December 2010, Acorda 
initiated the fi rst Phase 1 trial 
of GGF2 in patients with heart 
failure. GGF2 represents a 
unique approach to treating 
heart failure by repairing cardiac 
muscle and improving the 
heart’s ability to pump blood. 

their commercial prospects, 
if approved. Ideally, these 
compounds would have safety 
data in humans and possibly 
proof of concept or additional 
effi cacy data as well. Our 
second major asset is a 
commercial organization 
that has years of experience 
in marketing and selling 
successfully to neurologists. 
To leverage this asset we are 
exploring products that 
could be commercial as of 

We are also pursuing all available avenues to extend the 
exclusivity period for AMPYRA®. As this report goes to press, 
I am pleased to report that the United States Patent Offi ce, 
or USPTO, has notifi ed us that they have allowed the claims of 
our 2004 patent application, which pertains to the use of 
AMPYRA to improve walking in people with MS – our labeled 
indication. The term of this patent extends into 2026. This is in 
addition to AMPYRA’s orphan drug status, which provides 
seven years of exclusivity from 
the January 22, 2010 approval 
date. We have also applied 
for patent extension under the 
Hatch Waxman Act, which 
allows for up to fi ve additional 
years of protection based on 
the development timeline of a 
drug. The two patents under 
consideration for potential Hatch 
Waxman extension currently 
expire on December 6, 2011 and 
July 30, 2013, respectively, and 
have both been found by the 
USPTO to be eligible. In the next stage of this process, the FDA 
must determine by how much time, if any, these patents may 
be extended. 

We are working on other potential life cycle extension strategies, 
including the development of new formulations of dalfampridine 
and exploring additional indications for AMPYRA in MS and other 
neurological diseases. 

Our second priority in building shareholder value is to advance 
our existing pipeline. If we are able to establish proof of concept 
for GGF2 in human heart failure trials, we believe this could 
signifi cantly enhance the value of this asset and our ability to 
examine both potential cardiac and neurological indications for 
GGF2 and related neuregulin growth factors. Similarly, if we 
are able to advance our remyelinating antibody to the clinic and 
achieve proof of concept as a reparative intervention in MS, we 
should add signifi cant value to this product.

next year or beyond, and which may benefi t from Acorda’s 
co-promotion or outright acquisition. 

At the beginning of 2010, we announced a corporate goal to 
in-license at least one compound in the neurology space by the 
end of the year. We explored several potential opportunities, but 
ultimately did not bring in any products because we did not fi nd 
an asset that met our criteria on terms that we found reasonable. 
I believe that our thoughtful approach to this process and 
decision not to in-license assets in 2010 should provide investors 
with confi dence that Acorda’s management team is exercising 
prudence and seeking an appropriate balance between cash fl ow 
generation and investment in our future growth. 

In 2010, we achieved a transforming milestone for Acorda, fulfi lling 
the Company’s mission to deliver an important therapy to people 
with a devastating neurological disorder. AMPYRA provides 
Acorda with the opportunity to build signifi cant shareholder 
value, as well as to develop additional therapies that may improve 
patients’ lives. Thanks to you, our shareholders, for your ongoing 
support as we work to build the leading biotechnology company 
in the neurology space. 

Ron Cohen, M.D.
President and Chief Executive Offi cer

Fred

Age 60

Relapsing-remitting MS

Diagnosed in 1999

AMPYRA patient since 2010

Management Team

Ron Cohen, M.D.
President and Chief Executive Offi cer

Andrew R. Blight, Ph.D.
Chief Scientifi c Offi cer

Jennifer Burstein, M.B.A., CPA
Vice President, Finance

Anthony O. Caggiano, M.D., Ph.D.
Vice President, Research & Development

Kerry Clem 
Vice President, Sales

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

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

Douglas Kargman, M.D., M.S.
Vice President, Drug Safety

Ruhi Khan, M.B.A.
Vice President, Business Development

David Lawrence, M.B.A.
Chief Financial Offi cer

Adrian L. Rabinowicz, M.D., FAAN
Sr. Vice President, Medical Affairs

Kent Rogers, M.B.A.
Vice President, Managed Markets

Lauren Sabella
Executive Vice President, Commercial Development

Tierney Saccavino
Sr. Vice President, Corporate Communications

Brian Walter, Ph.D.
Vice President, Regulatory Affairs

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

Thomas C. Wessell, M.D., Ph.D.
Chief Medical Offi cer

Board of Directors

Ron Cohen, M.D.
Barry Greene
Peder Jensen, M.D.
John P. Kelley

Sandra Panem, Ph.D.
Lorin J. Randall
Steven M. Rauscher
Ian F. Smith

www.acorda.com

Contact:
Jeff Macdonald
Sr. Director, Corporate Communications
jmacdonald@acorda.com
914-347-4300 x 232