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Acorda Therapeutics

acor · NASDAQ Healthcare
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Industry Drug Manufacturers - Specialty & Generic
Employees 201-500
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FY2011 Annual Report · Acorda Therapeutics
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AMPYRA®
Walking in MS

AMPYRA®
Other MS Indications

AMPYRA®
Cerebral Palsy

AMPYRA®
Chronic Stroke

ZANAFLEX CAPSULES®
Spasticity

AC105
SCI

GGF2
Heart Failure

rHIgM22
MS

CHONDROITINASE
SCI

Product Pipeline

MARKETED
PHASE 3
PHASE 2
PHASE 2
MARKETED
PHASE 2
PHASE 1
PRE-IND
R&D

ACORDA THERAPEUTICS: 2011 ANNUAL REPORT

We were also pleased by our success, collaborating closely with
our partner Biogen Idec, in reversing earlier rejections of marketing
applications and achieving approvals of FAMPYRA® (the brand
name for AMPYRA outside the U.S.) in the European Union (2011)
and Canada (2012). To date, FAMPYRA has also been approved in 
Australia and New Zealand, with additional regulatory 
filings expected. 

One of the biggest pitfalls faced by biopharmaceutical companies
is investing too much and too long in initiatives that ultimately
are not productive. Consequently, at Acorda, we take a highly
disciplined approach to funding the Company’s programs. All
preclinical and clinical programs are built on a foundation of
reproducible and compelling evidence, with built-in, clear
“go/no-go” signals to ensure we are spending efficiently and

Disciplined
Investment

Long Term
Growth

Neurology Leadership

Dear Members of the Acorda Community:
In my letter to shareholders last year, I highlighted
three priorities to position Acorda for long-term growth:
maximizing the AMPYRA® franchise; advancing our
existing pipeline into the clinic; and pursuing accretive
product acquisitions. I’m pleased to report that we
have made steady progress against each of those
objectives over the past 12 months.

In 2011, AMPYRA showed quarter-over-quarter growth
throughout the year. Our marketing efforts since launch
have led to high awareness of AMPYRA among healthcare
professionals – approximately 90% of all neurologists and
virtually 100% of high-decile MS specialist neurologists have
written at least one prescription for AMPYRA. However, as
of mid-2011, awareness was approximately 30% among
people with MS. This represents a significant opportunity to 
increase awareness, motivate people with MS to speak with 
their healthcare professionals about walking and AMPYRA, 
and ultimately increase the number of people who initiate 

therapy. Therefore, we are now weighting our commercial 
activities more heavily towards reaching and educating people 
with MS and their caregivers. 

We added significant patent protection for AMPYRA in 
2011. The United States Patent and Trademark Office 
(USPTO) issued a key patent application related to the use 
of dalfampridine in improving walking and increasing walking 
speed in patients with MS. Based on the USPTO’s final patent 
term adjustment, this patent will extend into 2027. This issued 
patent is listed in the Orange Book.

Our new patent has added significant value and “runway” to the
brand. As a result, we are investing in exploring the potential to
expand the AMPYRA franchise to other areas of MS, and to other
diseases such as adult cerebral palsy (CP) and chronic stroke. In
December 2011, we initiated a proof-of-concept study in adults
with CP, and plan to start a proof-of-concept study in chronic 
stroke in the second half of 2012. We are also supporting
several investigator-initiated studies to explore new potential
endpoints within MS and in additional new disease indications. 

Our other R&D efforts have also made gratifying advances since
my last report, with a Phase 1 trial of GGF2 in heart failure ongoing
and continued progress in moving rHIgM22 into the clinic. We also
acquired a mid-stage clinical product in 2011 – neuroprotective
agent AC105 – and signed an agreement in early 2012 giving us
the right to buy Neuronex, Inc., a company developing an 
intranasal diazepam spray (DZNS) for breakthrough acute  
repetitive epileptic seizures in refractive patients. A Phase 2 trial for 
AC105 in acute spinal cord injury is expected to begin by the end 
of 2012, and DZNS data are being collected and will be prepared 
for U.S. Food and Drug Administration (FDA) review.

Acorda is now a fully integrated biopharmaceutical company.
We have brought to market an important therapeutic product,
AMPYRA, that addresses a critical unmet need for people with
MS and also has the potential for exciting new indications, and 
we have a robust pipeline of clinical or near-clinical stage products. 

supporting programs with the best likelihood of success. Likewise,
we measure the outputs of each of our commercial programs to
assess which are providing the greatest return on investments. 

Our priorities in 2012 are to continue to grow AMPYRA within
its current indication in the U.S., to advance trials for additional
potential indications in MS and in other disease states such as
adult CP and chronic stroke, and to advance our exciting pipeline
of other products in clinical trials. We believe that our current
pipeline is right-sized for a company at Acorda’s current stage
of development. For business development moving forward,
we are focused primarily on leveraging our neurology specialty
commercial organization, and are evaluating near-term commercial
opportunities in neurology that would be potentially accretive. 

I look forward to keeping you updated on our progress in
2012. Thank you for your continuing support as we work
toward becoming the leader in developing and commercializing
neurological therapies.

Ron Cohen
President and Chief Executive Officer

 
 
 
 
 
 
 
 
 
In 2012, our marketing efforts will focus
significantly on raising consumer awareness
of “The Walking Pill™,” as we have branded
AMPYRA.

AMPYRA 2011 Highlights 
and 2012 Opportunities

Prescription data since launch show high persistency and
compliance among patients taking AMPYRA. As of December
31, 2011, the rate of first refill for patients taking AMPYRA was
70%, and 40% continued to refill after six months of therapy. In
addition, the compliance rate was 90% (on average, patients
taking 1.8 pills per day). Based on this data, we believe that
investing in programs to drive consumer demand this year will
contribute meaningfully to the long-term value of the
AMPYRA franchise. 

Biogen has launched FAMPYRA® in several European
countries to date, and expects to launch in most of the
remaining EU countries by the end of 2012. FAMPYRA
has also been launched in Australia, and most recently in
Canada. Regulatory filings are planned for more than 20
additional markets in 2012. Acorda receives a double-digit
royalty from Biogen based on net sales in all markets outside
the United States. 

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg
U.S. net sales were $210.5 million in 2011, and approximately
19,000 people with MS tried AMPYRA in 2011. Through
the end of 2011, more than 60,000 people in the U.S. had
received an AMPYRA prescription since launch in March 2010,
representing approximately 30% of all eligible MS patients.
We believe this is excellent market penetration for the first
22 months of availability. It also indicates that the majority of
eligible patients have not yet tried AMPYRA, providing ample
room for the growth of the brand within its current indication. 

Physician awareness of AMPYRA is high, and we are
continuing programs launched in 2011 to further educate
physicians about the broad range of patients who can benefit
from therapy, including those who are at an early stage of
walking impairment. 

In 2012, our marketing efforts will focus significantly on raising
consumer awareness of AMPYRA. As of the middle of 2011,
about 30% of MS patients were aware of AMPYRA. We are
implementing new online and in-person programs to help
people with MS identify whether or not walking problems are
having an effect on their lives, and to educate them about
“The Walking Pill™,” as we have branded AMPYRA. These
programs will focus on motivating people with MS to ask 
their healthcare professionals about walking impairment
and AMPYRA.

In 2011, the ZANAFLEX® (tizanidine hydrochloride) franchise again
contributed meaningfully to our bottom line, with full year net
revenue of $45.8 million and full year shipments of $60.7 million.

ZANAFLEX CAPSULES

We were very pleased with our ability to retain exclusivity for
ZANAFLEX CAPSULES® (tizanidine hydrochloride) through
February 2012, when the FDA approved a generic version of the
drug. Immediately following availability of the generic, we partnered 
with Watson Pharmaceuticals, inc. to launch an authorized generic 
version of ZANAFLEX CAPSULES. We will receive a royalty on net 
sales of this product, enabling us to capture some of the revenue 
that would have otherwise been lost due to the availability of a 
generic. 

Acorda’s history with ZANAFLEX CAPSULES exemplifies the
Company’s strategic approach to building value. When we
acquired the ZANAFLEX franchise in 2004, it was primarily intended
to help fund the development of our commercial capabilities while
we were working to get AMPYRA approved. Eventually, even
though we launched the product into a market that was about 95%
generic, we were able to build the ZANAFLEX franchise to peak net
sales of approximately $50 million. Most importantly, it allowed us
to build a sales force and commercial infrastructure, gaining vital
experience in the neurology marketplace in advance of the launch
of AMPYRA. While the ZANAFLEX franchise was supposed to be 
only a bridge to AMPYRA, it lasted longer and added far more 
value to the Company than anyone expected.

While ZANAFLEX was 
supposed to be only a 
bridge to AMPYRA,  
it lasted longer and 
added far more value 
to our Company than 
anyone expected.

 
 
 
 
 
 
 
 
 
Following our successful launch of AMPYRA in 2010, we were
able to focus more on building the value in Acorda’s pipeline.
We made important progress in 2011, both in advancing our
existing pipeline, and in acquiring two potentially valuable new
product opportunities. 

AMPYRA
We believe that AMPYRA may potentially address additional
unmet needs both within MS and in other disease states. 

decades earlier. Over seven million Americans have suffered a
stroke, and about 800,000 new cases of stroke occur annually
in the U.S. More than half of stroke survivors have ongoing
sensorimotor and/or walking impairments, and there are no
pharmaceutical treatments for such impairments. In 2011,
an independent laboratory study showed that AMPYRA
significantly improved both forelimb and hind limb sensorimotor
function in a preclinical model of stroke. These data were
awarded an oral presentation at the International Stroke 
Conference in February 2012. 

rHIgM22
rHIgM22 is a human recombinant monoclonal antibody that has
been shown to stimulate repair of myelin in the nervous system.
Currently, there is no available therapy that directly repairs myelin
damage in demyelinating diseases such as MS. Pending the
needed final assay work, we plan to file an Investigational New
Drug (IND) application to initiate a clinical trial of rHIgM22 in
MS patients.

Advancing the Pipeline

Cerebral Palsy (CP) — In late 2011, we initiated a proof- 
of-concept study in adults with CP, a cluster of disorders 
involving perinatal brain damage including disruption of normal 
myelination, that results in motor weakness, walking impairment, 
spasticity and other neurological deficits. There are no medical 
therapies that specifically address motor weakness and walking 
impairment in these patients. More than 400,000 adults in the 
United States are afflicted with CP. 

Chronic Stroke — In the second half of 2012, we plan to begin
a proof-of-concept clinical trial examining AMPYRA’s potential
use in chronic stroke patients. Chronic stroke refers to the
neurological deficits that remain in people who have had a 
stroke, usually at least six months in the past, and up to

Over seven million Americans
have suffered a stroke, and
about 800,000 new cases
of stroke occur annually in
the U.S. More than half of
stroke survivors have ongoing
sensorimotor and/or walking
impairments, and there are no
pharmaceutical treatments for
such impairments.

Other Indications — We are supporting multiple investigator-
initiated studies assessing the use of AMPYRA in treating
a range of MS symptoms and other neurological diseases. 

GGF2
GGF2 is a member of the neuregulin family of proteins, and
has been shown in multiple preclinical studies to have powerful
protective and restorative effects on both heart muscle and
nerve tissues. We initiated a Phase 1 study at the end of 2010
in heart failure, and expect initial results by the end of this year.
We also have exciting preclinical data in protecting peripheral
nerves from traumatic damage, including damage associated
with prostate surgery, and in protecting the brain in acute stroke,
even if GGF2 is administered up to seven days after the
stroke itself. 

AC105
In July 2011, we in-licensed neuroprotective drug candidate
AC105 from Medtronic. A novel therapeutic composed of
magnesium chloride in a polyethylene glycol (PEG) formulation,
preclinical studies have shown that acute administration of
AC105 can improve functional outcomes following spinal cord
injury (SCI). We plan to initiate a Phase 2 clinical trial in acute
SCI by the end of 2012. There are approximately 12,000 new
spinal cord injuries each year. AC105 may also have application
in acute treatment of traumatic brain injury (TBI) and stroke. 

Acorda made a $3 million upfront payment to Medtronic in
2011 for the rights to develop AC105 in SCI and certain other
indications, and will make up to $32 million in regulatory and
development milestone payments. A single-digit sales royalty
will also be paid by Acorda to Medtronic if AC105 is
commercialized by Acorda. 

Both the potential Neuronex
transaction and our acquisition
of AC105 underscore our
commitment to spending capital
judiciously, investing in low-cost,
high-opportunity products.

Diazepam Nasal Spray (DZNS)
In February 2012, we signed an agreement to acquire Neuronex,
Inc., which is developing DZNS, a potential treatment for acute repetitive 
epileptic seizures that break through existing baseline antiepileptic 
regimens in certain patients. 

We made an upfront payment of $2.5 million, with obligations to pay
up to an additional $700,000 in certain research and development
costs. A $6.8 million payment is required, at Acorda’s discretion,
to close the acquisition following a pre-NDA meeting with the FDA
to determine the regulatory pathway for the product. Acorda would
also potentially pay additional milestones and sales royalties. 

Both this potential transaction and our acquisition of AC105
underscore our commitment to spending capital judiciously,
investing in low-cost, high-opportunity products. In both cases, we
were able to weight the majority of payments toward attainment
of important clinical and regulatory milestones, including marketing
approvals. While drug development cannot be completely de-risked,
the structure of these deals enabled us to acquire assets that have
solid scientific and commercial potential with reasonable
upfront investments.

Management Team

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

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

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

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

Enrique Carrazana, M.D. 
Chief Medical Officer

Kerry Clem  
Vice President, Sales

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

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

Elizabeth Keating 
Vice President, Marketing

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

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

Bonnie M. Pappacena 
Vice President, Quality

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. 
Chief, Strategic Development and General Counsel

Board of Directors

Ron Cohen, M.D.
Barry Greene
Peder K. 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 4232