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Acorda Therapeutics

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FY2013 Annual Report · Acorda Therapeutics
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Acorda Therapeutics is a biotechnology company 
focused on developing therapies that improve the 
lives of people with neurological disorders.

Dear Members of the Acorda Community: 

Acorda made great progress in 2013. Among the company’s most notable accomplishments were:  

v   AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg net sales increased 13.7% over 2012, to $302 million
v   Our intellectual property around AMPYRA was further strengthened with the issuance of two additional patents in 2013 and 

a third in early 2014 that are Orange Book-listed 

v	 	We	obtained	positive	Phase	2	data	for	dalfampridine-QD	in	post-stroke	walking	deficits
v	 	We	filed	a	New	Drug	Application	(NDA)	for	PLUMIAZTM	(diazepam)	Nasal	Spray	to	treat	cluster	seizures
v	 	We	acquired	an	in-market	product,	QUTENZA® (capsaicin) 8% patch, and a second generation Phase 3-ready neuropathic 

pain	product,	NP-1998

v	 	We	initiated	clinical	trials	for	GGF2	in	chronic	heart	failure,	rHIgM22	for	myelin	repair	in	multiple	sclerosis,	and	AC105	for	

neuroprotection in acute spinal cord injury

We	now	have	a	total	of	six	clinical	and/or	NDA-stage	programs,	comprising	one	of	the	most	interesting	pipelines	in	the	
neurology space. 

Acorda’s	goal	is	to	create	a	diverse	portfolio	of	marketed	products	and	development	programs	that	create	both	significant	
near-term value and intermediate and longer-term opportunities for further value accretion. To highlight just three of several 
key	initiatives	for	2014,	we	are	continuing	to	take	steps	to	prepare	for	the	potential	approval	of	PLUMIAZ,	planning	to	begin	
a	Phase	3	clinical	trial	of	a	new,	once-daily	formulation	of	dalfampridine	(dalfampridine-QD)	in	post-stroke	walking	deficits,	
and	determining	the	most	efficient	development	pathway	for	NP-1998,	which	we	believe	has	the	potential	to	be	a	standard	of	
care for neuropathic pain from various causes. 

We	ended	2013	in	a	strong	financial	position,	with	over	$335	million	in	annual	net	revenue,	$367	million	in	cash	and	 
negligible debt. 

We	expect	revenue	to	continue	to	grow	in	2014,	and	intend	to	use	our	financial	strength	to	invest	in	our	promising	pipeline	
and to acquire additional products. We are emphasizing products that leverage our key competitive advantages: our deep 
scientific	and	drug	development	expertise	in	neurology,	and	our	outstanding	commercial	expertise	and	infrastructure	in	both	
neurology and specialty pharmaceuticals. 

We are excited about the year ahead. On behalf of all Acorda’s associates and our Board of Directors, thank you for your 
continued	support.	I	look	forward	to	updating	you	on	our	progress	over	the	course	of	the	year.

Ron Cohen 
CEO and President

1

 
 
 
 
AMPYRA® in Multiple Sclerosis (MS)

PLUMIAZ

Since approval in 2010, more than 90,000 people with MS in 
the U.S. have tried AMPYRA tablets. Through a combination 
of scientific outreach and marketing initiatives, we have been 
able to achieve nearly universal awareness of AMPYRA among 
neurologists. We are proud to have contributed to improving the 
lives of people with MS, and that AMPYRA is now viewed as an 
integral part of MS management.

PLUMIAZ, the commercial name for our Diazepam Nasal Spray 
product, represents a much needed option for the approximately 
175,000 people in the U.S. with epilepsy who experience cluster 
seizures. Currently, many of these individuals do not find the 
available diazepam rectal gel acceptable and default to emergency 
room care or no care at all. PLUMIAZ potentially can provide a more 
viable outpatient option.

AMPYRA net sales of $302 million in 2013 represented a 13.7% 
increase over 2012. We expect continued growth for AMPYRA in 
2014, and have provided 2014 net sales guidance of  
$328-$335 million. 

AMPYRA GROWTH

In 2013, we submitted an NDA to the FDA for this product, and 
are continuing to take steps to prepare for its potential approval. 
If approved, PLUMIAZ would be an important addition to our 
commercial product line, and is an ideal fit for our expertise and 
infrastructure in neurology. We estimate that peak annual sales of 
PLUMIAZ could be substantially above $100 million. 

Since approval in 
2010, more than 
90,000 people with 
MS in the U.S. have 
tried AMPYRA tablets

$328-$335**

$302.6

$266.1

$M

350

300

250

200

150

100

50

0

$210.5

$133.1 *

2010

2011

2012

2013

2014

 * Ten months, Mar – Dec 2010
** 2014 guidance

Importantly, in 2013 we further strengthened our intellectual 
property position around AMPYRA with the issuance of two new 
U.S. patents. In addition, another patent was issued by the U.S. 
Patent and Trade Office in early 2014, giving us a total of five 
Orange Book-listed patents that provide patent coverage into 
2027. This is in addition to our Orphan Designation, which provides 
exclusivity into January 2017.

2

Advanced Pipeline Assets: Dalfampridine-QD and NP-1998

2011 PIPELINE

THERAPY

In April 2013, we announced positive findings from our dalfampridine proof-of-concept study in post-stroke deficits. Based on those clinical 
results, we are planning to initiate a Phase 3 post-stroke walking deficits study by the end of this year, pending final agreement with the FDA 
on the trial design. In April 2014, we announced that a short PK clinical study in healthy volunteers is needed to assess our new once-daily 
(QD) dalfampridine capsule formulation in the presence of alcohol. Laboratory tests indicated that in the presence of alcohol the active drug 
was released too rapidly from the formulation, and we need to determine if this is also the case in human use. We expect this study to be 
clinically completed by the end of the third quarter, and will announce results and our development plans following analysis of the data.

PRE
CLINICAL

Walking in MS

Spasticity

PHASE 3/4

PHASE 2

PHASE 1

R&D

MARKETED

AMPYRA® 

ZANAFLEX® 

Published reports indicate there are approximately seven million stroke survivors in the U.S., and about half of these suffer from continued 
walking impairments. The post-stroke program is built on compelling data from our proof-of-concept trial and preclinical studies, indicating 
that dalfampridine has the potential to be the first medical therapy to improve walking in people who have suffered strokes and have 
permanent walking impairments as a result. 

Stroke/SCI/PN

Heart Failure

GGF2

rHIgM22 

CHONDROITINASE 

MS

SCI

2014 PIPELINE

R&D

PRE
CLINICAL

PHASE 1

PHASE 2

PHASE 3/4

MARKETED

THERAPY

AMPYRA® 

Walking in MS

DALFAMPRIDINE-QD 

Post-Stroke Deficits

ZANAFLEX® 

Spasticity

QUTENZA® 

NP-1998 

Post-Shingles Nerve Pain

Neuropathic Pain

PLUMIAZ™ (diazepam) Nasal Spray 

Cluster Seizures

GGF2

rHIgM22 

AC105 

CHONDROITINASE 

Chronic Heart Failure

Stroke/SCI/PN

MS

SCI

SCI

3

 
 
 
 
NP-1998 is a clinical Phase 3-ready investigational drug for the 
treatment of neuropathic pain that we acquired in 2013, along 
with the marketed product QUTENZA. QUTENZA is a skin 
patch indicated for management of neuropathic pain associated 
with post herpetic neuralgia. Both NP-1998 and QUTENZA are 
capsaicin-based products, and we have preclinical and clinical 
data suggesting that NP-1998 is as effective as QUTENZA. Due to 
several advantages with respect to administration, we believe that 
NP-1998, if approved by the FDA, may represent a paradigm shift 
for the treatment of neuropathic pain from various causes that affect 
more than four million Americans. 

We are determining the most efficient development plan for  
NP-1998 and expect to advance this investigational drug in 2014.

Promising Earlier-Stage Clinical Therapies

In addition to the NDA filing of PLUMIAZ and development work 
on dalfampridine-QD and NP-1998, we initiated early-stage clinical 
trials for three products in 2013 that offer unique approaches to 
treating MS, chronic heart failure and acute spinal cord injury (SCI).

The first clinical trial of rHIgM22, a remyelinating antibody, was 
initiated in April 2013. More than 400,000 people in the U.S. have 
MS, and there are currently no approved therapies to restore myelin 
that has been damaged or destroyed by the disease. In multiple 
published preclinical studies of rHIgM22, this antibody stimulated 
remyelination and improved function. The Phase 1 clinical trial is 
evaluating safety and tolerability of rHIgM22 in people with MS, as 
well as incorporating several exploratory efficacy measures.  
These include MRI assessments of myelin regrowth, biomarkers 
and functional measures. Results from this trial are expected in  
early 2015. 

Glial Growth Factor 2 (GGF2), a member of the neuregulin family 
of proteins, has been shown in several preclinical studies to have 
reproducible, powerful protective and restorative effects on both 
heart muscle and nerve tissues. We completed a successful Phase 
1a trial in people with chronic heart failure in late 2012. In the study, 
single doses of GGF2 were well-tolerated through six escalating 
dose cohorts. Liver enzyme elevations, including a case of Hy’s 
Law, were observed in the seventh, highest dose cohort; all of 
these resolved within two weeks. In addition, the data showed 
dose-dependent increases in left ventricular ejection fraction that 
were durable for at least a month following a single dose, with 
average increases to 40% from a mean baseline of 29%. We 
initiated a Phase 1b clinical trial in October 2013. This second trial 
is evaluating safety and tolerability of GGF2 in people with chronic 
heart failure, using three of the middle doses from the Phase 1a 
study. This study is also evaluating efficacy measures, including 
measurement of ejection fraction and cardiovascular endurance. 
Results from this trial are expected in 2015.

In September 2013, we initiated a Phase 2 clinical trial of AC105 
in people with acute SCI. This study is assessing the safety of 
AC105 in patients with acute SCI and exploring efficacy measures 
of sensory and motor function. In preclinical studies, administration 
of AC105 within several hours after SCI improved functional 
outcomes. There are approximately 12,000 new spinal cord injuries 
in the U.S. each year, and there is no approved treatment for  
acute SCI. 

2013 AWARDS

MANAGEMENT TEAM 

BOARD OF DIRECTORS

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

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

Enrique Carrazana, M.D. 
Chief Medical Officer 

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

David Lawrence, M.B.A. 
Chief of Business Operations 

Michael Rogers 
Chief Financial Officer 

Lauren Sabella 
Executive Vice President, Commercial Development 

Tierney Saccavino 
Senior Vice President, Corporate Communications 

Jane Wasman, J.D. 
President, International and General Counsel

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

CONTACT

Jeff Macdonald 
Senior Director, Corporate Communications 
jmacdonald@acorda.com 
914-326-5232

5

www.acorda.com

© 2014 Acorda Therapeutics, Inc. All rights reserved.