Download Heart Disease and Stroke

2009
Report
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Heart Disease and Stroke
P R E S E N T E D
B Y
A M E R I C A
’
S
P H A R M A C E U T I C A L
R E S E A R C H
C O M P A N I E S
More Than 300 Medicines in Testing for Two
Leading Causes of Death in Americans
P
harmaceutical and biotechnology researchers are
working on 312 medicines for two of the three
leading causes of death in Americans—heart disease
and stroke—keeping up the momentum of drug discovery
that has helped cut deaths from these diseases by more
than a quarter between 1999 and 2005. All of the medicines
are either in clinical trials or awaiting approval by the
Food and Drug Administration.
According to the National Center for Health Statistics,
heart disease has topped the list of killer diseases every
year but one since 1900. (The exception was 1918,
when an influenza epidemic killed more than 450,000
Americans.) In 2002, cancer surpassed heart disease as
the top killer of Americans under age 85, who account
for 98.4 percent of the U.S. population. Stroke is the
third leading cause of death.
M EDICINES
IN
D EVELOPMENT
Acute Coronary Syndrome
Adjunctive Therapies
Angina
Arrhythmia/Atrial Fibrillation
Atherosclerosis
Coronary Artery Disease
Heart Attack
Heart Failure
Hypertension
Imaging Agents
Ischemic Disorders
Lipid Disorders
Peripheral Vascular Disease
Pulmonary Vascular Disease
Stroke
Thrombosis
Other
FOR
H EART D ISEASE
AND
S TROKE *
21
2
5
20
18
11
16
33
10
36
18
26
27
16
22
*Some medicines are listed in more than one category.
Thanks in large part to new drug treatments, death rates
from heart disease and stroke are falling. According to the
National Heart, Lung and Blood Institute (NHLBI), if death
rates were the same as those of 30 years ago, 815,000
more Americans would die of heart disease annually and
250,000 more would die of stroke. This reduction in
death rates is “one of the great triumphs of medicine in
the past 50 years,” according to cardiologist Dr. Eugene
Braunwald of Brigham and Women’s Hospital at
Harvard University.
cost of these diseases to American society is more than
$448 billion a year.
Much of the progress is due to the development of
effective medicines to control both blood pressure and
cholesterol, according to officials at the NHLBI. In
addition, treatment of heart attacks has vastly improved.
Twenty-five years ago, the treatment for heart attacks was
simply bed rest. Today, doctors have medicines that can
stop a heart attack in mid-stream as well as other hightech treatments.
• A new anticoagulant that regulates clot formation to
prevent deep vein thrombosis.
But, experts warn, the war against heart disease and
stroke is not yet won. According to the American Heart
Association, every 37 seconds an American dies of
cardiovascular disease, and nearly 80 million Americans
have one or more types of cardiovascular disease. Many
people who survive heart attacks develop heart failure, a
chronic disease that affects 5.3 million Americans. The
The medicines in development include 36 for high
blood pressure, 33 for heart failure, 16 for heart attacks,
and 22 for stroke. Many of the potential medicines use
cutting-edge technologies and new scientific approaches.
For example:
• Human stem cells that may restore cardiac function by
forming new heart muscle.
• A gene therapy that uses a patient’s own cells to treat
heart failure.
These new medicines promise to continue the already
remarkable progress against heart disease and stroke and
to raise the quality of life for patients suffering from these
diseases.
Billy Tauzin
President and CEO
PhRMA
40
39
Medicines in Development for
Heart Disease and Stroke
ACUTE CORONARY SYNDROME
Product Name
Sponsor
Indication
Development Status*
Angiomax®
bivalirudin
The Medicines Company
Parsippany, NJ
acute coronary syndrome
application submitted
(973) 656-1616
apixaban
(factor XA
inhibitor)
Bristol-Myers Squibb
Princeton, NJ
Pfizer
New York, NY
acute coronary syndrome
(see also stroke, thrombosis)
Phase III
(212) 546-4000
(860) 732-5156
Arixtra®
fondaparinux
GlaxoSmithKline
Rsch. Triangle Park, NC
acute coronary syndrome
application submitted
(888) 825-5249
cangrelor
The Medicines Company
Parsippany, NJ
acute coronary syndrome
Phase III
(800) 388-1183
DX9065a
Daiichi Sankyo
Parsippany, NJ
acute coronary syndrome
(see also coronary artery disease,
thrombosis)
Phase II
(973) 359-2600
E5555
Eisai Medical Research
Ridgefield Park, NJ
acute coronary syndrome/chronic
atherothrombotic disease
Phase II
(888) 422-4743
factor IIa/Xa
inhibitor
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
acute coronary syndrome
Phase I
(888) 842-2937
Integrelin®
eptifibatide
Schering-Plough
Kenilworth, NJ
early acute coronary syndrome
Phase III
(908) 298-4000
M118
Momenta Pharmaceuticals
Cambridge, MA
acute coronary syndrome
Phase II
(617) 491-9700
otamixaban
(XRP0673)
sanofi-aventis
Bridgewater, NJ
acute coronary syndrome
Phase II
(800) 633-1610
prasugrel
(CS-747)
Eli Lilly
Indianapolis, IN
Daiichi Sankyo
Parsippany, NJ
acute coronary syndrome
PRT060128
Portola Pharmaceuticals
South San Francisco, CA
acute coronary syndrome
(see also heart attack)
Phase II
rivaroxaban
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
Johnson & Johnson
Pharmaceutical Reseach
& Development
Raritan, NJ
acute coronary syndrome
(see also stroke, thrombosis)
Phase II
(888) 842-2937
SCH-530348
Schering-Plough
Kenilworth,NJ
acute coronary syndrome
Phase III
(908) 298-4000
application submitted
(800) 545-5979
(973) 359-2600
-------------------------------------------------------------------------------------acute coronary syndrome
Phase II
(combination therapy)
(800) 545-5979
(973) 359-2600
* For more information about a specific medicine in this report, please call the telephone number listed.
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ACUTE CORONARY SYNDROME
Product Name
Sponsor
Indication
Development Status
TAK-442
Takeda Pharmaceuticals
North America
Deerfield, IL
acute coronary syndrome
(see also thrombosis)
Phase II
(877) 582-5332
Thelin™
sitaxentan
Encysive Pharmaceuticals
Houston, TX
acute coronary disorders
(see also heart failure,
pulmonary vascular disease)
Phase I
(713) 796-8822
ticagrelor
AstraZeneca
Wilmington, DE
acute coronary syndrome
(see also thrombosis)
Phase III
(800) 236-9933
varespladib
Anthera Pharmaceuticals
San Mateo, CA
acute coronary syndrome
(see also atherosclerosis)
Phase II
(510) 277-0356
VIA-2291
VIA Pharmaceuticals
San Francisco, CA
acute coronary syndrome
(see also atherosclerosis)
Phase II
(415) 283-2200
VT-111
Viron Therapeutics
London, ON
acute coronary syndrome
(see also atherosclerosis,
coronary artery disease)
Phase II
(519) 858-5109
Vytorin™
ezetimibe/
simvastatin
Merck
Whitehouse Station, NJ
Schering-Plough
Kenilworth, NJ
acute coronary syndrome
Phase III
(800) 672-6372
(908) 298-4000
A D J U N C T I V E T H E R A P I E S ; R E VA S C U L A R I Z AT I O N
Product Name
Sponsor
Indication
Development Status
CCX140
ChemoCentryx
Mountain View, CA
treatment of vascular restinosis
following angioplasty or stenting
Phase I
(650) 210-2900
fibrin patch
Omrix Biopharmaceuticals
New York, NY
Ethicon,
a Johnson & Johnson
Company
Somerville, NJ
surgical blood loss
Phase II
(212) 887-6500
NovoSeven®
eptacog alfa
Novo Nordisk
Princeton, NJ
post-operative hemorrhage in
cardiac surgery
Phase II
(800) 727-6500
rFXIII
Novo Nordisk
Princeton, NJ
post-operative hemorrhage in
cardiac surgery
Phase I
(800) 727-6500
Trinam®
(EG004)
Ark Therapeutics
London, England
prevention of vascular restinosis
following vascular graft surgery
Phase III
Product Name
Sponsor
Indication
Development Status
ACCLAIM™
isosorbide
mononitrate/
arginine
Angiogenix
Burlingame, CA
angina pectoris
Phase II
(650) 579-6685
ANGINA
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ANGINA
Product Name
Sponsor
Indication
Development Status
FGF-1
(fibroblast growth
factor 1)
CardioVascular
BioTherapeutics
Las Vegas, NV
angina pectoris
Phase II
(see also peripheral vascular disease) (702) 248-1174
ARRHYTHMIA, ATRIAL FIBRILLATION
4
Product Name
Sponsor
Indication
Amio-Aqueous™
aqueous
amiodarone
Academic Pharmaceuticals supraventricular arrhythmia,
Lake Bluff, IL
ventricular tachycardia
Phase III
(847) 735-1170
ATI-2042
ARYx Therapeutics
Fremont, CA
atrial fibrillation
Phase II
(510) 585-2200
ATPace™
adenosine
triphosphate
injection
Duska Therapeutics
La Jolla, CA
diagnosis of bradycardia,
treatment of paroxysmal
supraventricular tachycardia
Phase II
(858) 551-5700
Avapro®
irbesartan
sanofi-aventis
Bridgewater, NJ
atrial fibrillation
(see also heart failure)
Phase III
(800) 633-1610
AZD1305
AstraZeneca
Wilmington, DE
atrial fibrillation, left ventricular
Phase II
dysfunction
(800) 236-9933
-------------------------------------------------------------------------------------atrial flutter
Phase I/II
(800) 236-9933
-------------------------------------------------------------------------------------arrhythmia
Phase I
(800) 236-9933
capadenoson
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
atrial fibrillation
Phase II
(888) 842-2937
celivarone
(SSR149744)
sanofi-aventis
Bridgewater, NJ
atrial fibrillation
Phase II
(800) 633-1610
GAP-134
Wyeth Pharmaceuticals
Collegeville, PA
arrhythmia
Phase I
(800) 934-5556
idrabiotaparinux
sanofi-aventis
Bridgewater, NJ
atrial fibrillation
(see also thrombosis)
Phase III
(800) 633-1610
idraparinux
sanofi-aventis
Bridgewater, NJ
atrial fibrillation
(see also thrombosis)
Phase III
(800) 633-1610
Lipitor®
atorvastatin
Pfizer
New York, NY
atrial fibrillation
Phase II/III
(860) 732-5156
Lovaza®
GlaxoSmithKline
omega-3 ethylester Rsch. Triangle Park, NC
concentrate
atrial fibrillation
Phase III
(888) 825-5249
Multaq®
dronedarone
sanofi-aventis
Bridgewater, NJ
atrial fibrillation
application submitted
(800) 633-1610
nifekalant
Mitsui Chemicals America
Rye Brook, NY
arrhythmia
Phase II
(914) 253-0777
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Heart Disease and Stroke 2009
ARRHYTHMIA, ATRIAL FIBRILLATION
Product Name
Sponsor
Indication
Development Status
Pulzium®
tedisamil
Solvay Pharmaceuticals
Marietta, GA
atrial fibrillation
application submitted
(770) 578-9000
sematilide
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
arrhythmia
Phase III
(888) 842-2937
Stedicor®
azimilide
Procter & Gamble
Pharmaceuticals
Cincinnati, OH
atrial fibrillation, atrial flutter,
application submitted
supraventricular arrhythmia
(513) 983-1100
(see also heart attack)
-------------------------------------------------------------------------------------arrhythmia
Phase III
(513) 983-1100
tecadenoson
CV Therapeutics
Palo Alto, CA
paroxysmal supraventricular
Phase III
tachycardia
(650) 384-8500
-------------------------------------------------------------------------------------acute atrial fibrillation, atrial flutter
Phase II
(650) 384-8500
vernakalant
Astellas Pharma
Deerfield, IL
Cardiome Pharma
Vancouver, BC
atrial fibrillation (intravenous)
YM-758
Astellas Pharma
Deerfield, IL
atrial fibrillation
Phase II
(800) 727-7003
application submitted
(800) 727-7003
(800) 330-9928
-------------------------------------------------------------------------------------atrial flutter (intravenous)
Phase III
(800) 727-7003
(800) 330-9928
-------------------------------------------------------------------------------------atrial fibrillation (oral)
Phase II
(800) 727-7003
(800) 330-9928
ATHEROSCLEROSIS
Product Name
Sponsor
Indication
Development Status
568859
(lipoproteinassociated
phospholipase AZ
[Lp-PLA2]
inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
atherosclerosis
Phase I
(888) 825-5249
681323
(p38 kinase
inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
atherosclerosis
Phase II
(888) 825-5249
856553
(p38 kinase
inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
atherosclerosis
(combination therapy)
Phase I
(888) 825-5249
anacetrapib
(MK-0859)
Merck
Whitehouse Station, NJ
atherosclerosis
(see also lipid disorders)
Phase III
(800) 672-6372
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ATHEROSCLEROSIS
Product Name
Sponsor
Indication
Development Status
CER002
Cerenis Therapeutics
Ann Arbor, MI
atherosclerosis
Phase I
(734) 769-1110
CP-800569
Pfizer
New York, NY
atherosclerosis
Phase I
(860) 732-5156
darapladib
(Lp-PLA2
inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
Human Genome Sciences
Rockville, MD
atherosclerosis
Phase III
(888) 825-5249
K-604
Kowa Research Institute
Morrisville, NC
atherosclerosis
Phase I
www.kowa.co.jp
liver XR agonist
Bristol-Myers Squibb
Princeton, NJ
Exelixis
San Francisco, CA
atherosclerosis
in clinical trials
(212) 546-4000
MK-1903
Merck
Whitehouse Station, NJ
atherosclerosis
Phase I
(800) 672-6372
MLN1202
Millennium
Pharmaceuticals
Cambridge, MA
atherosclerosis
Phase II
(800) 390-5663
niacin receptor
agonist
Arena Pharmaceuticals
San Diego, CA
Merck
Whitehouse Station, NJ
atherosclerosis
Phase I
(858) 453-7200
(800) 672-6372
PF-3185043
Pfizer
New York, NY
atherosclerosis
Phase I
(860) 732-5156
PSI-697/
WAY-197697
Wyeth Pharmaceuticals
Collegeville, PA
atherosclerosis
(see also thrombosis)
Phase I
(800) 934-5556
rilapladib
(Lp-PLA2
inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
Human Genome Sciences
Rockville, MD
atherosclerosis
Phase I
(888) 825-5249
(301) 309-8504
varespladib
Anthera Pharmaceuticals
San Mateo, CA
atherosclerosis
(see also acute coronary syndrome)
Phase II
(510) 277-0356
VIA-2291
VIA Pharmaceuticals
San Francisco, CA
atherosclerosis
(see also acute coronary syndrome)
Phase II
(415) 383-2200
VT-111
Viron Therapeutics
London, ON
atherosclerosis
(see also acute coronary syndrome,
coronary artery disease)
Phase I
(519) 858-5109
CORONARY ARTERY DISEASE
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Product Name
Sponsor
Indication
Development Status
APL180
Novartis Pharmaceuticals
East Hanover, NJ
coronary heart disease
Phase I/II
(888) 669-6682
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CORONARY ARTERY DISEASE
Product Name
Sponsor
Indication
Development Status
coronary artery
disease gene
therapy
BioCardia
South San Francisco, CA
coronary artery disease
Phase II
(650) 624-0900
Coroxane™
albumin-bound
paclitaxel
Abraxis BioScience
Los Angeles, CA
coronary artery restenosis
Phase II
(see also peripheral vascular disease) (310) 437-7700
DX9065a
Daiichi Sankyo
Parsippany, NJ
coronary artery restenosis
(see also acute coronary syndrome,
thrombosis)
Phase II
(973) 359-2600
K-134
Kowa Research Institute
Morrisville, NC
arteriosclerosis obliterans
Phase II
www.kowa.co.jp
LT-1951
Lumen Therapeutics
Mountain View, CA
coronary artery restenosis
Phase I/II
(650) 641-0084
mycophenolic
acid
Avantec Vascular
Sunnyvale, CA
coronary artery restinosis
in clinical trials
(408) 329-5400
myolimus
Elixir Medical
Sunnyvale, CA
coronary artery restenosis
in clinical trials
(408) 636-2000
Resten-MP™
AVI BioPharma
Portland, OR
coronary artery restenosis
Phase I
(503) 227-0554
Resten-NG®
AVI BioPharma
Portland, OR
coronary artery restenosis
Phase II
(503) 227-0554
VT-111
Viron Therapeutics
London, ON
coronary artery restenosis
(see also acute coronary syndrome,
atherosclerosis)
Phase I
(519) 858-5109
HEART ATTACK (MYOCARDIAL INFARCTION)
Product Name
Sponsor
Indication
Development Status
AMR-001
Amorcyte
Hackensack, NJ
Progenitor Cell Therapy
Hackensack, NJ
myocardial infarction
Phase I
(201) 883-5300
(201) 883-5303
BVI-007
BioVascular
San Diego, CA
myocardial infarction
(see also stroke)
Phase I
(858) 455-5000
caldaret
Mitsubishi
Pharma America
Warren, NJ
myocardial infarction
Phase II
(908) 607-1950
KAI-9803/
BMS-875944
(PKC-Delta
inhibitor)
Bristol-Myers Squibb
Princeton, NJ
KAI Pharmaceuticals
South San Francisco, CA
prevention of reperfusion injury
following acute myocardial
infarction
Phase II
(212) 546-4000
(650) 244-1100
MultiStem®
stem cell therapy
Athersys
Cleveland, OH
myocardial infarction
Phase I
(216) 431-9900
NEU2000
Amkor Pharma
Seattle, WA
myocardial infarction
(see also stroke)
Phase I
(206) 332-5587
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HEART ATTACK (MYOCARDIAL INFARCTION)
Product Name
Sponsor
Indication
Development Status
NX CP-105
Neuronyx
Malvern, PA
myocardial infarction
Phase I
(610) 240-4150
PL2100
(aspirin/
phosphatidylcholine)
PLx Pharma
Houston, TX
myocardial infarction
(see also stroke)
Phase I
(713) 842-1249
Prochymal™
mesenchymal
stem cell therapy
(human)
Osiris Therapeutics
Baltimore, MD
acute myocardial infarction
Phase II
(410) 522-5005
PRT060128
Portola Pharmaceuticals
South San Francisco, CA
myocardial infarction
(see also acute coronary syndrome)
Phase II
(650) 246-7000
ReoPro®
abciximab
Centocor
Horsham, PA
Eli Lilly
Indianapolis, IN
myocardial infarction
Phase III completed
(see also peripheral vascular disease) (610) 651-6000
(800) 545-5979
Stedicor®
azimilide
Procter & Gamble
Pharmaceuticals
Cincinnati, OH
post-myocardial infarction
(see also arrhythmia)
Phase III
(513) 983-1100
Tekturna®
aliskiren
Novartis Pharmaceuticals
East Hanover, NJ
myocardial infarction
(see also heart failure)
Phase III
(888) 669-6682
thymosin beta-4
ReGeneRx
Biopharmaceuticals
Bethesda, MD
myocardial infarction
Phase I
(301) 280-1992
V10153
Vernalis Pharmaceuticals
Morristown, NJ
myocardial infarction
(see also stroke)
Phase II
(973) 867-5555
VMD-30283
VM Discovery
Fremont, CA
myocardial infarction
Phase I/II
(510) 661-6770
HEART FAILURE (CONGESTIVE HEART FAILURE)
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Product Name
Sponsor
Indication
Development Status
AC2592
Amylin Pharmaceuticals
San Diego, CA
congestive heart failure
Phase II
(858) 552-2200
Adentri™
Biogen Idec
Cambridge, MA
acute heart failure
alagebrium
chloride
(ALT-711)
Synvista Therapeutics
Montvale, NJ
heart failure
Phase II
(201) 934-5000
Anginera™
epicardial
angiogenesis
patch
Theregen
San Francisco, CA
heart failure
(see also ischemic disorders)
Phase I
(415) 439-8320
Phase III
(617) 679-2000
-------------------------------------------------------------------------------------chronic heart failure
Phase II
(617) 679-2000
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HEART FAILURE (CONGESTIVE HEART FAILURE)
Product Name
Sponsor
Indication
Development Status
autologous stem
cell therapy
Aldagen
Durham, NC
heart failure
(see also ischemic disorders)
Phase I
(919) 484-2571
AVE3085
sanofi-aventis
Bridgewater, NJ
congestive heart failure
Phase I
(800) 633-1610
BAY 60-4552
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
heart failure
Phase II
(888) 842-2937
BB3
Angion Therapeutics
Manhasset, NY
prevention of congestive
heart failure
Phase II
(516) 869-6400
Bidil XR™
NitroMed
hydralazine
Lexington, MA
hydrochloride/
isosorbide dinitrate
(extended-release)
heart failure
Phase I
(781) 266-4000
bucindolol
ARCA biopharma
Broomfield, CO
heart failure
application submitted
(720) 940-2200
Cardeva™
B-type natriuretic
peptide
Teva Pharmaceuticals USA
North Wales, PA
chronic heart failure
Phase I/II
(215) 591-3000
carperitide
Asubio Pharmaceuticals
Rochelle Park, NJ
heart failure
Phase II
(201) 368-5020
CD-NP
Niles Therapeutics
San Francisco, CA
heart failure
Phase II
(415) 875-7880
cinaciguat
(BAY 58-2667)
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
heart failure
Phase II
(888) 842-2937
CK-1827452
Cytokinetics
South San Francisco, CA
heart failure
Phase II
(650) 624-3000
daglutril
Solvay Pharmaceuticals
Marietta, GA
heart failure
(see also hypertension)
Phase II
(770) 578-9000
icodextrin solution Baxter Healthcare
Deerfield, IL
heart failure
Phase II
(800) 422-9837
INOmax®
nitric oxide
inhalation
Ikaria
Clinton, NJ
congestive heart failure
Phase II
(see also pulmonary vascular disease) (908) 238-6600
Mydicar™
AAV1/SERCA2a
gene therapy
Celladon
La Jolla, CA
Targeted Genetics
Seattle, WA
congestive heart failure
myoblast cell
transplantation
therapy
Advanced Cell Technology heart failure
Los Angeles, CA
Mytogen
Charlestown, MA
MyoCell™
Bioheart
cell-based heart
Sunrise, FL
damage therapy
(tissue regeneration)
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Phase I/II
(858) 366-4288
(206) 623-7612
Phase I
(617) 242-9100
Phase II/III
(954) 835-1500
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HEART FAILURE (CONGESTIVE HEART FAILURE)
Product Name
Sponsor
Indication
Development Status
Natrecor®
nesiritide
Scios
Mountain View, CA
chronic heart failure (IV-infusion)
NeoFuse™
mesenchymal
stem cell therapy
Mesoblast
Melbourne, Australia
prevention of heart failure
Phase II
www.mesoblast.com
PL-3994
Palatin Technologies
Cranbury, NJ
congestive heart failure
(see also hypertension)
Phase I
(609) 495-2200
recombinant
relaxin
Corthera
San Mateo, CA
acute heart failure
(see also hypertension)
Phase II/III
(650) 235-3555
Renormax®
spirapril
Schering-Plough
Kenilworth, NJ
heart failure
application submitted
(908) 298-4000
rolofylline
NovaCardia
San Diego, CA
congestive heart failure
Phase III
(intravenous)
(858) 509-0455
-------------------------------------------------------------------------------------congestive heart failure
Phase I
(oral)
(858) 509-0455
Samska™
tolvaptan
Otsuka America
Pharmaceutical
Rockville, MD
congestive heart failure
(see also other)
application submitted
(800) 562-3974
SLV320
Solvay Pharmaceuticals
Marietta, GA
congestive heart failure
Phase II
(770) 578-9000
Tekturna®
aliskiren
Novartis Pharmaceuticals
East Hanover, NJ
congestive heart failure
(see also heart attack)
Phase III
(888) 669-6682
Thelin™
sitaxentan
Encysive Pharmaceuticals
Houston, TX
congestive heart failure
(see also acute coronary syndrome,
pulmonary vascular disease)
Phase II
(713) 796-8822
ularitide
EKR Therapeutics
Bedminster, NJ
acute decompensated heart failure
Phase I
(877) 435-2524
urocortin 2
Neurocrine Biosciences
San Diego, CA
congestive heart failure
Phase II
(858) 617-7600
Phase II
(650) 564-5000
-------------------------------------------------------------------------------------heart failure (subcutaneous)
Phase I
(650) 564-5000
HYPERTENSION (HIGH BLOOD PRESSURE)
10
Product Name
Sponsor
Indication
Development Status
ADX415
Sciele Pharma
Atlanta, GA
hypertension
Phase II
(800) 461-3696
Altace HCT®
ramipril/hydrochlorothiazide
King Pharmaceuticals
Bristol, VA
hypertension
Phase III
(800) 776-3637
Angeliq®
estradiol/
drospirenone
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
hypertension
Phase III
(888) 842-2937
M
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HYPERTENSION (HIGH BLOOD PRESSURE)
Product Name
Sponsor
Indication
Development Status
AR9281
Arête Therapeutics
Hayward, CA
hypertension
Phase I
(510) 785-7060
CloniBID®
clonidine
controlled-release
Adderex Pharmaceuticals
Durham, NC
Sciele Pharma
Atlanta, GA
hypertension
application submitted
(919) 941-0800
(800) 461-3695
cobiprostone
Sucampo Pharmaceuticals
Bethesda, MD
portal hypertension
Phase II
(301) 961-3400
Coreg® CR
carvedilol/
lisinopril
(fixed-dose
combination)
GlaxoSmithKline
Rsch. Triangle Park, NC
hypertension
Phase III
(888) 825-5249
CS-8635
Daiichi Sankyo
(olmesartan
Parsippany, NJ
medoxomil/
amlodipine/
hydrochlorothiazide
combination)
hypertension
Phase III
(973) 359-2600
CYT006 AngQb
vaccine
Cytos Biotechnology
Zurich, Switzerland
treatment of hypertension
Phase II
www.cytos.com
daglutril
Solvay Pharmaceuticals
Marietta, GA
hypertension
(see also heart failure)
Phase II
(770) 578-9000
darusentan
Gilead Sciences
Foster City, CA
resistant hypertension
Phase III
(800) 445-3235
DigiFab™ and
Digibind®
digoxin immune
Fabs (ovine)
combination
Protherics (BTG)
Brentwood, TN
severe preeclampsia
Phase II
(615) 327-1027
imidapril
Xanodyne Pharmaceuticals hypertension
Newport, KY
Phase II
(859) 371-6383
LCI699
Novartis Pharmaceuticals
East Hanover, NJ
hypertension
Phase I
(888) 669-6682
LCZ696
Novartis Pharmaceuticals
East Hanover, NJ
hypertension
Phase II
(888) 669-6682
lercanidipine MR
(modified-release)
Forest Laboratories
New York, NY
hypertension
Phase II
(800) 678-1605
MK-1597
Merck
Whitehouse Station, NJ
hypertension
Phase I
(800) 672-6372
MK-3614
Merck
Whitehouse Station, NJ
hypertension
Phase I
(800) 672-6372
MK-8984
Merck
Whitehouse Station, NJ
hypertension
Phase I
(800) 672-6372
moxonidine
Solvay Pharmaceuticals
Marietta, GA
hypertension
Phase III
(770) 578-9000
M
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Heart Disease and Stroke 2009
11
HYPERTENSION (HIGH BLOOD PRESSURE)
12
Product Name
Sponsor
Indication
Development Status
naproxcinod
NicOx
Warren, NJ
hypertension
Phase I
(908) 604-1070
NCX-899
Merck
Whitehouse Station, NJ
NicOx
Warren, NJ
hypertension
Phase I
(800) 672-6372
(908) 604-1070
PL-3994
Palatin Technologies
Cranbury, NJ
hypertension
(see also heart failure)
Phase II
(609) 495-2200
PS433540
Pharmacopeia
Cranbury, NJ
hypertension
Phase II
(609) 452-3600
recombinant
relaxin
Corthera
San Mateo, CA
preeclampsia
(see also heart failure)
Phase I
(650) 235-3555
sapropterin
BioMarin Pharmaceutical
Novato, CA
hypertension
Phase II completed
(see also peripheral vascular disease, (415) 506-6700
pulmonary vascular disease)
SPP635
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
hypertension
Phase I
(732) 537-2290
SPP676
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
hypertension
Phase I
(732) 537-2290
SPP1148
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
hypertension
Phase I
(732) 537-2290
SPP1234
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
hypertension
Phase 0
(732) 537-2290
SPP2745
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
hypertension
Phase 0
(732) 537-2290
tadalafil
Eli Lilly
Indianapolis, IN
hypertension
(see also pulmonary vascular
disease)
Phase II
(800) 545-5979
TAK-491
(azilsartan
kamedoxomil)
Takeda Pharmaceuticals
North America
Deerfield, IL
hypertension
Phase III
(877) 582-5332
TAK-536
(azilsartan)
Takeda Pharmaceuticals
North America
Deerfield, IL
hypertension
Phase II
(877) 582-5332
TBC3711
Encysive Pharmaceuticals
Houston, TX
resistant hypertension
Phase II
(713) 796-8822
VNP489
Novartis Pharmaceuticals
East Hanover, NJ
hypertension
Phase I
(888) 669-6682
M
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Heart Disease and Stroke 2009
IMAGING AGENTS
Product Name
Sponsor
Indication
Development Status
AdreView™
123I-mIBG
GE Healthcare
Waukesha, WI
diagnosis of heart failure
Phase III
(800) 345-2700
cardiac PET
imaging agent
FluoroPharma
Boston, MA
diagnosis of coronary artery disease
Phase I
(617) 482-2333
CorVue™
binodenoson
King Pharmaceuticals
Bristol, TN
imaging agent for cardiovascular
disorders
application submitted
(800) 776-3637
Feraheme™
ferumoxytol
AMAG Pharmaceuticals
Lexington, MA
diagnosis of peripheral arterial
disorders
Phase II
(617) 498-3300
gadobutrol
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
diagnosis of vascular disorders
Phase II
(888) 842-2937
Imagify™
perflubutane
Acusphere
Watertown, MA
detection of coronary artery
disease
application submitted
(617) 648-8800
myocardial
perfusion
imaging agent
FluoroPharma
Boston, MA
diagnosis of coronary disorders
Phase I
(617) 482-2333
SHU 555C
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
imaging of ischemic heart disorders
Phase III
(888) 842-2937
Stedivaze™
apadenoson
PGx Health
New Haven, CT
myocardial perfusion imaging
Phase II
(877) 274-9432
Zemiva™
iodofiltic acid
I-123
Molecular Insight
Pharmaceuticals
Cambridge, MA
diagnosis of myocardial ischemia
Phase II completed
(617) 492-5554
ISCHEMIC DISORDERS
Product Name
Sponsor
Indication
Development Status
acadesine
Schering-Plough
Kenilworth, NJ
ischemia-reperfusion injury
Phase III
(908) 298-4000
ACY001
(stem cell therapy)
Arteriocyte
Cleveland, OH
ischemia
Phase I
(216) 658-3970
adult stem cell
therapy
Baxter Healthcare
Deerfield, IL
myocardial ischemia
Phase II
(see also peripheral vascular
(800) 422-9837
disorders)
-------------------------------------------------------------------------------------ischemic heart disease
Phase I
(800) 422-9837
Anginera™
Theregen
epicardial
San Francisco, CA
angiogenesis patch
ischemic heart disease
(see also heart failure)
Phase I
(415) 439-8320
Aricept®
donepezil
Pfizer
New York, NY
vascular dementia
application submitted
(860) 732-5156
autologous cell
therapy
BioCardia
South San Francisco, CA
ischemic heart disease
Phase I
(650) 624-0900
M
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Heart Disease and Stroke 2009
13
ISCHEMIC DISORDERS
Product Name
Sponsor
Indication
Development Status
autologous stem
cell therapy
Aldagen
Durham, NC
critical limb ischemia
(see also heart failure)
Phase I/II
(919) 484-2572
CGT-2168
(clopidogrel/
omeprazole)
Cogentus Pharmaceuticals
Palo Alto, CA
ischemic heart disorders
(fixed combination)
Phase III
(650) 543-4730
Exelon®
rivastigmine
Novartis
East Hanover, NJ
vascular dementia
Phase III
(888) 669-6682
Generx™
alferminogene
tadenovec
Cardium Therapeutics
San Diego, CA
myocardial ischemia
Phase III
(858) 436-1000
HGF DNA plasmid AnGes
Gaithersburg, MD
Daiichi Sankyo
Parsippany, NJ
ischemic heart disease
Phase I
(see also peripheral vascular disease) (973) 359-2600
KAI-1455
KAI Pharmaceuticals
South San Francisco, CA
prevention of ischemic injury
during surgical procedures
Phase I
(650) 244-1100
MEM 1003
Memory Pharmaceuticals
Montvale, NJ
vascular dementia
Phase I
(201) 802-7100
MLN-2222
Millennium
Pharmaceuticals
Cambridge, MA
post-ischemic reperfusion injury
Phase I
(800) 390-5663
Ranexa®
ranolazine
extended-release
CV Therapeutics
Palo Alto, CA
myocardial ischemia
Phase II
(650) 384-8500
Reminyl®
galantamine
(extended release)
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
vascular dementia
Phase III
(800) 817-5286
tissue repair
stem cell therapy
Aastrom Biosciences
Ann Arbor, MI
ischemia
(see also other)
Phase I/II
(734) 930-5555
VM-202
(modified
hepatocyte
growth factor
gene therapy)
ViroMed
Seoul, Korea
ischemic heart disease
Phase I
(see also peripheral vascular disease) www.viromed.co.kr
LIPID DISORDERS
14
Product Name
Sponsor
Indication
Development Status
256073
(high affinity
nicotinic acid
receptor [HM74A]
agonist)
GlaxoSmithKline
Rsch. Triangle Park, NC
dyslipidemia
Phase I
(888) 825-5249
AEGR-427
(implitapide)
Aegerion Pharmaceuticals
Bridgewater, NJ
primary hypercholesterolemia
Phase II
(908) 707-2100
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Heart Disease and Stroke 2009
LIPID DISORDERS
Product Name
Sponsor
Indication
AEGR-733
Aegerion Pharmaceuticals
Bridgewater, NJ
hyperlipoproteinemia type II
anacetrapib
(MK-0859)
Merck
Whitehouse Station, NJ
hypercholesterolemia,
mixed hyperlipidemia
(see also atherosclerosis)
Phase II
(800) 672-6372
atorvastatin/
fenofibrate
LifeCycle Pharma
New York, NY
dyslipidemia
Phase II/III
(646) 200-8500
AVE5530
sanofi-aventis
Bridgewater, NJ
hypercholesterolemia
Phase III
(800) 633-1610
Crestor®
rosuvastatin and
Trilipix™
choline fenofibrate
combination
Abbott Laboratories
Abbott Park, IL
AstraZeneca
Wilmington, DE
hyperlipidemia
Phase III
(847) 937-6100
(800) 236-9933
Evista®
raloxifene
Eli Lilly
Indianapolis, IN
hypercholesterolemia
(see also other)
in clinical trials
(800) 545-5979
fenofibrate/
pravastatin
combination
Sciele Pharma
Atlanta, GA
hyperlipidemia
Phase III
(800) 461-3696
laropiprant/niacin/
simvastatin
combination
Merck
Whitehouse Station, NJ
hyperlipidemia
Phase III
(800) 672-6372
MB-07811
Metabasis Therapeutics
La Jolla, CA
hyperlipidemia
Phase I
(858) 587-2770
MBX-8025
Metabolex
Hayward, CA
hyperlipidemia
Phase II completed
(510) 293-8800
MD-0727
Ironwood Pharmaceuticals
Cambridge, MA
hypercholesterolemia
Phase II
(617) 621-7722
mipomersen
Genzyme
Cambridge, MA
Isis Pharmaceuticals
Carlsbad, CA
hypercholesterolemia
Phase III
(617) 252-7500
(760) 931-9200
MK-6213
Merck
Whitehouse Station, NJ
hypercholesterolemia
Phase II
(800) 672-6372
MPC-028
URL Pharma
Philadelphia, PA
hypercholesterolemia,
hyperlipidemia,
hypertriglyceridemia
application submitted
(800) 523-3684
pitavastatin
(NK-104)
Daiichi Sankyo
Parsippany, NJ
hypercholesterolemia,
hyperlipidemia
application submitted
(973) 359-2600
R1658
Roche
Nutley, NJ
hyperlipidemia
Phase III
(973) 235-5000
R7232
Roche
Nutley, NJ
hyperlipidemia
Phase I
(973) 235-5000
M
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D
E V E L O P M E N T
F O R
Development Status
Phase III
(908) 707-2100
-------------------------------------------------------------------------------------hypercholesterolemia
Phase II
(908) 707-2100
Heart Disease and Stroke 2009
15
LIPID DISORDERS
Product Name
Sponsor
Indication
Development Status
RBx10558
PPD
Wilmington, DE
hyperlipidemia
Phase I
(910) 251-0081
SLx-4090
Surface Logix
Brighton, MA
dyslipidemia,
hypercholesterolemia
Phase II
(617) 746-8500
sobetirome
QuatRx Pharmaceuticals
Ann Arbor, MI
dyslipidemia
Phase I
(734) 913-9900
sodelglitazar
GlaxoSmithKline
Rsch. Triangle Park, NC
hyperlipidemia
Phase II
(888) 825-5249
Tredaptive™
laropiprant/niacin
Merck
Whitehouse Station, NJ
hypercholesterolemia
Phase III
(800) 672-6372
TriLipix®
Abbott Laboratories
choline fenofibrate Abbott Park, IL
Solvay Pharmaceuticals
Marietta, GA
hyperlipidemia
(combination therapy)
Phase III
(847) 937-6100
(770) 578-9000
Uros®
ursodeoxycholic
acid
hypercholesterolemia
Phase II
(908) 927-9600
Axcan Pharma US
Bridgewater, NJ
P E R I P H E R A L VA S C U L A R D I S E A S E
16
Product Name
Sponsor
Indication
Development Status
adult stem cell
therapy
Baxter Healthcare
Deerfield, IL
critical limb ischemia
(see also ischemic disorders)
Phase I/II
(800) 422-9837
ANGX-1039
Angiogenix
Burlingame, CA
intermittent claudication
Phase I
(650) 579-6685
ataciguat
(HMR1766)
sanofi-aventis
Bridgewater, NJ
peripheral arterial disease
Phase II
(800) 633-1610
Coroxane™
albumin-bound
paclitaxel
Abraxis BioScience
Los Angeles, CA
peripheral arterial disease,
prevention of vascular restinosis
(see also coronary artery disease)
Phase II
(310) 437-7700
CS-8080
Daiichi Sankyo
Parsippany, NJ
arterial occlusive disorders
Phase I
(973) 359-2600
EWA-401
Sangamo BioSciences
Richmond, CA
intermittent claudication,
peripheral vascular disease
Phase I
(510) 970-6000
FGF-1
(fibroblast growth
factor 1)
CardioVascular
BioTherapeutics
Las Vegas, NV
peripheral arterial disorder
(see also angina)
Phase I
(702) 248-1174
HGF DNA plasmid AnGes
Gaithersburg, MD
Daiichi Sankyo
Parsippany, NJ
peripheral arterial disease
(see also ischemic disorders)
Phase II
(973) 359-2600
HIF-1 alpha
gene therapy
Genzyme
Cambridge, MA
peripheral arterial disease
Phase II
(617) 252-7500
hypoxia
therapeutic
(TSC)
Diffusion Pharmaceuticals
Charlottesville, VA
arterial occlusive disorders
Phase I/II
(434) 220-0718
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Heart Disease and Stroke 2009
P E R I P H E R A L VA S C U L A R D I S E A S E
Product Name
Sponsor
Indication
Development Status
iloprost
Actelion
Pharmaceuticals US
South San Francisco, CA
peripheral vascular disorder
application submitted
(650) 624-6900
INDI-702
Indigo Pharmaceuticals
New York, NY
peripheral arterial occlusive
disorders
Phase II completed
(212) 554-4283
Liprostin™
alprostadil
Endovasc
Montgomery, TX
peripheral arterial occlusive disease
Phase II
(936) 582-5920
NV1FGF
(XRP0038)
sanofi-aventis
Bridgewater, NJ
peripheral arterial disease
Phase III
(800) 633-1610
paclitaxel
Angiotech Pharmaceuticals vascular restenosis
Vancouver, Canada
Phase III
(604) 221-7676
propionyl
carnitine
(ST-261)
Sigma-Tau Pharmaceuticals peripheral arterial occlusive
Gaithersburg, MD
disorder
application submitted
(800) 447-0169
R1512
Roche
Nutley, NJ
peripheral vascular disorder
Phase I
(973) 235-5000
Remodulin®
treprostinil
United Therapeutics
Silver Spring, MD
peripheral vascular disorder
Phase II
(see also pulmonary vascular disease) (301) 608-9292
ReoPro®
abciximab
Centocor
Horsham, PA
Eli Lilly
Indianapolis, IN
arterial occlusive disorders
(see also heart attack)
Phase II
(610) 651-6000
(800) 545-5979
RO4905417
Roche
Nutley, NJ
peripheral arterial disorder in
elderly patients
Phase I
(973) 235-5000
sapropterin
BioMarin Pharmaceutical
Novato, CA
peripheral arterial disorder,
vascular disease
(see also hypertension,
pulmonary vascular disease)
Phase II
(415) 506-6700
sarpogrelate
Mitsubishi
Pharma America
Warren, NJ
arterial occlusive disorders
Phase II
(908) 607-1950
SL65.0472
sanofi-aventis
Bridgewater, NJ
peripheral arterial disease
Phase II
(800) 633-1610
SPP200
(PEG hirudin)
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
prevention of vascular graft
occlusion
(see also thrombosis)
Phase II
(732) 537-2290
TAL-0500018
Talecris Therapeutics
Rsch. Triangle Park, NC
peripheral arterial occlusive disorder Phase I/II
(see also thrombosis)
(919) 316-6300
Vascugel™
endothelial
cell-therapy
Pervasis Therapeutics
Cambridge, MA
vascular disease
Phase II
(617) 621-3407
peripheral arterial disease
(see also ischemic disorders)
Phase I
www.viromed.co.kr
VM-202
ViroMed
(modified
Seoul, Korea
hepatocyte growth
factor gene therapy)
M
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17
P U L M O N A RY VA S C U L A R D I S E A S E
18
Product Name
Sponsor
Indication
Development Status
Aironite™
nitrite inhalation
(Orphan Drug)
Aires Pharmaceuticals
Woburn, MA
pulmonary arterial hypertension
Phase I
(781) 937-0110
aviptadil
(vasoactive
intestinal
polypeptide)
(Orphan Drug)
Biogen Idec
Cambridge, MA
pulmonary arterial hypertension
Phase II
(617) 679-2000
beraprost
modified release
United Therapeutics
Silver Spring, MD
pulmonary arterial hypertension
Phase II
(301) 608-9292
Gleevec®
imatinib
Novartis Pharmaceuticals
East Hanover, NJ
pulmonary hypertension
Phase II/III
(888) 669-6682
INOmax®
nitric oxide
inhalation
Ikaria
Clinton, NJ
pulmonary hypertension
(see also heart failure)
Phase I
(908) 238-6600
macitentan
Actelion
Pharmaceuticals US
South San Francisco, CA
pulmonary hypertension
Phase III
(650) 624-6900
nitric oxide
synthase
gene therapy
MaxCyte
Gaithersburg, MD
Northern Therapeutics
Montreal, QC
pulmonary arterial hypertension
Phase II
(301) 944-1700
(514) 842-0071
PF-489791
Pfizer
New York, NY
pulmonary hypertension
Phase I
(860) 732-5156
PRX-08066
EPIX Pharmaceuticals
Lexington, MA
pulmonary hypertension
Phase II
(781) 761-7600
PulmoLAR®
PR Pharmaceuticals
2-methoxyestradiol Fort Collins, CO
pulmonary arterial hypertension
Phase I
(970) 484-5560
Remodulin®
treprostinil
United Therapeutics
Silver Spring, MD
pulmonary arterial hypertension
Phase III
(oral)
(301) 608-9292
(see also peripheral vascular disease)
riociguat
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
pulmonary hypertension
Phase II
(888) 842-2937
sapropterin
BioMarin Pharmaceutical
Novato, CA
pulmonary hypertension
(see also hypertension,
peripheral vascular disease)
Phase I
(415) 506-6700
tadalafil
Eli Lilly
Indianapolis, IN
pulmonary arterial hypertension
(see also hypertension)
application submitted
(800) 545-5979
Thelin™
sitaxsentan
(Orphan Drug)
Encysive Pharmaceuticals
Houston, TX
pulmonary arterial hypertension
(see also acute coronary syndrome,
heart failure)
application submitted
(713) 796-8822
Viveta™
treprostinil
Lung RX
Silver Spring, MD
pulmonary arterial hypertension
(inhalation)
application submitted
www.lungrx.com
M
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STROKE
Product Name
Sponsor
Indication
Development Status
813893
(factor Xa
inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
prevention of stroke in patients
with atrial fibrillation
Phase I
(888) 825-5249
apixaban
(factor XA
inhibitor)
Bristol-Myers Squibb
Princeton, NJ
Pfizer
New York, NY
prevention of stroke in patients
with atrial fibrillation
(see also acute coronary syndrome,
thrombosis)
Phase III
(212) 546-4000
(860) 732-5156
arundic acid
Merck
Whitehouse Station, NJ
stroke
Phase II
(800) 672-6372
betrixaban
Portola Pharmaceuticals
South San Francisco, CA
prevention of stroke in patients
with atrial fibrillation
(see also thrombosis)
Phase II
(650) 246-7000
BVI-007
BioVascular
San Diego, CA
thrombotic stroke in patients
who have had a previous
cardiovascular event
(see also heart attack)
Phase I
(858) 455-5000
clazosentan
Actelion
Pharmaceuticals US
South San Francisco, CA
vasospasm as a consequence of
subarachnoid hemorrhage
Phase II
(650) 624-6900
crobenetine
Boehringer Ingelheim
Pharmaceuticals
Ridgefield, CT
stroke
Phase I
(800) 243-0127
desmoteplase
Lundbeck Research USA
Paramus, NJ
ischemic stroke
Phase III
(201) 261-1331
DU176b
Daiichi Sankyo
Parsippany, NJ
prevention of stroke
(see also thrombosis)
Phase III
(973) 359-2600
MC-1
Medicure
Winnipeg, Canada
stroke
Phase I completed
(888) 435-2220
MK-0724
Merck
Whitehouse Station, NJ
stroke
Phase II
(800) 672-6372
NA 1
Arbor Vita
Sunnyvale, CA
stroke
Phase I
(408) 585-3900
Nectiv®
traxoprodil
Pfizer
New York, NY
stroke
Phase II
(860) 732-5156
NEU2000
Amkor Pharma
Seattle, WA
stroke
(see also heart attack)
Phase I
(206) 332-5587
PL2100
(aspirin/
phosphatidylcholine)
PLx Pharma
Houston, TX
stroke
(see also heart attack)
Phase I
(713) 842-1249
rivaroxaban
Bayer HealthCare
Pharmaceuticals
West Haven, CT
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
prevention of stroke
(see also acute coronary syndrome,
thrombosis)
Phase III
(888) 842-2937
M
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STROKE
Product Name
Sponsor
Indication
Development Status
S-0139
GlaxoSmithKline
Rsch. Triangle Park, NC
Shionogi
Florham Park, NJ
stroke
Phase II
(888) 825-5249
(973) 966-6900
SUN N8075
Asubio Pharmaceuticals
Rochelle Park, NJ
acute ischemic stroke
Phase I
(201) 368-5020
TNKase®
tenecteplase
Genentech
South San Francisco, CA
stroke
(see also thrombosis)
Phase II
(800) 626-3553
TS-011
Taisho
Pharmaceutical R&D
Morristown, NJ
stroke
Phase I
V10153
Vernalis Pharmaceuticals
Morristown, NJ
stroke
(see also heart attack)
Phase II completed
(973) 867-5555
zonampanel
Astellas Pharma US
Deerfield, IL
acute ischemic stroke
Phase II
(800) 727-7003
THROMBOSIS
20
Product Name
Sponsor
Indication
Development Status
APD-791
Arena Pharmaceuticals
San Diego, CA
arterial thrombosis
Phase I completed
(858) 453-7200
apixaban
(factor XA
inhibitor)
Bristol-Myers Squibb
Princeton, NJ
Pfizer
New York, NY
prevention and treatment of
deep vein thrombosis (DVT)
(see also acute coronary syndrome,
stroke)
Phase III
(212) 546-4000
(860) 732-5156
ARC1779
Archemix
Cambridge, MA
thrombosis associated with acute
coronary syndrome
Phase II
(617) 621-7700
ATI-5923
ARYx Therapeutics
Fremont, CA
prevention of thromboembolism
in patients requiring chronic
anticoagulation treatment
Phase II/III
(510) 585-2200
AVE5026
sanofi-aventis
Bridgewater, NJ
prevention of venous
thromboembolism
Phase II
(800) 633-1610
AZD0837
AstraZeneca
Wilmington, DE
thrombosis
Phase II
(800) 236-9933
AZD6482
AstraZeneca
Wilmington, DE
thrombosis
Phase I
(800) 236-9933
betrixaban
Portola Pharmaceuticals
South San Francisco, CA
prevention of thromboembolism
(see also stroke)
Phase II
(650) 246-7000
BIBT986
Boehringer Ingelheim
Pharmaceuticals
Ridgefield, CT
thrombosis
Phase I
(800) 243-0127
certoparin
Novartis Pharmaceuticals
East Hanover, NJ
thromboembolism
Phase III
(888) 669-6682
diaplasinin
(PAI-749)
Wyeth Pharmaceuticals
Collegeville, PA
thrombosis
Phase I
(800) 934-5556
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THROMBOSIS
Product Name
Sponsor
Indication
Development Status
DU176b
Daiichi Sankyo
Parsippany, NJ
prevention of embolism
(see also stroke)
Phase III
(973) 359-2600
DX9065a
Daiichi Sankyo
Parsippany, NJ
thrombosis
(see also acute coronary syndrome,
coronary artery disease)
Phase I
(973) 359-2600
Elaprin®
oral heparin
Emisphere Technologies
Tarrytown, NY
deep vein thrombosis (DVT)
Phase III
(914) 347-2220
eribaxaban
Pfizer
New York, NY
venous thrombosis
Phase II
(860) 732-5156
idrabiotaparinux
sanofi-aventis
Bridgewater, NJ
long-term treatment of DVT and
pulmonary embolism
(see also arrhythmia)
Phase III
(800) 633-1610
idraparinux
sanofi-aventis
Bridgewater, NJ
long-term treatment of DVT and
pulmonary embolism
(see also arrhythmia)
Phase III
(800) 633-1610
LMWH
(low molecular
weight heparin
oral)
Emisphere Technologies
Cedar Knolls, NJ
thrombosis
Phase I
(973) 532-8000
LY517717
Eli Lilly
Indianapolis, IN
thrombosis
Phase I
(800) 545-5979
MER-102
Merrion Pharmaceuticals
Wilmington, NC
thrombosis
Phase I
(910) 799-1847
MPC-0920
Myriad Pharmaceuticals
Salt Lake City, UT
thrombosis
Phase I
(801) 584-3600
NU-172
Nuvelo
San Carlos, CA
thrombosis
Phase I
(650) 517-8000
ORG-27306
Schering-Plough
Kenilworth, NJ
thrombosis
Phase I
(908) 298-4000
PCI-27483
Pharmacyclics
Sunnyvale, CA
treatment of thrombotic
complications of cancer
Phase I
(408) 774-0330
PM103
CyDex Pharmaceuticals
Lenexa, KS
Prism Pharmaceuticals
King of Prussia, PA
thrombosis
Phase I
(913) 685-8850
(610) 265-7710
Plavix™
clopidogrel
Bristol-Myers Squibb
Princeton, NJ
sanofi-aventis
Bridgewater, NJ
prevention of thromboembolism
complications associated with
atrial fibrillation
in clinical trials
(212) 546-4000
(800) 633-1610
PSI-697/
WAY-197697
Wyeth Pharmaceuticals
Collegeville, PA
thrombosis
(see also atherosclerosis)
Phase I
(800) 934-5556
R1663
Roche
Nutley, NJ
thrombosis
Phase I
(973) 235-5000
RB006/RB007
Regado Biosciences
Durham, NC
thrombosis
Phase II
(919) 287-9428
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THROMBOSIS
Product Name
Sponsor
Indication
Development Status
Rendix™
dabigatran
etexilate
Boehringer Ingelheim
Pharmaceuticals
Ridgefield, CT
thromboembolism
(prevention and treatment)
Phase III
(203) 798-9988
rivaroxaban
Bayer HealthCare
Pharmaceuticals
Wayne, NJ
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
prevention of DVT,
pulmonary embolism and
thromboembolism in patients
undergoing hip or knee
replacement surgery
(see also acute coronary syndrome,
stroke)
application submitted
(888) 842-2937
saratin
BioVascular
San Diego, CA
thrombosis
Phase I/II
(858) 455-5000
SPP200
(PEG-hirudin)
Speedel Pharmaceuticals
(Novartis)
Bridgewater, NJ
thrombosis
Phase II
(see also peripheral vascular disease) (732) 537-2290
TAK-442
Takeda Pharmaceuticals
North America
Deerfield, IL
thromboembolism
(see also acute coronary syndrome)
TAL-0500018
Talecris Therapeutics
Rsch. Triangle Park, NC
thrombosis
Phase I
(see also peripheral vascular disease) (919) 316-6300
ticagrelor
AstraZeneca
Wilmington, DE
arterial thrombosis
(see also acute coronary syndrome)
Phase III
(800) 236-9933
tiplasinin
Wyeth Pharmaceuticals
Collegeville, PA
thrombosis
Phase I
(800) 934-5556
TNKase®
tenecteplase
Genentech
South San Francisco, CA
catheter thrombosis
(see also stroke)
Phase III
(800) 626-3553
TTP-889
TransTech Pharma
High Point, NC
thrombosis
Phase II
(336) 841-0300
YM-150
Astellas Pharma US
Deerfield, IL
DVT, thromboembolism
Phase II
(800) 727-7003
Product Name
Sponsor
Indication
Development Status
2190914
(AM103)
Amira Pharmaceuticals
San Diego, CA
GlaxoSmithKline
Rsch. Triangle Park, NC
cardiovascular disorders
Phase I
(858) 228-4650
(888) 825-5249
AM803
Amira Pharmaceuticals
San Diego, CA
GlaxoSmithKline
Rsch. Triangle Park, NC
cardiovascular disorders
Phase I
(858) 228-4650
(888) 825-5249
Aranesp®
darbepoetin alfa
Amgen
Thousand Oaks, CA
anemia in heart failure
Phase III
(805) 447-1000
OTHER
22
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Phase II
(877) 582-5332
Heart Disease and Stroke 2009
OTHER
Product Name
Sponsor
Indication
Development Status
ART-123
(recombinant
human
thrombomodulin
alpha)
Artisan Pharma
Waltham, MA
disseminated intravascular
coagulation
Phase II
(781) 419-1919
Certican®
everolimus
Abbott Laboratories
Abbott Park, IL
prevention of rejection episodes
following heart transplantation
application submitted
(847) 937-6100
Crestor®
rosuvastatin
Abbott Laboratories
Abbott Park, IL
AstraZeneca
Wilmington, DE
cardiovascular outcomes in patients
with elevated C-reactive protein
Phase III
(847) 937-6100
(800) 236-9933
DB-772d
Daiichi Sankyo
Parsippany, NJ
cardiovascular disorders
Phase I
(973) 359-2600
defibrotide
Sigma-Tau Pharmaceuticals venous-occlusive disorders
Gaithersburg, MD
droxidopa
Chelsea Therapeutics
Charlotte, NC
orthostatic hypotension
Evista®
raloxifene HCl
Eli Lilly
Indianapolis, IN
cardiovascular disorders
(see also lipid disorders)
Phase III
(800) 545-5979
fluasterone
(DHEA)
Aeson Therapeutics
Tucson, AZ
cardiovascular disorders
Phase II
(520) 748-4462
Fx 1006A
FoldRx Pharmaceuticals
Cambridge, MA
familial amyloid cardiomyopathy
Phase II
(617) 252-5500
Hemospan™
human
hemoglobin
Sangart
San Diego, CA
hypovolemia
Phase II
(858) 450-2400
INO-1001
Inotek Pharmaceuticals
Beverly, MA
cardiac reperfusion injury
Phase II
(978) 232-9660
iroxanadine
Cytrx
Los Angeles, CA
cardiovascular disorders
Phase II
(310) 826-5648
ISIS 353512
Isis Pharmaceuticals
Carlsbad, CA
cardiovascular disorders
Phase I
(760) 931-9200
ivabradine
Servier
Cedex, France
left ventricular dysfunction
Phase III
www.servier.com
Lantus®
insulin glargine
sanofi-aventis
Bridgewater, NJ
reduction in cardiovascular
morbidity and mortality
Phase III
(800) 633-1610
lixivaptan
Biogen Idec
Cambridge, MA
Cardiokine
Philadelphia, PA
hyponatremia
Phase III
(617) 679-2000
LY458202
Cardiome Pharma
Vancouver, BC
cardiogenic shock
Phase I
(800) 330-9928
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Phase III
(800) 447-0169
Phase III
(704) 341-1516
----------------------------------------------------------------------------------intradialytic hypotension
Phase II
(704) 341-1516
Heart Disease and Stroke 2009
23
OTHER
24
Product Name
Sponsor
Indication
Development Status
MK-0448
Merck
Whitehouse Station, NJ
cardiovascular disease
Phase I
(800) 672-6372
MK-1809
Merck
Whitehouse Station, NJ
cardiovascular disorders
Phase I
(800) 672-6372
MTR-104
Meditor Pharmaceuticals
Fort Lauderdale, FL
hypotension
Phase II
(904) 501-5882
mycophenolate
Novartis Pharmaceuticals
East Hanover, NJ
heart transplant rejection
in clinical trials
(888) 669-6682
PA32540
(aspirin/
omeprazole)
POZEN
Chapel Hill, NC
cardiovascular disorders
Phase I
(919) 913-1030
polidocanol
(intravenous)
BioForm
San Mateo, CA
Chemische Fabrik
KREUSSLER
Wiesbaden, Germany
varicose veins
Phase III
(650) 286-4000
polidocanol
(microfoam
formulation)
BTG International
West Conshohocken, PA
varicose veins
Phase II/III
(610) 278-1660
PolyHeme®
human
hemoglobin
Northfield Laboratories
Evanston, IL
hypovolemia
application submitted
(847) 864-3500
Rapamune®
sirolimus
Wyeth Pharmaceuticals
Collegeville, PA
heart transplant rejection
Phase II
(800) 934-5556
renin inhibitor
Actelion
Pharmaceuticals US
South San Francisco, CA
Merck
Whitehouse Station, NJ
cardiovascular disorders
Phase I
(650) 624-6900
(800) 672-6372
RVX-208
Resverlogix
Calgary, AB
cardiovascular disorders
Phase I/II
(403) 254-9252
Samska™
tolvaptan
Otsuka America
Pharmaceutical
Rockville, MD
hyponatremia
(see also heart failure)
application submitted
(800) 562-3974
SLx-2101
Surface Logix
Brighton, MA
cardiovascular disorders
Phase I
(617) 746-8500
tissue repair
stem cell therapy
Aastrom Biosciences
Ann Arbor, MI
cardiomyopathy
(see also ischemic disorders)
Phase II
(734) 930-5555
TP10
Celldex Therapeutics
Phillipsburg, NJ
reperfusion injury
Phase II
(908) 454-7120
Vascana™
nitroglycerin
topical
MediQuest Therapeutics
Bothell, WA
Raynaud’s disease
application submitted
(425) 398-9580
xemilofiban
VDDI Pharmaceuticals
Brentwood, TN
cardiovascular disorders
Phase III
(615) 467-3080
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OTHER
Product Name
Sponsor
Indication
Development Status
Zenapax®
daclizumab
PDL BioPharma
Incline Village, NV
heart transplant rejection
Phase III
(775) 832-8500
zoniporide
Pfizer
New York, NY
cardiovascular disorders
Phase II
(860) 732-5156
The content of this report has been obtained through industry sources and the Adis “R&D Insight” database based
on the latest information. Report current as of January 30, 2009. The information in this report may not be
comprehensive. For more specific information about a particular product, contact the individual company directly
or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA’s web site.
A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460
www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info | www.sharingmiracles.com
Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.
Copyright © 2009 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded
if proper credit is given.
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GLOSSARY
adjunctive therapy—Auxiliary
treatment that is secondary to the
main treatment.
the patient or by using synthetic
tubing.
angina pectoris—Chest pain,
usually caused by “myocardial
ischemia,” a low supply of oxygen
to the heart muscle resulting from
hardening, narrowing, and
sometimes spasm of the coronary
arteries.
cardiovascular—Of or relating to
the heart and blood vessels.
application submitted—An
application for marketing has been
submitted by the company to the
Food and Drug Administration
(FDA).
arrhythmia—Abnormal heart
rhythm, usually detected by an
electrocardiogram. Arrhythmias can
be caused by several factors, such
as coronary artery disease, heart
valve problems or hyperthyroidism.
atherosclerosis—A common
disease in which deposits of
plaque containing calcium and
fatty substances, such as
cholesterol, are formed within the
inner layers of the arteries. It is a
condition that progresses over
decades, chiefly affecting the
arteries of the heart, brain and
extremities. Its complications
include heart attacks and strokes.
atrial fibrillation and atrial flutter—
Very fast electrical discharge
patterns that make the heart’s atria
contract extremely rapidly, which
causes the ventricles to contract
faster and less efficiently than
normal. As a result, inadequate
amounts of blood are pumped out
of the heart, blood pressure falls,
and heart failure may occur.
bypass graft—A vein or artery graft
that bypasses blockage in an artery.
bypass surgery—A surgical
procedure to bypass the blockage
or narrowing of an artery. Blockages
can be bypassed using sections of
normal artery or vein taken from
26
substances, including cholesterol)
in the blood. Hyperlipidemia is
a risk factor for accelerated
atherosclerosis and premature
heart attacks.
cardiac—Of or relating to the heart.
hypertension (high blood
pressure)—Persistent elevation of
blood pressure above the normal
range while the heart is in systolic
(contracting) or diastolic (relaxed)
mode. Uncontrolled, chronic
hypertension strains the heart,
damages arteries and creates a
greater risk of heart attack, stroke
and kidney problems.
coronary artery disease—Caused
by atherosclerosis of the arteries
that supply the heart.
critical limb ischemia—CLI is a
severe obstruction of the arteries
that seriously decreases blood flow
to the extremities (arms, hands,
legs, feet) and has progressed to
the point of severe pain and even
skin ulcers of sores. The pain,
called “rest pain,” caused by CLI
can wake up a person at night. CLI
is a very severe condition of
peripheral arterial disease and
needs comprehensive treatment by
a vascular surgeon or specialist.
hypertriglyceridemia—An elevated
triglyceride concentration in the
blood.
hyponatremia—Reduced sodium
concentration in the blood.
hypotension—A sudden fall in
blood pressure that occurs when a
person assumes a standing position.
It may be caused by hypovolemia
resulting from the excessive use of
diuretics, vasodilators, or other
types of drugs, dehydration, or
prolonged bed rest. The disorder
may be associated with Addison’s
disease, atherosclerosis (build-up
of fatty deposits in the arteries),
diabetes, and certain neurological
disorders. Symptoms, which
generally occur after sudden
standing, include dizziness, lightheadedness, blurred vision, and the
temporary loss of consciousness.
deep vein thrombosis—Blood
clotting within the deep-lying
veins, often in the legs or pelvic
veins.
dyslipidemia—A condition marked
by abnormal concentrations of
lipids or lipoproteins in the blood.
heart attack (myocardial
infarction)—A part of the heart
muscle (myocardium) dies as a
result of blood and oxygen
deprivation.
heart failure—The end result of
many different types of heart
disease. The heart cannot pump
blood out normally. This results
in congestion (water and salt
retention) in the lungs, swelling
in the extremities, and reduced
blood flow to body tissues.
hypovolemia—A deficiency in the
amount of blood in the body.
imaging agent—A substance used
to enhance x-ray images of organs
and spaces in the body.
hypercholesterolemia—The
presence of an abnormally large
amount of cholesterol in the cells
and plasma of the circulating blood.
intermittent claudication—The
most prominent symptom of
peripheral arterial disease (PAD).
It occurs in one-third to one-half
of PAD patients. Claudication
refers to the pain that occurs in
PAD patients when they exercise,
hyperlipidemia—A group of
metabolic disorders characterized
by high levels of lipids (fatty
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GLOSSARY
particularly during walking, which
is relieved only by rest. Leg pain
occurs in one leg in 40 percent of
patients and in both legs in 60
percent of patients.
ischemia—Insufficient supply of
blood to an organ or tissue, which
can cause organ damage such as an
ischemic stroke.
lipids—A group of fatty substances
that includes triglycerides (the
principal forms of fat in body fat),
phospholipids (important
constituents of cell membranes),
and sterols (such as cholesterol).
peripheral vascular disease—The
obstruction of blood supply to the
extremities, particularly the legs,
caused by atherosclerosis.
Phase 0—First-in-human trials
conducted in accordance with
FDA’s 2006 guidance on
exploratory Investigational New
Drug (IND) studies designed to
speed up development of promising
drugs by establishing very early
on whether the agent behaves in
human subjects as was anticipated
from preclinical studies.
Phase I—Safety testing and
pharmacological profiling in
humans.
Phase II—Effectiveness testing in
humans.
Phase III—Extensive clinical trials
in humans.
plaque—An area of atherosclerosis
(hardening of the arteries). The
atheromatous plaques give no
indication of their presence until
they become so large that they
reduce blood flow in a vessel or
until some disturbance of the
plaque surface develops, causing
thrombosis (blood clot) at the site.
When this occurs in a small- or
medium-sized vessel, blockage is
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likely. Plaques in the coronary
arteries, which supply blood to the
heart muscle, are the cause of
coronary heart disease.
preeclampsia—The development
of hypertension with proteinuria or
edema, or both, due to pregnancy or
the influence of a recent pregnancy.
pulmonary hypertension—High
blood pressure in the arteries
supplying the lungs due to
increased resistance to blood flow
through the lungs.
Raynaud’s disease—A circulatory
disorder caused by insufficient
blood supply to the hands and feet,
resulting in cyanosis, numbness,
pain, and, in extreme cases,
gangrene.
reperfusion injury—Refers to
myocardial, vascular, or electrophysiological dysfunction that is
induced by the restoration of blood
flow to previously ischemic tissue.
restenosis—A condition where an
artery plugs up again following
treatment to open it up.
stroke—A blood clot obstructing a
major blood vessel of the brain or
by bleeding into a major brain
blood vessel. Stroke can result in
death or serious brain damage,
such as paralysis or loss of
speech.
supraventricular arrhythmia—
Irregular heart beats (arrhythmias)
that occur in the area above the
ventricles, usually in the upper
chambers of the heart, called the
atria. The irregular beats can be
either too slow (bradycardia) or
too fast (tachycardia).
supraventricular tachycardia—An
abnormally fast but regular heart
rate that occurs in intermittent
episodes lasting for several hours
or days. It is caused by abnormal
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Heart Disease and Stroke 2009
electrical impulses arising within
the upper chambers of the heart
taking over control of the heart
beat from the heart’s pacemaker
(sinoatrial node).
systolic—A period of muscular
contraction of a chamber of the
heart that alternates with a resting
period (diastolic).
thromboembolism—Blockage of a
blood vessel by a fragment that
has broken off and been carried
from a thrombus (blood clot)
elsewhere in the circulation.
thrombosis—The formation of a
blood clot within the heart or a
blood vessel.
vascular dementia—A common
form of dementia in older people
that is due to cerebrovascular
disease, usually with stepwise
deterioration from a series of small
strokes and a patchy distribution
of neurologic deficits affecting
some functions and not others.
Risk factors include high blood
pressure and advanced age.
Symptoms include confusion,
problems with recent memory,
wandering or getting lost in familiar
places, incontinence, emotional
problems such as laughing or crying
inappropriately, and difficulty
following instructions. The damage
is typically so slight that the change
is noticeable only as a series of
small steps. However, over time,
as more small blood vessels in the
brain are blocked, there is noticeable gradual mental decline.
Vascular dementia commonly
begins between the ages of 60
and 75 and affects men more
often than women. It is also known
as multi-infarct dementia.
vasospasm—A sudden constriction
of a blood vessel that reduces the
blood flow.
27
SELECTED FACTS ABOUT HEART DISEASE
STROKE IN THE UNITED STATES
AND
Cardiovascular Diseases (CVD)1
• More than 80.7 million American adults (37.9 million men; 42.7 million women) have one or more types of
CVD. Of that total, 38.2 million are estimated to be age 60 and older.
• The average annual rates of first major cardiovascular events rise from 3 per 1,000 men at ages 35-44 to 74 per
1,000 at ages 85-94. For women, comparable rates occur 10 years later in life, and the gap narrows with
advancing age.
• CVD accounted for 36.3 percent of all 2,397,615 deaths, or 1 of every 2.8 deaths, in 2004. CVD total mention
deaths accounted for about 57 percent of all deaths in 2004. Nearly 2,400 Americans die of CVD each day, an
average of one death every 37 seconds. CVD claims about as many lives each year as cancer, chronic lower
respiratory diseases, accidents, and diabetes mellitus combined.
• More than 148,000 Americans killed by CVD in 2004 were under age 65.
• The estimated direct and indirect costs of CVD for 2008 are $448.5 billion.
Arrhythmias
• Millions of Americans have arrhythmias (disorders of heart rhythm), which are very common in older adults.2
• Arrhythmias were responsible for 835,000 hospital discharges and for 37,633 deaths in 2005.3
• About 2.2 million Americans have atrial fibrillation (AF).2
• In 2006, $3.1 billion ($7,783 per discharge) was paid to Medicare beneficiaries for cardiac dysrhythmias.3
Arterial Diseases 2
• Atherosclerosis of the coronary arteries is the leading cause of illness and death in the United States. In men,
the risk increases after age 45; in women, the risk increases after age 55.
Coronary Heart Disease (CHD)1
(Heart Attack, Angina Pectoris, or both)
• In 2005, 16 million American adults (age 20 and older) suffered from coronary heart disease (8.7 million men;
7.3 million women). Annually, more than 1 million people are diagnosed with CHD (710,000 males; 490,000
females). Nearly half a million Americans die each year from CHD, which caused one of every five deaths in
2004. About 82 percent of the people who die of CHD are age 65 or older.
• CHD comprises more than half of all cardiovascular events in men and women under age 75. The lifetime risk
of developing CHD after age 40 is 49 percent for men and 32 percent for women.
• In 2005, of the 9.1 million Americans who had angina pectoris, 4.6 million were women and 4.4 million were
men. Each year, some 500,000 people are diagnosed with stable angina.
• In 2005, 920,000 new or recurrent myocardial infarctions (MIs or heart attack) occurred, and in 2004 nearly
157,000 people died. In addition, some 190,000 silent first heart attacks occur annually. The average age of a
person having a first heart attack is 64.5 for men and 70.4 for women.
• Within one year following a first MI, at age 40 and older, 18 percent of men and 23 percent of women will die;
within five years for that same age group, 33 percent of men and 43 percent of women will die.
• The estimated direct and indirect costs of CHD for 2008 are $156.4 billion.
Heart Failure (HF)1
• Of the 5.3 million adults living with heart failure (HF), 2.7 million are women and 2.7 million are men. At
age 40, the lifetime risk of developing HF for both men and women is 1 in 5. High blood pressure precedes
75 percent of HF cases.
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SELECTED FACTS ABOUT HEART DISEASE
STROKE IN THE UNITED STATES
AND
Heart Failure (HF)1 (continued)
• In 2004, 57,120 people died from HF. Eighty percent of men and 70 percent of women under age 65 who have
HF will die within eight years.
• In people diagnosed with HF, sudden cardiac death occurs up to nine times the rate of the general population.
• Hospital discharges for HF rose from 400,000 in 1979 to nearly 1.1 million in 2005, an increase of 171 percent.
• The estimated direct and indirect costs of HF for 2008 are $34.8 billion.
Hypertension 1
(High Blood Pressure—HBP)
• In 2005, 73 million people (39 million females and 34 million males) had high blood pressure (HBP). Nearly one in
three adults has HBP. Of those with HBP age 18 and older, 71.8 percent were aware of their condition, 61.4 percent
were under current treatment, 35.1 percent had it under control, and 64.9 percent did not have it controlled.
• A higher percentage of men than women have HBP until age 45. From ages 45-54, the percentage of men and
women is similar. After that, a much higher percentage of women have HBP than men do.
• The prevalence of HBP in African Americans is among the highest in the world, and it is increasing. Compared
with whites, blacks develop HBP earlier in life and their average blood pressures are much higher. As a result,
blacks have a 1.3 times greater rate of nonfatal stroke, a 1.8 times greater rate of fatal stroke, a 1.5 times greater
rate of heart disease death, and a 4.2 times greater rate of end-stage kidney disease.
• In 2004, HBP was responsible for 54,707 deaths—23,099 males and 31,608 females. That year, the death rates
for HBP were 15.7 for white males, 51 for black males, 14.5 for white females, and 40.9 for black females.
• The estimated direct and indirect costs of HBP for 2008 are $69.4 billion.
Lipid Disorders 1
• Among adolescents ages 12-19, the mean total blood cholesterol level is 161.7 mg/dL. About 10 percent of
adolescents in that age group have total cholesterol levels exceeding 200 mg/dL.
• The 2005 estimated prevalence of total cholesterol in adults age 20 and older at or above 200 mg/dL was
106.7 million (50.8 million men; 55.9 million women). Overall in 2005, 35.6 percent of adults age 18 and older
had been told that they had high blood cholesterol.
Peripheral Vascular Disease 1
• Peripheral arterial disease (PAD) affects about 8 million Americans and is associated with significant morbidity
and mortality. PAD affects between 12 percent to 20 percent of Americans age 65 and older.
• In the general population, only about 10 percent of people with PAD have the classic symptoms of intermittent
claudication, which is present in less than 1 percent of people under age 50 and about 5 percent or more in
those over age 80.
Risk Factors 1
• The 2005 estimated prevalence of physician-diagnosed diabetes among adults age 20 and older was 15.1 million.
The prevalence of undiagnosed diabetes was 6 million. About 154,369 people age 20 or younger have diabetes.
The incidence of diabetes doubled over the past 30 years, most dramatically during the 1990s.
• At least 65 percent of people with diabetes mellitus die of some form of heart disease or stroke. Heart disease
death rates among adults with diabetes are two to four times higher than the rates for adults without diabetes.
People who have diabetes are about two to six times more likely to have a stroke.
• More than 9 million children and adolescents ages 6-19 are considered overweight. The prevalence of overweight
in children ages 6-11 increased from 4 percent between 1971-74 to 17.5 percent between 2001-04. The prevalence
of overweight in adolescents ages 12-19 increased from 6.1 percent to 17 percent during the same time periods.
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SELECTED FACTS ABOUT HEART DISEASE
STROKE IN THE UNITED STATES
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Risk Factors 1 (continued)
• In 2005, an estimated 142 million U.S. adults (age 20 and older) were overweight, and 67.3 million were obese.
• About 80 percent of people who use tobacco start doing so before age 18. The most common age of initiation is
14-15. Each day, about 4,000 people ages 12-17 begin smoking cigarettes in the United States, and an estimated
1,140 people in that age group become daily smokers.
• In 2005, the estimated prevalence for smoking among people age 18 and older was 46.6 million. That’s
23.9 percent of men and 18.1 percent of women who are smokers, putting them at increased risk of heart
attack and stroke. Since 1965, smoking in the United States has declined by 50 percent among people in
that age group.
• From 1997-2001, an estimated 438,000 Americans died each year of smoking-related illnesses, and 34.7 percent
of these deaths were related to cardiovascular disease.
• Cigarette smoking results in a two- to three-fold risk of dying from coronary heart disease (CHD), and it
approximately doubles a person’s risk for stroke. Cigarette smokers are two to four times more likely to develop
CHD than nonsmokers and are more than 10 times as likely as nonsmokers to develop peripheral vascular
disease.
Stroke 1
• On average, someone in this country has a stroke every 40 seconds. In 2005, 5.8 million Americans (3.4 million
females; 2.3 million males) suffered a stroke, and each year about 780,000 people experience a new or recurrent
stroke.
• African Americans have almost twice the risk of first-ever stroke compared with whites. In 2004, death rates for
stroke were 48.1 for white males, 74.9 for black males, 47.2 for white females, and 65.5 for black females.
• Of all strokes, 87 percent are ischemic; strokes due to intracerebral hemorrhage and subarachnoid hemorrhage
make up the remainder. Among people ages 45-64, up to 12 percent of ischemic strokes and 38 percent of
hemorrhagic strokes result in death within 30 days.
• On average, every three to four minutes someone dies of a stroke, which accounted for about one of every
16 deaths in 2004. That year, 150,074 people died of stroke—91,274 females and 58,800 males. Stroke ranks
as the third leading cause of death behind diseases of the heart and cancer.
• The estimated direct and indirect costs of stroke for 2008 are $65.5 billion.
Sources:
1. Heart Disease and Stroke Statistics—2008 Update (At-A-Glance Version), American Heart Association,
www.americanheart.org
2. National Heart, Lung and Blood Institute, www.nhlbi.nih.gov
3. Heart Disease and Stroke Statistics—2009 Update, American Heart Association, www.americanheart.org
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T H E D R U G D I S C O V E RY, D E V E L O P M E N T
AND
APPROVAL PROCESS
It takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000
compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.
Clinical Trials
Phase
II
Phase
III
FDA
Years
6.5
1.5
2
3.5
1.5
Test
Population
Laboratory and
animal studies
20 to 100
healthy
volunteers
100 to 500
patient
volunteers
1,000 to 5,000
patient
volunteers
Determine
safety
and
dosage
Evaluate
effectiveness,
look for
side effects
Confirm effectiveness,
monitor adverse
reactions from
long-term use
Assess safety,
biological
activity and
formulations
Purpose
Success
Rate
5
enter trials
5,000
compounds evaluated
THE DRUG DEVELOPMENT
T
he U.S. system of new drug approvals is perhaps
the most rigorous in the world.
It takes 10-15 years, on average, for an experimental
drug to travel from lab to U.S. patients, according to
the Tufts Center for the Study of Drug Development,
based on drugs approved from 1994 through 1998.
Only five in 5,000 compounds that enter preclinical
testing make it to human testing. And only one of those
five is approved for sale.
On average, it costs a company $1.3 billion to get
one new medicine from the laboratory to U.S. patients,
according to a 2007 study by the Tufts Center for the
Study of Drug Development.
Once a new compound has been identified in the
laboratory, medicines are developed as follows:
Preclinical Testing. A pharmaceutical company conducts laboratory and animal studies to show biological
activity of the compound against the targeted disease,
and the compound is evaluated for safety.
Investigational New Drug Application (IND). After
completing preclinical testing, a company files an IND
with the U.S. Food and Drug Administration (FDA) to
begin to test the drug in people. The IND becomes
effective if FDA does not disapprove it within 30 days.
The IND shows results of previous experiments; how,
where and by whom the new studies will be conducted;
the chemical structure of the compound; how it is
thought to work in the body; any toxic effects found
in the animal studies; and how the compound is manufactured. All clinical trials must be reviewed and
approved by the Institutional Review Board (IRB)
where the trials will be conducted. Progress reports
on clinical trials must be submitted at least annually
to FDA and the IRB.
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File NDA/BLA at FDA
Phase
I
File IND at FDA
Discovery/
Preclinical Testing
Review
process/
approval
Phase
IV
Additional
postmarketing
testing
required
by FDA
1
approved
APPROVAL PROCESS
Clinical Trials, Phase I. These tests involve about 20
to 100 normal, healthy volunteers. The tests study a
drug’s safety profile, including the safe dosage range.
The studies also determine how a drug is absorbed,
distributed, metabolized, and excreted as well as the
duration of its action.
Clinical Trials, Phase II. In this phase, controlled
trials of approximately 100 to 500 volunteer patients
(people with the disease) assess a drug’s effectiveness.
Clinical Trials, Phase III. This phase usually involves
1,000 to 5,000 patients in clinics and hospitals.
Physicians monitor patients closely to confirm efficacy
and identify adverse events.
New Drug Application (NDA)/Biologic License
Application (BLA). Following the completion of all
three phases of clinical trials, a company analyzes all
of the data and files an NDA or BLA with FDA if the
data successfully demonstrate both safety and effectiveness. The applications contain all of the scientific
information that the company has gathered.
Applications typically run 100,000 pages or more.
The average review time for the 26 new therapeutics
approved by the FDA in 2007 was 11.1 months.
Approval. Once FDA approves an NDA or BLA, the
new medicine becomes available for physicians to
prescribe. A company must continue to submit periodic
reports to FDA, including any cases of adverse reactions
and appropriate quality-control records. For some
medicines, FDA requires additional trials (Phase IV) to
evaluate long-term effects.
Discovering and developing safe and effective new
medicines is a long, difficult, and expensive process.
Pharmaceutical companies invested an estimated
$58.8 billion in research and development in 2007.
Heart Disease and Stroke 2009
31
Medicines in Development for Heart Disease and Stroke is presented by PhRMA in cooperation with
the following organizations:
American Association of Cardiovascular and Pulmonary Rehabilitation
American College of Cardiology
American Nurses Association
American Society of Hypertension
Children’s Cardiomyopathy Foundation
The Children’s Heart Foundation
Interamerican College of Physicians and Surgeons
National Alliance for Hispanic Health
National Hypertension Association
National Medical Association
Pulmonary Hypertension Association
WomenHeart: The National Coalition for Women with Heart Disease
Women’s Heart Foundation
Being listed in this report in no way implies that the above-mentioned organizations endorse or
recommend the use of any of the products in development contained in this publication. For further
information, patients should consult their physicians or health care providers.
New Medicines. New Hope.®
Pharmaceutical Research and Manufacturers of America
950 F Street, NW
Washington, DC 20004
www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info | www.sharingmiracles.com
2/09