20
13 R
EPO
RT
Biopharmaceutical research companies
are developing 465 medicines and vac-
cines for the 10 leading chronic diseases
affecting Medicare beneficiaries.* This
report lists medicines and vaccines in
human clinical trials or under review by
the U.S. Food and Drug Administration
(FDA).
The medicines in development include:
• 142 for diabetes, which affects 10.9
million Americans age 65 and older.
• 92 for rheumatoid arthritis and osteo-
arthritis, which affects 12.4 million
people, age 65 and older.
• 82 for Alzheimer’s disease, which
could afflict nearly 8 million people by
2030 unless a cure or prevention is
found.
• 48 for heart failure and ischemic heart
disease, two of many cardiovascular dis-
eases affecting 80.7 million Americans,
half of which are age 60 and older.
• 40 for COPD, which affects Americans
over age 65 at a higher rate.
• 34 for depression, which affects an
estimated 6.5 million Americans age
65 and older.
• 20 for chronic kidney disease, where
prevalence grows with older age.
• 15 for osteoporosis, a major health
threat for an estimated 44 million
Americans.
Definitions for selected terms can be
found on page 36. A link to the sponsor
company’s web site provides more de-
tailed information on the science behind
each potential product.
For information on the value of medicines,
an in-depth look at current innovation
and key medical breakthroughs benefit-
ing older Americans, please see Medi-
cines in Development for Older Ameri-
cans 2013—Overview.
The medicines in this report provide hope
to older Americans who suffer from these
debilitating chronic diseases and are
seeking to live longer, more independent
and healthier lives.
More Than 400 Medicines in Development for
Leading Chronic Diseases Affecting Older Americans
MeDiCines in DeveLOpMenT
Older Americans
The Medicare population and Leading Chronic Diseases
presenTeD by AMeriCA’s biOphArMACeuTiCAL reseArCh COMpAnies
D
ep
re
ss
io
n
Ar
th
rit
is
82
92
40
C
O
PD
D
ia
be
te
s
34
142
H
ea
rt
D
is
ea
se
48
Al
zh
ei
m
er
’s
Application
Submitted
Phase III
Phase II
Phase I
Medicines in Development
For Leading Chronic
Diseases Affecting seniors
*Centers for Medicare and Medicaid Services (CMS), Chronic Condition Data Warehouse (CCW) Medicare 5% Sample, 2009
OSTEOARTHRITIS
CHRONIC KIDNEY DISEASE COPD
HEART FAILURE
ISCHEMIC HEART DISEASE
AL
ZH
EI
M
ER
'S
DE
M
EN
TI
A
RHEUMATOID ARTHRITIS
CATARACTS
DEPRESSION
DIABETES
OSTEOPOROSIS
ALZHEIMER'S DISEASE
DEM
EN
TIA
RHEUM
ATOID ARTHRITIS
CATARACTS
CHRONIC KIDNEY DISEASE
COPD
DEPRESSION
DIABETES
OSTEOPOROSIS
HAVE PRESCRIPTION DRUG COVERAGEHAVE PRESCRIPTION DRUG COVERAGE
MORE4040THANMORETHAN MILLION MEDICARE RECIPIENTSMILLION MEDICARE RECIPIENTS
9090BENEFICIARIESPERCENT OF ALLBENEFICIARIESPERCENT OF ALL
Medicines in Development Older Americans 20132
Medicines in Development for Older Americans
*For more information about a specific medicine or company in the report, please click on the provided link.
Alzheimer’s Disease and Dementia
Product Name Sponsor Indication Development Phase*
18F-florbetaben
(BAY 94-9172)
Piramal Healthcare
Mumbai, India
Alzheimer’s disease (diagnosis) Phase III
piramalenterprises.com
AAB-003/PF-05236812
(amyloid beta protein inhibitor)
Janssen Alzheimer Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease Phase I
janimm.com
pfizer.com
ABT-126
(α7-NNR antagonist)
AbbVie
North Chicago, IL
mild to moderate Alzheimer’s
disease
Phase II
abbvie.com
ABT-288
(neurotransmitter receptor
modulator)
AbbVie
North Chicago, IL
Alzheimer’s disease Phase II completed
abbvie.com
ABT-384 AbbVie
North Chicago, IL
Alzheimer’s disease Phase II completed
abbvie.com
ABT-957
(calpain inhibitor)
AbbVie
North Chicago, IL
Alzheimer’s disease Phase I
abbvie.com
AC-1204 Accera
Broomfield, CO
Alzheimer’s disease Phase II/III
accerapharma.com
ACC-001/PF-05236806 Janssen Alzheimer Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease Phase II
janimm.com
pfizer.com
AD02 vaccine Affiris
Vienna, Austria
GlaxoSmithKline
Rsch. Triangle Park, NC
treatment of Alzheimer’s disease Phase II
gsk.com
AD03 vaccine Affiris
Vienna, Austria
GlaxoSmithKline
Rsch. Triangle Park, NC
treatment of Alzheimer’s disease Phase I
gsk.com
AD4833/TOMM40 Takeda Pharmaceuticals International
Deerfield, IL
Alzheimer’s disease prevention Phase I
takeda.com
APH-0703
(protein kinase C activator)
Aphios
Woburn, MA
Alzheimer’s disease Phase I/II
aphios.com
Medicines in Development Older Americans 2013 3
Medicines in Development for Older Americans
Alzheimer’s Disease and Dementia
Product Name Sponsor Indication Development Phase
ARC029
(nilvadipine)
Archer Pharmaceuticals
Sarasota, FL
Alzheimer’s disease Phase I
archerpharma.com
ARC031
(soluble amyloid reducing/clearing
agent)
Archer Pharmaceuticals
Sarasota, FL
Alzheimer’s disease Phase I
archerpharma.com
ARC031 SR
(soluble amyloid reducing/clearing
agent)
Archer Pharmaceuticals
Sarasota, FL
Alzheimer’s disease Phase I
archerpharma.com
AVN 101
(serotonin 5-HT6 receptor
antagonist)
Avineuro Pharmaceuticals
San Diego, CA
Alzheimer’s disease Phase II
avineuro.com
AVN 322
(serotonin 5-HT6 receptor
antagonist)
Avineuro Pharmaceuticals
San Diego, CA
Alzheimer’s disease Phase I
avineuro.com
AVN 397 Avineuro Pharmaceuticals
San Diego, CA
Alzheimer’s disease Phase II
avineuro.com
AZD1446
(alpha4/beta2 neuronal nicotinic
receptor agonist)
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
Alzheimer’s disease Phase I
astrazeneca.com
AZD2184
(PET imaging)
Navidea Biopharmaceuticals
Dublin, OH
Alzheimer’s disease (diagnosis) Phase I
navidea.com
AZD2995
(PET imaging)
Navidea Biopharmaceuticals
Dublin, OH
Alzheimer’s disease (diagnosis) Phase I
navidea.com
AZD3293
(beta secretase)
AstraZeneca
Wilmington, DE
Astex Pharmaceuticals
Dublin, CA
Alzheimer’s disease Phase I
astrazeneca.com
AZD5213
(histamine-3 receptor antagonist)
AstraZeneca
Wilmington, DE
Alzheimer’s disease Phase II
astrazeneca.com
ß-secretase inhibitor
(LY2886721)
Eli Lilly
Indianapolis, IN
Alzheimer’s disease
(slow disease progression)
Phase II
lilly.com
BAN2401 Eisai
Woodcliff Lake, NJ
early-stage Alzheimer’s disease Phase II
eisai.com
BAY 85-8101
(18F-labeled radiopharmaceutical)
Piramal Healthcare
Mumbai, India
Alzheimer’s disease (diagnosis) Phase I completed
piramalenterprises.com
Medicines in Development Older Americans 20134
Medicines in Development for Older Americans
Alzheimer’s Disease and Dementia
Product Name Sponsor Indication Development Phase
BIIB037
(anti-ß-amyloid antibody)
Biogen Idec
Weston, MA
Alzheimer’s disease Phase I
biogenidec.com
bisnorcymserine
(BNC)
QR Pharma
Berwyn, PA
Alzheimer’s disease Phase I
qrpharma.com
BMS-241027
(microtubule stabilizer)
Bristol-Myers Squibb
Princeton, NJ
Alzheimer’s disease,
senile dementia
Phase I
bms.com
CAD106 Novartis Pharmaceuticals
East Hanover, NJ
Alzheimer’s disease Phase II
novartis.com
CERE-110
(AAV-NGF gene therapy)
Ceregene
San Diego, CA
Alzheimer’s disease Phase II
ceregene.com
crenezumab
(anti-Abeta)
Genentech
South San Francisco, CA
Alzheimer’s disease Phase II
gene.com
davunetide intranasal Allon Therapeutics
Vancouver, Canada
Alzheimer’s disease Phase II
allontherapeutics.com
donepezil/memantine
extended-release fixed-dose
combination
Adamas Pharmaceuticals
Emeryville, CA
Forest Laboratories
New York, NY
moderate to severe Alzheimer’s
disease
Phase II
adamaspharma.com
frx.com
DSP-8658
(PPAR alpha/gamma agonist)
Sunovion Pharmaceuticals
Marlborough, MA
Alzheimer’s disease
(see also diabetes)
Phase I
sunovion.com
E2609 Eisai
Woodcliff Lake, NJ
Alzheimer’s disease Phase I completed
eisai.com
ELND005
(amyloid beta-protein inhibitor)
Elan
Dublin, Ireland
Alzheimer’s disease Phase II
elan.com
EVP-0962
(gamma secretase modulation)
EnVivo Pharmaceuticals
Watertown, MA
Alzheimer’s disease Phase II
envivopharma.com
EVP-6124
(nicotine A7 agonist)
EnVivo Pharmaceuticals
Watertown, MA
Alzheimer’s disease Phase II
envivopharma.com
Exebryl-1®
Alzheimer’s disease therapeutic
ProteoTech
Kirkland, WA
Alzheimer’s disease Phase I
proteotech.com
F-18 T808
(PET imaging agent)
Siemens Molecular Imaging
Malvern, PA
Alzheimer’s disease (diagnosis) Phase 0
medical.siemens.com
F18-flutemetamol
(PET imaging agent)
GE Healthcare
Waukesha, WI
Alzheimer’s disease (diagnosis) application submitted
gehealthcare.com
Medicines in Development Older Americans 2013 5
Alzheimer’s Disease and Dementia
Product Name Sponsor Indication Development Phase
Gammagard®
immune globulin
Baxter International
Deerfield, IL
early-stage Alzheimer’s disease,
mid-stage Alzheimer’s disease
Phase III
baxter.com
gamma secretase modulator,
A-beta modulator
Bristol-Myers Squibb
Princeton, NJ
Alzheimer’s disease,
senile dementia
in clinical trials
bms.com
gantenerumab
(amyloid beta-protein inhibitor)
Roche
Nutley, NJ
early-stage Alzheimer’s disease Phase II/III
roche.com
GSK742457
(5-HT6 receptor antagonist)
GlaxoSmithKline
Rsch. Triangle Park, NC
dementia Phase II
gsk.com
GSK2647544
(Lp-PLA2 inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
Alzheimer’s disease Phase I
gsk.com
HPP 854
(BACE1 protein inhibitor)
High Point Pharmaceuticals
High Point, NC
Alzheimer’s disease Phase I
highpointpharma.com
human immunoglobulin
(intravenous)
Grifols
Los Angeles, CA
Alzheimer’s disease Phase III
grifols.com
KU-046
(amyloid-ß protein modulator)
Kareus Therapeutics
La Chaux-de-Fonds, Switzerland
Alzheimer’s disease Phase I
kareustherapeutics.com
Lu AE58054 Lundbeck USA
Deerfield, IL
Alzheimer’s disease Phase II
lundbeck.com
masitinib
(AB-1010)
AB Science USA
Short Hills, NJ
Alzheimer’s disease Phase III completed
ab-science.com
MCD-386 Mithridion
Madison, WI
Alzheimer’s disease Phase I
mithridion.com
MK-3328
(PET imaging)
Merck
Whitehouse Station, NJ
Alzheimer’s disease (diagnosis) Phase I completed
merck.com
MK-8931
(BACE1 protein inhibitor)
Merck
Whitehouse Station, NJ
Alzheimer’s disease Phase II/III
merck.com
MSDC-0160 Metabolic Solutions Development
Kalamazoo, MI
Alzheimer’s disease
(see also diabetes)
Phase II
msdrx.com
NAV4694
(fluorine-18 labeled PET
imaging agent)
Navidea Biopharmaceuticals
Dublin, OH
Alzheimer’s disease (diagnosis) Phase III
navidea.com
NIC5-15 Humanetics
Minneapolis, MN
Alzheimer’s disease Phase II
humaneticscorp.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 20136
Alzheimer’s Disease and Dementia
Product Name Sponsor Indication Development Phase
PF-05212377
(SAM-760)
Pfizer
New York, NY
Alzheimer’s disease Phase II
pfizer.com
Posiphen®
R-phenserine
QR Pharma
Berwyn, PA
Alzheimer’s disease,
mild cognitive impairment
Phase II
qrpharma.com
PRX-3140
(serotonin 4 receptor agonist)
Nanotherapeutics
Alachua, FL
Alzheimer’s disease Phase II
nanotherapeutics.com
RG1577
(MAO-B inhibitor)
Roche
Nutley, NJ
Alzheimer’s disease Phase II
roche.com
RG7129
(BACE-1 inhibitor)
Roche
Nutley, NJ
Alzheimer’s disease Phase I
roche.com
rilapladib
(Lp-PLA2 inhibitor)
GlaxoSmithKline
Rsch. Triangle Park, NC
Alzheimer’s disease Phase II
gsk.com
RVX-208 Resverlogix
Calgary, Canada
Alzheimer’s disease Phase I
resverlogix.com
SAR110894
(H3 antagonist)
Sanofi US
Bridgewater, NJ
Alzheimer’s disease Phase II
sanofi.com
SAR228810
(anti-protofibrillar AB mAb)
Sanofi US
Bridgewater, NJ
Alzheimer’s disease Phase I
sanofi.com
sGC-1061 sGC Pharma
Wellesley, MA
Alzheimer’s disease Phase I
sgcpharma.com
solanezumab
(LY2062430)
Eli Lilly
Indianapolis, IN
Alzheimer’s disease Phase III
lilly.com
ST101 Sonexa Therapeutics
San Diego, CA
Alzheimer’s disease Phase II
sonexa.com
T-817MA
(amyloid beta-protein inhibitor)
Toyota Chemical
Tokyo, Japan
mild to moderate Alzheimer’s
disease
Phase II completed
toyama-chemical.co.jp
TAK-357
(oral cognitive enhancer)
Takeda Pharmaceuticals International
Deerfield, IL
Alzheimer’s disease Phase I
takeda.com
TC-1734
(alpha4/beta2 neuronal nicotinic
receptor agonist)
Targacept
Winston-Salem, NC
Alzheimer’s disease Phase II
targacept.com
TC-5619
(alpha7 nAChR)
Targacept
Winston-Salem, NC
Alzheimer’s disease Phase I
targacept.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 7
Alzheimer’s Disease and Dementia
Product Name Sponsor Indication Development Phase
TRx-0237
(LMTX)
TauRx Therapeutics
Singapore, Republic of Singapore
Alzheimer’s disease, dementia Phase III
taurx.com
TTP4000 TransTech Pharma
High Point, NC
Alzheimer’s disease Phase I
ttpharma.com
TTP488 TransTech Pharma
High Point, NC
Alzheimer’s disease Phase II
ttpharma.com
UB-311
(amyloid beta protein inhibitor
vaccine)
United Biomedical
Hauppauge, NY
mild to moderate Alzheimer’s
disease
Phase I
unitedbiomedical.com
V950 Merck
Whitehouse Station, NJ
Alzheimer’s disease Phase I
merck.com
velusetrag
(TD-5108)
Theravance
South San Francisco, CA
Alzheimer’s disease Phase I completed
theravance.com
VI-1121 VIVUS
Mountain View, CA
Alzheimer’s disease Phase II
vivus.com
XEL-001HP
(transdermal patch)
Xel Pharmaceuticals
Draper, UT
Alzheimer’s disease Phase I
xelpharmaceuticals.com
Arthritis
Product Name Sponsor Indication Development Phase
2ME2 EntreMed
Rockville, MD
rheumatoid arthritis Phase I
entremed.com
ABT-122
(anti-TNF/anti-IL-17 mAb)
AbbVie
North Chicago, IL
rheumatoid arthritis Phase I
abbvie.com
ABT-413
(sphingosine 1 phosphate receptor
modulator)
AbbVie
North Chicago, IL
rheumatoid arthritis Phase I
abbvie.com
ABT-494
(JAK-1, 2, 3 inhibitor)
AbbVie
North Chicago, IL
rheumatoid arthritis Phase I
abbvie.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 20138
Arthritis
Product Name Sponsor Indication Development Phase
ABT-652
(histamine H3 receptor modulator)
AbbVie
North Chicago, IL
osteoarthritis of the knee Phase II
abbvie.com
ABT-981
(anti-IL-1 α and β mAb)
AbbVie
North Chicago, IL
osteoarthritis Phase I
abbvie.com
Actemra®
tocilizumab
Genentech
South San Francisco, CA
Roche
Nutley, NJ
rheumatoid arthritis
(first-line therapy)
--------------------------------------
rheumatoid arthritis
(early-stage disease)
application submitted
gene.com
roche.com
-----------------------------------------
Phase III
gene.com
roche.com
adalimumab biosimilar Boehringer Ingelheim Pharmaceuticals
Ridgefield, CT
rheumatoid arthritis Phase I completed
boehringer-ingelheim.com
AF-219
(purinoceptor P2X3 antagonist)
Afferent Pharmaceuticals
San Mateo, CA
osteoarthritis Phase II
afferentpharma.com
AIN457
(secukinumab)
Novartis Pharmaceuticals
East Hanover, NJ
rheumatoid arthritis Phase III
novartis.com
ARG301 arGentis Pharmaceuticals
Memphis, TN
rheumatoid arthritis Phase I
argentisrx.com
ARRY-797
(p38 MAPK inhibitor)
Array BioPharma
Boulder, CO
moderate to severe pain associated
with osteoarthritis of the knee
Phase II
arraybiopharma.com
ASP015K
(JAK-3 inhibitor)
Astellas Pharma US
Northbrook, IL
rheumatoid arthritis Phase II
astellas.com
ASP2408
(CTLA4-Ig fusion protein)
Perseid Therapeutics
Redwood City, CA
rheumatoid arthritis Phase I
perseidtherapeutics.com
baricitinib
(LY3009104)
Eli Lilly
Indianapolis, IN
rheumatoid arthritis
(see also chronic kidney)
Phase III
lilly.com
BI-695500
(rituximab biosimilar)
Boehringer Ingelheim Pharmaceuticals
Ridgefield, CT
rheumatoid arthritis Phase III
boehringer-ingelheim.com
BMS-817399
(CCR1 antagonist)
Bristol-Myers Squibb
Princeton, NJ
osteoarthritis,
rheumatoid arthritis
Phase II
bms.com
BT-061 AbbVie
North Chicago, IL
Biotest
Dreieich, Germany
rheumatoid arthritis Phase II
abbvie.com
biotest.de
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 9
Arthritis
Product Name Sponsor Indication Development Phase
buprenorphine transmucosal BioDelivery Sciences International
Raleigh, NC
Endo Pharmaceuticals
Malvern, PA
chronic pain associated with
osteoarthritis
Phase III
bdsi.com
endo.com
canakinumab
(ACZ885)
Novartis Pharmaceuticals
East Hanover, NJ
gouty arthritis
(see also diabetes)
--------------------------------------
osteoarthritis
application submitted
novartis.com
-----------------------------------------
Phase II
novartis.com
cebranopadol Forest Laboratories
New York, NY
pain due to osteoarthritis of the
knee
Phase II
frx.com
CEP-33237
(hydrocodone extended-release)
Cephalon
Frazer, PA
osteoarthritis pain Phase III
cephalon.com
CF101 Can-Fite BioPharma
Waltham, MA
rheumatoid arthritis Phase II
canfite.com
Chondrogen™
mesenchymal stem cell therapy
Osiris Therapeutics
Columbia, MD
osteoarthritis (prevention) Phase II
osiris.com
Cimzia®
certolizumab pegol
UCB
Smyrna, GA
early rheumatoid arthritis Phase III
ucb.com
clazakizumab
(anti-IL6-mAb)
Bristol-Myers Squibb
Princeton, NJ
osteoarthritis,
rheumatoid arthritis
Phase II
bms.com
CNTO-1959 Janssen Biotech
Horsham, PA
rheumatoid arthritis Phase II
janssenbiotech.com
COV-155 Mallinckrodt
Hazelwood, MO
osteoarthritis Phase III
mallinckrodt.com
COV-795 Mallinckrodt
Hazelwood, MO
osteoarthritis Phase III
mallinckrodt.com
CT-1578
(JAK2/FLT-3/c-Fms inhibitor)
Cell Therapeutics
Seattle, WA
rheumatoid arthritis Phase I
celltherapeutics.com
Dekavil
(F8-IL10)
Pfizer
New York, NY
Philogen
Sovicille, Italy
rheumatoid arthritis Phase I
pfizer.com
philogen.com
DMI-9523 Ampio Pharmaceuticals
Greenwood Village, CO
osteoarthritis Phase I
ampiopharma.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 201310
Arthritis
Product Name Sponsor Indication Development Phase
etoricoxib Merck
Whitehouse Station, NJ
rheumatoid arthritis Phase III
merck.com
fostamatinib
(SYK inhibitor)
AstraZeneca
Wilmington, DE
Rigel Pharmaceuticals
South San Francisco, CA
rheumatoid arthritis Phase III
astrazeneca.com
rigel.com
FX005
(p38 MAPK inhibitor)
Flexion Therapeutics
Woburn, MA
osteoarthritis of the knee Phase I/II
flexiontherapeutics.com
FX006
(triamcinolone acetonide
intra-articular sustained-release)
Flexion Therapeutics
Woburn, MA
osteoarthritis of the knee Phase II
flexiontherapeutics.com
gevokizumab
(XOMA 052)
XOMA
Berkeley, CA
osteoarthritis of the hand Phase II
xoma.com
GLPG-0555 Galapagos
Mechelen, Belgium
GlaxoSmithKline
Rsch. Triangle Park, NC
osteoarthritis Phase I
gsk.com
GLPG-0634 AbbVie
North Chicago, IL
Galapagos
Mechelen, Belgium
rheumatoid arthritis Phase II
abbvie.com
GSK2941266
(CCR1 chemokine receptor
antagonist)
GlaxoSmithKline
Rsch. Triangle Park, NC
rheumatoid arthritis Phase II
gsk.com
HE3286 Harbor Biosciences
San Diego, CA
rheumatoid arthritis
(see also diabetes)
Phase II
harbortx.com
INCB39110
(JAK1 inhibitor)
Incyte
Wilmington, DE
active rheumatoid arthritis Phase II
incyte.com
IP045
(meloxicam)
Iroko Pharmaceuticals
Philadelphia, PA
pain associated with osteoarthritis
of the knee
Phase I
iroko.com
IP-880
(low dose diclofenac)
Iroko Pharmaceuticals
Philadelphia, PA
osteoarthritis pain Phase III
iroko.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 11
Arthritis
Product Name Sponsor Indication Development Phase
ISIS-CRPRx
(C-reactive protein inhibitor)
Isis Pharmaceuticals
Carlsbad, CA
rheumatoid arthritis Phase II
isispharm.com
JNJ-38518168
(histamine H4 receptor
antagonist)
Janssen Research & Development
Raritan, NJ
rheumatoid arthritis Phase II
janssenrnd.com
JNJ-39439335
(mavatrep)
Janssen Research & Development
Raritan, NJ
chronic pain associated with
osteoarthritis of the