2013 medicines in development: older americans
DESCRIPTION
Biopharmaceutical research companies are developing 465 medicines and vaccines 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).TRANSCRIPT
2013 R
EPORT
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 AmericansThe Medicare population and Leading Chronic Diseases
presenTeD by AMeriCA’s biOphArMACeuTiCAL reseArCh COMpAnies
Dep
ress
ion
Arth
ritis
82
92
40
CO
PD
Dia
bete
s
34
142
Hea
rt D
isea
se
48
Alzh
eim
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 FAILUREISCHEMIC HEART DISEASE
ALZH
EIM
ER'S
DE
MEN
TIA
RHEUMATOID ARTHRITIS
CATARACTS
DEPRESSION
DIABETESOSTEOPOROSIS
ALZHEIMER'S DISEASE
DEMEN
TIARHEUM
ATOID ARTHRITISCATARACTS
CHRONIC KIDNEY DISEASECOPDDEPRESSION
DIABETESOSTEOPOROSIS
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 DementiaProduct Name Sponsor Indication Development Phase*
18F-florbetaben(BAY 94-9172)
Piramal HealthcareMumbai, India
Alzheimer’s disease (diagnosis) Phase IIIpiramalenterprises.com
AAB-003/PF-05236812(amyloid beta protein inhibitor)
Janssen Alzheimer ImmunotherapySouth San Francisco, CAPfizerNew York, NY
Alzheimer’s disease Phase Ijanimm.compfizer.com
ABT-126(α7-NNR antagonist)
AbbVieNorth Chicago, IL
mild to moderate Alzheimer’s disease
Phase IIabbvie.com
ABT-288(neurotransmitter receptor modulator)
AbbVieNorth Chicago, IL
Alzheimer’s disease Phase II completedabbvie.com
ABT-384 AbbVieNorth Chicago, IL
Alzheimer’s disease Phase II completedabbvie.com
ABT-957(calpain inhibitor)
AbbVieNorth Chicago, IL
Alzheimer’s disease Phase Iabbvie.com
AC-1204 AcceraBroomfield, CO
Alzheimer’s disease Phase II/IIIaccerapharma.com
ACC-001/PF-05236806 Janssen Alzheimer ImmunotherapySouth San Francisco, CAPfizerNew York, NY
Alzheimer’s disease Phase IIjanimm.compfizer.com
AD02 vaccine AffirisVienna, AustriaGlaxoSmithKlineRsch. Triangle Park, NC
treatment of Alzheimer’s disease Phase IIgsk.com
AD03 vaccine AffirisVienna, AustriaGlaxoSmithKlineRsch. Triangle Park, NC
treatment of Alzheimer’s disease Phase Igsk.com
AD4833/TOMM40 Takeda Pharmaceuticals InternationalDeerfield, IL
Alzheimer’s disease prevention Phase Itakeda.com
APH-0703(protein kinase C activator)
AphiosWoburn, MA
Alzheimer’s disease Phase I/IIaphios.com
Medicines in Development Older Americans 2013 3
Medicines in Development for Older Americans
Alzheimer’s Disease and DementiaProduct Name Sponsor Indication Development Phase
ARC029(nilvadipine)
Archer PharmaceuticalsSarasota, FL
Alzheimer’s disease Phase Iarcherpharma.com
ARC031(soluble amyloid reducing/clearing agent)
Archer PharmaceuticalsSarasota, FL
Alzheimer’s disease Phase Iarcherpharma.com
ARC031 SR(soluble amyloid reducing/clearing agent)
Archer PharmaceuticalsSarasota, FL
Alzheimer’s disease Phase Iarcherpharma.com
AVN 101(serotonin 5-HT6 receptor antagonist)
Avineuro PharmaceuticalsSan Diego, CA
Alzheimer’s disease Phase IIavineuro.com
AVN 322(serotonin 5-HT6 receptor antagonist)
Avineuro PharmaceuticalsSan Diego, CA
Alzheimer’s disease Phase Iavineuro.com
AVN 397 Avineuro PharmaceuticalsSan Diego, CA
Alzheimer’s disease Phase IIavineuro.com
AZD1446(alpha4/beta2 neuronal nicotinic receptor agonist)
AstraZenecaWilmington, DETargaceptWinston-Salem, NC
Alzheimer’s disease Phase Iastrazeneca.com
AZD2184(PET imaging)
Navidea BiopharmaceuticalsDublin, OH
Alzheimer’s disease (diagnosis) Phase Inavidea.com
AZD2995(PET imaging)
Navidea BiopharmaceuticalsDublin, OH
Alzheimer’s disease (diagnosis) Phase Inavidea.com
AZD3293(beta secretase)
AstraZenecaWilmington, DEAstex PharmaceuticalsDublin, CA
Alzheimer’s disease Phase Iastrazeneca.com
AZD5213(histamine-3 receptor antagonist)
AstraZenecaWilmington, DE
Alzheimer’s disease Phase IIastrazeneca.com
ß-secretase inhibitor(LY2886721)
Eli LillyIndianapolis, IN
Alzheimer’s disease(slow disease progression)
Phase IIlilly.com
BAN2401 EisaiWoodcliff Lake, NJ
early-stage Alzheimer’s disease Phase IIeisai.com
BAY 85-8101(18F-labeled radiopharmaceutical)
Piramal HealthcareMumbai, India
Alzheimer’s disease (diagnosis) Phase I completedpiramalenterprises.com
Medicines in Development Older Americans 20134
Medicines in Development for Older Americans
Alzheimer’s Disease and DementiaProduct Name Sponsor Indication Development Phase
BIIB037(anti-ß-amyloid antibody)
Biogen IdecWeston, MA
Alzheimer’s disease Phase Ibiogenidec.com
bisnorcymserine(BNC)
QR PharmaBerwyn, PA
Alzheimer’s disease Phase Iqrpharma.com
BMS-241027(microtubule stabilizer)
Bristol-Myers SquibbPrinceton, NJ
Alzheimer’s disease, senile dementia
Phase Ibms.com
CAD106 Novartis PharmaceuticalsEast Hanover, NJ
Alzheimer’s disease Phase IInovartis.com
CERE-110(AAV-NGF gene therapy)
CeregeneSan Diego, CA
Alzheimer’s disease Phase IIceregene.com
crenezumab(anti-Abeta)
GenentechSouth San Francisco, CA
Alzheimer’s disease Phase IIgene.com
davunetide intranasal Allon TherapeuticsVancouver, Canada
Alzheimer’s disease Phase IIallontherapeutics.com
donepezil/memantine extended-release fixed-dose combination
Adamas PharmaceuticalsEmeryville, CAForest LaboratoriesNew York, NY
moderate to severe Alzheimer’s disease
Phase IIadamaspharma.comfrx.com
DSP-8658(PPAR alpha/gamma agonist)
Sunovion PharmaceuticalsMarlborough, MA
Alzheimer’s disease (see also diabetes)
Phase Isunovion.com
E2609 EisaiWoodcliff Lake, NJ
Alzheimer’s disease Phase I completedeisai.com
ELND005(amyloid beta-protein inhibitor)
Elan Dublin, Ireland
Alzheimer’s disease Phase IIelan.com
EVP-0962(gamma secretase modulation)
EnVivo PharmaceuticalsWatertown, MA
Alzheimer’s disease Phase IIenvivopharma.com
EVP-6124(nicotine A7 agonist)
EnVivo PharmaceuticalsWatertown, MA
Alzheimer’s disease Phase IIenvivopharma.com
Exebryl-1® Alzheimer’s disease therapeutic
ProteoTechKirkland, WA
Alzheimer’s disease Phase Iproteotech.com
F-18 T808(PET imaging agent)
Siemens Molecular ImagingMalvern, PA
Alzheimer’s disease (diagnosis) Phase 0medical.siemens.com
F18-flutemetamol(PET imaging agent)
GE HealthcareWaukesha, WI
Alzheimer’s disease (diagnosis) application submittedgehealthcare.com
Medicines in Development Older Americans 2013 5
Alzheimer’s Disease and DementiaProduct Name Sponsor Indication Development Phase
Gammagard®
immune globulinBaxter InternationalDeerfield, IL
early-stage Alzheimer’s disease, mid-stage Alzheimer’s disease
Phase IIIbaxter.com
gamma secretase modulator,A-beta modulator
Bristol-Myers SquibbPrinceton, NJ
Alzheimer’s disease,senile dementia
in clinical trials bms.com
gantenerumab (amyloid beta-protein inhibitor)
RocheNutley, NJ
early-stage Alzheimer’s disease Phase II/IIIroche.com
GSK742457(5-HT6 receptor antagonist)
GlaxoSmithKlineRsch. Triangle Park, NC
dementia Phase IIgsk.com
GSK2647544(Lp-PLA2 inhibitor)
GlaxoSmithKlineRsch. Triangle Park, NC
Alzheimer’s disease Phase Igsk.com
HPP 854(BACE1 protein inhibitor)
High Point PharmaceuticalsHigh Point, NC
Alzheimer’s disease Phase Ihighpointpharma.com
human immunoglobulin(intravenous)
GrifolsLos Angeles, CA
Alzheimer’s disease Phase IIIgrifols.com
KU-046(amyloid-ß protein modulator)
Kareus TherapeuticsLa Chaux-de-Fonds, Switzerland
Alzheimer’s disease Phase Ikareustherapeutics.com
Lu AE58054 Lundbeck USADeerfield, IL
Alzheimer’s disease Phase IIlundbeck.com
masitinib(AB-1010)
AB Science USAShort Hills, NJ
Alzheimer’s disease Phase III completedab-science.com
MCD-386 MithridionMadison, WI
Alzheimer’s disease Phase Imithridion.com
MK-3328(PET imaging)
MerckWhitehouse Station, NJ
Alzheimer’s disease (diagnosis) Phase I completedmerck.com
MK-8931(BACE1 protein inhibitor)
MerckWhitehouse Station, NJ
Alzheimer’s disease Phase II/IIImerck.com
MSDC-0160 Metabolic Solutions DevelopmentKalamazoo, MI
Alzheimer’s disease(see also diabetes)
Phase IImsdrx.com
NAV4694(fluorine-18 labeled PET imaging agent)
Navidea BiopharmaceuticalsDublin, OH
Alzheimer’s disease (diagnosis) Phase IIInavidea.com
NIC5-15 HumaneticsMinneapolis, MN
Alzheimer’s disease Phase IIhumaneticscorp.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 20136
Alzheimer’s Disease and DementiaProduct Name Sponsor Indication Development Phase
PF-05212377(SAM-760)
PfizerNew York, NY
Alzheimer’s disease Phase IIpfizer.com
Posiphen®
R-phenserineQR PharmaBerwyn, PA
Alzheimer’s disease, mild cognitive impairment
Phase IIqrpharma.com
PRX-3140(serotonin 4 receptor agonist)
NanotherapeuticsAlachua, FL
Alzheimer’s disease Phase IInanotherapeutics.com
RG1577(MAO-B inhibitor)
RocheNutley, NJ
Alzheimer’s disease Phase IIroche.com
RG7129(BACE-1 inhibitor)
RocheNutley, NJ
Alzheimer’s disease Phase Iroche.com
rilapladib(Lp-PLA2 inhibitor)
GlaxoSmithKlineRsch. Triangle Park, NC
Alzheimer’s disease Phase IIgsk.com
RVX-208 ResverlogixCalgary, Canada
Alzheimer’s disease Phase Iresverlogix.com
SAR110894(H3 antagonist)
Sanofi USBridgewater, NJ
Alzheimer’s disease Phase IIsanofi.com
SAR228810(anti-protofibrillar AB mAb)
Sanofi USBridgewater, NJ
Alzheimer’s disease Phase Isanofi.com
sGC-1061 sGC PharmaWellesley, MA
Alzheimer’s disease Phase Isgcpharma.com
solanezumab(LY2062430)
Eli LillyIndianapolis, IN
Alzheimer’s disease Phase IIIlilly.com
ST101 Sonexa TherapeuticsSan Diego, CA
Alzheimer’s disease Phase IIsonexa.com
T-817MA(amyloid beta-protein inhibitor)
Toyota ChemicalTokyo, Japan
mild to moderate Alzheimer’s disease
Phase II completedtoyama-chemical.co.jp
TAK-357(oral cognitive enhancer)
Takeda Pharmaceuticals InternationalDeerfield, IL
Alzheimer’s disease Phase Itakeda.com
TC-1734(alpha4/beta2 neuronal nicotinic receptor agonist)
TargaceptWinston-Salem, NC
Alzheimer’s disease Phase IItargacept.com
TC-5619(alpha7 nAChR)
TargaceptWinston-Salem, NC
Alzheimer’s disease Phase Itargacept.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 7
Alzheimer’s Disease and DementiaProduct Name Sponsor Indication Development Phase
TRx-0237(LMTX)
TauRx TherapeuticsSingapore, Republic of Singapore
Alzheimer’s disease, dementia Phase IIItaurx.com
TTP4000 TransTech PharmaHigh Point, NC
Alzheimer’s disease Phase Ittpharma.com
TTP488 TransTech PharmaHigh Point, NC
Alzheimer’s disease Phase IIttpharma.com
UB-311(amyloid beta protein inhibitor vaccine)
United BiomedicalHauppauge, NY
mild to moderate Alzheimer’s disease
Phase Iunitedbiomedical.com
V950 MerckWhitehouse Station, NJ
Alzheimer’s disease Phase Imerck.com
velusetrag(TD-5108)
TheravanceSouth San Francisco, CA
Alzheimer’s disease Phase I completedtheravance.com
VI-1121 VIVUSMountain View, CA
Alzheimer’s disease Phase IIvivus.com
XEL-001HP(transdermal patch)
Xel PharmaceuticalsDraper, UT
Alzheimer’s disease Phase Ixelpharmaceuticals.com
ArthritisProduct Name Sponsor Indication Development Phase
2ME2 EntreMedRockville, MD
rheumatoid arthritis Phase Ientremed.com
ABT-122(anti-TNF/anti-IL-17 mAb)
AbbVieNorth Chicago, IL
rheumatoid arthritis Phase Iabbvie.com
ABT-413(sphingosine 1 phosphate receptor modulator)
AbbVieNorth Chicago, IL
rheumatoid arthritis Phase Iabbvie.com
ABT-494(JAK-1, 2, 3 inhibitor)
AbbVieNorth Chicago, IL
rheumatoid arthritis Phase Iabbvie.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 20138
ArthritisProduct Name Sponsor Indication Development Phase
ABT-652(histamine H3 receptor modulator)
AbbVieNorth Chicago, IL
osteoarthritis of the knee Phase IIabbvie.com
ABT-981(anti-IL-1 α and β mAb)
AbbVieNorth Chicago, IL
osteoarthritis Phase Iabbvie.com
Actemra®
tocilizumabGenentechSouth San Francisco, CARocheNutley, NJ
rheumatoid arthritis(first-line therapy)
--------------------------------------rheumatoid arthritis(early-stage disease)
application submittedgene.comroche.com-----------------------------------------Phase IIIgene.comroche.com
adalimumab biosimilar Boehringer Ingelheim PharmaceuticalsRidgefield, CT
rheumatoid arthritis Phase I completedboehringer-ingelheim.com
AF-219(purinoceptor P2X3 antagonist)
Afferent PharmaceuticalsSan Mateo, CA
osteoarthritis Phase IIafferentpharma.com
AIN457(secukinumab)
Novartis PharmaceuticalsEast Hanover, NJ
rheumatoid arthritis Phase IIInovartis.com
ARG301 arGentis PharmaceuticalsMemphis, TN
rheumatoid arthritis Phase Iargentisrx.com
ARRY-797(p38 MAPK inhibitor)
Array BioPharmaBoulder, CO
moderate to severe pain associated with osteoarthritis of the knee
Phase IIarraybiopharma.com
ASP015K(JAK-3 inhibitor)
Astellas Pharma USNorthbrook, IL
rheumatoid arthritis Phase IIastellas.com
ASP2408(CTLA4-Ig fusion protein)
Perseid TherapeuticsRedwood City, CA
rheumatoid arthritis Phase Iperseidtherapeutics.com
baricitinib(LY3009104)
Eli LillyIndianapolis, IN
rheumatoid arthritis(see also chronic kidney)
Phase IIIlilly.com
BI-695500(rituximab biosimilar)
Boehringer Ingelheim PharmaceuticalsRidgefield, CT
rheumatoid arthritis Phase IIIboehringer-ingelheim.com
BMS-817399(CCR1 antagonist)
Bristol-Myers SquibbPrinceton, NJ
osteoarthritis, rheumatoid arthritis
Phase IIbms.com
BT-061 AbbVieNorth Chicago, ILBiotestDreieich, Germany
rheumatoid arthritis Phase IIabbvie.combiotest.de
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 9
ArthritisProduct Name Sponsor Indication Development Phase
buprenorphine transmucosal BioDelivery Sciences InternationalRaleigh, NCEndo PharmaceuticalsMalvern, PA
chronic pain associated with osteoarthritis
Phase IIIbdsi.comendo.com
canakinumab(ACZ885)
Novartis PharmaceuticalsEast Hanover, NJ
gouty arthritis(see also diabetes)--------------------------------------osteoarthritis
application submittednovartis.com-----------------------------------------Phase IInovartis.com
cebranopadol Forest LaboratoriesNew York, NY
pain due to osteoarthritis of the knee
Phase IIfrx.com
CEP-33237(hydrocodone extended-release)
CephalonFrazer, PA
osteoarthritis pain Phase IIIcephalon.com
CF101 Can-Fite BioPharmaWaltham, MA
rheumatoid arthritis Phase IIcanfite.com
Chondrogen™mesenchymal stem cell therapy
Osiris TherapeuticsColumbia, MD
osteoarthritis (prevention) Phase IIosiris.com
Cimzia®
certolizumab pegolUCBSmyrna, GA
early rheumatoid arthritis Phase IIIucb.com
clazakizumab (anti-IL6-mAb)
Bristol-Myers SquibbPrinceton, NJ
osteoarthritis, rheumatoid arthritis
Phase IIbms.com
CNTO-1959 Janssen BiotechHorsham, PA
rheumatoid arthritis Phase IIjanssenbiotech.com
COV-155 MallinckrodtHazelwood, MO
osteoarthritis Phase IIImallinckrodt.com
COV-795 MallinckrodtHazelwood, MO
osteoarthritis Phase IIImallinckrodt.com
CT-1578(JAK2/FLT-3/c-Fms inhibitor)
Cell TherapeuticsSeattle, WA
rheumatoid arthritis Phase Icelltherapeutics.com
Dekavil(F8-IL10)
PfizerNew York, NYPhilogenSovicille, Italy
rheumatoid arthritis Phase Ipfizer.comphilogen.com
DMI-9523 Ampio PharmaceuticalsGreenwood Village, CO
osteoarthritis Phase Iampiopharma.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 201310
ArthritisProduct Name Sponsor Indication Development Phase
etoricoxib MerckWhitehouse Station, NJ
rheumatoid arthritis Phase IIImerck.com
fostamatinib (SYK inhibitor)
AstraZenecaWilmington, DERigel PharmaceuticalsSouth San Francisco, CA
rheumatoid arthritis Phase IIIastrazeneca.comrigel.com
FX005(p38 MAPK inhibitor)
Flexion TherapeuticsWoburn, MA
osteoarthritis of the knee Phase I/IIflexiontherapeutics.com
FX006(triamcinolone acetonide intra-articular sustained-release)
Flexion TherapeuticsWoburn, MA
osteoarthritis of the knee Phase IIflexiontherapeutics.com
gevokizumab (XOMA 052)
XOMABerkeley, CA
osteoarthritis of the hand Phase IIxoma.com
GLPG-0555 GalapagosMechelen, BelgiumGlaxoSmithKlineRsch. Triangle Park, NC
osteoarthritis Phase Igsk.com
GLPG-0634 AbbVieNorth Chicago, ILGalapagosMechelen, Belgium
rheumatoid arthritis Phase IIabbvie.com
GSK2941266(CCR1 chemokine receptor antagonist)
GlaxoSmithKlineRsch. Triangle Park, NC
rheumatoid arthritis Phase IIgsk.com
HE3286 Harbor BiosciencesSan Diego, CA
rheumatoid arthritis (see also diabetes)
Phase IIharbortx.com
INCB39110(JAK1 inhibitor)
IncyteWilmington, DE
active rheumatoid arthritis Phase IIincyte.com
IP045(meloxicam)
Iroko PharmaceuticalsPhiladelphia, PA
pain associated with osteoarthritis of the knee
Phase Iiroko.com
IP-880(low dose diclofenac)
Iroko PharmaceuticalsPhiladelphia, PA
osteoarthritis pain Phase IIIiroko.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 11
ArthritisProduct Name Sponsor Indication Development Phase
ISIS-CRPRx(C-reactive protein inhibitor)
Isis PharmaceuticalsCarlsbad, CA
rheumatoid arthritis Phase IIisispharm.com
JNJ-38518168(histamine H4 receptor antagonist)
Janssen Research & DevelopmentRaritan, NJ
rheumatoid arthritis Phase IIjanssenrnd.com
JNJ-39439335(mavatrep)
Janssen Research & DevelopmentRaritan, NJ
chronic pain associated with osteoarthritis of the knee
Phase Ijanssenrnd.com
JNJ-40346527(M-CSF receptor antagonist)
Janssen Research & DevelopmentRaritan, NJ
rheumatoid arthritis Phase IIjanssenrnd.com
LT-NS001(naproxen etemesil)
Logical TherapeuticsFoxboro, MA
osteoarthritis Phase II/IIIlogicaltx.com
LX2931(S1P lyase inhibitor)
Lexicon PharmaceuticalsThe Woodlands, TX
rheumatoid arthritis Phase IIlexicon-genetics.com
mavrilimumab(anti-GM-CSFR mAb)
AstraZenecaWilmington, DEMedImmuneGaithersburg, MD
rheumatoid arthritis Phase IIastrazeneca.commedimmune.com
MEDI-5117(anti-IL-6 mAb)
AstraZenecaWilmington, DEMedImmuneGaithersburg, MD
rheumatoid arthritis Phase Iastrazeneca.commedimmune.com
mesenchymal stem cell therapy for cartilage repair
MedipostSeoul, South Korea
osteoarthritis Phase I/IImedi-post.com
MK-8457 MerckWhitehouse Station, NJ
rheumatoid arthritis Phase IImerck.com
MK-8808 MerckWhitehouse Station, NJ
rheumatoid arthritis Phase Imerck.com
MORAb-022(IgG1 mAb)
EisaiWoodcliff Lake, NJ
rheumatoid arthritis Phase Ieisai.com
namilumab Takeda Pharmaceuticals InternationalDeerfield, IL
rheumatoid arthritis Phase Itakeda.com
naproxcinod NicOxSophia Antipolis, France
osteoarthritis application submittednicox.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 201312
Medicines in Development for Older Americans
ArthritisProduct Name Sponsor Indication Development Phase
NN8209(anti-C5aR-151)
Novo NordiskPrinceton, NJ
rheumatoid arthritis Phase IInovonordisk.com
NN8210(anti-C5aR-215)
Novo NordiskPrinceton, NJ
rheumatoid arthritis Phase Inovonordisk.com
NN8226(anti-IL20 mAb)
Novo NordiskPrinceton, NJ
rheumatoid arthritis Phase IInovonordisk.com
NN8765(anti-NKG2A)
Novo NordiskPrinceton, NJ
rheumatoid arthritis Phase Inovonordisk.com
NN8828(anti-IL21 mAb)
Novo NordiskPrinceton, NJ
rheumatoid arthritis Phase IInovonordisk.com
olokizumab UCBSmyrna, GA
rheumatoid arthritis Phase IIucb.com
OLT-1177 Olatec IndustriesNew York, NY
pain associated with osteoarthritis of the knee
Phase II
osteoarthritis medicine(NCE)
Eli LillyIndianapolis, IN
osteoarthritis pain Phase Ililly.com
otelixizumab(CD3 mAb)
GlaxoSmithKlineRsch. Triangle Park, NC
rheumatoid arthritis Phase Igsk.com
Otrexup™methotrexate subcutaneous auto-injection
Antares PharmaEwing, NJ
rheumatoid arthritis application submittedantarespharma.com
ozoralizumab AblynxGhent, Belgium
rheumatoid arthritis Phase IIablynx.com
PDA-001(stem cell therapy)
Celgene Cellular TherapeuticsSummit, NJ
rheumatoid arthritis Phase I/IIcelgene.com
Pennsaid® 2%diclofenac transdermal
MallinckrodtHazelwood, MO
osteoarthritis pain and stiffness application submittedmallinckrodt.com
PF-04171327(SGRM)
PfizerNew York, NY
rheumatoid arthritis Phase IIpfizer.com
PF-04236921(mAb)
PfizerNew York, NY
rheumatoid arthritis Phase Ipfizer.com
PF-05280586(rituximab biosimilar)
PfizerNew York, NY
rheumatoid arthritis Phase Ipfizer.com
Medicines in Development Older Americans 2013 13
Medicines in Development for Older Americans
ArthritisProduct Name Sponsor Indication Development Phase
PLX5622(FGF-1 antagonist)
PlexxikonBerkeley, CA
rheumatoid arthritis Phase Iplexxikon.com
Prolia®
denosumabAmgenThousand Oaks, CA
rheumatoid arthritis Phase IIamgen.com
PRTX-100(staphylococcal protein A)
ProtalexSummit, NJ
rheumatoid arthritis Phase Iprotalex.com
Ravax™rheumatoid arthritis vaccine
Immune Response BioPharmaNew York, NY
rheumatoid arthritis Phase IIIimmuneresponsebiopharma.com
RX-10001(synthetic resolvin)
Resolvyx PharmaceuticalsCambridge, MA
rheumatoid arthritis Phase Iresolvyx.com
SAN-300(anti-VLA-1 antibody)
Santarus San Diego, CA
rhematoid arthritis Phase Isantarus.com
SAR113945(IKK-ß inhibitor)
Sanofi USBridgewater, NJ
osteoarthritis Phase IIsanofi.com
SAR292833(TRVP3 antagonist)
Sanofi USBridgewater, NJ
osteoarthritis pain Phase IIsanofi.com
sarilumab(anti-IL-6R mAb)
Sanofi USBridgewater, NJ
rheumatoid arthritis Phase IIIsanofi.com
Simponi®golimumab (intravenous)
Janssen BiotechHorsham, PA
moderate to severe rheumatoid arthritis
application submittedjanssenbiotech.com
sirukumab(anti-IL-6 mAb)
GlaxoSmithKlineRsch. Triangle Park, NCJanssen BiotechHorsham, PA
rheumatoid arthritis Phase IIIgsk.comjanssenbiotech.com
sprifermin(FGF-18)
EMD SeronoRockland, MA
osteoarthritis Phase Iemdserono.com
TG-C(allogeneic cell therapy)
TissueGeneRockville, MD
osteoarthritis Phase IItissuegene.com
Stelara®
ustekinumabJanssen Research & DevelopmentRaritan, NJ
rheumatoid arthritis Phase IIjanssenrnd.com
Medicines in Development Older Americans 201314
ArthritisProduct Name Sponsor Indication Development Phase
V116517 Purdue PharmaStamford, CT
pain associated with osteoarthritis of the knee
Phase IIpurduepharma.com
veltuzumab subcutaneous
ImmunomedicsMorris Plains, NJTakeda Pharmaceuticals InternationalDeerfield, IL
rheumatoid arthritis Phase IIimmunomedics.comtakeda.com
VX30 VaccinexRochester, NY
rheumatoid arthritis Phase Ivaccinex.com
VX-509 Vertex PharmaceuticalsCambridge, MA
rheumatoid arthritis Phase IIvrtx.com
CataractsProduct Name Sponsor Indication Development Phase
dexamethasone ophthalmic(EGP-437)
EyeGate PharmaWaltham, MA
cataracts Phase IIeyegatepharma.com
Chronic Kidney DiseaseProduct Name Sponsor Indication Development Phase
Acthar® Gelcorticotropin gel
Questcor PharmaceuticalsAnaheim Hills, CA
diabetic nephropathy Phase IIquestcor.com
atrasentan AbbVieNorth Chicago, IL
diabetic nephropathy Phase IIabbvie.com
AZD1722(NHE3 inhibitor)
ArdelyxFremont, CAAstraZenecaWilmington, DE
chronic kidney disease Phase Iardelyx.comastrazeneca.com
baricitinib(LY3009104)
Eli LillyIndianapolis, IN
diabetic nephropathy(see also arthritis)
Phase IIlilly.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 15
Chronic Kidney DiseaseProduct Name Sponsor Indication Development Phase
BB-3 AngionUniondale, NY
chronic kidney fibrosis Phase Iangion.com
BMS-813160(dual CCR2/CCR5 antagonist)
Bristol-Myers SquibbPrinceton, NJ
chronic kidney disease Phase Ibms.com
CCX140(CCR2 receptor antagonist)
ChemoCentryxMountain View, CA
diabetic nephropathy Phase Ichemocentryx.com
chronic kidney disease therapeutic Eli LillyIndianapolis, IN
chronic kidney disease Phase Ililly.com
CLP-1004(potassium channel modulator)
Sorbent TherapeuticsSunnyvale, CA
chronic kidney disease Phase Isorbent.com
CTP-499 Concert PharmaceuticalsLexington, MA
diabetic nephropathy Phase Iconcertpharma.com
INV-144(losartan/thioctic acid)
InVasc TherapeuticsTucker, GA
chronic kidney disease Phase IIinvasc.net
linagliptin Boehringer Ingelheim PharmaceuticalsRidgefield, CTEli LillyIndianapolis, IN
diabetic nephropathy Phase IIIboehringer-ingelheim.comlilly.com
LY3016859 Eli LillyIndianapolis, IN
diabetic nephropathy Phase Ililly.com
MP-146 Mitsubishi Tanabe PharmaOsaka, Japan
chronic kidney disease Phase IIImt-pharma.co.jp
MR antagonist (LY2623091)
Eli LillyIndianapolis, IN
chronic kidney disease Phase IIlilly.com
PF-00489791(PDE5 inhibitor)
PfizerNew York, NY
diabetic nephropathy Phase IIpfizer.com
PF-04634817(CCR2/CCR5 receptor antagonist)
PfizerNew York, NY
diabetic nephropathy Phase IIpfizer.com
Pyridorin™pyridoxamine
NephroGenexRsch. Triangle Park, NC
diabetic nephropathy(Fast Track)
Phase IInephrogenex.com
TGF-ß mAb(LY2382770)
Eli LillyIndianapolis, IN
diabetic nephropathy Phase IIlilly.com
VTP-27999(renin inhibitor)
Vitae PharmaceuticalsFort Washington, PA
chronic kidney disease Phase Ivitaepharma.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 201316
Medicines in Development for Older Americans
Chronic Obstructive Pulmonary Disease (COPD)Product Name Sponsor Indication Development Phase
aclidinium bromide/formoterol combination
Forest LaboratoriesNew York, NY
chronic obstructive pulmonary disease (COPD)
Phase IIIfrx.com
AZD2115(MABA)
AstraZenecaWilmington, DEPulmagen TherapeuticsSlough, United Kingdom
COPD Phase IIastrazeneca.com
AZD5423(inhaled SGRM)
AstraZenecaWilmington, DE
COPD Phase IIastrazeneca.com
AZD7594(inhaled SGRM)
AstraZenecaWilmington, DE
COPD Phase Iastrazeneca.com
BCT197 Novartis PharmaceuticalsEast Hanover, NJ
COPD Phase IInovartis.com
bedoradrine (MN-221)
MediciNovaSan Diego, CA
exacerbations of COPD Phase IImedicinova.com
benralizumab (anti-IL-5R mAb)
AstraZenecaWilmington, DEMedImmuneGaithersburg, MD
COPD Phase IIastrazeneca.commedimmune.com
BI-137882 Boehringer Ingelheim PharmaceuticalsRidgefield, CT
COPD Phase Iboehringer-ingelheim.com
BIO-11006 BioMarck PharmaceuticalsDurham, NC
COPD Phase IIbiomarck.com
Dulera®
mometasone/formoterolMerckWhitehouse Station, NJ
COPD application submittedmerck.com
fluticasone furoate/vilanterol/umeclidinium combination
GlaxoSmithKlineRsch. Triangle Park, NC
COPD Phase Igsk.com
formoterol/fluticasone propionatefixed-dose combination
Mylan SpecialtyBasking Ridge, NJ
COPD Phase II completedmylanspecialty.com
glycopyrrolate(SUN-101)
Sunovion Respiratory DevelopmentMarlborough, MA
COPD Phase IIsunovion.com
GSK225629(soluble epoxide hydrolase inhibitor)
GlaxoSmithKlineRsch. Triangle Park, NC
COPD Phase Igsk.com
Medicines in Development Older Americans 2013 17
Medicines in Development for Older Americans
Chronic Obstructive Pulmonary Disease (COPD)Product Name Sponsor Indication Development Phase
GSK1325756(CXCR2 chemokine receptor antagonist)
GlaxoSmithKlineRsch. Triangle Park, NC
COPD Phase Igsk.com
GSK2269557(phosphoinositide 3 kinase inhibitor)
GlaxoSmithKlineRsch. Triangle Park, NC
COPD Phase Igsk.com
GSK961081(muscarinic antagonist/beta2 agonist)
GlaxoSmithKlineRsch. Triangle Park, NCTheravanceSouth San Francisco, CA
COPD Phase IIgsk.comtheravance.com
losmapimod(oral p38 kinase inhibitor)
GlaxoSmithKlineRsch. Triangle Park, NC
COPD Phase IIgsk.com
MEDI-7814(anti-C5/C5a mAb)
AstraZenecaWilmington, DEMedImmuneGaithersburg, MD
COPD Phase Iastrazeneca.commedimmune.com
MEDI-8968(nati-IL-1R mAb)
AstraZenecaWilmington, DEMedImmuneGaithersburg, MD
COPD Phase IIastrazeneca.commedimmune.com
NVA237(glycopyrrolate inhalation)
Novartis PharmaceuticalsEast Hanover, NJ
COPD Phase IIInovartis.com
olodaterol/tiotropium bromide fixed-dose combination
Boehringer Ingelheim PharmaceuticalsRidgefield, CT
COPD Phase IIIboehringer-ingelheim.com
OPC-6535(tetomilast)
Otsuka America PharmaceuticalRockville, MD
COPD Phase IIotsuka.com
PF-03715455(MAPK-14 inhibitor)
PfizerNew York, NY
COPD Phase Ipfizer.com
PH-797804(p38 MAP kinase inhibitor)
PfizerNew York, NY
COPD Phase IIpfizer.com
Prochymal™remestemcel-L
Osiris TherapeuticsColumbia, MD
COPD(see also diabetes)
Phase IIosiris.com
PT001(glycopyrrolate inhalation aerosol)
Pearl TherapeuticsRedwood City, CA
COPD Phase IIpearltherapeutics.com
PT003(glycopyrrolate/formoterol inhalation aerosol)
Pearl TherapeuticsRedwood City, CA
COPD Phase IIpearltherapeutics.com
Medicines in Development Older Americans 201318
Medicines in Development for Older Americans
Chronic Obstructive Pulmonary Disease (COPD)Product Name Sponsor Indication Development Phase
PT005(formoterol inhalation aerosol)
Pearl TherapeuticsRedwood City, CA
COPD Phase IIpearltherapeutics.com
PUR118 PulmatrixLexington, MA
COPD Phase Ipulmatrix.com
QMF149(indacaterol/mometasome fixed-dose combination)
Novartis PharmaceuticalsEast Hanover, NJ
COPD Phase IInovartis.com
QVA149(glycopyrrolate/indacaterol fixed-dose combination)
Novartis PharmaceuticalsEast Hanover, NJ
COPD Phase IIInovartis.com
salbutamol dry-powder inhalation
Teva PharmaceuticalNorth Wales, PA
COPD Phase IItevapharm.com
Striverdi Respimat™olodaterol
Boehringer Ingelheim PharmaceuticalsRidgefield, CT
COPD application submittedboehringer-ingelheim.com
suvorexant(dual orexin receptor antagonist)
MerckWhitehouse Station, NJ
COPD Phase I completedmerck.com
TD-4208(LAMA)
TheravanceSouth San Francisco, CA
COPD Phase IItheravance.com
umeclidinium(muscarinic acetylcholine antagonist)
GlaxoSmithKlineRsch. Triangle Park, NC
COPD Phase IIIgsk.com
umeclidinium/vilanterol fixed-dose combination
GlaxoSmithKlineRsch. Triangle Park, NC
COPD application submittedgsk.com
vilanterol(long-acting beta2 agonist)
GlaxoSmithKlineRsch. Triangle Park, NCTheravanceSouth San Francisco, CA
COPD Phase IIIgsk.comtheravance.com
vilanterol/fluticasone furoate fixed-dose combination
GlaxoSmithKlineRsch. Triangle Park, NCTheravanceSouth San Francisco, CA
COPD
--------------------------------------COPD (mortality claim)
application submittedgsk.comtheravance.com-----------------------------------------Phase IIIgsk.comtheravance.com
Medicines in Development Older Americans 2013 19
Medicines in Development for Older Americans
DepressionProduct Name Sponsor Indication Development Phase
ABT-436(selective vasopressin receptor antagonist)
AbbVieNorth Chicago, IL
major depressive disorder Phase IIabbvie.com
ALKS-5461(buprenorphine/samidorphan fixed-dose combination)
AlkermesWaltham, MA
major depressive disorder Phase IIalkermes.com
amitifadine EuthymicsCambridge, MA
major depressive disorder Phase II/IIIeuthymics.com
ARA 290 Araim PharmaceuticalsOssining, NY
depressive disorders Phase IIaraim.org
armodafinil Teva PharmaceuticalTikvah, Israel
major depressive disorder Phase IIItevapharm.com
AZD6765(NMDA receptor antagonist)
AstraZenecaWilmington, DE
major depressive disorder Phase IIastrazeneca.com
BCI-632(mGluR2/3 antagonist)
BrainCellsSan Diego, CA
major depressive disorder Phase Ibraincellsinc.com
BCI-838(mGluR2/3 antagonist)
BrainCellsSan Diego, CA
major depressive disorder Phase Ibraincellsinc.com
BMS-820836(triple reuptake inhibitor)
Bristol-Myers SquibbPrinceton, NJ
major depressive disorder Phase IIbms.com
brexpiprazole(OPC-34712)
Otsuka PharmaceuticalRockville, MD
adjunct therapy for major depressive disorder
Phase IIIotsuka.com
Brintellix™vortioxetine
LundbeckDeerfield, ILTakeda Pharmaceuticals InternationalDeerfield, IL
major depressive disorder application submittedlundbeck.comtakeda.com
cariprazine Forest LaboratoriesNew York, NY
major depressive disorder Phase IIIfrx.com
CX157(monoamine oxidase A inhibitor)
CeNeRx BioPharmaCary, NC
major depressive disorder Phase II completedcenerx.com
DSP-1053(serotonin uptake inhibitor)
Sunovion PharmaceuticalsMarlborough, MA
depression Phase Isunovion.com
Medicines in Development Older Americans 201320
Medicines in Development for Older Americans
DepressionProduct Name Sponsor Indication Development Phase
edivoxetine(LY2216684)
Eli LillyIndianapolis, IN
major depressive disorder Phase IIIlilly.com
GLYX-13 NaurexEvanston, IL
major depressive disorder Phase IInaurex.com
HT-2157(GALR3 antagonist)
Dart NeuroScienceSan Diego, CA
major depressive disorder Phase I/IIdartneuroscience.com
JNJ-40411813(mGluR2 modulator)
Janssen Research & DevelopmentRaritan, NJ
major depressive disorder with anxiety symptoms
Phase IIjanssenrnd.com
levomilnacipran(F2695)
Forest LaboratoriesNew York, NY
major depressive disorder application submittedfrx.com
lisdexamfetamine ShireWayne, PA
major depressive disorder Phase IIIshire.com
lurasidone Sunovion PharmaceuticalsMarlborough, MA
bipolar depression application submittedsunovion.com
LY2940094 Eli LillyIndianapolis, IN
major depressive disorder Phase IIlilly.com
mifepristone Corcept TherapeuticsMenlo Park, CA
psychotic major depression (Fast Track)
Phase IIIcorcept.com
MK-6096(orexin receptor 1/2 antagonist)
MerckWhitehouse Station, NJ
major depressive disorder Phase IImerck.com
nefiracetam Neuren PharmaceuticalsBethesda, MD
major depressive disorder post-stroke
Phase IIneurenpharma.com
NSI-189(stimulating neurogenesis)
NeuralstemRockville, MD
major depressive disorder Phase Ineuralstem.com
PNB01(citalopram/pipamperone fixed-dose combination)
PharmaNeuroBoostAlken, Belgium
severe major depressive disorder Phase IIIpharmaneuroboost.com
RG1578(mGluR2 modulator)
RocheNutley, NJ
major depression disorder Phase IIroche.com
RG7090(mGluR5 antagonist)
RocheNutley, NJ
treatment-resistent depression Phase IIroche.com
RO4995819 RocheNutley, NJ
major depressive disorder Phase IIroche.com
Medicines in Development Older Americans 2013 21
Medicines in Development for Older Americans
DepressionProduct Name Sponsor Indication Development Phase
SEP-228432 Sunovion PharmaceuticalsMarlborough, MA
major depressive disorder Phase Isunovion.com
SKL-DEP SK BiopharmaceuticalsSeoul, South Korea
major depressive disorder Phase Iskbp.com
tedatioxetine LundbeckDeerfield, ILTakeda Pharmaceuticals InternationalDeerfield, IL
major depressive disorder Phase IIlundbeck.comtakeda.com
TGBA01AD Fabre-Kramer PharmaceuticalsHouston, TX
major depressive disorder Phase IIfabrekramer.com
DiabetesProduct Name Sponsor Indication Development Phase
11ß-HSD1 inhibitor(LY2523199)
Eli LillyIndianapolis, IN
type 2 diabetes Phase IIlilly.com
AC-201 TWi PharmaceuticalsTaipei, Taiwan
type 2 diabetes Phase IItwipharma.com
Afrezza®
insulin inhalationMannkindValencia, CA
type 1 diabetes, type 2 diabetes Phase IIImannkindcorp.com
albiglutide GlaxoSmithKlineRsch. Triangle Park, NC
type 2 diabetes(see also heart)
application submittedgsk.com
aleglitazar GenentechSouth San Francisco, CARocheNutley, NJ
type 2 diabetes Phase IIIgene.comroche.com
alpha-1 antitrypsin (AAT) OmniBio PharmaceuticalsGreenwood Village, CO
type 1 diabetes Phase I/IIomnibiopharma.com
AMG 151 AmgenThousand Oaks, CA
type 2 diabetes Phase IIamgen.com
anagliptin(DPP-4 inhibitor)
Kowa Research InstituteMorrisville, NC
type 2 diabetes Phase IIkowaus.com
Medicines in Development Older Americans 201322
DiabetesProduct Name Sponsor Indication Development Phase
analog insulin-PH20 HalozymeSan Diego, CA
type 1 diabetes, type 2 diabetes Phase IIhalozyme.com
ARI-2243(DPP-4 inhibitor)
Arisaph PharmaceuticalsBoston, MA
type 2 diabetes Phase Iarisaph.com
BGP-15 N-Gene Research LaboratoriesNew York, NY
type 2 diabetes Phase IIngene.us
BI-135585(11ß-HSD1 inhibitor)
Boehringer Ingelheim PharmaceuticalsRidgefield, CT
type 2 diabetes Phase Iboehringer-ingelheim.com
BIOD-123(ultra-rapid-acting recombinant human insulin)
BiodelDanbury, CT
type 1 diabetes Phase IIbiodel.com
BIOD-125(ultra-rapid-acting recombinant human insulin)
BiodelDanbury, CT
type 1 diabetes Phase I completedbiodel.com
BIOD-238(ultra-rapid-acting recombinant human insulin)
BiodelDanbury, CT
diabetes Phase Ibiodel.com
BIOD-250(ultra-rapid-acting recombinant human insulin)
BiodelDanbury, CT
diabetes Phase Ibiodel.com
BMS-770767(11ßHSD inhibitor)
Bristol-Myers SquibbPrinceton, NJ
type 2 diabetes Phase IIbms.com
canagliflozin Janssen Research & DevelopmentRaritan, NJ
type 2 diabetes application submittedjanssenrnd.com
canagliflozin/metformin extended-release formulation
Janssen Research & DevelopmentRaritan, NJ
type 2 diabetes Phase IIIjanssenrnd.com
canagliflozin/metformin immediate-release formulation
Janssen Research & DevelopmentRaritan, NJ
type 2 diabetes application submittedjanssenrnd.com
canakinumab(ACZ885)
Novartis PharmaceuticalsEast Hanover, NJ
type 2 diabetes(see also arthritis)
Phase II/IIInovartis.com
CAT 1004 Catabasis PharmaceuticalsCambridge, MA
type 2 diabetes Phase Icatabasis.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 23
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
cetilistat NorgineAmsterdam, Netherlands
type 2 diabetes in clinically obese patients
Phase IInorgine.com
CJC-1134-PC ConjuChemLos Angeles, CA
type 2 diabetes Phase IIconjuchem.com
COV 096(PF-04856883)
PfizerNew York, NY
type 2 diabetes Phase Ipfizer.com
dapagliflozin AstraZenecaWilmington, DEBristol-Myers SquibbPrinceton, NJ
type 2 diabetes application submittedastrazeneca.combms.com
dapagliflozin/metformin fixed-dose combination
AstraZenecaWilmington, DEBristol-Myers SquibbPrinceton, NJ
type 2 diabetes Phase IIIastrazeneca.combms.com
DC-9703 Obio PharmaceuticalKowloon, Hong Kong
type 2 diabetes Phase Iobiopharma.com
diabetes medicine (biologic)
Eli LillyIndianapolis, IN
diabetes Phase Ililly.com
diabetes medicine(biologic)
Eli LillyIndianapolis, IN
diabetes Phase Ililly.com
diabetes medicine(biologic)
Eli LillyIndianapolis, IN
diabetes Phase Ililly.com
diabetes medicine(biologic)
Eli LillyIndianapolis, IN
diabetes Phase Ililly.com
diabetes medicine(NCE)
Eli LillyIndianapolis, IN
diabetes Phase Ililly.com
diabetes medicine(NCE)
Eli LillyIndianapolis, IN
diabetes Phase Ililly.com
DiaPep277® Andromeda BiotechYavne, Israel
type 1 diabetes Phase IIIandromedabio.com
DS-7250(DGAT1 inhibitor)
Daiichi SankyoParsippany, NJ
diabetes Phase Idsi.com
Medicines in Development Older Americans 201324
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
DSP-8658(PPAR alpha/gamma agonist)
Sunovion PharmaceuticalsMarlborough, MA
type 2 diabetes(see also Alzheimer’s)
Phase Isunovion.com
dulaglutide(LY2189265)
Eli LillyIndianapolis, IN
type 2 diabetes Phase IIIlilly.com
EGT-0001442(SGLT2 inhibitor)
TheracosMarlborough, MA
type 2 diabetes Phase IItheracos.com
EGT-0001474(SGLT2 inhibitor)
TheracosMarlborough, MA
type 2 diabetes Phase I completedtheracos.com
empagliflozin(BI-10773)
Boehringer Ingelheim PharmaceuticalsRidgefield, CTEli LillyIndianapolis, IN
type 2 diabetes Phase IIIboehringer-ingelheim.comlilly.com
empagliflozin/linagliptin fixed-dose combination
Boehringer Ingelheim PharmaceuticalsRidgefield, CTEli LillyIndianapolis, IN
type 2 diabetes Phase IIIboehringer-ingelheim.comlilly.com
empagliflozin/metformin fixed-dose combination
Boehringer Ingelheim PharmaceuticalsRidgefield, CTEli LillyIndianapolis, IN
type 2 diabetes Phase Iboehringer-ingelheim.comlilly.com
emricasan Conatus PharmaceuticalsSan Diego, CA
type 1 diabetes Phase I/IIconatuspharma.com
enclomifene Repros TherapeuticsThe Woodlands, TX
type 2 diabetes in men with secondary hypogonadism
Phase IIreprosrx.com
fasiglifam(TAK-875)
Takeda Pharmaceuticals InternationalDeerfield, IL
type 2 diabetes Phase IIItakeda.com
GK1-399(glucokinase activator)
Forest LaboratoriesNew York, NY
type 2 diabetes Phase IIfrx.com
glimepiride extended-release/metformin extended-release fixed-dose combination
GlaxoSmithKlineRsch. Triangle Park, NC
type 2 diabetes Phase Igsk.com
glucagon-R antagonist (LY2409021)
Eli LillyIndianapolis, IN
type 2 diabetes Phase IIlilly.com
GPR40 Bristol-Myers SquibbPrinceton, NJ
type 2 diabetes in clinical trials bms.com
Medicines in Development Older Americans 2013 25
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
GPR119 agonist Bristol-Myers SquibbPrinceton, NJ
type 2 diabetes in clinical trials bms.com
GSK1070806 (anti-IL18 mAb)
GlaxoSmithKlineRsch. Triangle Park, NC
type 2 diabetes Phase IIgsk.com
GSK1614235/GSK2330672(SGLT1 inhibitor/iBAT inhibitor)
GlaxoSmithKlineRsch. Triangle Park, NC
type 2 diabetes Phase Igsk.com
HE3286 Harbor BiosciencesSan Diego, CA
type 2 diabetes(see also arthritis)
Phase IIharbortx.com
HM-11260C(exenatide long-acting)
Hanmi PharmaceuticalsSeoul, South Korea
type 2 diabetes Phase IIhanmipharm.com
HPP404(histamine H3 receptor antagonist)
High Point PharmaceuticalsHigh Point, NC
diabetes Phase Ihighpointpharma.com
HPP593(PPAR-delta agonist)
High Point PharmaceuticalsHigh Point, NC
diabetes Phase Ihighpointpharma.com
human proislet peptide(HIP2B)
CureDMWilmington, DE
type 2 diabetes Phase Icuredm.com
IDegLirainsulin degludec/liraglutide
Novo NordiskPrinceton, NJ
type 2 diabetes Phase IIInovonordisk.com
insulin B-chain vaccine Orban BiotechBrookline, MA
type 1 diabetes Phase I completedorbanbiotech.com
insulin glargine(new formulation)
Sanofi USBridgewater, NJ
type 2 diabetes Phase IIIsanofi.com
insulin lispro Eli LillyIndianapolis, IN
type 1 diabetes, type 2 diabetes Phase Ililly.com
INT131 InteKrin TherapeuticsLos Altos, CA
type 2 diabetes Phase IIintekrin.com
ISIS-GCCRRx Isis PharmaceuticalsCarlsbad, CA
type 2 diabetes Phase Iisispharm.com
ISIS-GCGRRx Isis PharmaceuticalsCarlsbad, CA
type 2 diabetes Phase Iisispharm.com
ISIS-PTP1BRx Isis PharmaceuticalsCarlsbad, CA
type 2 diabetes Phase Iisispharm.com
Medicines in Development Older Americans 201326
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
ISIS-SGLT2Rx Isis PharmaceuticalsCarlsbad, CA
type 2 diabetes Phase Iisispharm.com
ITCA 650(exenatide subcutaneous implant)
Intarcia TherapeuticsHayward, CA
type 2 diabetes Phase IIIintarcia.com
Januvia®
sitagliptinMerckWhitehouse Station, NJ
type 2 diabetes in elderly patients with inadequate glycemic control
Phase IIImerck.com
JNJ-16269110(usistapide)
Janssen Research & DevelopmentRaritan, NJ
type 2 diabetes Phase II completedjanssenrnd.com
JNJ-41443532 Janssen Research & DevelopmentRaritan, NJ
type 2 diabetes Phase II completedjanssenrnd.com
JTT-851 Akros PharmaPrinceton, NJ
type 2 diabetes Phase IIakrospharma.com
KD026(MTP inhibitor)
Kadmon PharmaceuticalsNew York, NY
type 2 diabetes Phase IIkadmon.com
KRP-104 ActivX BiosciencesLa Jolla, CA
type 2 diabetes Phase IIactivx.com
Lantus®/lixisenatide insulin glargine and lixisenatide fixed-ratio combination
Sanofi USBridgewater, NJ
type 2 diabetes Phase IIsanofi.com
Lantus®/lixisenatide insulin glargine and lixisenatide fix-flex combination
Sanofi USBridgewater, NJ
type 2 diabetes Phase Isanofi.com
LCQ908(DGAT 1 inhibitor)
Novartis PharmaceuticalsEast Hanover, NJ
type 2 diabetes(see also heart)
Phase IInovartis.com
LEZ763 Novartis PharmaceuticalsEast Hanover, NJ
type 2 diabetes Phase IInovartis.com
LIK066(SGLT 1/2 inhibitor)
Novartis PharmaceuticalsEast Hanover, NJ
type 2 diabetes Phase I/IInovartis.com
linagliptin/pioglitazone fixed-dose combination
Boehringer Ingelheim PharmaceuticalsRidgefield, CTEli LillyIndianapolis, IN
type 2 diabetes Phase IIIboehringer-ingelheim.comlilly.com
Medicines in Development Older Americans 2013 27
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
luseogliflozin(TS-071)
Taisho PharmaceuticalsTokyo, Japan
type 2 diabetes Phase Itaisho.co.jp
LX4211(SLGT1/SLGT2 inhibitor)
Lexicon PharmaceuticalsThe Woodlands, TX
type 1 diabetes, type 2 diabetes Phase IIlexicon-genetics.com
Lyxumia®
lixisenatide(GLP-1 agonist)
Sanofi USBridgewater, NJ
type 2 diabetes application submittedsanofi.com
MABp1 XBiotechAustin, TX
type 2 diabetes Phase IIxbiotech.com
MBX-2982 MetabolexHayward, CA
type 2 diabetes Phase IImetabolex.com
mesenchymal stem cell therapy MesoblastNew York, NY
type 2 diabetes(see also heart)
Phase I/IImesoblast.com
mitiglinide Elixir PharmaGujarat, India
type 2 diabetes Phase IIIelixirpharma.in
MK-8655 MerckWhitehouse Station, NJ
type 2 diabetes Phase Imerck.com
MSDC-0160(MTOR protein inhibitor)
Metabolic Solutions DevelopmentKalamazoo, MI
type 2 diabetes(see also Alzheimer’s)
Phase IImsdrx.com
MSDC-0602(MTOR protein inhibitor)
Metabolic Solutions DevelopmentKalamazoo, MI
type 2 diabetes Phase IImsdrx.com
new insulin glargine product (LY2963016)
Boehringer Ingelheim PharmaceuticalsRidgefield, CTEli LillyIndianapolis, IN
type 2 diabetes Phase IIIboehringer-ingelheim.comlilly.com
NewMet™delayed-release metformin
Elcelyx TherapeuticsSan Diego, CA
type 2 diabetes Phase IIelcelyx.com
NGM-282 NGM BiopharmaceuticalsSouth San Francisco, CA
diabetes Phase Ingmbio.com
NN1218(insulin aspart fast-acting)
Novo NordiskPrinceton, NJ
type 1 diabetes, type 2 diabetes Phase Inovonordisk.com
Medicines in Development Older Americans 201328
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
NN1436(LAI287)
Novo NordiskPrinceton, NJ
type 1 diabetes, type 2 diabetes Phase Inovonordisk.com
NN1953(OI338GT)
Novo NordiskPrinceton, NJ
type 1 diabetes, type 2 diabetes Phase Inovonordisk.com
NN1954(OI362GT)
Novo NordiskPrinceton, NJ
type 1 diabetes, type 2 diabetes Phase Inovonordisk.com
NN9924(OG217SC)
Novo NordiskPrinceton, NJ
type 2 diabetes Phase Inovonordisk.com
NN9926(OG987GT)
Novo NordiskPrinceton, NJ
type 2 diabetes Phase Inovonordisk.com
NN9927(OG987SC)
Novo NordiskPrinceton, NJ
type 2 diabetes Phase Inovonordisk.com
novel basal insulin/insulin peglispro(LY2605541)
Eli LillyIndianapolis, IN
type 2 diabetes
--------------------------------------type 1 diabetes
Phase IIIlilly.com-----------------------------------------Phase Ililly.com
omarigliptin(MK-3102)
MerckWhitehouse Station, NJ
type 2 diabetes Phase IIImerck.com
Onglyza®
saxagliptinAstraZenecaWilmington, DEBristol-Myers SquibbPrinceton, NJ
type 2 diabetes (combination therapy)
Phase IIIastrazeneca.combms.com
Oral-lyn™oral insulin
Generex BiotechnologyToronto, Canada
type 1 diabetes, type 2 diabetes Phase IIIgenerex.com
oxyntomodulin MerckWhitehouse Station, NJ
type 2 diabetes Phase Imerck.com
PAZ320 Boston TherapeuticsManchester, NH
type 2 diabetes Phase IIbostonti.com
PB1023 PhaseBio PharmaceuticalsMalvern, PA
type 2 diabetes Phase IIphasebio.com
PEG-FGF21 Bristol-Myers SquibbPrinceton, NJ
type 2 diabetes in clinical trials bms.com
Medicines in Development Older Americans 2013 29
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
PF-04937319 PfizerNew York, NY
type 2 diabetes Phase IIpfizer.com
PF-04971729 (ertugliflozin)
PfizerNew York, NY
type 2 diabetes Phase IIpfizer.com
PF-05175157 PfizerNew York, NY
type 2 diabetes Phase Ipfizer.com
PF-05231023 PfizerNew York, NY
type 2 diabetes Phase Ipfizer.com
PF-06291874 PfizerNew York, NY
type 2 diabetes Phase Ipfizer.com
PF-06342674 PfizerNew York, NY
type 1 diabetes Phase Ipfizer.com
Prochymal®remestemcel-L
Osiris TherapeuticsColumbia, MD
type 1 diabetes(see also COPD)
Phase IIosiris.com
Qsymia™phentermine/topiramate
VIVUSMountain View, CA
type 2 diabetes Phase IIvivus.com
ranolazine extended-release(late sodium current inhibitor)
Gilead SciencesFoster City, CA
type 2 diabetes Phase IIIgilead.com
RG7697(GLP-1/GIP receptors)
RocheNutley, NJ
type 2 diabetes Phase Iroche.com
RM-493(MC4R peptide)
Rhythm PharmaceuticalsBoston, MA
diabetes Phase Irhythmtx.com
RO6811135 RocheNutley, NJ
type 2 diabetes Phase Iroche.com
roflumilast Takeda Pharmaceuticals InternationalDeerfield, IL
type 2 diabetes Phase Itakeda.com
Ryzodeg®
insulin degludec/insulin aspartNovo NordiskPrinceton, NJ
type 1 diabetes, type 2 diabetes application submittednovonordisk.com
S-707106 ShionogiFlorham Park, NJ
type 2 diabetes Phase IIshionogi.com
SaxaDapasaxagliptin/dapagliflozin fixed-dose combination
AstraZenecaWilmington, DEBristol-Myers SquibbPrinceton, NJ
diabetes Phase IIIastrazeneca.combms.com
Medicines in Development Older Americans 201330
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
semaglutide(NN9535)
Novo NordiskPrinceton, NJ
type 2 diabetes Phase IInovonordisk.com
SRT2104(SIRT1 protein stimulant)
SirtrisCambridge, MA
type 2 diabetes Phase IIsirtrispharma.com
SRT2379(SIRT1 protein stimulant)
SirtrisCambridge, MA
type 2 diabetes Phase Isirtrispharma.com
SRT3025(SIRT1 protein stimulant)
SirtrisCambridge, MA
type 2 diabetes Phase Isirtrispharma.com
SYR-472(trelagliptin)
Takeda Pharmaceuticals InternationalDeerfield, IL
type 2 diabetes Phase IItakeda.com
TAK-329(glucokinase stimulant)
Takeda Pharmaceuticals InternationalDeerfield, IL
type 1 diabetes Phase Itakeda.com
teneligliptin(MP-513)
Mitsubishi Tanabe PharmaOsaka, Japan
type 2 diabetes Phase Imt-pharma.co.jp
teplizumab(anti-CD3 mAb)
MacroGenicsRockville, MD
type 1 diabetes Phase IIImacrogenics.com
tofogliflozin(CSG452)
Chugai PharmaceuticalTokyo, JapanGenentechSouth San Francisco, CA
type 2 diabetes Phase IIchugai-pharm.co.jpgene.com
Tresiba®
insulin degludecNovo NordiskPrinceton, NJ
type 1 diabetes, type 2 diabetes application submittednovonordisk.com
TTP054(GLP-1 receptor agonist)
TransTech PharmaHigh Point, NC
type 2 diabetes Phase IIttpharma.com
TTP814(PTP-1B inhibitor)
TransTech PharmaHigh Point, NC
type 2 diabetes Phase I/IIttpharma.com
U-Strip(insulin transdermal)
Transdermal GlobalNorwalk, CT
type 1 diabetes, type 2 diabetes Phase Itransdermalspecialties.com
vildagliptin Novartis PharmaceuticalsEast Hanover, NJ
type 2 diabetes Phase IIInovartis.com
vildagliptin/metformin combination
Novartis PharmaceuticalsEast Hanover, NJ
type 2 diabetes Phase IIInovartis.com
VRS-859 Diartis PharmaceuticalsRedwood City, CA
type 2 diabetes Phase Idiartispharma.com
Medicines in Development Older Americans 2013 31
Medicines in Development for Older Americans
DiabetesProduct Name Sponsor Indication Development Phase
VVP808(insulin sensitizer)
Verva PharmaceuticalsCarlsbad, CA
type 2 diabetes Phase IIvervapharma.com
ZP2929 Boehringer Ingelheim PharmaceuticalsRidgefield, CTZealand PharmaCopenhagen, Denmark
type 2 diabetes Phase Iboehringer-ingelheim.comzealandpharma.com
Heart Failure/Ischemic Heart DiseaseProduct Name Sponsor Indication Development Phase
ACP-501(rhLCAT)
AlphaCore PharmaAnn Arbor, MI
coronary artery disease Phase Ialphacorepharma.com
ACY001(stem cell therapy)
Compass Biomedical(Arteriocyte)Cleveland, OH
cardiac ischemia Phase Icompassbiomedical.com
adult mesenchymal stem cell therapy
BioCardiaSan Carlos, CA
ischemic heart disorders Phase I/IIbiocardia.com
albiglutide GlaxoSmithKlineRsch. Triangle Park, NC
heart failure(see also diabetes)
Phase IIgsk.com
ALD-201(stem cell therapy)
CytomedixGaithersburg, MD
ischemic heart disorder Phase Icytomedix.com
ANX-042(natriuretic peptide)
AnexonCambridge, MA
acute decompensated heart failure Phase Ianexonrx.com
BAY 10-21189(sGC stimulator)
Bayer HealthCare PharmaceuticalsWayne, NJ
heart failure Phase Ibayerpharma.com
BAY 10-67197(partial adenosin A1 agonist)
Bayer HealthCare PharmaceuticalsWayne, NJ
heart failure Phase Ibayerpharma.com
BAY 86-8050(vasopressin receptor)
Bayer HealthCare PharmaceuticalsWayne, NJ
heart failure Phase Ibayerpharma.com
BAY 94-8862(MR antagonist)
Bayer HealthCare PharmaceuticalsWayne, NJ
chronic heart failure Phase IIbayerpharma.com
Medicines in Development Older Americans 201332
Medicines in Development for Older Americans
Heart Failure/Ischemic Heart DiseaseProduct Name Sponsor Indication Development Phase
beperminogene perplasmid AnGes MGOsaka, Japan
ischemic heart disorders Phase Ianges-mg.com
BFPET™blood flow imaging agent
FluoroPharmaMontclair, NJ
coronary artery disease (diagnosis) Phase IIfluoropharma.com
BR-4628(MR antagonist)
Bayer HealthCare PharmaceuticalsWayne, NJ
heart failure Phase IIbayerpharma.com
bucindolol ARCA BiopharmaBroomfield, CO
heart failure(Fast Track)
application submittedarcabiopharma.com
bucindolol companion diagnostic ARCA BiopharmaBroomfield, COLabCorpBurlington, NC
heart failure (diagnosis) in clinical trialsarcabiopharma.comlabcorp.com
cangrelor The Medicines CompanyParsippany, NJ
coronary artery disease Phase IIIthemedicinescompany.com
CardioPET™muscle state imaging agent
FluoroPharmaMontclair, NJ
fatty acid uptake in coronary artery disease (diagnosis)
Phase IIfluoropharma.com
cenderitide(CD-NP)
Nile TherapeuticsSan Mateo, CA
acute heart failure(Fast Track)--------------------------------------chronic heart failure(Fast Track)
Phase IInilethera.com-----------------------------------------Phase Inilethera.com
CLP-1001 Sorbent TherapeuticsSunnyvale, CA
heart failure in patients with chronic kidney disease
Phase IIsorbent.com
combination autologous stem cell therapy
TCA Cellular TherapyCovington, LA
ischemic heart disorders Phase IItcacellulartherapy.com
CXL-1020-IV Cardioxyl PharmaceuticalsChapel Hill, NC
acute heart failure Phase IIcardioxyl.com
endometrial blood stem cell therapy
MediStemSan Diego, CA
heart failure Phase IImedisteminc.com
epicardial angiogenesis patch TheregenSan Francisco, CA
heart failure, ischemic heart disorders
Phase Itheregen.com
GGF 2(glial growth factor 2)
Acroda TherapeuticsArdsley, NY
heart failure Phase Iacroda.com
Medicines in Development Older Americans 2013 33
Medicines in Development for Older Americans
Heart Failure/Ischemic Heart DiseaseProduct Name Sponsor Indication Development Phase
GSK2849466(selective androgen receptor modulator)
GlaxoSmithKlineRsch. Triangle Park, NC
heart failure Phase Igsk.com
JNJ-39588146 Janssen Research & DevelopmentRaritan, NJ
heart failure Phase II completedjanssenrnd.com
JVS-100 Juventas TherapeuticsCleveland, OH
heart failure Phase IIjuventasinc.com
LCQ908(DGAT1 inhibitor)
Novartis PharmaceuticalsEast Hanover, NJ
coronary artery disease(see also diabetes)
Phase IInovartis.com
LCZ696(NEP inhibitor/ARB)
Novartis PharmaceuticalsEast Hanover, NJ
heart failure Phase IIInovartis.com
LMI 1195(cardiac neuronal agent)
Lantheus Medical ImagingN. Billerica, MA
heart failure (diagnosis) Phase Ilantheus.com
mesenchymal stem cell therapy MesoblastNew York, NY
heart failure(see also diabetes)
Phase IImesoblast.com
MTP-131 Stealth PeptidesNewton Centre, MA
chronic heart failure Phase Istealthpeptides.com
Mydicar®
SERCA 2a gene therapyCelladonSan Diego, CA
advanced (Class III/IV) heart failure(Fast Track)
Phase IIcelladon.net
MyoCell®cell-based heart damage therapy
BioheartSunrise, FL
heart failure Phase II/IIIbioheartinc.com
MyoCell® SDF-1cell-based heart damage therapy
BioheartSunrise, FL
heart failure Phase Ibioheartinc.com
omecamtiv mecarbil AmgenThousand Oaks, CA
heart failure Phase IIamgen.com
PCSK9 adnectin Bristol-Myers SquibbPrinceton, NJ
ischemic heart disease in clinical trials bms.com
PEG-relaxin Bristol-Myers SquibbPrinceton, NJ
heart failure in clinical trials bms.com
PL-3994(NP receptor A agonist)
Palatin TechnologiesCranbury, NJ
heart failure Phase IIpalatin.com
recombinant human neuregulin-1 beta
ZensunShanghai, China
chronic heart failure Phase IIzensun.com
Medicines in Development Older Americans 201334
Heart Failure/Ischemic Heart DiseaseProduct Name Sponsor Indication Development Phase
RLX030(serelaxin)
Novartis PharmaceuticalsEast Hanover, NJ
acute heart failure(Fast Track)--------------------------------------chronic heart failure
Phase IIInovartis.com-----------------------------------------Phase IInovartis.com
SAR126119(TAFIa inhibitor)
Sanofi USBridgewater, NJ
acute ischemic stroke Phase Isanofi.com
sirolimus-eluting coronary stent Svelte Medical SystemsNew Providence, NJ
ischemic heart disorder Phase IIsveltemedical.com
Tekturna®
aliskirenNovartis PharmaceuticalsEast Hanover, NJ
acute heart failure in the elderly, chronic heart failure
Phase IIInovartis.com
TRV027(AT1R)
TrevenaKing of Prussia, PA
acute heart failure Phase IItrevena.com
ularitide CardiorentisZug, Switzerland
acute heart failure Phase IIIcardiorentis.com
urocortin 2 Neurocrine BiosciencesSan Diego, CA
heart failure Phase IIneurocrine.com
VM202(modified hepatocyte growth factor gene therapy)
CordisBridgewater, NJViroMedMinneapolis, MN
myocardial ischemia Phase I/IIcordis.comviromed.com
OsteoporosisProduct Name Sponsor Indication Development Phase
AUS-131(estrogen receptor beta agonist)
Ausio PharmaceuticalsCincinnati, OH
osteoporosis Phase I completedausiopharma.com
BA-058 SC(human parathyroid hormone-related protein)
Radius HealthCambridge, MA
postmenopausal osteoporosis Phase IIIradiuspharm.com
BA-058 TD(human parathyroid hormone-related protein)
Radius HealthCambridge, MA
postmenopausal osteoporosis Phase IIradiuspharm.com
bazedoxifene/conjugated estrogens combination
PfizerNew York, NY
postmenopausal osteoporosis(prevention)
application submittedpfizer.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 2013 35
OsteoporosisProduct Name Sponsor Indication Development Phase
blosozumab(LY2541546)
Eli LillyIndianapolis, IN
postmenopausal osteoporosis Phase IIlilly.com
BPS804(anti-sclerostin IgG2 antibody)
Novartis PharmaceuticalsEast Hanover, NJ
postmenopausal osteoporosis Phase IInovartis.com
calcitonin oral(recombinant)
Tarsa TherapeuticsPhiladelphia, PA
postmenopausal osteoporosis Phase IItarsatherapeutics.com
DP-001 Deltanoid PharmaceuticalsMadison, WI
osteoporosis Phase IIdeltanoid.com
Fablyn®
lasofoxifeneLigand PharmaceuticalsLa Jolla, CA
postmenopausal osteoporosis application submittedligand.com
odanacatib MerckWhitehouse Station, NJ
postmenopausal osteoporosis, male osteoporosis
Phase IIImerck.com
romosozumab(anti-sclerostin mAb)
AmgenThousand Oaks, CAUCBBrussels, Belgium
postmenopausal osteoporosis Phase IIIamgen.comucb.com
sotatercept(ACE-011)
Acceleron PharmaCambridge, MACelgeneSummit, NJ
postmenopausal osteoporosis Phase Iacceleronpharma.comcelgene.com
Viviant™bazedoxifene
PfizerNew York, NY
osteoporosis treatment and prevention
application submittedpfizer.com
ZT-034(teriparatide nasal spray formulation)
Azelon PharmaceuticalsWest Conshohocken, PA
osteoporosis Phase II
ZP-PTH(teriparatide transdermal)
Zosano PharmaFremont, CA
osteoporosis Phase IIzosanopharma.com
Medicines in Development for Older Americans
Medicines in Development Older Americans 201336
Glossary
adjunctive therapy—Auxiliary treatment that is secondary to the main treatment.
Alzheimer’s disease—The most com-mon form of dementia, characterized by progressive and chronic deteriora-tion of cognitive functions, including memory, thinking and reasoning. Early manifestations include forgetfulness, impaired ability to focus, and changes in mood and personality. As the disease progresses, there is a loss of computa-tional ability, in addition to word-finding problems and difficulty with ordinary activities. Ultimately, the disease leads to severe memory loss, complete dis-orientation, social withdrawal, loss of independence, and death.
application submitted—An application for marketing has been submitted to the U.S. Food and Drug Administration (FDA). The application can either be an NDA (new drug application) or a BLA (biologic license application).
chronic obstructive pulmonary disease (COPD)—A group of lung diseases, including chronic bronchitis and em-physema, in which there is a persistent disruption of airflow out of the lungs and eventual hypoxemia (low level of oxygen in the blood).
cognitive disorders—Disorders of the higher mental processes, including understanding, reasoning, knowledge, and intellectual capacity. A person with a cognitive disorder, such as Alzheimer’s disease, does not process information correctly within the brain, resulting in impaired awareness and judgment, dif-ficulty reasoning and focusing, loss of memory and abnormal mental capacity. People with cognitive disorders have problems acquiring, mentally organizing and responding to information, which results in an inability to function nor-mally in everyday life situations.
dementia—Loss of mental ability that interferes with normal daily activities. It lasts more than six months, is not present at birth and is not associated with loss or altered consciousness. The
natural decline of these functions with age is grossly exaggerated in dementia.
depression—A mental illness character-ized by an intense feeling of sadness, which is of greater proportion and duration than expected by objective reason (i.e., recent loss or other sad event). Major depressive disorder (or major depression) includes an episode of depression defined as a persistent (for at least 2 weeks) mood disturbance, plus at least four of the following symptoms: sleep disturbance, changes in psychomo-tor activity, loss of ability to experience pleasure and interest, fatigue, feelings of worthlessness or guilt, difficulty in concentrating, and/or suicidal thoughts. Major depression is associated with im-pairment in social functioning. If criteria for major depression have been met but in addition an episode of mania has ever occurred, then the diagnosis becomes bipolar disorder (or manic-depressive ill-ness). The essential feature of mania is a distinct period when the mood is either elevated, expansive, or irritable, with as-sociated symptoms including hyperactiv-ity, flight of ideas, inflated self-esteem, decreased need for sleep, distractibility and excessive involvement in activities that often are flamboyant, bizarre or disorganized.
diabetes—A chronic disease in which the body does not produce or properly use insulin, a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. Symptoms may include excessive thirst, hunger, urination and weight loss. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles. Type 1 diabetes, the more severe form, results from the body’s failure to pro-duce insulin, which “unlocks” the cells of the body, allowing glucose to enter and fuel them. It is estimated that 5 percent to 10 percent of Americans who are diagnosed with diabetes have type 1, which requires insulin treatment. Type 2 diabetes results from insulin resistance
(a condition in which the body fails to properly use insulin), combined with relative insulin deficiency. Most Ameri-cans who are diagnosed with diabetes have type 2, which in most cases can be controlled if treated properly by a combination of dietary measures, weight loss, and oral medication.
diabetic nephropathy—Kidney disease or damage that can occur in people with diabetes. The kidneys have many tiny blood vessels that filter waste from the blood. High blood sugar from diabetes can destroy those blood vessels. Over time, the kidney isn’t able to do its job as well and may stop working com-pletely, which is called kidney failure. Out of 100 people with diabetes, as many as 40 will develop kidney dam-age. Currently, diabetic nephropathy is the leading cause of chronic kidney disease in the United States and other Western societies. It is also one of the most significant long-term complications in terms of morbidity and mortality for individual patients with diabetes, which is responsible for up to 40 percent of all end-stage renal disease (ESRD) cases in the United States.
Fast Track—Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The status is assigned by the U.S. Food and Drug Administration. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Generally, determining fac-tors include whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially supe-rior to existing therapy. Once a drug re-ceives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged
Medicines in Development Older Americans 2013 37
Glossary
throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and ac-cess by patients.
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.
ischemia—Insufficient supply of blood to an organ or tissue, which can cause organ damage such as an ischemic stroke.
mild Alzheimer’s disease—A stage of Alzheimer’s disease characterized by a series of changes in cognitive abilities that may include memory loss for recent events, difficulty with problem solving, changes in personality, difficulty orga-nizing and expressing thoughts, getting lost or misplacing belongings. This is the stage at which the disease is often first diagnosed.
moderate Alzheimer’s disease—A stage of Alzheimer’s disease characterized by increased confusion, greater memory
loss, significant changes in personal-ity, and the need for assistance with basic daily activities. These changes are related to damage in areas of the brain that control language, reasoning, sensory processing, and conscious think-ing. At this stage, patients may have problems recognizing family and friends, experience hallucinations, delusions, and paranoia, and may behave impulsively.
osteoarthritis—The most common form of joint disease, characterized by degen-eration of the cartilage that lines joints and by the formation of reactive bony outgrowths at the boundary of a joint.
osteoporosis—The most common metabolic bone disease in older people in which a reduction in bone mass leads to fractures, especially of the vertebrae, hips and wrists.
PET imaging—Positron emission to-mography (PET), a noninvasive medical imaging technique that utilizes a ra-dioactive agent (“tracer”) incorporated in a biologically active molecule and a scanner to produce three-dimensional images of the body.
Phase 0—First-in-human trials conduct-ed in accordance with FDA’s 2006 guid-ance 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—Researchers test the drug in a small group of people, usually between 20 and 80 healthy adult volunteers, to evaluate its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.
Phase II—The drug is given to volun-teer patients, usually between 100 and 300, to see if it is effective, identify an optimal dose, and to further evaluate its short-term safety.
Phase III—The drug is given to a larger, more diverse patient population, often involving between 1,000 and 3,000 patients (but some time many more thousands), to generate statistically significant evidence to confirm its safety and effectiveness. They are the longest studies and usually take place in multiple sites around the world.
rheumatoid arthritis—A type of arthritis that particularly attacks the small joints of the hands, wrists and feet. The joints become painful, swollen, stiff and, in severe cases, deformed.
The content of this report has been obtained through public, government and industry sources, and the Adis “R&D Insight” data-base based on the latest information. Report current as of March 10, 2013. The medicines in this report include medicines being developed by U.S. based companies conducting trials in the United States and abroad, PhRMA-member companies conducting trials in the United States and abroad and foreign companies conducting clinical trials in the United States. 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
Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.
Copyright © 2013 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if proper credit is given.
Pharmaceutical Research and Manufacturers of America • 950 F Street, NW, Washington, DC 20004
The Drug Discovery, Development and Approval Process
The U.S. system of new drug approvals is per-haps the most rigorous in the world.
It takes 10-15 years, on average, for an experi-mental drug to travel from lab to U.S. patients, according to the Tufts Center for the Study of Drug Development. Only five in 5,000 com-pounds 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 $1.2 billion, including the cost of failures, to get one new medicine from the laboratory to U.S. patients, according to a recent study by the Tufts Center for the Study of Drug Development.
Once a new compound has been identified in the laboratory, medicines are usually 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 evalu-ated for safety.
Investigational New Drug Application (IND). After completing preclinical testing, a com-pany files an IND with the U.S. Food and Drug Administration (FDA) to begin to test the drug
in people. 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 manufac-tured. All clinical trials must be reviewed and ap-proved 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.
Clinical Trials, Phase I—Researchers test the drug in a small group of people, usually between 20 and 80 healthy adult volunteers, to evaluate its initial safety and tolerability profile, deter-mine a safe dosage range, and identify potential side effects.
Clinical Trials, Phase II—The drug is given to volunteer patients, usually between 100 and 300, to see if it is effective, identify an optimal dose, and to further evaluate its short-term safety.
Clinical Trials, Phase III—The drug is given to a larger, more diverse patient population, often involving between 1,000 and 3,000 patients (but sometime many more thousands), to gener-
ate statistically significant evidence to confirm its safety and effectiveness. They are the lon-gest studies, and usually take place in multiple sites around the world.
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.
Approval. Once FDA approves an NDA or BLA, the new medicine becomes available for physi-cians 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. PhRMA member companies invested an estimated $49.5 billion in research and develop-ment in 2011.
Developing a new medicine takes an average of 10-15 years; For every 5,000-10,000 compounds in the pipeline, only 1 is approved.
The Drug Development and Approval Process
PRE-
DIS
COV
ERY
DRUG DISCOVERY PRECLINICAL CLINICAL TRIALS FDA REVIEW LG-SCALE MFG
3 – 6 Y E A RS 6 – 7 Y E A RS 0. 5 – 2 Y E A RS
100 – 300 1,000 – 3,00020 –80
PHASE 2
PHASE 3
PHASE 1
IND
SU
BM
ITTE
D
ND
A S
UB
MIT
TED
PHA
SE 4
: PO
ST-M
AR
KET
ING
SU
RVEI
LLA
NCE
NUMBER OF VOLUNTEERS
ONE FDA-APPROVED
DRUG
5,000 – 10,000
COMPOUNDS
250 5
Drug Discovery and Development: A LONG, RISKY ROAD