medicines in development 2013 older...

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 RECIPIENTS9090BENEFICIARIESPERCENT 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)


Alzheimer’s disease Phase II completedabbvie.com

ABT-384 AbbVieNorth Chicago, IL

Alzheimer’s disease Phase II completedabbvie.com

ABT-957(calpain inhibitor)


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

http://www.piramalenterprises.comwww.janimm.comwww.pfizer.comwww.pfizer.comwww.janimm.comwww.abbvie.comwww.abbvie.comwww.abbvie.comwww.abbvie.comwww.gsk.comwww.gsk.comwww.takeda.comwww.aphios.comwww.accerapharma.com

Medicines in Development Older Americans 2013 3


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)



ARC031 SR(soluble amyloid reducing/clearing agent)



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)


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

www.archerpharma.comwww.archerpharma.comwww.archerpharma.comwww.avineuro.comwww.avineuro.comwww.avineuro.comwww.astrazeneca.comwww.astrazeneca.comwww.astrazeneca.comwww.navidea.comwww.navidea.comwww.lilly.comwww.eisai.comhttp://www.piramalenterprises.com




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

www.bigenidec.comwww.qrpharma.comwww.bms.comwww.novartis.comwww.ceregene.comwww.gene.comwww.sunovion.comwww.eisai.comwww.elan.comwww.frx.comwww.allontherapeutics.comwww.adamaspharma.comwww.envivopharma.comwww.envivopharma.comwww.proteotech.comwww.gehealthcare.comhttp://www.medical.siemens.com



Gammagard®immune globulin

Baxter InternationalDeerfield, IL

early-stage Alzheimer’s disease, mid-stage Alzheimer’s disease

Phase IIIbaxter.com

gamma secretase modulator,A-beta modulator


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)


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)


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)


Alzheimer’s disease (diagnosis) Phase IIInavidea.com

NIC5-15 HumaneticsMinneapolis, MN

Alzheimer’s disease Phase IIhumaneticscorp.com


www.bms.comwww.baxter.comwww.roche.comwww.gsk.comwww.gsk.comwww.highpointpharma.comwww.grifols.comhttp://www.kareustherapeutics.comwww.lundbeck.comhttp://www.ab-science.comwww.mithridion.comwww.merck.comwww.merck.comwww.msdrx.comwww.navidea.comwww.humaneticscorp.com



PF-05212377(SAM-760)

PfizerNew York, NY

Alzheimer’s disease Phase IIpfizer.com

Posiphen®R-phenserine

QR 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)


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)


Alzheimer’s disease Phase Isanofi.com

sGC-1061 sGC PharmaWellesley, MA

Alzheimer’s disease Phase Isgcpharma.com

solanezumab(LY2062430)


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


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


www.pfizer.comwww.qrpharma.comwww.nanotherapeutics.comwww.roche.comwww.roche.comwww.gsk.comhttp://www.resverlogix.comwww.sanofi.comwww.sanofi.comwww.sgcpharma.comwww.lilly.comwww.sonexa.comwww.takeda.comwww.targacept.comwww.targacept.comhttp://www.toyama-chemical.co.jp



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


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)


rheumatoid arthritis Phase Iabbvie.com

ABT-413(sphingosine 1 phosphate receptor modulator)



ABT-494(JAK-1, 2, 3 inhibitor)




http://www.taurx.comwww.ttpharma.comwww.ttpharma.comwww.unitedbiomedical.comwww.merck.comwww.theravance.comwww.vivus.comwww.abbvie.comwww.abbvie.comwww.abbvie.comwww.entremed.comwww.xelpharmaceuticals.com



ABT-652(histamine H3 receptor modulator)


osteoarthritis of the knee Phase IIabbvie.com

ABT-981(anti-IL-1 α and β mAb)


osteoarthritis Phase Iabbvie.com

Actemra®tocilizumab

GenentechSouth 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)


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)


osteoarthritis, rheumatoid arthritis

Phase IIbms.com

BT-061 AbbVieNorth Chicago, ILBiotestDreieich, Germany

rheumatoid arthritis Phase IIabbvie.combiotest.de


www.abbvie.comwww.abbvie.comwww.abbvie.comwww.gene.comwww.gene.comwww.roche.comwww.roche.comwww.novartis.comwww.astellas.comwww.lilly.comwww.bms.comhttp://www.boehringer-ingelheim.comhttp://www.boehringer-ingelheim.comhttp://www.biotest.dewww.afferentpharma.comwww.argentisrx.comwww.arraybiopharma.comwww.perseidtherapeutics.com



buprenorphine transmucosal BioDelivery Sciences InternationalRaleigh, NCEndo PharmaceuticalsMalvern, PA

chronic pain associated with osteoarthritis

Phase IIIbdsi.comendo.com

canakinumab(ACZ885)


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 pegol

UCBSmyrna, GA

early rheumatoid arthritis Phase IIIucb.com

clazakizumab (anti-IL6-mAb)


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


www.novartis.comwww.novartis.comwww.bdsi.comwww.endo.comwww.frx.comwww.cephalon.comwww.canfite.comwww.osiris.comwww.ucb.comwww.bms.comwww.janssenbiotech.comwww.mallinckrodt.comwww.mallinckrodt.comwww.celltherapeutics.comwww.pfizer.comwww.philogen.comwww.ampiopharma.com



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)


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


www.merck.comwww.astrazeneca.comwww.rigel.comwww.xoma.comwww.gsk.comwww.abbvie.comwww.gsk.comwww.harbortx.comwww.incyte.comwww.iroko.comwww.iroko.comhttp://www.flexiontherapeutics.comhttp://www.flexiontherapeutics.com



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)


chronic pain associated with osteoarthritis of the knee

Phase Ijanssenrnd.com

JNJ-40346527(M-CSF receptor antagonist)



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)


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


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


www.janssenrnd.comwww.janssenrnd.comwww.janssenrnd.comwww.isispharm.comwww.logicaltx.comhttp://www.lexicon-genetics.comwww.astrazeneca.comwww.astrazeneca.comwww.medimmune.comwww.medimmune.comwww.merck.comwww.merck.comwww.eisai.comwww.takeda.comwww.nicox.comhttp://www.medi-post.com




NN8209(anti-C5aR-151)

Novo NordiskPrinceton, NJ

rheumatoid arthritis Phase IInovonordisk.com

NN8210(anti-C5aR-215)


rheumatoid arthritis Phase Inovonordisk.com

NN8226(anti-IL20 mAb)



NN8765(anti-NKG2A)


rheumatoid arthritis Phase Inovonordisk.com

NN8828(anti-IL21 mAb)



olokizumab UCBSmyrna, GA

rheumatoid arthritis Phase IIucb.com

OLT-1177 Olatec IndustriesNew York, NY


Phase II

osteoarthritis medicine(NCE)


osteoarthritis pain Phase Ililly.com

otelixizumab(CD3 mAb)


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

www.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.ucb.comwww.lilly.comwww.gsk.comwww.antarespharma.comwww.ablynx.comwww.celgene.comwww.mallinckrodt.comwww.pfizer.comwww.pfizer.comwww.pfizer.com




PLX5622(FGF-1 antagonist)

PlexxikonBerkeley, CA

rheumatoid arthritis Phase Iplexxikon.com

Prolia®denosumab

AmgenThousand 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)


osteoarthritis Phase IIsanofi.com

SAR292833(TRVP3 antagonist)


osteoarthritis pain Phase IIsanofi.com

sarilumab(anti-IL-6R mAb)


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®ustekinumab



www.plexxikon.comwww.amgen.comwww.protalex.comwww.immuneresponsebiopharma.comwww.resolvyx.comwww.santarus.comwww.sanofi.comwww.sanofi.comwww.sanofi.comwww.janssenbiotech.comwww.janssenbiotech.comwww.janssenrnd.comwww.emdserono.comwww.tissuegene.com



V116517 Purdue PharmaStamford, CT


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)


diabetic nephropathy(see also arthritis)

Phase IIlilly.com


www.purduepharma.comwww.immunomedics.comwww.takeda.comwww.vaccinex.comwww.vrtx.comwww.eyegatepharma.comwww.questcor.comwww.abbvie.comwww.lilly.comwww.ardelyx.comwww.astrazeneca.com


Chronic Kidney DiseaseProduct Name Sponsor Indication Development Phase

BB-3 AngionUniondale, NY

chronic kidney fibrosis Phase Iangion.com

BMS-813160(dual CCR2/CCR5 antagonist)


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)


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)


diabetic nephropathy Phase IIlilly.com

VTP-27999(renin inhibitor)

Vitae PharmaceuticalsFort Washington, PA

chronic kidney disease Phase Ivitaepharma.com


www.angion.comwww.bms.comwww.chemocentryx.comwww.lilly.comwww.sorbent.comwww.concertpharma.comwww.invasc.netwww.lilly.comwww.lilly.comwww.pfizer.comwww.pfizer.comwww.nephrogenex.comwww.lilly.comwww.vitaepharma.comwww.lilly.comhttp://www.boehringer-ingelheim.comhttp://www.mt-pharma.co.jp



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)


COPD Phase IIastrazeneca.com

AZD7594(inhaled SGRM)


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)


COPD(see also asthma)

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/formoterol


COPD application submittedmerck.com

fluticasone furoate/vilanterol/umeclidinium combination


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)


COPD Phase Igsk.com

www.astrazeneca.comwww.astrazeneca.comwww.astrazeneca.comwww.astrazeneca.comwww.frx.comwww.novartis.comwww.medicinova.comwww.medimmune.comwww.biomarck.comwww.merck.comwww.gsk.comwww.gsk.comwww.sunovion.comwww.mylanspecialty.comhttp://www.boehringer-ingelheim.com




GSK1325756(CXCR2 chemokine receptor antagonist)


COPD Phase Igsk.com

GSK2269557(phosphoinositide 3 kinase inhibitor)


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)


COPD Phase IIgsk.com

MEDI-7814(anti-C5/C5a mAb)


COPD Phase Iastrazeneca.commedimmune.com

MEDI-8968(nati-IL-1R mAb)


COPD Phase IIastrazeneca.commedimmune.com

NVA237(glycopyrrolate inhalation)


COPD Phase IIInovartis.com

olodaterol/tiotropium bromide fixed-dose combination


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


COPD(see also diabetes)

Phase IIosiris.com

PT001(glycopyrrolate inhalation aerosol)

Pearl TherapeuticsRedwood City, CA

COPD Phase IIpearltherapeutics.com

PT003(glycopyrrolate/formoterol inhalation aerosol)



www.gsk.comwww.gsk.comwww.gsk.comwww.gsk.comwww.astrazeneca.comwww.astrazeneca.comwww.medimmune.comwww.medimmune.comwww.novartis.comwww.otsuka.comwww.pfizer.comwww.pfizer.comwww.osiris.comwww.pearltherapeutics.comwww.pearltherapeutics.comwww.theravance.comhttp://www.boehringer-ingelheim.com




PT005(formoterol inhalation aerosol)



PUR118 PulmatrixLexington, MA

COPD Phase Ipulmatrix.com

QMF149(indacaterol/mometasome fixed-dose combination)


COPD Phase IInovartis.com

QVA149(glycopyrrolate/indacaterol fixed-dose combination)


COPD Phase IIInovartis.com

salbutamol dry-powder inhalation

Teva PharmaceuticalNorth Wales, PA

COPD Phase IItevapharm.com

Striverdi Respimat™olodaterol


COPD application submittedboehringer-ingelheim.com

suvorexant(dual orexin receptor antagonist)


COPD Phase I completedmerck.com

TD-4208(LAMA)

TheravanceSouth San Francisco, CA

COPD Phase IItheravance.com

umeclidinium(muscarinic acetylcholine antagonist)


COPD Phase IIIgsk.com

umeclidinium/vilanterol fixed-dose combination


COPD application submittedgsk.com

vilanterol(long-acting beta2 agonist)


COPD Phase IIIgsk.comtheravance.com

vilanterol/fluticasone furoate fixed-dose combination


COPD

--------------------------------------COPD (mortality claim)

application submittedgsk.comtheravance.com-----------------------------------------Phase IIIgsk.comtheravance.com

www.pearltherapeutics.comwww.pulmatrix.comwww.novartis.comwww.novartis.comwww.tevapharm.comwww.merck.comwww.theravance.comwww.theravance.comwww.theravance.comwww.theravance.comwww.gsk.comwww.gsk.comwww.gsk.comwww.gsk.comwww.gsk.comhttp://www.boehringer-ingelheim.com



DepressionProduct Name Sponsor Indication Development Phase

ABT-436(selective vasopressin receptor antagonist)


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)


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)


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(serotin uptake inhibitor)

SunovionMarlborough, MA

depression Phase Isunovion.com

www.abbvie.comwww.alkermes.comwww.euthymics.comhttp://araim.orgwww.tevapharm.comwww.astrazeneca.comwww.braincellsinc.comwww.braincellsinc.comwww.bms.comwww.otsuka.comwww.lundbeck.comwww.takeda.comwww.frx.comwww.cenerx.comwww.sunovion.com




edivoxetine(LY2216684)


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)


major depressive disorder with anxiety symptoms

Phase IIjanssenrnd.com

levomilnacipran(F2695)


major depressive disorder application submittedfrx.com

lisdexamfetamine ShireWayne, PA

major depressive disorder Phase IIIshire.com

lurasidone Sunovion Marlborough, 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)


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

www.dartneuroscience.comwww.lilly.comwww.naurex.comwww.janssenrnd.comwww.frx.comwww.shire.comwww.sunovion.comwww.lilly.comwww.corcept.comwww.merck.comwww.neurenpharma.comwww.neuralstem.comwww.roche.comwww.roche.comwww.roche.comwww.pharmaneuroboost.com




SEP-228432 SunovionMarlborough, 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 disorders 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)


type 2 diabetes Phase IIlilly.com

AC-201 TWi PharmaceuticalsTaipei, Taiwan

type 2 diabetes Phase IItwipharma.com

Afrezza®insulin inhalation

MannkindValencia, 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

www.sunovion.comwww.skbp.comwww.lundbeck.comwww.takeda.comwww.fabrekramer.comwww.lilly.comwww.twipharma.comwww.mannkindcorp.comwww.gsk.comwww.gene.comwww.roche.comwww.omnibiopharma.comwww.amgen.comwww.kowaus.com



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)


type 2 diabetes Phase Iboehringer-ingelheim.com

BIOD-123(ultra-rapid-acting recombinant human insulin)

BiodelDanbury, CT

type 1 diabetes Phase IIbiodel.com


BiodelDanbury, CT

type diabetes Phase I completedbiodel.com


BiodelDanbury, CT

diabetes Phase Ibiodel.com


BiodelDanbury, CT

diabetes Phase Ibiodel.com

BMS-770767(11ßHSD inhibitor)


type 2 diabetes Phase IIbms.com

canagliflozin Janssen Research & DevelopmentRaritan, NJ

type 2 diabetes application submittedjanssenrnd.com

canagliflozin/metformin extended-release formulation


type 2 diabetes Phase IIIjanssenrnd.com

canagliflozin/metformin immediate-release formulation


type 2 diabetes application submittedjanssenrnd.com

canakinumab(ACZ885)


type 2 diabetes(see also arthritis)

Phase II/IIInovartis.com

CAT 1004 Catabasis PharmaceuticalsCambridge, MA

type 2 diabetes Phase Icatabasis.com


www.halozyme.comwww.arisaph.comwww.ngene.comwww.biodel.comwww.biodel.comwww.biodel.comwww.biodel.comwww.bms.comwww.janssenrnd.comwww.janssenrnd.comwww.janssenrnd.comwww.novartis.comwww.catabasis.comhttp://www.boehringer-ingelheim.com




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)


diabetes Phase Ililly.com

diabetes medicine(biologic)









diabetes medicine(NCE)



diabetes medicine(NCE)



DiaPep277® Andromeda BiotechYavne, Israel

type 1 diabetes Phase IIIandromedabio.com

DS-7250(DGAT1 inhibitor)

Daiichi SankyoParsippany, NJ

diabetes Phase Idsi.com

www.andromedabio.comwww.dsi.comwww.norgine.comwww.conjuchem.comwww.pfizer.comwww.astrazeneca.comwww.astrazeneca.comwww.bms.comwww.bms.comwww.obiopharma.comwww.lilly.comwww.lilly.comwww.lilly.comwww.lilly.comwww.lilly.comwww.lilly.com




DSP-8658(PPAR alpha/gamma agonist)

Sunovion PharmaceuticalsMarlborough, MA

type 2 diabetes(see also Alzheimer’s)

Phase Isunovion.com

dulaglutide(LY2189265)


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



empagliflozin/metformin fixed-dose combination


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)


type 2 diabetes Phase IIItakeda.com

GK1-399(glucokinase activator)


type 2 diabetes Phase IIfrx.com

glimepiride extended-release/metformin extended-release fixed-dose combination


type 2 diabetes Phase Igsk.com

glucagon-R antagonist (LY2409021)


type 2 diabetes Phase IIlilly.com

GPR40 Bristol-Myers SquibbPrinceton, NJ

type 2 diabetes in clinical trials bms.com

http://www.boehringer-ingelheim.comhttp://www.boehringer-ingelheim.comhttp://www.boehringer-ingelheim.comwww.lilly.comwww.lilly.comwww.lilly.comwww.lilly.comwww.lilly.comwww.reprosrx.comwww.conatuspharma.comwww.takeda.comwww.frx.comwww.gsk.comwww.bms.comwww.sunovion.comwww.theracos.comwww.theracos.com




GPR119 agonist Bristol-Myers SquibbPrinceton, NJ


GSK1070806 (anti-IL18 mAb)


type 2 diabetes Phase IIgsk.com

GSK1614235/GSK2330672(SGLT1 inhibitor/iBAT inhibitor)


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)


diabetes Phase Ihighpointpharma.com

HPP593(PPAR-delta agonist)


diabetes Phase Ihighpointpharma.com

human proislet peptide(HIP2B)

CureDMWilmington, DE

type 2 diabetes Phase Icuredm.com

IDegLirainsulin degludec/liraglutide


type 2 diabetes Phase IIInovonordisk.com

insulin B-chain vaccine Orban BiotechBrookline, MA

type 1 diabetes Phase I completedorbanbiotech.com

insulin glargine(new formulation)


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


ISIS-PTP1BRx Isis PharmaceuticalsCarlsbad, CA


www.bms.comwww.gsk.comwww.gsk.comwww.harbortx.comhttp://www.hanmipharm.comwww.highpointpharma.comwww.highpointpharma.comwww.curedm.comwww.novonordisk.comwww.orbanbiotech.comwww.sanofi.comwww.lilly.comwww.intekrin.comwww.isispharm.comwww.isispharm.comwww.isispharm.com




ISIS-SGLT2Rx Isis PharmaceuticalsCarlsbad, CA


ITCA 650(exenatide subcutaneous implant)

Intarcia TherapeuticsHayward, CA

type 2 diabetes Phase IIIintarcia.com

Januvia®sitagliptin


type 2 diabetes in elderly patients with inadequate glycemic control

Phase IIImerck.com

JNJ-16269110(usistapide)


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


type 2 diabetes Phase IIsanofi.com

Lantus®/lixisenatide insulin glargine and lixisenatide fix-flex combination


type 2 diabetes Phase Isanofi.com

LCQ908(DGAT 1 inhibitor)



Phase IInovartis.com

LEZ763 Novartis PharmaceuticalsEast Hanover, NJ

type 2 diabetes Phase IInovartis.com

LIK066(SGLT 1/2 inhibitor)


type 2 diabetes Phase I/IInovartis.com

linagliptin/pioglitazone fixed-dose combination



www.isispharm.comwww.intarcia.comwww.merck.comwww.janssenrnd.comwww.janssenrnd.comwww.akrospharma.comwww.kadmon.comwww.activx.comwww.sanofi.comwww.sanofi.comwww.novartis.comwww.novartis.comwww.novartis.comwww.lilly.comhttp://www.boehringer-ingelheim.com




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)


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


Phase I/IImesoblast.com

mitiglinide Elixir PharmaGujarat, India

type 2 diabetes Phase IIIelixirpharma.in


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)



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)


type 1 diabetes, type 2 diabetes Phase Inovonordisk.com

http://www.taisho.co.jphttp://www.lexicon-genetics.comhttp://www.boehringer-ingelheim.comhttp://www.elixirpharma.inwww.metabolex.comwww.sanofi.comwww.xbiotech.comwww.mesoblast.comwww.merck.comwww.msdrx.comwww.msdrx.comwww.lilly.comwww.elcelyx.comwww.ngmbio.comwww.novonordisk.com




NN1436(LAI287)



NN1953(OI338GT)



NN1954(OI362GT)



NN9924(OG217SC)


type 2 diabetes Phase Inovonordisk.com

NN9926(OG987GT)



NN9927(OG987SC)



novel basal insulin/insulin peglispro(LY2605541)


type 2 diabetes

--------------------------------------type 1 diabetes

Phase IIIlilly.com-----------------------------------------Phase Ililly.com

omarigliptin(MK-3102)


type 2 diabetes Phase IIImerck.com

Onglyza®saxagliptin


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


www.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.novonordisk.comwww.lilly.comwww.lilly.comwww.merck.comwww.merck.comwww.astrazeneca.comwww.bms.comwww.generex.comwww.bostonti.comwww.phasebio.comwww.bms.com




PF-04937319 PfizerNew York, NY

type 2 diabetes Phase IIpfizer.com

PF-04971729 (ertugliflozin)

PfizerNew York, NY

type 2 diabetes Phase IIpfizer.com









Prochymal®remestemcel-L


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 aspart


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


diabetes Phase IIIastrazeneca.combms.com

www.pfizer.comwww.pfizer.comwww.pfizer.comwww.pfizer.comwww.pfizer.comwww.pfizer.comwww.osiris.comwww.vivus.comwww.gilead.comwww.roche.comwww.roche.comwww.rhythmtx.comwww.takeda.comwww.novonordisk.comwww.shionogi.comwww.astrazeneca.comwww.bms.com




semaglutide(NN9535)


type 2 diabetes Phase IInovonordisk.com

SRT2104(SIRT1 protein stimulant)

SirtrisCambridge, MA

type 2 diabetes Phase IIsirtrispharma.com



type 2 diabetes Phase Isirtrispharma.com



type 2 diabetes Phase Isirtrispharma.com

SYR-472(trelagliptin)


type 2 diabetes Phase IItakeda.com

TAK-329(glucokinase stimulant)


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 degludec


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


type 2 diabetes Phase IIInovartis.com

VRS-859 Diartis PharmaceuticalsRedwood City, CA

type 2 diabetes Phase Idiartispharma.com

www.novonordisk.comwww.novonordisk.comwww.sirtrispharma.comwww.sirtrispharma.comwww.sirtrispharma.comwww.takeda.comwww.takeda.comwww.macrogenics.comwww.gene.comwww.ttpharma.comwww.ttpharma.comwww.transdermalspecialties.comwww.novartis.comwww.novartis.comwww.diartispharma.comhttp://www.mt-pharma.co.jphttp://www.chugai-pharm.co.jp




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)



BAY 86-8050(vasopressin receptor)



BAY 94-8862(MR antagonist)


chronic heart failure Phase IIbayerpharma.com

http://www.boehringer-ingelheim.comhttp://www.zealandpharma.comwww.compassbiomedical.comwww.alphacorepharma.comwww.vervapharma.comwww.biocardia.comwww.gsk.comwww.cytomedix.comwww.anexonrx.comwww.bayerpharma.comwww.bayerpharma.comwww.bayerpharma.comwww.bayerpharma.com




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)


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

www.themedicinescompany.comwww.fluoropharma.comwww.fluoropharma.comwww.bayerpharma.comwww.arcabiopharma.comwww.arcabiopharma.comwww.labcorp.comwww.nilethera.comwww.nilethera.comwww.sorbent.comwww.tcacellulartherapy.comwww.cardioxyl.comwww.medisteminc.comwww.theregen.comwww.acroda.comhttp://www.anges-mg.com




GSK2849466(selective androgen receptor modulator)


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)


coronary artery disease(see also diabetes)

Phase IInovartis.com

LCZ696(NEP inhibitor/ARB)


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 therapy

CelladonSan 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

www.stealthpeptides.comwww.gsk.comwww.janssenrnd.comwww.juventasinc.comwww.novartis.comwww.novartis.comwww.lantheus.comwww.mesoblast.comwww.celladon.netwww.bioheartinc.comwww.bioheartinc.comwww.amgen.comwww.palatin.comwww.bms.comwww.bms.comhttp://www.zensun.com



RLX030(serelaxin)


acute heart failure(Fast Track)--------------------------------------chronic heart failure

Phase IIInovartis.com-----------------------------------------Phase IInovartis.com

SAR126119(TAFIa inhibitor)


acute ischemic stroke Phase Isanofi.com

sirolimus-eluting coronary stent Svelte Medical SystemsNew Providence, NJ

ischemic heart disorder Phase IIsveltemedical.com

Tekturna®aliskiren


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


www.novartis.comwww.novartis.comwww.sanofi.comwww.sveltemedical.comwww.novartis.comwww.trevena.comwww.cardiorentis.comwww.neurocrine.comwww.cordis.comwww.viromed.comwww.ausiopharma.comwww.radiuspharm.comwww.radiuspharm.comwww.pfizer.com


OsteoporosisProduct Name Sponsor Indication Development Phase

blosozumab(LY2541546)


postmenopausal osteoporosis Phase IIlilly.com

BPS804(anti-sclerostin IgG2 antibody)


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®lasofoxifene

Ligand 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


www.lilly.comwww.novartis.comwww.tarsatherapeutics.comwww.deltanoid.comwww.ligand.comwww.merck.comwww.amgen.comwww.ucb.comwww.acceleronpharma.comwww.celgene.comwww.pfizer.comwww.zosanopharma.com


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


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 h

medicines in development 2013 older...

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