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2013年在研老年人用药物

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