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Older Americans, Please See Medi- See Please Ing Older Americans, Ameri- for Older Cines in Development 2013 MEDICINES IN DEVEloPMENT REPORT Older Americans The Medicare Population and Leading Chronic Diseases PRESENTED BY amERIca’s biOPHARmacEUTIcal RESEARCH comPANIES More Than 400 Medicines in Development for Leading Chronic Diseases Affecting Older Americans C D R AT EMENTIA CHRONIC KIDNEY DISEASECOPD CHRONIC KIDNEY DISEASE HE AR COPD ISCHEMIC HEART DISEASEALZHEIMER'S DISEASE U A MA DEPRESSION OSTEOARTHRITIS HEART FAILURE C T OSTEOPOROSIS S T Medicines in Development MMOREORE MILLION DIABETES O I For Leading Chronic D A Diseases Affecting Seniors THANTHAN S MEDICARE RECIPIENTS R ' A R 40 TH CATARACTS DIABETES PERCENT OF ALL R OSTEOPOROSIS ITI Application 142 EMENTI DEPRESSION S Submitted LZHEIME D BENEFICIARIES A BENEFICIARIES RHEUMATOID ARTHRITIS 90 Phase III HAVE PRESCRIPTION DRUG COVERAGE Phase II Biopharmaceutical research companies • 20 for chronic kidney disease, where are developing 465 medicines and vac- prevalence grows with older age. Phase I cines for the 10 leading chronic diseases • 15 for osteoporosis, a major health affecting Medicare beneficiaries.* This threat for an estimated 44 million report lists medicines and vaccines in Americans. 92 human clinical trials or under review by the U.S. Food and Drug Administration Definitions for selected terms can be 82 (FDA). found on page 36. A link to the sponsor company’s web site provides more de- The medicines in development include: tailed information on the science behind • 142 for diabetes, which affects 10.9 each potential product. million Americans age 65 and older. For information on the value of medicines, • 92 for rheumatoid arthritis and osteo- an in-depth look at current innovation arthritis, which affects 12.4 million and key medical breakthroughs benefit- 48 people, age 65 and older. ing older Americans, please see Medi- 40 • 82 for Alzheimer’s disease, which cines in Development for Older Ameri- cans 2013—Overview. 34 could afflict nearly 8 million people by 2030 unless a cure or prevention is The medicines in this report provide hope found. to older Americans who suffer from these • 48 for heart failure and ischemic heart debilitating chronic diseases and are disease, two of many cardiovascular dis- seeking to live longer, more independent eases affecting 80.7 million Americans, and healthier lives. half of which are age 60 and older. • 40 for COPD, which affects Americans ’s over age 65 at a higher rate. COPD Arthritis • 34 for depression, which affects an Diabetes Alzheimer Depression estimated 6.5 million Americans age Heart Disease 65 and older. *Centers for Medicare and Medicaid Services (CMS), Chronic Condition Data Warehouse (CCW) Medicare 5% Sample, 2009 Medicines in Development for Older Americans Alzheimer’s Disease and Dementia Product Name Sponsor Indication Development Phase* 18F-florbetaben Piramal Healthcare Alzheimer’s disease (diagnosis) Phase III (BAY 94-9172) Mumbai, India piramalenterprises.com AAB-003/PF-05236812 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase I (amyloid beta protein inhibitor) South San Francisco, CA janimm.com Pfizer pfizer.com New York, NY ABT-126 AbbVie mild to moderate Alzheimer’s Phase II (α7-NNR antagonist) North Chicago, IL disease abbvie.com ABT-288 AbbVie Alzheimer’s disease Phase II completed (neurotransmitter receptor North Chicago, IL abbvie.com modulator) ABT-384 AbbVie Alzheimer’s disease Phase II completed North Chicago, IL abbvie.com ABT-957 AbbVie Alzheimer’s disease Phase I (calpain inhibitor) North Chicago, IL abbvie.com AC-1204 Accera Alzheimer’s disease Phase II/III Broomfield, CO accerapharma.com ACC-001/PF-05236806 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase II South San Francisco, CA janimm.com Pfizer pfizer.com New York, NY AD02 vaccine Affiris treatment of Alzheimer’s disease Phase II Vienna, Austria gsk.com GlaxoSmithKline Rsch. Triangle Park, NC AD03 vaccine Affiris treatment of Alzheimer’s disease Phase I Vienna, Austria gsk.com GlaxoSmithKline Rsch. Triangle Park, NC AD4833/TOMM40 Takeda Pharmaceuticals International Alzheimer’s disease prevention Phase I Deerfield, IL takeda.com APH-0703 Aphios Alzheimer’s disease Phase I/II (protein kinase C activator) Woburn, MA aphios.com *For more information about a specific medicine or company in the report, please click on the provided link. 2 Medicines in Development Older Americans 2013 Medicines in Development for Older Americans Alzheimer’s Disease and Dementia Product Name Sponsor Indication Development Phase ARC029 Archer Pharmaceuticals Alzheimer’s disease Phase I (nilvadipine) Sarasota, FL archerpharma.com ARC031 Archer Pharmaceuticals Alzheimer’s disease Phase I (soluble amyloid reducing/clearing Sarasota, FL archerpharma.com agent) ARC031 SR Archer Pharmaceuticals Alzheimer’s disease Phase I (soluble amyloid reducing/clearing Sarasota, FL archerpharma.com agent) AVN 101 Avineuro Pharmaceuticals Alzheimer’s disease Phase II (serotonin 5-HT6 receptor San Diego, CA avineuro.com antagonist) AVN 322 Avineuro Pharmaceuticals Alzheimer’s disease Phase I (serotonin 5-HT6 receptor San Diego, CA avineuro.com antagonist) AVN 397 Avineuro Pharmaceuticals Alzheimer’s disease Phase II San Diego, CA avineuro.com AZD1446 AstraZeneca Alzheimer’s disease Phase I (alpha4/beta2 neuronal nicotinic Wilmington, DE astrazeneca.com receptor agonist) Targacept Winston-Salem, NC AZD2184 Navidea Biopharmaceuticals Alzheimer’s disease (diagnosis) Phase I (PET imaging) Dublin, OH navidea.com AZD2995 Navidea Biopharmaceuticals Alzheimer’s disease (diagnosis) Phase I (PET imaging) Dublin, OH navidea.com AZD3293 AstraZeneca Alzheimer’s disease Phase I (beta secretase) Wilmington, DE astrazeneca.com Astex Pharmaceuticals Dublin, CA AZD5213 AstraZeneca Alzheimer’s disease Phase II (histamine-3 receptor antagonist) Wilmington, DE astrazeneca.com ß-secretase inhibitor Eli Lilly Alzheimer’s disease Phase II (LY2886721) Indianapolis, IN (slow disease progression) lilly.com BAN2401 Eisai early-stage Alzheimer’s disease Phase II Woodcliff Lake, NJ eisai.com BAY 85-8101 Piramal Healthcare Alzheimer’s disease (diagnosis) Phase I completed (18F-labeled radiopharmaceutical) Mumbai, India piramalenterprises.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 BIIB037 Biogen Idec Alzheimer’s disease Phase I (anti-ß-amyloid antibody) Weston, MA biogenidec.com bisnorcymserine QR Pharma Alzheimer’s disease Phase I (BNC) Berwyn, PA qrpharma.com BMS-241027 Bristol-Myers Squibb Alzheimer’s disease, Phase I (microtubule stabilizer) Princeton, NJ senile dementia bms.com CAD106 Novartis Pharmaceuticals Alzheimer’s disease Phase II East Hanover, NJ novartis.com CERE-110 Ceregene Alzheimer’s disease Phase II (AAV-NGF gene therapy) San Diego, CA ceregene.com crenezumab Genentech Alzheimer’s disease Phase II (anti-Abeta) South San Francisco, CA gene.com davunetide intranasal Allon Therapeutics Alzheimer’s disease Phase II Vancouver, Canada allontherapeutics.com donepezil/memantine Adamas Pharmaceuticals moderate to severe Alzheimer’s Phase II extended-release fixed-dose Emeryville, CA disease adamaspharma.com combination Forest Laboratories frx.com New York, NY DSP-8658 Sunovion Pharmaceuticals Alzheimer’s disease Phase I (PPAR alpha/gamma agonist) Marlborough, MA (see also diabetes) sunovion.com E2609 Eisai Alzheimer’s disease Phase I completed Woodcliff Lake, NJ eisai.com ELND005 Elan Alzheimer’s disease Phase II (amyloid beta-protein inhibitor) Dublin, Ireland elan.com EVP-0962 EnVivo Pharmaceuticals Alzheimer’s disease Phase II (gamma secretase modulation) Watertown, MA envivopharma.com EVP-6124 EnVivo Pharmaceuticals Alzheimer’s disease Phase II (nicotine A7 agonist) Watertown, MA envivopharma.com Exebryl-1® ProteoTech Alzheimer’s disease Phase I Alzheimer’s disease therapeutic Kirkland, WA proteotech.com F-18 T808 Siemens Molecular Imaging Alzheimer’s disease (diagnosis) Phase 0 (PET imaging agent) Malvern, PA medical.siemens.com F18-flutemetamol GE Healthcare Alzheimer’s disease (diagnosis) application submitted (PET imaging agent) Waukesha, WI gehealthcare.com 4 Medicines in Development Older Americans 2013 Medicines in Development for Older Americans Alzheimer’s Disease and Dementia Product Name Sponsor Indication Development Phase Gammagard® Baxter International early-stage Alzheimer’s disease, Phase III immune globulin Deerfield, IL mid-stage Alzheimer’s disease baxter.com gamma secretase modulator, Bristol-Myers Squibb Alzheimer’s disease, in clinical trials A-beta modulator Princeton, NJ senile dementia bms.com gantenerumab Roche early-stage Alzheimer’s disease Phase II/III (amyloid beta-protein inhibitor) Nutley, NJ roche.com GSK742457 GlaxoSmithKline dementia Phase II (5-HT6 receptor antagonist) Rsch. Triangle Park, NC gsk.com GSK2647544 GlaxoSmithKline Alzheimer’s disease Phase I (Lp-PLA2 inhibitor) Rsch. Triangle Park, NC gsk.com HPP 854 High Point Pharmaceuticals Alzheimer’s disease Phase I (BACE1 protein inhibitor) High Point, NC highpointpharma.com human immunoglobulin Grifols Alzheimer’s disease Phase III (intravenous) Los Angeles, CA grifols.com KU-046 Kareus Therapeutics Alzheimer’s disease Phase I (amyloid-ß protein modulator) La Chaux-de-Fonds, Switzerland kareustherapeutics.com Lu AE58054 Lundbeck USA Alzheimer’s disease Phase II Deerfield, IL lundbeck.com masitinib AB Science USA Alzheimer’s disease Phase III completed (AB-1010) Short Hills, NJ ab-science.com MCD-386 Mithridion Alzheimer’s disease Phase I Madison,
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