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2012 REPO Medicines in Development ALZHEIMER’S DISEASE R PRESENTED BY AMERICA’S BIOPHARMACEUTICAL T RESEARCH COMPANIES Biopharmaceutical Research Companies are Developing Nearly 100 Medicines for Alzheimer’s Disease and Other Dementias Medicines in Development For Alzheimer’s Disease* 81 Today, more than 5 million Americans are suf- human clinical trials or awaiting U.S. Food and fering from Alzheimer’s disease. The disease Drug Administration (FDA) review. They are ravages the minds of patients, crushes entire exploring various new approaches to treating families and currently costs the health care Alzheimer’s disease, including: system $200 billion a year. These sobering $PHGLFLQHWKDWLQKLELWVWKHIRUPDWLRQDQG statistics are projected to get much worse as accumulation of amyloid-beta and tau the 76 million American baby boomers age. protein deposits. If no new medicines are found to prevent, $QLQWUDQDVDOPHGLFLQHWKDWLVDEOHWR delay or stop the progression of Alzheimer’s penetrate the blood-brain barrier for mild disease, the number of people affected in cognitive impairment, a precursor to America will jump to 13.5 million by 2050, Alzheimer’s. according to the Alzheimer’s Association. Costs for care for Alzheimer’s patients will $JHQHWKHUDS\IRUWKHWUHDWPHQWRI LQFUHDVH¿YHIROGWRWULOOLRQD\HDU Alzheimer’s disease. Even modest progress can drastically change 7KHTXHVWLVLQWHQVHDQG¿QDQFLDOO\ULVN\,W takes, on average, more than $1 billion and 11 this trajectory. A breakthrough medicine that delays the onset of Alzheimer’s disease by 10 to 15 years to develop a new medicine. But MXVW¿YH\HDUVFRXOGGHFUHDVHWKHQXPEHURI QHZVFLHQWL¿FDGYDQFHVDUHLQFUHDVLQJRXU 5 Americans suffering from the disease in 2050 knowledge, and researchers are using every 2 by 43 percent and the related costs of care by cutting-edge tool at their disposal. With contin- ued dedication, we hope to make a difference $447 billion. Hope for the future lies in medical ’s e s innovation. for every person at risk of suffering from this terrible, debilitating disease. Diseas CognitionDisorder America’s biopharmaceutical companies cur- Alzheimer Dementias Diagnostics rently have 93 medicines in development for * Some medicines are in development Alzheimer’s disease and dementias—either in for more than one disorder. Medicines in Development for Alzheimer’s Disease ALZHEIMER’S DISEASE AND DEMENTIAS Product Name Sponsor Indication Development Status* AAB-002 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase 0 (amyloid beta-protein inhibitor South San Francisco, CA mAb) 3¿]HU New York, NY $$%3) Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase I (amyloid beta-protein inhibitor South San Francisco, CA mAb) 3¿]HU New York, NY ABT-126 Abbott Laboratories mild to moderate Alzheimer’s disease Phase II (alpha-7 neuronal nicotinic Abbott Park, IL receptor antagonist) -------------------------------------------------- ------------------------------------------- Alzheimer’s disease Phase I (combination therapy), Alzheimer’s disease (elderly) $%7 Abbott Laboratories Alzheimer’s disease Phase II (neurotransmitter receptor Abbott Park, IL modulator) $%7 Abbott Laboratories mild to moderate Alzheimer’s disease Phase II Abbott Park, IL ABT-560 Abbott Laboratories cognitive disorders Phase I (alpha-4 beta-2 nicotinic Abbott Park, IL receptor modulators) ABT-957 Abbott Laboratories Alzheimer’s disease Phase I (calpain inhibitor) Abbott Park, IL ACC-002 Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase 0 (amyloid-beta peptide South San Francisco, CA conjugate) 3¿]HU New York, NY AD02 vaccine $I¿ULV Alzheimer’s disease Phase II Vienna, Austria GlaxoSmithKline Rsch. Triangle Park, NC AD03 vaccine $I¿ULV Alzheimer’s disease Phase I Vienna, Austria GlaxoSmithKline Rsch. Triangle Park, NC )RUPRUHLQIRUPDWLRQDERXWDVSHFL¿FPHGLFLQHLQWKLVUHSRUWSOHDVHFDOOWKHWHOHSKRQHQXPEHUOLVWHG 2 Medicines in Development Alzheimer’s Disease 2012 Medicines in Development for Alzheimer’s Disease ALZHEIMER’S DISEASE AND DEMENTIAS Product Name Sponsor Indication Development Status $'6 Adamas Pharmaceuticals moderate to severe Alzheimer’s Phase II (donepezil/memantine) Emeryville, CA disease (510) 450-3500 APH-0703 Aphios Alzheimer’s disease, Phase I/II Woburn, MA cognitive disorders ARC029 Archer Pharmaceuticals mild to moderate Alzheimer’s disease Phase I (soluble amyloid Sarasota, FL (941) 755-6644 reducing/clearing agent) (Orphan Drug) ARC031 Archer Pharmaceuticals Alzheimer’s disease Phase I (soluble amyloid Sarasota, FL (941) 755-6644 reducing/clearing agent) ASP0777 Astellas Pharma US dementia associated with Alzheimer’s Phase I 'HHU¿HOG,/ disease AVN 101 Avineuro Pharmaceuticals cognitive enhancer in Alzheimer’s Phase II (serotonin 6 receptor San Diego, CA disease antagonist) AVN 322 Avineuro Pharmaceuticals Alzheimer’s disease Phase I (serotonin 6 receptor San Diego, CA antagonist) AVN 397 Avineuro Pharmaceuticals Alzheimer’s disease Phase II San Diego, CA AZD1446 AstraZeneca Alzheimer’s disease Phase I (alpha4/beta2 neuronal Wilmington, DE nicotinic receptor agonist) Targacept Winston-Salem, NC $=' AstraZeneca Alzheimer’s disease Phase II (ispronicline) Wilmington, DE Targacept Winston-Salem, NC AZD4694 Navidea Biopharmaceuticals Alzheimer’s disease (diagnosis) Phase II ÀXRULQHODEHOHGSUHFLVLRQ Dublin, OH (614) 793-7500 radiopharmaceutical) AZD5213 AstraZeneca Alzheimer’s disease Phase II (histamine-3 receptor Wilmington, DE antagonist) Medicines in Development Alzheimer’s Disease 2012 3 Medicines in Development for Alzheimer’s Disease ALZHEIMER’S DISEASE AND DEMENTIAS Product Name Sponsor Indication Development Status ß secretase inhibitor Eli Lilly Alzheimer’s disease Phase II Indianapolis, IN (800) 545-5979 BAN2401 BioArtic Neuroscience mild to moderate Alzheimer’s disease Phase I (amyloid beta-protein inhibitor) Stockholm, Sweden www.bioarti.se Eisai (888) 274-2378 Woodcliff Lake, NJ bapineuzumab subcutaneous Janssen Alzheimer Immunotherapy Alzheimer’s disease Phase II (AAB-001) South San Francisco, CA (subcutaneous) (888) 381-4595 3¿]HU (800) 879-3477 New York, NY BCI-632 BrainCells Alzheimer’s disease Phase I San Diego, CA (858) 812-7700 BCI-838 BrainCells Alzheimer’s disease Phase I San Diego, CA (858) 812-7700 BIIB037 Biogen Idec Alzheimer’s disease Phase I (amyloid beta-protein inhibitor) Cambridge, MA (617) 679-2000 bisnorcymserine QR Pharma Alzheimer’s disease Phase I (BNC) Berwyn, PA (610) 727-3913 BMS-241027 Bristol-Myers Squibb Alzheimer’s disease, tauopathies Phase I (microtubule stabilizer) Princeton, NJ (800) 332-2056 BMS-708163 Bristol-Myers Squibb Alzheimer’s disease Phase II (avagacestat) Princeton, NJ (800) 332-2056 BMS-932481 Bristol-Myers Squibb Alzheimer’s disease Phase I (gamma secretase modulator) Princeton, NJ (800) 332-2056 BMS-933043 Bristol-Myers Squibb cognitive impairment Phase I (a-7 nicotinic agonist) Princeton, NJ (800) 332-2056 CAD106 Novartis Pharmaceuticals Alzheimer’s disease Phase II (amyloid beta-protein inhibitor) East Hanover, NJ (888) 669-6682 CERE-110 Ceregene Alzheimer’s disease Phase II (AAV-NGF gene therapy) San Diego, CA (858) 458-8800 CHF-5074 Chiesi Pharmaceuticals mild cognitive impairment Phase II (amyloid precursor protein Rockville, MD (301) 424-2661 secretase modulator) 4 Medicines in Development Alzheimer’s Disease 2012 Medicines in Development for Alzheimer’s Disease ALZHEIMER’S DISEASE AND DEMENTIAS Product Name Sponsor Indication Development Status crenezumab Genentech Alzheimer’s disease Phase II (anti-Abeta) South San Francisco, CA CTS-21166 Astellas Pharma US Alzheimer’s disease Phase I (ß-secretase inhibitor) 'HHU¿HOG,/ CoMentis (650) 359-2600 South San Francisco, CA CX717 Cortex Pharmaceuticals Alzheimer’s disease Phase II completed Irvine, CA (949) 727-3157 davunetide intranasal Allon Therapeutics Alzheimer’s disease, mild cognitive Phase II Vancouver, Canada impairment (604) 736-0634 docosahexaenoic acid Martek Biosciences Alzheimer’s disease Phase III (DHA) Parsippany, NJ '63 Sunovion Pharmaceuticals Alzheimer’s disease Phase I (PPAR _/a agonist) Marlborough, MA E2212 Eisai Alzheimer’s disease Phase I (amyloid precursor protein Woodcliff Lake, NJ secretase modulator) E2609 Eisai Alzheimer’s disease Phase I (BACE1 protein inhibitor) Woodcliff Lake, NJ ELND005 Elan mild to moderate Alzheimer’s disease Phase II (amyloid beta-protein inhibitor) South San Francisco, CA (Fast Track) Transition Therapeutics (416) 260-7770 Toronto, Canada EVP-0962 EnVivo Pharmaceuticals Alzheimer’s disease Phase I (amyloid precursor protein Watertown, MA (617) 225-4250 secretase modulator) EVP-6124 EnVivo Pharmaceuticals mild to moderate Alzheimer’s disease Phase II ĮQ$&K5DJRQLVW Watertown, MA (617) 225-4250 Exebryl-1® ProteoTech Alzheimer’s disease Phase I Kirkland, WA )ÀRUEHWDEHQ Piramal Healthcare Alzheimer’s disease (diagnosis) Phase III (molecular imaging agent) Mumbai, India www.piramalhealthcare.com )ÀXWHPHWDPRO GE Healthcare Alzheimer’s disease (diagnosis) Phase III (PET imaging agent) Waukesha, WI www.gehealthcare.com Medicines in Development Alzheimer’s Disease 2012 5 Medicines in Development for Alzheimer’s Disease ALZHEIMER’S DISEASE AND DEMENTIAS Product Name Sponsor Indication Development Status Gammagard® Baxter Healthcare early-stage Alzheimer’s disease, Phase III immune globulin intravenous 'HHU¿HOG,/ mid-stage Alzheimer’s disease (human), 10% solution gantenerumab Roche prodromal Alzheimer’s disease Phase II/III (RG1450) Nutley, NJ (973) 235-5000 GSK239512 GlaxoSmithKline
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