美国2013年开发中的心脏病新药

20 13 R EPO RT Biopharmaceutical research companies are developing 215 medicines for two of the leading causes of death in Ameri- cans—heart disease and stroke. Medi- cines have helped cut deaths from these diseases by 30 percent between 2001 and 2011, and in 2008 stroke dropped to the fourth leading cause of death after being the third for more than 50 years. This progress is in large part due to innovative medicines. Despite this progress, heart disease and stroke persist as key public health chal- lenges. According to the American Heart Association, every 39 seconds an Ameri- can dies from cardiovascular disease, and more than 83 million Americans have at least one type of the disease. These diseases cost our society more than $312 billion a year. The medicines in development include: 30 for heart failure, 29 for lipid disorders (such as high cholesterol), 19 for stroke, and 17 each for high blood pressure and ischemic disorders. Many of the potential medicines use cutting-edge technologies and new scientific approaches, such as: • A gene therapy that uses a patient’s own cells to treat heart failure. • A medicine that blocks the transfer of good (HDL) cholesterol to bad (LDL). • A genetically-engineered medicine that dissolves clots to treat stroke. All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration. A glossary of terms begins on page 24. Links to sponsor company websites provide more informa- tion on the potential products. For information on the current innovative products in the pipeline for cardiovascular disease and the value of medicines for patients and our healthcare system, please see Medicines in Development for Heart Disease and Stroke 2013—Overview. Biopharmaceutical Research Companies Are Developing More Than 200 Medicines for Cardiovascular Disease MeDiCines in DevelopMenT Heart Disease and stroke A Report on Cardiovascular Disease presented by america’s biopharmaceutical research companies Li pi d Di so rd er s Hy pe rte ns io n 30 17 17 Isc he m ic Di so rd er s 29 He ar t F ail ur e St ro ke 19 Application Submitted Phase III Phase II Phase I Medicines in Development For Heart Disease and stroke 83.6 million americans suffer From cardiovascular disease more than 700,000 die each year Medicines in Development heart disease and stroke 20132 medicines in development for heart disease and stroke *For more information about a specific medicine or company in the report, please click on the provided link. Acute Coronary Syndrome Product Name Sponsor Indication Development Phase* cangrelor The Medicines Company Parsippany, NJ acute coronary syndrome (see also coronary artery disease, thrombosis) Phase I www.themedicinescompany.com CER-001 (recombinant HDL) Cerenis Therapeutics Ann Arbor, MI acute coronary syndrome (see also lipid disorders) Phase II www.cerenis.com gevokizumab Servier Paris, France XOMA Berkeley, CA acute coronary syndrome Phase II www.servier.com www.xoma.com inclacumab (RG1512) Roche Nutley, NJ acute coronary syndrome (see also heart attack, peripheral vascular disease) Phase II www.roche.com losmapimod (p38 kinase inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC acute coronary syndrome Phase II www.gsk.com PF-06282999 Pfizer New York, NY acute coronary syndrome Phase I www.pfizer.com REG1 (anivamersen-pegnivacogin intravenous) Regado Biosciences Basking Ridge, NJ acute coronary syndrome Phase II www.regadobio.com RVX-208 (BET protein inhibitor) Resverlogix Calgary, Canada acute coronary syndrome (see also atherosclerosis) Phase II www.resverlogix.com vorapaxar (thrombin/PAR-1 receptor antagonist) Merck Whitehouse Station, NJ acute coronary syndrome (prevention) (Fast Track) (see also thrombosis) Phase III www.merck.com VT-111a Viron Therapeutics Ontario, Canada acute coronary syndrome Phase II www.vironinc.com Vytorin® ezetimibe/simvastatin fixed-dose combination Merck Whitehouse Station, NJ acute coronary syndrome Phase III www.merck.com Xarelto® rivaroxaban Bayer HealthCare Pharmaceuticals Wayne, NJ Janssen Research & Development Raritan, NJ acute coronary syndrome (Fast Track) (see also thrombosis, other) application submitted www.bayerpharma.com www.janssenrnd.com Medicines in Development heart disease and stroke 2013 3 medicines in development for heart disease and stroke Adjunctive Therapies, Revascularization Product Name Sponsor Indication Development Phase ATryn® antithrombin (recombinant) (Orphan Drug) rEVO Biologics Framingham, MA heparin resistance in patients undergoing coronary artery bypass graft (CABG) surgery (see also hypertension) -------------------------------------- heparin resistance in patients undergoing CABG surgery in neonates Phase III www.gtc-bio.com ----------------------------------------- Phase I www.gtc-bio.com CMX-2043 (proto-oncogene protein C AKT modulator) Ischemix Maynard, MA prevention of ischemia-reperfusion injury in patients undergoing percutaneous coronary intervention (PCI) Phase II www.ischemix.com myolimus-eluting stent Elixir Medical Sunnyvale, CA coronary artery restenosis (prevention) Phase I www.elixirmedical.com novolimus-eluting coronary stent Elixir Medical Sunnyvale, CA coronary artery restenosis (prevention) in clinical trials www.elixirmedical.com PRT-201 Proteon Therapeutics Waltham, MA vascular access for hemodialysis (see also peripheral vascular disease) Phase II www.proteontherapeutics.com ranolazine Gilead Sciences Foster City, CA incomplete revascularization in patients who undergo PCI Phase III www.gilead.com sirolimus-eluting coronary stent REVA Medical San Diego, CA coronary artery restenosis in clinical trials www.teamreva.com sirolimus-eluting coronary stent Svelte Medical Systems New Providence, NJ ischemic heart disorder Phase I/II www.sveltemedical.com SRM003 (endothelial cell therapy) Shire Pharmaceuticals Wayne, PA prevention of peripheral vascular complications in patients undergoing arteriovenous access procedures for hemodialysis Phase II www.shire.com Medicines in Development heart disease and stroke 20134 medicines in development for heart disease and stroke Arrhythmia, Atrial Fibrillation Product Name Sponsor Indication Development Phase ARM036 ARMGO Pharma Tarrytown, NY catecholaminergic polymorphic ventricular tachycardia type 1 (see also heart failure) Phase II www.armgo.com azimilide Forest Laboratories New York, NY ventricular arrhythmia Phase III www.frx.com BMS-919373 (Ikur antagonist) Bristol-Myers Squibb Princeton, NJ atrial fibrillation Phase I www.bms.com danegaptide (ZP1609) Zealand Pharma Copenhagen, Denmark atrial fibrillation Phase I www.zealandpharma.com GS-6615 (sodium channel antagonist) Gilead Sciences Foster City, CA arrhythmia (see also ischemic disorders) Phase I www.gilead.com ISIS-CRPRx (C-reactive protein inhibitor) Isis Pharmaceuticals Carlsbad, CA paroxysmal atrial fibrillation Phase I www.isispharm.com OPC-108459 Otsuka America Pharmaceutical Rockville, MD paroxysmal and persistent atrial fibrillation Phase I www.otsuka.com ranolazine/dronedarone fixed-dose combination Gilead Sciences Foster City, CA paroxysmal atrial fibrillation Phase II www.gilead.com vanoxerine ChanRx Cleveland, OH atrial fibrillation Phase II www.chanrx.com vernakalant (oral) Cardiome Pharma Vancouver, Canada atrial fibrillation Phase II www.cardiome.com Atherosclerosis Product Name Sponsor Indication Development Phase ACP-501 (rhLCAT) AlphaCore Pharma Ann Arbor, MI atherosclerosis (see also coronary artery disease) Phase I www.alphacorepharma.com ACZ885 (canakinumab) Novartis Pharmaceuticals East Hanover, NJ atherosclerosis in patients with type 2 diabetes (see also other) Phase II www.novartis.com anacetrapib (MK-0859) Merck Whitehouse Station, NJ atherosclerosis (see also lipid disorders) Phase III www.merck.com BMS-852927 (LXR modulator) Bristol-Myers Squibb Princeton, NJ atherosclerosis Phase I www.bms.com Medicines in Development heart disease and stroke 2013 5 medicines in development for heart disease and stroke Atherosclerosis Product Name Sponsor Indication Development Phase BMS-962476 (PCSK9 adnectin) Bristol-Myers Squibb Princeton, NJ atherosclerosis Phase I www.bms.com CSL-112 (cholesterol modulator) CSL Victoria, Australia atherosclerosis Phase II www.csl.com.au darapladib (Lp-PLA2 inhibitor) GlaxoSmithKline Rsch. Triangle Park, NC atherosclerosis Phase III www.gsk.com ISIS-APOARx (antisense RNA inhibitor) Isis Pharmaceuticals Carlsbad, CA atherosclerosis Phase I www.isispharm.com rilapladib GlaxoSmithKline Rsch. Triangle Park, NC atherosclerosis Phase II completed www.gsk.com RVX-208 (BET protein inhibitor) Resverlogix Calgary, Canada atherosclerosis (see also acute coronary syndrome) Phase II www.resverlogix.com Tekturna® aliskiren Novartis Pharmaceuticals East Hanover, NJ atherosclerosis in coronary artery disease (see also heart failure, hypertension) Phase III www.novartis.com VB201 (IL-12 subunit p40 inhibitor) VBL Therapeutics Or Yehuda, Israel atherosclerosis Phase II www.vblrx.com Coronary Artery Disease Product Name Sponsor Indication Development Phase ACP-501 (rhLCAT) AlphaCore Pharma Ann Arbor, MI coronary artery disease (see also atherosclerosis) Phase I www.alphacorepharma.com cangrelor The Medicines Company Parsippany, NJ coronary artery disease in patients requiring percutaneous coronary intervention (PCI) (see also acute coronary syndrome, thrombosis) Phase III www.themedicinescompany.com cardiovascular therapy releasing balloon (drug-coated Angiosculpt®) AngioScore Fremont, CA coronary artery restenosis Phase II www.angioscore.com coronary artery disease gene therapy BioCardia San Carlos, CA coronary artery disease Phase II www.biocardia.com Medicines in Development heart disease and stroke 20136 medicines in development for heart disease and stroke Coronary Artery Disease Product Name Sponsor Indication Development Phase fibroblast growth factor-1 (FGF-1) CardioVascular BioTherapeutics Las Vegas, NV severe coronary heart disease Phase II www.cvbt.com LT-1951 (oligo-L-arginine) Lumen Therapeutics Menlo Park, CA coronary artery restenosis Phase I/II www.lumentherapeutics.com pradigastat (LCQ908) Novartis Pharmaceuticals East Hanover, NJ coronary artery disease (see also lipid disorders) Phase II www.novartis.com RG7652 (PCSK9 protein inhibitor) Genentech South San Francisco, CA coronary heart disease Phase II www.gene.com Heart Attack (Myocardial Infarction) Product Name Sponsor Indication Development Phase abciximab (intracoronary infusion) Atrium Medical Corporation Hudson, NH myocardial infarction (new delivery system) Phase III www.atriummed.com adipose-derived regenerative cell (ADRC) therapy Cytori Therapeutics San Diego, CA acute myocardial infarction (see also ischemic disorders) Phase II www.cytori.com AMR-001 (stem cell therapy) Amorcyte (NeoStem) New York, NY myocardial infarction Phase I www.neostem.com BB3 (HGF mimetic) Angion Biomedica Uniondale, NY acute myocardial infarction Phase II www.angion.com Brilinta® ticagrelor AstraZeneca Wilmington, DE prior myocardial infarction (see also peripheral vascular disease) Phase III www.astrazeneca.com CAP-1002 (allogeneic cardiosphere-derived stem cell therapy) Capricor Beverly Hills, CA myocardial infarction Phase I/II www.capricor.com inclacumab Roche Nutley, NJ myocardial infarction (see also acute coronary syndrome, peripheral vascular disease) Phase II www.roche.com ischemic tolerant allogeneic mesenchymal stem cell therapy Stemedica Cell Technologies San Diego, CA acute myocardial infarction Phase II www.stemedica.com mesenchymal stem cell therapy Mesoblast New York, NY heart attack (see also heart failure) Phase II www.mesoblast.com Medicines in Development heart disease and stroke 2013 7 medicines in development for heart disease and stroke Heart Attack (Myocardial Infarction) Product Name Sponsor Indication Development Phase MultiStem® stem cell therapy Athersys Cleveland, OH acute myocardial infarction (see also stroke) Phase I completed www.athersys.com NEU 2000 GNT Pharma Yongin, South Korea myocardial infarction (see also stroke) Phase I completed www.gntpharma.com Prochymal® remestemcel-L Osiris Therapeutics Columbia, MD acute myocardial infarction Phase II www.osiris.com Heart Failure (Congestive Heart Failure) Product Name Sponsor Indication Development Phase albiglutide (GSK716155) GlaxoSmithKline Rsch. Triangle Park, NC heart failure Phase II completed www.gsk.com ANX-042 (natriuretic-peptide) Anexon Cambridge, MA acute decompensated heart failure Phase I www.anexonrx.com ARM036 ARMGO Pharma Tarrytown, NY chronic heart failure (see also arrhythmia) Phase II www.armgo.com BAY 868050 (vasopressin receptor antagonist) Bayer HealthCare Pharmaceuticals Wayne, NJ heart failure Phase I www.bayerpharma.com BAY 948862 (mineralocorticoid receptor [MR] antagonist) Bayer HealthCare Pharmaceuticals Wayne, NJ chronic heart failure Phase II www.bayerpharma.com BAY 1021189 (guanylate cyclase stimulant) Bayer HealthCare Pharmaceuticals Wayne, NJ heart failure Phase I www.bayerpharma.com BAY 1067197 (partial adenosine A1 agonist) Bayer HealthCare Pharmaceuticals Wayne, NJ heart failure Phase I www.bayerpharma.com BMS-986046 (PEG-relaxin) Ambrx La Jolla, CA Bristol-Myers Squibb Princeton, NJ heart failure Phase I www.ambrx.com www.bms.com bucindolol companion diagnostic ARCA biopharma Broomfield, CO LabCorp Burlington, NC heart failure (diagnosis) in clinical trials www.arcabiopharma.com www.labcorp.com Medicines in Development heart disease and stroke 20138 medicines in development for heart disease and stroke cenderitide Nile Therapeutics San Mateo, CA acute heart failure (Fast Track) -------------------------------------- chronic heart failure (Fast Track) Phase II www.nilethera.com ----------------------------------------- Phase I www.nilethera.com CLP-1001 (sodium-potassium-chloride symporter inhibitor) Sorbent Therapeutics Sunnyvale, CA congestive heart failure in patients with chronic kidney disease Phase II www.sorbent.com CXL-1020 (nitroxyl donor) Cardioxyl Pharmaceuticals Chapel Hill, NC acute decompensated heart failure Phase II www.cardioxyl.com Gencaro™ bucindolol ARCA biopharma Broomfield, CO genotype-defined heart failure (Fast Track) application submitted www.arcabiopharma.com GGF2 (recombinant neuregulin-1) Acorda Therapeutics Ardsley, NY heart failure (Fast Track) Phase I www.acorda.com GSK2849466 (selective androgen receptor modulator) GlaxoSmithKline Rsch. Triangle Park, NC heart failure Phase I www.gsk.com JNJ-39588146 Janssen Research & Development Raritan, NJ heart failure Phase II www.janssenrnd.com JVS-100 (stromal cell-derived factor-1) Juventas Therapeutics Cleveland, OH heart failure (see also ischemic disorders) Phase II www.juventasinc.com LCZ696 (ARB/NEP inhibitor) Novartis Pharmaceuticals East Hanover, NJ heart failure (see also hypertension) Phase III www.novartis.com mesenchymal stem cell therapy Mesoblast New York, NY congestive heart failure (see also heart attack) Phase II www.mesoblast.com Mydicar® SERCA 2a gene therapy Celladon San Diego, CA advanced (Class III/IV) heart failure (Fast Track) -------------------------------------- chronic heart failure Phase II www.celladon.net ----------------------------------------- Phase II completed www.celladon.net MyoCell® stem cell therapy Bioheart Sunrise, FL heart failure Phase II/III www.bioheartinc.com MyoCell® SDF1 muscle stem cell therapy (second-generation) BioHeart Sunrise, FL congestive heart post myocardial infarction Phase I www.bioheartinc.com Heart Failure (Congestive Heart Failure) Product Name Sponsor Indication Development Phase Medicines in Development heart disease and stroke 2013 9 medicines in development for heart disease and stroke omecamtiv mecarbil Amgen Thousand Oaks, CA Cytokinetics South San Francisco, CA heart failure Phase II www.amgen.com www.cytokinetics.com PL-3994 (natriuretic-peptide) Palatin Technologies Cranbury, NJ congestive heart failure (see also hypertension) Phase II www.palatin.com recombinant human neuregulin-1 beta Zensun Shanghai, China stable chronic heart failure Phase II www.zensun.com serelaxin (RLX030) Novartis Pharmaceuticals East Hanover, NJ acute heart failure (Fast Track) -------------------------------------- chronic heart failure Phase III www.novartis.com ----------------------------------------- Phase II www.novartis.com Tekturna® aliskiren Novartis Pharmaceuticals East Hanover, NJ acute decompensated heart failure (see also atherosclerosis, hypertension) -------------------------------------- reduction of cardiovascular death/ hospitalization in chronic heart failure patients Phase III completed www.novartis.com ----------------------------------------- Phase III www.novartis.com TRV027 (angiotensin type 1 receptor antagonist) Forest Laboratories New York, NY Trevena King of Prussia, PA acute heart failure (late-stage disease) Phase II www.frx.com www.trevenainc.com ularitide Cardiorentis Zug, Switzerland acute heart failure Phase III www.cardiorentis.ch urocortin 2 Neurocrine Biosciences San Diego, CA congestive heart failure Phase II www.neurocrine.com Hypertension (High Blood Pressure) Product Name Sponsor Indication Development Phase AHU377 (neprilysin inhibitor) Novartis Pharmaceuticals East Hanover, NJ essential hypertension Phase II www.novartis.com ATryn® antithrombin (recombinant) rEVO Biologics Framingham, MA preeclampsia (see also adjunctive therapies) Phase II www.gtc-bio.com Heart Failure (Congestive Heart Failure) Product Name Sponsor Indication Development Phase Medicines in Development heart disease and stroke 201310 medicines in development for heart disease and stroke candesartan cilexetil/nifedipine fixed-dose combination Bayer HealthCare Pharmaceuticals Wayne, NJ essential hypertension Phase III www.bayerpharma.com digoxin immune Fab (DIF) (Orphan Drug) Glenveigh Pharmaceuticals Chattanooga, TN preeclampsia (Fast Track) Phase II www.glenveigh.com Edarbi® azilsartan medoxomil Takeda Pharmaceuticals Deerfield, IL hypertension (pediatric) Phase I www.takeda.com GSK2944406 (amlodipine/losartan fixed-dose combination) GlaxoSmithKline Rsch. Triangle Park, NC hypertension Phase I www.gsk.com HL-040XC (atorvastatin/losartan fixed-dose combination) HanAll Biopharma Seoul, South Korea hypertension (see also lipid disorders) Phase II www.hanall.co.kr HT-101 (amiloride/spironolactone) Hemodynamic Therapeutics Durham, NC obesity-related resistant hypertension Phase II www.hemodynamictx.com KD027 (PDE5 inhibitor) Kadmon Pharmaceuticals Warrendale, PA hypertension Phase I www.kadmon.com LCZ696 (ARB/NEP inhibitor) Novartis Pharmaceuticals East Hanover, NJ essential hypertension (see also heart failure) Phase II www.novartis.com MK-7145 Merck Whitehouse Station, NJ hypertension Phase I completed www.merck.com MK-8150 Merck Whitehouse Station, NJ hypertension Phase I www.merck.com nebivolol/valsartan fixed-dose combination Forest Laboratories New York, NY essential hypertension Phase III www.frx.com PB1046 (Vasomera) PhaseBio Pharmaceuticals Malvern, PA essential hypertension Phase I/II www.phasebio.com perindopril/amlodipine fixed-dose combination XOMA Berkeley, CA hypertension Phase III www.xoma.com PL-3994 (natriuretic-peptide) Palatin Technologies Cranbury, NJ hypertension (see also heart failure) Phase II www.palatin.com Tekturna® aliskiren Novartis Pharmaceu