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Heart Disease and Stroke

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Heart Disease and Stroke 2013 MEDICINES IN DEVELOPMENT REPORT Heart Disease and Stroke A Report on Cardiovascular Disease PRESENTED BY AMERICA’s biopharmACEUTICAL RESEARCH COMPANIES Biopharmaceutical Research Companies Are Developing More Than 200 Medicines for Cardiovascular Disease 83.6 Million Americans Suffer From Cardiovascular Medicines in Development For Heart Disease and Stroke Disease Application Submitted More Than Phase III Phase II 700,000 Phase I Die Each Year 30 29 Biopharmaceutical research companies medicines use cutting-edge technologies are developing 215 medicines for two of and new scientific approaches, such as: the leading causes of death in Ameri- cans—heart disease and stroke. Medi- • A gene therapy that uses a patient’s cines have helped cut deaths from these own cells to treat heart failure. diseases by 30 percent between 2001 • A medicine that blocks the transfer of and 2011, and in 2008 stroke dropped to good (HDL) cholesterol to bad (LDL). 19 the fourth leading cause of death after • A genetically-engineered medicine that dissolves clots to treat stroke. 17 17 being the third for more than 50 years. This progress is in large part due to All of the medicines are either in clinical innovative medicines. trials or awaiting review by the Food and Despite this progress, heart disease and Drug Administration. A glossary of terms stroke persist as key public health chal- begins on page 24. Links to sponsor lenges. According to the American Heart company websites provide more informa- Association, every 39 seconds an Ameri- tion on the potential products. can dies from cardiovascular disease, and For information on the current innovative more than 83 million Americans have products in the pipeline for cardiovascular at least one type of the disease. These disease and the value of medicines for diseases cost our society more than $312 patients and our healthcare system, please billion a year. see Medicines in Development for Heart The medicines in development include: Disease and Stroke 2013—Overview. Stroke 30 for heart failure, 29 for lipid disorders t Failure (such as high cholesterol), 19 for stroke, Hear Hypertension Lipid Disorders and 17 each for high blood pressure and Ischemic Disorders ischemic disorders. Many of the potential Medicines in Development for Heart Disease and Stroke Acute Coronary Syndrome Product Name Sponsor Indication Development Phase* cangrelor The Medicines Company acute coronary syndrome Phase I Parsippany, NJ (see also coronary artery disease, www.themedicinescompany.com thrombosis) CER-001 Cerenis Therapeutics acute coronary syndrome Phase II (recombinant HDL) Ann Arbor, MI (see also lipid disorders) www.cerenis.com gevokizumab Servier acute coronary syndrome Phase II Paris, France www.servier.com XOMA www.xoma.com Berkeley, CA inclacumab Roche acute coronary syndrome Phase II (RG1512) Nutley, NJ (see also heart attack, peripheral www.roche.com vascular disease) losmapimod GlaxoSmithKline acute coronary syndrome Phase II (p38 kinase inhibitor) Rsch. Triangle Park, NC www.gsk.com PF-06282999 Pfizer acute coronary syndrome Phase I New York, NY www.pfizer.com REG1 Regado Biosciences acute coronary syndrome Phase II (anivamersen-pegnivacogin Basking Ridge, NJ www.regadobio.com intravenous) RVX-208 Resverlogix acute coronary syndrome Phase II (BET protein inhibitor) Calgary, Canada (see also atherosclerosis) www.resverlogix.com vorapaxar Merck acute coronary syndrome Phase III (thrombin/PAR-1 receptor Whitehouse Station, NJ (prevention) (Fast Track) www.merck.com antagonist) (see also thrombosis) VT-111a Viron Therapeutics acute coronary syndrome Phase II Ontario, Canada www.vironinc.com Vytorin® Merck acute coronary syndrome Phase III ezetimibe/simvastatin Whitehouse Station, NJ www.merck.com fixed-dose combination Xarelto® Bayer HealthCare Pharmaceuticals acute coronary syndrome application submitted rivaroxaban Wayne, NJ (Fast Track) www.bayerpharma.com Janssen Research & Development (see also thrombosis, other) www.janssenrnd.com Raritan, NJ *For more information about a specific medicine or company in the report, please click on the provided link. 2 Medicines in Development Heart Disease and Stroke 2013 Medicines in Development for Heart Disease and Stroke Adjunctive Therapies, Revascularization Product Name Sponsor Indication Development Phase ATryn® rEVO Biologics heparin resistance in patients Phase III antithrombin Framingham, MA undergoing coronary artery bypass www.gtc-bio.com (recombinant) graft (CABG) surgery (Orphan Drug) (see also hypertension) -------------------------------------- ----------------------------------------- heparin resistance in patients Phase I undergoing CABG surgery in www.gtc-bio.com neonates CMX-2043 Ischemix prevention of ischemia-reperfusion Phase II (proto-oncogene protein C Maynard, MA injury in patients undergoing www.ischemix.com AKT modulator) percutaneous coronary intervention (PCI) myolimus-eluting stent Elixir Medical coronary artery restenosis Phase I Sunnyvale, CA (prevention) www.elixirmedical.com novolimus-eluting coronary stent Elixir Medical coronary artery restenosis in clinical trials Sunnyvale, CA (prevention) www.elixirmedical.com PRT-201 Proteon Therapeutics vascular access for hemodialysis Phase II Waltham, MA (see also peripheral vascular www.proteontherapeutics.com disease) ranolazine Gilead Sciences incomplete revascularization Phase III Foster City, CA in patients who undergo PCI www.gilead.com sirolimus-eluting coronary stent REVA Medical coronary artery restenosis in clinical trials San Diego, CA www.teamreva.com sirolimus-eluting coronary stent Svelte Medical Systems ischemic heart disorder Phase I/II New Providence, NJ www.sveltemedical.com SRM003 Shire Pharmaceuticals prevention of peripheral vascular Phase II (endothelial cell therapy) Wayne, PA complications in patients www.shire.com undergoing arteriovenous access procedures for hemodialysis Medicines in Development Heart Disease and Stroke 2013 3 Medicines in Development for Heart Disease and Stroke Arrhythmia, Atrial Fibrillation Product Name Sponsor Indication Development Phase ARM036 ARMGO Pharma catecholaminergic polymorphic Phase II Tarrytown, NY ventricular tachycardia type 1 www.armgo.com (see also heart failure) azimilide Forest Laboratories ventricular arrhythmia Phase III New York, NY www.frx.com BMS-919373 Bristol-Myers Squibb atrial fibrillation Phase I (Ikur antagonist) Princeton, NJ www.bms.com danegaptide Zealand Pharma atrial fibrillation Phase I (ZP1609) Copenhagen, Denmark www.zealandpharma.com GS-6615 Gilead Sciences arrhythmia Phase I (sodium channel antagonist) Foster City, CA (see also ischemic disorders) www.gilead.com ISIS-CRPRx Isis Pharmaceuticals paroxysmal atrial fibrillation Phase I (C-reactive protein inhibitor) Carlsbad, CA www.isispharm.com OPC-108459 Otsuka America Pharmaceutical paroxysmal and persistent atrial Phase I Rockville, MD fibrillation www.otsuka.com ranolazine/dronedarone Gilead Sciences paroxysmal atrial fibrillation Phase II fixed-dose combination Foster City, CA www.gilead.com vanoxerine ChanRx atrial fibrillation Phase II Cleveland, OH www.chanrx.com vernakalant Cardiome Pharma atrial fibrillation Phase II (oral) Vancouver, Canada www.cardiome.com Atherosclerosis Product Name Sponsor Indication Development Phase ACP-501 AlphaCore Pharma atherosclerosis Phase I (rhLCAT) Ann Arbor, MI (see also coronary artery disease) www.alphacorepharma.com ACZ885 Novartis Pharmaceuticals atherosclerosis in patients with Phase II (canakinumab) East Hanover, NJ type 2 diabetes www.novartis.com (see also other) anacetrapib Merck atherosclerosis Phase III (MK-0859) Whitehouse Station, NJ (see also lipid disorders) www.merck.com BMS-852927 Bristol-Myers Squibb atherosclerosis Phase I (LXR modulator) Princeton, NJ www.bms.com 4 Medicines in Development Heart Disease and Stroke 2013 Medicines in Development for Heart Disease and Stroke Atherosclerosis Product Name Sponsor Indication Development Phase BMS-962476 Bristol-Myers Squibb atherosclerosis Phase I (PCSK9 adnectin) Princeton, NJ www.bms.com CSL-112 CSL atherosclerosis Phase II (cholesterol modulator) Victoria, Australia www.csl.com.au darapladib GlaxoSmithKline atherosclerosis Phase III (Lp-PLA2 inhibitor) Rsch. Triangle Park, NC www.gsk.com ISIS-APOARx Isis Pharmaceuticals atherosclerosis Phase I (antisense RNA inhibitor) Carlsbad, CA www.isispharm.com rilapladib GlaxoSmithKline atherosclerosis Phase II completed Rsch. Triangle Park, NC www.gsk.com RVX-208 Resverlogix atherosclerosis Phase II (BET protein inhibitor) Calgary, Canada (see also acute coronary syndrome) www.resverlogix.com Tekturna® Novartis Pharmaceuticals atherosclerosis in coronary Phase III aliskiren East Hanover, NJ artery disease www.novartis.com (see also heart failure, hypertension) VB201 VBL Therapeutics atherosclerosis Phase II (IL-12 subunit p40 inhibitor) Or Yehuda, Israel www.vblrx.com Coronary Artery Disease Product Name Sponsor Indication Development Phase ACP-501 AlphaCore Pharma coronary artery disease Phase I (rhLCAT) Ann Arbor, MI (see also atherosclerosis) www.alphacorepharma.com cangrelor The Medicines Company coronary artery disease in patients Phase III Parsippany, NJ requiring percutaneous coronary www.themedicinescompany.com intervention (PCI) (see also acute coronary syndrome, thrombosis) cardiovascular therapy AngioScore coronary artery restenosis Phase II releasing balloon Fremont, CA www.angioscore.com (drug-coated Angiosculpt®) coronary artery disease BioCardia coronary artery disease Phase II gene
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