2011年在研心脑血管药物

2011 Heart Disease and Stroke M E D I C I N E S I N D E V E L O P M E N T F O R Report P R E S E N T E D B Y A M E R I C A ’ S B I O P H A R M A C E U T I C A L R E S E A R C H C O M P A N I E S Biopharmaceutical research companies aredeveloping 299 new medicines for two of theleading causes of death of Americans—heart disease and stroke. The work continues the momentum of drug discovery that has helped cut deaths from these diseases by 28 percent between 1997 and 2007. All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration. According to the National Center for Health Statistics, heart disease has topped the list of killer diseases every year but one since 1900. (The exception was 1918, when an influenza epidemic killed more than 450,000 Americans.) Thanks in large part to new drug treatments, death rates from heart disease and stroke are falling. In 2008, stroke dropped to the fourth leading cause of death after being the third for over 50 years. According to the National Heart, Lung and Blood Institute (NHLBI), if death rates were the same as those of 30 years ago, 815,000 more Americans would die of heart disease annually and 250,000 more would die of stroke. This reduction in death rates is “one of the great triumphs of medicine in the past 50 years,” according to cardiologist Dr. Eugene Braunwald of Brigham and Women’s Hospital in Boston. Much of the progress is due to the development of effective medicines to control both blood pressure and cholesterol, according to officials at the NHLBI. In addition, treatment of heart attacks has vastly improved. Twenty-five years ago, the treatment for heart attacks was simply bed rest. Today, doctors have medicines that can stop a heart attack in mid-stream as well as other effective treatments. But, the war against heart disease and stroke is not yet won. According to the American Heart Association, every 39 seconds an American dies from cardiovascular disease, and more than 82 million Americans have at least one type of the disease. Many people who survive heart attacks develop heart failure, a chronic disease that affects 5.7 million Americans. The cost of these diseases to American society is more than $503 billion a year. The medicines in development include 43 for lipid disorders, such as high cholesterol, 36 for heart failure, 27 for high blood pressure, 17 for heart attacks, and 27 for stroke. Many of the potential medicines use cutting-edge technologies and new scientific approaches. For example: • Human stem cells that restore cardiac function by forming new heart muscle. • A new anticoagulant that regulates clot formation to prevent deep vein thrombosis. • 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). These new medicines promise to continue the already remark able progress against heart disease and stroke and to raise the quality of life for patients suffering from these diseases. Sincerely, John J. Castellani President and CEO PhRMA Biopharmaceutical Research Companies Are Developing Nearly 300 Medicines for Cardiovascular Disease MEDICINES IN DEVELOPMENT FOR HEART DISEASE AND STROKE* Acute Coronary Syndrome Adjunctive Therapies Arrhythmia/Atrial Fibrillation Atherosclerosis Coronary Artery Disease Heart Attack Heart Failure Hypertension Imaging Agents Ischemic Disorders Lipid Disorders Peripheral Vascular Disease Pulmonary Vascular Disease Stroke Thrombosis Other 22 5 15 15 9 17 17 36 27 11 23 43 20 27 28 35 *Some medicines are l is ted in more than one category. Medicines in Development for Heart Disease and Stroke A C U T E C O R O N A R Y S Y N D R O M E Product Name Sponsor Indication Development Status* Brilinta™ AstraZeneca prevention of acute coronary syndrome application submitted ticagrelor Wilmington, DE (800) 236-9933 CER-001 Cerenis Therapeutics post-acute coronary syndrome Phase I Ann Arbor, MI (734) 769-1110 CSL112 CSL Behring acute coronary syndrome Phase I King of Prussia, PA (610) 878-4000 E5555 Eisai acute coronary syndrome/chronic Phase II (atopaxar) Woodcliff Lake, NJ atherothrombotic disease (888) 422-4743 Effient® Eli Lilly acute coronary syndrome Phase III prasugrel Indianapolis, IN (combination therapy) (800) 545-5979 Daiichi Sankyo (973) 359-2600 Parsippany, NJ elinogrel Novartis Pharmaceuticals acute coronary syndrome Phase II East Hanover, NJ (see also heart attack) (888) 669-6682 Portola Pharmaceuticals South San Francisco, CA losmapimod GlaxoSmithKline acute coronary syndrome Phase II Rsch. Triangle Park, NC (see also atherosclerosis, (888) 825-5249 lipid disorders) M118 Momenta Pharmaceuticals acute coronary syndrome Phase II (adomiparin) Cambridge, MA (617) 491-9700 MDCO-216 The Medicines Company acute coronary syndrome Phase II Parsippany, NJ (see also atherosclerosis) (800) 388-1183 otamixaban sanofi-aventis acute coronary syndrome Phase III (direct Xa inhibitor) Bridgewater, NJ (800) 633-1610 Plavix® Bristol-Myers Squibb acute coronary syndrome Phase III clopidogrel Princeton, NJ (high loading dose) (212) 546-4000 sanofi-aventis (see also arrhythmia, other) (800) 633-1610 Bridgewater, NJ Pradaxa® Boehringer Ingelheim acute coronary syndrome Phase II dabigatran etexilate Pharmaceuticals (prevention of cardiovascular events) (203) 798-9988 Ridgefield, CT (see also thrombosis) REG1 Regado Biosciences acute coronary syndrome Phase II Basking Ridge, NJ (908) 580-2100 rivaroxaban Bayer HealthCare acute coronary syndrome Phase III Pharmaceuticals (Fast Track) (888) 842-2937 Wayne, NJ (see also stroke, thrombosis) (800) 817-5286 Johnson & Johnson Pharmaceutical Reseach & Development Raritan, NJ * For more information about a specific medicine in this report, please use contact information provided. M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 20112 A C U T E C O R O N A R Y S Y N D R O M E Product Name Sponsor Indication Development Status RVX-208 Resverlogix acute coronary syndrome Phase II Calgary, Canada (see also atherosclerosis) (403) 254-9252 TAK-442 Takeda Pharmaceuticals acute coronary syndrome Phase II (letaxaban) North America (see also thrombosis) (877) 582-5332 Deerfield, IL Valturna® Novartis Pharmaceuticals acute coronary syndrome Phase II aliskiren/valsartan East Hanover, NJ (888) 669-6682 varespladib Anthera Pharmaceuticals acute coronary syndrome Phase III San Mateo, CA (see also atherosclerosis) (510) 277-0356 VIA-2291 VIA Pharmaceuticals acute coronary syndrome Phase II San Francisco, CA (see also atherosclerosis) (415) 283-2200 vorapaxar Merck acute coronary syndrome Phase III Whitehouse Station, NJ (Fast Track) (800) 672-6372 (see also thrombosis) VT-111 Viron Therapeutics acute coronary syndrome Phase II London, Canada (519) 858-5109 Vytorin™ Merck acute coronary syndrome Phase III ezetimibe/ Whitehouse Station, NJ (800) 672-6372 simvastatin A D J U N C T I V E T H E R A P I E S ; R E V A S C U L A R I Z A T I O N Product Name Sponsor Indication Development Status AP 214 Action Pharma prevention of kidney disorders in Phase II Arhus, Denmark cardiac surgery www.actionpharma.com CCX140 ChemoCentryx treatment of vascular restinosis Phase I completed Mountain View, CA following angioplasty or stenting (650) 210-2900 CU-2010 The Medicines Company prevention of blood loss during Phase I Parsippany, NJ cardiac surgery (800) 388-1183 rFXIII Novo Nordisk post-operative hemorrhage in Phase II Princeton, NJ cardiac surgery (800) 727-6500 Trinam® Ark Therapeutics prevention of vascular restinosis Phase II/III taberminogene London, United Kingdom following vascular graft surgery www.arktherapeutics.com vadenovec (Fast Track) (Orphan Drug) A R R H Y T H M I A , A T R I A L F I B R I L L A T I O N Product Name Sponsor Indication Development Status ATI-2042 ARYx Therapeutics atrial fibrillation Phase II completed (budiodarone) Fremont, CA (510) 585-2200 M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 3 4 M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 A R R H Y T H M I A , A T R I A L F I B R I L L A T I O N Product Name Sponsor Indication Development Status ATPace™ Cordex Pharma bradycardia Phase II adenosine La Jolla, CA (858) 551-5700 triphosphate -------------------------------------------------------------------------------------- injection paroxysmal supraventricular Phase II tachycardia (PSVT) (858) 551-5700 azimilide Blue Ash Therapeutics ventricular arrhythmia Phase III Cincinnati, OH (513) 554-0696 BMS-394136 Bristol-Myers Squibb arrhythmia Phase I (potassium Princeton, NJ (212) 546-4000 channel blocker) BMS-914392 Bristol-Myers Squibb atrial fibrillation Phase I Princeton, NJ (212) 546-4000 capadenoson Bayer HealthCare atrial fibrillation Phase II completed Pharmaceuticals (888) 842-2937 Wayne, NJ celivarone sanofi-aventis ventricular arrhythmia Phase II Bridgewater, NJ (800) 633-1610 danegaptide Pfizer atrial fibrillation Phase I completed New York, NY (860) 732-5156 Zealand Pharma Copenhagen, Denmark K201 Sequel Pharmaceuticals atrial fibrillation Phase II (JTV-519) San Diego, CA (858) 509-0455 Kynapid™ Astellas Pharma atrial fibrillation application submitted vernakalant Deerfield, IL (800) 727-7003 (intravenous) Cardiome Pharma (800) 330-9928 Vancouver, Canada Lipitor® Pfizer prevention of atrial fibrillation in clinical trials atorvastatin New York, NY (860) 732-5156 Lovaza® GlaxoSmithKline atrial fibrillation Phase III completed omega-3 acid Rsch. Triangle Park, NC (see also lipid disorders) (888) 825-5249 ethyl esters NTC-801 Bristol-Myers Squibb atrial fibrillation, atrial flutter Phase II Princeton, NJ (212) 546-4000 Nissan Chemical Tokyo, Japan Teijin Pharma Tokyo, Japan Plavix® Bristol-Myers Squibb atrial fibrillation application submitted clopidogrel Princeton, NJ (see also acute coronary syndrome, (212) 546-4000 sanofi-aventis other) (800) 633-1610 Bridgewater, NJ vernakalant Cardiome Pharma atrial fibrillation Phase II (oral) Vancouver, Canada (800) 330-9928 Merck (800) 672-6372 Whitehouse Station, NJ 5M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 A T H E R O S C L E R O S I S Product Name Sponsor Indication Development Status anacetrapib Merck atherosclerosis Phase III (MK-0859) Whitehouse Station, NJ (see also lipid disorders) (800) 672-6372 BMS-582949 Bristol-Myers Squibb atherosclerosis Phase II (kinase inhibitor) Princeton, NJ (212) 546-4000 BMS-779788 Bristol-Myers Squibb atherosclerosis Phase I completed (liver XR agonist) Princeton, NJ (212) 546-4000 Exelixis San Francisco, CA darapladib GlaxoSmithKline atherosclerosis Phase III (Lp-PLA2 Rsch. Triangle Park, NC (888) 825-5249 inhibitor) GSK568859 GlaxoSmithKline atherosclerosis Phase I (lipoprotein- Rsch. Triangle Park, NC (888) 825-5249 associated phospholipase A2 [Lp-PLA2] inhibitor) K-604 Kowa Pharmaceuticals atherosclerosis Phase I America (334) 288-1288 Montgomery, AL losmapimod GlaxoSmithKline atherosclerosis Phase I Rsch. Triangle Park, NC (see also acute coronary syndrome, (888) 825-5249 lipid disorders) MDCO-216 The Medicines Company atherosclerosis Phase II Parsippany, NJ (see also acute coronary syndrome) (800) 388-1183 PSI-697 Pfizer atherosclerosis Phase I New York, NY (see also thrombosis) (860) 732-5156 RG1658 Roche atherosclerosis Phase III (dalcetrapib) Nutley, NJ (cardiovascular risk reduction) (973) 235-5000 RG7418 BioInvent atherosclerosis Phase I (BI204) Lund, Sweden (800) 626-3553 Genentech South San Francisco, CA rilapladib GlaxoSmithKline atherosclerosis Phase II completed (Lp-PLA2 Rsch. Triangle Park, NC (888) 825-5249 inhibitor) Human Genome Sciences (301) 309-8504 Rockville, MD RVX-208 Resverlogix atherosclerosis Phase II Calgary, Canada (see also acute coronary syndrome) (403) 254-9252 varespladib Anthera Pharmaceuticals atherosclerosis Phase II completed San Mateo, CA (see also acute coronary syndrome) (510) 277-0356 VIA-2291 VIA Pharmaceuticals atherosclerosis Phase II San Francisco, CA (see also acute coronary syndrome) (415) 383-2200 6 M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 C O R O N A R Y A R T E R Y D I S E A S E Product Name Sponsor Indication Development Status coronary artery BioCardia coronary artery disease Phase II disease gene South San Francisco, CA (650) 624-0900 therapy Coroxane™ Abraxis BioScience coronary artery restenosis Phase II albumin-bound Los Angeles, CA (see also peripheral vascular disease) (310) 437-7700 paclitaxel (intra-arterial) ivabradine Servier coronary artery disease with Phase III Cedex, France left ventricular dysfunction www.servier.com K-134 Kowa Pharmaceuticals arteriosclerosis obliterans Phase II America (334) 288-1288 Montgomery, AL LT-1951 Lumen Therapeutics coronary artery restenosis Phase I/II Mountain View, CA (650) 641-0084 myolimus Elixir Medical coronary artery restenosis in clinical trials Sunnyvale, CA (408) 636-2000 novolimus Elixir Medical prevention of coronary artery Phase II/III Sunnyvale, CA restenosis (408) 636-2000 Resten-MP™ Cook Pharmica coronary artery restenosis Phase I Bloomington, IN (877) 312-2665 Resten-NG® Cook Pharmica coronary artery restenosis Phase II Bloomington, IN (877) 312-2665 H E A R T A T T A C K ( M Y O C A R D I A L I N F A R C T I O N ) Product Name Sponsor Indication Development Status adipose stem Cytori Therapeutics myocardial infarction Phase I cell therapy San Diego, CA (see also ischemic disorders) (858) 458-0900 AMR-001 Amorcyte myocardial infarction Phase I (stem cell therapy) Hackensack, NJ (201) 883-5300 Progenitor Cell Therapy (201) 883-5303 Hackensack, NJ APN01 Apeiron Biologics myocardial infarction Phase I Vienna, Austria (see also heart failure, hypertension) (888) 825-5249 GlaxoSmithKline Rsch. Triangle Park, NC Bendavia™ Stealth Peptides acute myocardial infarction Phase II Newton Centre, MA (617) 244-2800 BVI-007 BioVascular myocardial infarction Phase I San Diego, CA (see also stroke) (858) 455-5000 carperitide Asubio Pharmaceuticals acute myocardial infarction Phase III Rochelle Park, NJ (201) 368-5020 elinogrel Novartis Pharmaceuticals myocardial infarction Phase II East Hanover, NJ (see also acute coronary syndrome) (888) 669-6682 Portola Pharmaceuticals South San Francisco, CA 7M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 H E A R T A T T A C K ( M Y O C A R D I A L I N F A R C T I O N ) Product Name Sponsor Indication Development Status MultiStem® Athersys myocardial infarction Phase II stem cell therapy Cleveland, OH (see also stroke) (216) 431-9900 Neu2000 AmKor Pharma myocardial infarction Phase I Seattle, WA (see also stroke) www.amkorpharma.com NX-CP-105 Neuronyx myocardial infarction Phase I (stem cell therapy) Malvern, PA (610) 240-4150 PL2100 PLx Pharma myocardial infarction Phase I/II (aspirin/ Houston, TX (see also stroke) (713) 842-1249 phosphatidyl- choline) Prochymal™ Osiris Therapeutics repair of heart tissue following Phase II mesenchymal Baltimore, MD myocardial infarction (410) 522-5005 stem cell therapy (human) Revascor™ Angioblast Systems myocardial infarction Phase II mesenchymal stem New York, NY (see also heart failure) (212) 880-2060 cell therapy Mesoblast Melbourne, Australia Tekturna® Novartis Pharmaceuticals myocardial infarction Phase III aliskiren East Hanover, NJ (see also heart failure, hypertension) (888) 669-6682 TG-100115 sanofi-aventis myocardial infarction Phase I/II Bridgewater, NJ (Fast Track) (800) 633-1610 thymosin beta-4 ReGeneRx myocardial infarction Phase I Biopharmaceuticals (301) 280-1992 Bethesda, MD VMD-30283 VM Discovery myocardial infarction Phase I/II Fremont, CA (510) 661-6770 H E A R T F A I L U R E ( C O N G E S T I V E H E A R T F A I L U R E ) Product Name Sponsor Indication Development Status AMG 423 Amgen heart failure Phase II (omecamtiv Thousand Oaks, CA (see also other) (805) 447-1000 mecarbil) CytoKinetics (650) 624-3000 South San Francisco, CA Anginera™ Theregen heart failure Phase I epicardial San Francisco, CA (see also ischemic disorders) (415) 439-8320 angiogenesis patch APN01 Apeiron Biologics heart failure Phase I Vienna, Austria (see also heart attack, hypertension) (888) 825-5249 GlaxoSmithKline Rsch. Triangle Park, NC BAY 60-4552 Bayer HealthCare heart failure Phase II Pharmaceuticals (888) 842-2937 Wayne, NJ 8 M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 H E A R T F A I L U R E ( C O N G E S T I V E H E A R T F A I L U R E ) Product Name Sponsor Indication Development Status BB3 Angion Therapeutics prevention of congestive Phase II Manhasset, NY heart failure (516) 869-6400 Bidil XR™ NitroMed heart failure Phase I hydralazine Charlotte, NC (704) 941-2020 hydrochloride/ isosorbide dinitrate (extended-release) BR-4628 Bayer HealthCare congestive heart failure Phase I Pharmaceuticals (888) 842-2937 Wayne, NJ Bystolic® Forest Laboratories congestive heart failure application submitted nebivolol New York, NY (800) 678-1605 Cardeva™ Teva Pharmaceuticals USA chronic heart failure Phase I/II B-type natriuretic North Wales, PA (215) 591-3000 peptide CD-NP Niles Therapeutics heart failure Phase II San Francisco, CA (415) 875-7880 cinaciguat Bayer HealthCare acute decompensated heart failure Phase II (BAY 58-2667) Pharmaceuticals (888) 842-2937 Wayne, NJ CXL-1020 Cardioxyl Pharmaceuticals chronic heart failure Phase II Chapel Hill, NC (919) 869-8585 daglutril Abbott Laboratories congestive heart failure Phase II Abbott Park, IL (see also hypertension) (847) 937-6100 Gencaro™ ARCA biopharma genotype-defined heart failure application submitted bucindolol Broomfield, CO (Fast Track) (720) 940-2200 GGF Acorda Therapeutics congestive heart failure Phase I (glial growth factor) Hawthorne, NY (914) 347-4300 icodextrin solution Baxter Healthcare congestive heart failure Phase II Deerfield, IL (800) 422-9837 IK-5001 Ikaria cardiac remodeling and subsequent Phase II Clinton, NJ congestive heart failure following (908) 238-6600 acute myocardial infarction INOmax® Ikaria congestive heart failure Phase II completed nitric oxide Clinton, NJ (see also ischemic disorders) (908) 238-6600 inhalation Inspra® Pfizer mild to moderate chronic heart failure Phase III eplerenone New York, NY (860) 732-5156 JNJ-39588146 Johnson & Johnson heart failure Phase II Pharmaceutical Research (800) 817-5286 & Development Raritan, NJ LCI699 Novartis Pharmaceuticals heart failure Phase II East Hanover, NJ (see also hypertension) (888) 669-6682 LCZ696 Novartis Pharmaceuticals heart failure Phase III East Hanover, NJ (see also hypertension) (888) 669-6682 9M E D I C I N E S I N D E V E L O P M E N T F O R Heart Disease and Stroke 2011 H E A R T F A I L U R E ( C O N G E S T I V E H E A R T F A I L U R E ) Product Name Sponsor Indication Development Status Mydicar™ Celladon advanced heart failure Phase I/II AAV1/SERCA2a La Jolla, CA (class III/IV) (858) 366-4288 gene therapy Targeted Genetics (206) 623-7612 Seattle, WA myoblast cell Advanced Cell Technology congestive heart failure Phase I transplantation Santa Monica, CA (310) 576-0611 therapy MyoCell® Bioheart congestive heart failure Phase II/III cell-based heart Sunrise, FL (954) 835-1500 damage therapy (tissue regeneration) PL-3994 Palatin Technologies congestive heart failure Phase II Cranbury, NJ (see also hypertension) (609) 495-2200 recombinant Novartis Pharmaceuticals acute heart failure Phase III relaxin East Hanover, NJ (Fast Track) (888) 669-6682 (RLX030) Revascor™ Angioblast Systems prevention of heart failure Phase II mesenchymal New York, NY (see also heart attack) (212) 880-2060 stem cell therapy Mesoblast Melbourne, Aus