美国2001年开发中的心脏病新药

2001 Heart Disease and Stroke N E W 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 Survey P R E S E N T E D B Y A M E R I C A ’ S P H A R M A C E U T I C A L C O M P A N I E S Keeping up the momentum of drug discovery that hashelped cut deaths from heart disease and stroke inhalf in the past 30 years, pharmaceutical and biotech- nology companies are developing 122 new medicines for cardiovascular diseases—up from 104 in 1999. 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.) And stroke is the third leading cause of death in the United States, following cancer. Although heart disease and stroke were once considered inevitable consequences of aging, today these diseases can be treated aggressively. Doctors and patients have a wide variety of treatment options, including medicines for high blood pressure, a leading risk factor for both heart disease and stroke; medicines that lower cholesterol and prevent heart attacks and may also be able to prevent strokes and diabetes; clot-buster medicines that can save the lives of heart attack patients and prevent permanent brain damage due to stroke; and drugs that can prevent second heart attacks and those that can make life both longer and better for people with congestive heart failure. Despite this progress, nearly 61 million Americans—more than one in five—suffer from at least one type of cardio- vascular disease, and nearly a million Americans a year die of these diseases—more that 2,600 every day. These diseases are expected to cost nearly $300 billion this year. And some experts believe that the incidence—and the cost—of these diseases will rise as our population ages— unless better treatments or preventive measures are found. The 122 medicines in the pharmaceutical pipeline are an encouraging sign that the pharmaceutical industry is meeting this challenge. Many of the potential treatments use cutting edge technologies and new scientific approaches. These include: • An anti-clotting drug derived from the venom of the Malaysian pit viper that may be able to help some stroke patients recover faster. • A vaccine that may be able to boost levels of “good” cholesterol, or HDL, by blocking its transition into “bad” cholesterol, or LDL. • A medicine now used to treat rheumatoid arthritis that may be able to block a substance that damages the heart and causes congestive heart failure. • A gene therapy that prompts the growth of new blood vessels to bypass blocked arteries that may be able to help some of the millions of Americans with coronary artery disease and peripheral vascular disease. • A medicine that has been shown to cut heart attacks and deaths in people undergoing coronary angioplasty. The medicines in development, all of which are either in human clinical trials or awaiting approval by the Food and Drug Administration, include 18 for congestive heart failure, which costs about $21 billion a year and causes nearly 47,000 deaths annually and 18 for stroke, which kills someone in the United States every 3.3 minutes. Thanks to pharmaceutical research and development, hundreds of powerful medicines that can control the risk factors for heart disease and stroke and treat these diseases when they occur are already available. The 122 medicines currently in development provide hope for even more formidable weapons against these deadly and tenacious diseases. Sincerely, President and CEO PhRMA 122 Medicines in the Pipeline Offer Hope of More Powerful Weapons Against Heart Disease and Stroke MEDICINES IN DEVELOPMENT FOR HEART DISEASE AND STROKE* *Some medicines are l isted in more than one category. 2 N E W 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 2001 New Medicines in Development for Heart Disease and Stroke 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 Company Indication Development Status* Angiomax™ The Medicines Company percutaneous coronary Phase III bivalirudin Cambridge, MA intervention (PCI) (617) 225-9099 (see also heart attack) ----------------------------------------------------------------------------------------------- heparin-induced thrombocytopenia Phase III in patients undergoing PCI ----------------------------------------------------------------------------------------------- off-pump coronary bypass Phase II Argatroban Texas Biotechnology for patients undergoing PCI who application submitted Houston, TX have or are at risk of developing (713) 796-8822 heparin-induced thrombocytopenia (see also stroke) Hemapure Biopure Biopharmaceutics alternative to red blood cell Phase II completed Cambridge, MA transfusion during cardiac and (617) 234-6500 vascular surgery HOE 642 Aventis Pharmaceuticals coronary artery bypass graft (CABG) Phase III (cariporide) Bridgewater, NJ (see also heart attack) (800) 633-1610 Neutralase™ Ibex Technologies heparin reversal post-CABG, Phase III heparinase I-IBEX Montreal, Quebec angioplasty (514) 344-4004 (see also peripheral vascular disease) Oxygent™ Alliance Pharmaceutical temporary oxygen carrier in Phase III perflubron San Diego, CA cardiopulmonary bypass (858) 410-5200 emulsion surgery pexelizumab Alexion Pharmaceuticals reduction of cardiac damage Phase II (5G1.1-SC) Cheshire, CT and other inflammation-related (203) 272-2596 Procter & Gamble sequelae associated with Pharmaceuticals cardiopulmonary bypass procedures Cincinnati, OH (see also heart attack) RSR 13 Allos Therapeutics cardiopulmonary bypass surgery, Phase II Denver, CO acute ischemic heart disease (303) 426-6262 TP10 AVANT post-bypass syndromes Phase II soluble complement Immunotherapeutics (781) 433-0771 receptor 1 Needham, MA transgenic anti- Genzyme Transgenics use in heparin-resistant patients Phase III thrombin III Framingham, MA undergoing cardiopulmonary (508) 620-9700 bypass VAS971 Vasogen cardiovascular surgery Phase II Mississauga, Ontario (905) 569-2265 * For more information about a specific medicine in this report, please call the telephone number listed. 3N E W 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 2001 A N G I N A Product Name Company Indication Development Status Generx™ Berlex Laboratories stable exertional angina Phase III Ad5FGF-4 Montville, NJ (858) 794-3400 Collateral Therapeutics San Diego, CA nifedipine Hoffmann-La Roche Phase III (new formulation) Nutley, NJ (973) 235-5000 Plavix® Bristol-Myers Squibb unstable angina Phase III clopidogrel Princeton, NJ (212) 546-4000 Sanofi-Synthelabo New York, NY ranolazine CV Therapeutics chronic stable angina Phase III Palo Alto, CA (see also congestive heart failure) (650) 812-0585 rNAPc2 Corvas International unstable angina Phase II (recombinant San Diego, CA (see also deep vein thrombosis, (858) 455-9800 small protein pulmonary vascular disease) anticoagulant) Vanlev® Bristol-Myers Squibb (see also congestive heart failure, Phase II omapatrilat Princeton, NJ hypertension) (212) 546-4000 A R R H Y T H M I A Product Name Company Indication Development Status Amio-Aqueous Academic Pharmaceuticals ventricular tachycardia, Phase III I.V. Lake Bluff, IL supraventricular arrhythmia Azimilide Procter & Gamble atrial fibrillation, atrial flutter, Phase III Pharmaceuticals paroxysmal supraventricular Cincinnati, OH tachycardia (PSVT) CVT-510 CV Therapeutics Phase II Palo Alto, CA (650) 812-0585 drondarone Sanofi-Synthelabo acute fibrillation Phase II/III (SR 33589) New York, NY (212) 551-4000 DTI-0009 Discovery Therapeutics atrial fibrillation, PSVT Phase II Richmond, VA (804) 358-9468 Fujisawa Healthcare Deerfield, IL RSD1235 Nortran Pharmaceuticals Phase I Vancouver, British Columbia (604) 222-5577 tedisamil Solvay Pharmaceuticals Phase III Marietta, GA (770) 578-5581 A T H E R O S C L E R O S I S Product Name Company Indication Development Status AGI-1067 AtheroGenics Phase II Atlanta, GA (408) 298-7409 Schering-Plough Kenilworth, NJ 4 N E W 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 2001 A T H E R O S C L E R O S I S Product Name Company Indication Development Status Antrin® Pharmacyclics (see also coronary artery disease, Phase I/II motexafin lutetium Sunnyvale, CA peripheral vascular disease, other) avasimibe Pfizer Phase III (ACAT inhibitor) New York, NY (860) 441-6058 CETi-1 vaccine AVANT Phase I Immunotherapeutics (781) 433-0771 Needham, MA CP-529,414 Pfizer Phase II (CETP inhibitor) New York, NY (860) 441-6058 VasoCare Vasogen Phase II Mississauga, Ontario (905) 569-2265 Zithromax® Pfizer Phase III azithromycin New York, NY (860) 441-6058 C O N G E S T I V E H E A R T F A I L U R E Product Name Company Indication Development Status Atacand® AstraZeneca Phase III candesartan Wilmington, DE (302) 886-3000 cilexetil Avapro® Bristol-Myers Squibb Phase III irbesartan Princeton, NJ (212) 546-4000 Sanofi-Synthelabo New York, NY BMS 207940 Bristol-Myers Squibb Phase II endothelin Princeton, NJ (212) 546-4000 antagonist compound 501 Celgene Phase II Warren, NJ (732) 271-1001 Dilatrend Hoffmann-La Roche Phase III carvedilol Nutley, NJ (973) 235-5000 (extended-release formulation) Diovan® Novartis Pharmaceuticals Phase III valsartan East Hanover, NJ (888) 669-6682 Enbrel Immunex Phase II/III entanercept Seattle, WA (888)-4ENBREL Wyeth-Ayerst Laboratories Philadelphia, PA eplerenone Pharmacia (see also hypertension) Phase III Peapack, NJ (616) 833-8244 LU135252 Knoll Pharmaceutical (see also hypertension) Phase II Mount Olive, NJ (800) 240-3820 M100240 Aventis Pharmaceuticals (see also hypertension) Phase II (ACE/NEP inhibitor) Bridgewater, NJ (800) 633-1610 Natrecor® Scios acute congestive heart failure application submitted nesiritide Sunnyvale, CA (408) 616-8200 5N E W 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 2001 C O N G E S T I V E H E A R T F A I L U R E Product Name Company Indication Development Status ranolazine CV Therapeutics (see also angina) Phase II Palo Alto, CA (650) 812-0585 Remicade® Centocor Phase II infliximab Malvern, PA (610) 651-6122 Eli Lilly Indianapolis, IN TBC3711 ICOS (see also hypertension) Phase I (endothelin A Bothell, WA (713) 796-8822 receptor Texas Biotechnology antagonist) Houston, TX Toprol-XL AstraZeneca Phase III completed metoprolol Wilmington, DE (302) 886-3000 succinate Vanlev® Bristol-Myers Squibb (see also angina, hypertension) Phase II omapatrilat Princeton, NJ (212) 546-4000 VAS991 Vasogen Phase II Mississauga, Ontario (905) 569-2265 YM087 Yamanouchi USA (see also other) Phase II Paramus, NJ C O R O N A R Y A R T E R Y D I S E A S E Product Name Company Indication Development Status Antrin® Pharmacyclics (see also atherosclerosis, peripheral Phase I/II motexafin lutetium Sunnyvale, CA vascular disease, other) BioByPass™ GenVec (see also peripheral vascular Phase II Angiogen Rockville, MD disease) (240) 632-0740 AdGVVEGF121.10 Pfizer (gene therapy) New York, NY CI-1023 Pfizer (see also peripheral vascular Phase II (VEGF adenovirus) New York, NY disease) (860) 441-6058 DEL-1 Valentis (see also peripheral vascular Phase I/II gene medicine Burlingame, CA disease) (650) 697-1900 fibroblast Chiron (see also peripheral vascular Phase II growth factor Emeryville, CA disease) (510) 655-8730 (FGF-2) Scios Sunnyvale, CA D E E P V E I N T H R O M B O S I S Product Name Company Indication Development Status CI-1031 Pfizer Phase II (factor Xa inhibitor) New York, NY (860) 441-6058 heparin Emisphere Technologies Phase III (liquid oral) Tarrytown, NY (914) 347-2220 6 N E W 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 2001 D E E P V E I N T H R O M B O S I S Product Name Company Indication Development Status MH1 American Biogenetic (see also heart attack, peripheral Phase I Sciences vascular disease, pulmonary (631) 789-2600 Copiague, NY vascular disease) rNAPc2 Corvas International (see also angina, pulmonary Phase II (recombinant San Diego, CA vascular disease) (858) 455-9800 small protein anticoagulant) SR34006 Sanofi-Synthelabo Phase II New York, NY (212) 551-4000 Xantidar™ Organon Phase III fondiparinux West Orange, NJ Sanofi-Synthelabo New York, NY 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 Company Indication Development Status Angiomax™ The Medicines Company acute myocardial infarction Phase III bivalirudin Cambridge, MA (see also adjunctive therapies) (617) 225-9099 CP-597,396 Pfizer Phase II New York, NY (860) 441-6058 HOE 642 Aventis Pharmaceuticals acute myocardial infarction Phase III (cariporide) Bridgewater, NJ (see also adjunctive therapies) (800) 633-1610 Integrilin® COR Therapeutics acute myocardial infarction Phase II Injection S. San Francisco, CA (650) 244-6893 eptifibatide Schering-Plough Kenilworth, NJ MH1 American Biogenetic (see also deep vein thrombosis, Phase I Sciences peripheral vascular disease, (631) 789-2600 Copiague, NY pulmonary vascular disease) pexelizumab Alexion Pharmaceuticals (see also adjunctive therapies) Phase II (5G1.1-SC) Cheshire, CT (203) 272-2596 Procter & Gamble Pharmaceuticals Cincinnati, OH ReoPro® Centocor acute myocardial infarction Phase III abciximab/ Malvern, PA (see also peripheral vascular (610) 651-6122 Retavase® Eli Lilly disease) reteplase Indianapolis, IN (combination therapy) TNKase™ Genentech combination therapy for acute Phase II tenecteplase S. San Francisco, CA myocardial infarction (650) 225-1000 XRP0579A Aventis Pharmaceuticals (see also other) Phase II (A1/A2 adenosine Bridgewater,NJ (800) 633-1610 receptor antagonist) 7N E W 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 2001 H Y P E R L I P I D E M I A Product Name Company Indication Development Status ApoA-1 milano Esperion Therapeutics hypercholesterolemia Phase I completed (single dose) Ann Arbor, MI (734) 332-0506 (x-210) Cardiorex™ Forbes Medi-Tech Phase II Vancouver, British Columbia (604) 689-5899 cholesterol Schering-Plough inhibits intestinal absorption Phase III absorption Kenilworth, NJ of dietary cholesterol while allowing (908) 298-4000 inhibitor free passage of other nutrients (as monotherapy) ----------------------------------------------------------------------------------------------- inhibits intestinal absorption Phase III of dietary cholesterol while allowing free passage of other nutrients (with statins) Crestor AstraZeneca Phase III ZD4522 Wilmington, DE (302) 886-3000 extended-release Kos Pharmaceuticals application submitted niacin/lovastatin Miami, FL (305) 523-3620 GT102-279 GelTex Pharmaceuticals Phase II Waltham, MA (781) 290-5888 LUV Esperion Therapeutics hypercholesterolemia Phase II (large uniamellar Ann Arbor, MI (734) 332-0506 vesicles) NK-104 Sankyo Pharma hypercholesterolemia Phase I New York, NY (973) 359-2600 NL Statin Du Pont Pharmaceuticals hypercholesterolemia Phase III niaspan (extended Wilmington, DE (302) 992-5000 release Niacin) and lovastatin combination therapy Pravachol® Bristol-Myers Squibb secondary prevention application submitted pravastatin Princeton, NJ (212) 546-4000 ----------------------------------------------------------------------------------------------- pediatric use (high dose) Phase III H Y P E R T E N S I O N ( H I G H B L O O D P R E S S U R E ) Product Name Company Indication Development Status CS-866 Sankyo Pharma Phase III New York, NY (973) 359-2600 eplerenone Pharmacia (see also congestive heart failure) Phase III Peapack, NJ (616) 833-8244 gemopatrilat Bristol-Myers Squibb Phase I BMS 189921 Princeton, NJ (212) 546-4000 (vasopeptidase inhibitor) lercanidipine Forest Laboratories Phase III New York, NY (800) 947-5227 8 N E W 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 2001 H Y P E R T E N S I O N ( H I G H B L O O D P R E S S U R E ) Product Name Company Indication Development Status LU135252 Knoll Pharmaceutical (see also congestive heart failure) Phase II Mount Olive, NJ (800) 240-3820 M100240 Aventis Pharmaceuticals (see also congestive heart failure) Phase II (ACE/NEP inhibitor) Bridgewater, NJ (800) 633-1610 sampatrilat Shire Laboratories Phase I Rockville, MD (800) 536-7878 TBC3711 ICOS (see also congestive heart failure) Phase I (endothelin A Bothell, WA (713) 796-8822 receptor Texas Biotechnology antagonist) Houston, TX Teveten® Plus GlaxoSmithKline application submitted eprosartan Philadelphia, PA (770) 578-5581 mesylate/HCTZ Solvay Pharmaceuticals Marietta, GA Vanlev® Bristol-Myers Squibb isolated systolic hypertension Phase III omapatrilat Princeton, NJ (see also angina, congestive heart (212) 546-4000 failure) Vanlev®/HCTZ Bristol-Myers Squibb Phase II omapatrilat/HCTZ Princeton, NJ (212) 546-4000 I M A G I N G A G E N T S Product Name Company Indication Development Status Clariscan™ Nycomed Amersham MRI agent for coronary angiography Phase II NC 100150 Princeton, NJ and assessment of cardiac perfusion (609) 514-6000 CVT-3146 CV Therapeutics cardiac imaging Phase I Palo Alto, CA (650) 812-0585 Fujisawa Healthcare Deerfield, IL Definity Du Pont Pharmaceuticals coronary ultrasound imaging agent Phase III Wilmington, DE (302) 992-5000 Imavist™ Alliance Pharmaceutical endocardial border delineation application submitted San Diego, CA (cardiac function) (858) 410-5200 ------------------------------------------------------------------------------------- myocardial perfusion Phase II Myoview™ Nycomed Amersham radiopharmaceutical for coronary Phase III Tc 99m tetrofosmin Princeton, NJ angiography following pharmacologic- (609) 514-6000 induced stress testing and for assessment of left ventricular function Omniscan™ Nycomed Amersham MRI agent for assessment of cardiac Phase II gadodiamide Princeton, NJ perfusion (609) 514-6000 Sonazoid™ Nycomed Amersham ultrasound agent for assessment Phase II NC 100100 Princeton, NJ of cardiac perfusion (609) 514-6000 9N E W 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 2001 P E R I P H E R A L V A S C U L A R D I S E A S E Product Name Company Indication Development Status Antrin® Pharmacyclics (see also atherosclerosis, coronary Phase I/II motexafin lutetium Sunnyvale, CA artery disease, other) BioByPass™ GenVec (see also coronary artery disease) Phase II Angiogen Rockville, MD (240) 632-0740 AdGVVEGF121.10 Pfizer (gene therapy) New York, NY CI-1023 Pfizer (see also coronary artery disease) Phase II (VEGF adenovirus) New York, NY (860) 441-6058 DEL-1 Valentis (see also coronary artery disease) Phase I/II gene medicine Burlingame, CA (650) 697-1900 fibroblast Chiron peripheral arterial disease Phase II growth factor Emeryville, CA (see also coronary artery disease) (510) 655-8730 (FGF-2) Scios Sunnyvale, CA Genvascor™ Berlex Laboratories Phase I/II Ad5FGF-4 Montville, NJ (858) 794-3400 Collateral Therapeutics San Diego, CA Lumaxis® Du Pont Pharmaceuticals peripheral arterial disease Phase III roxifiban IIb/IIIa Wilmington, DE (302) 992-5000 MH1 American Biogenetic (see also deep vein thrombosis, Phase I Sciences heart attack, pulmonary vascular (631) 789-2600 Copiague, NY disease) Neutralase™ Ibex Technologies (see also adjunctive therapies) Phase III neparinase I-IBEX Montreal, Quebec (514) 344-4004 propionyl-L- Sigma-Tau Pharmaceuticals Phase III carnitine HCl Gaithersburg, MD (800) 447-0169 ReoPro® Centocor (see also heart attack) Phase II abciximab/ Malvern, PA (610) 651-6122 Retavase® Eli Lilly reteplase Indianapolis, IN (combination therapy) XRP0038A Aventis Pharmaceuticals peripheral artery disease Phase I (fibroblast growth Bridgewater, NJ (800) 633-1610 factor) Gencell Hayward, CA P U L M O N A R Y V A S C U L A R D I S E A S E Product Name Company Indication Development Status CI-1034 Pfizer Ph