200R9ep ort M EDICINES IN D EVELOPMENT FOR Heart Disease and Stroke PRESENTED BY AMERICA ’ S PHARMACEUTICAL RESEARCH COMPANIES More Than 300 Medicines in Testing for Two Leading Causes of Death in Americans harmaceutical and biotechnology researchers are MEDICINES IN DEVELOPMENT FOR HEART DISEASE AND STROKE * working on 312 medicines for two of the three Pleading causes of death in Americans—heart disease Acute Coronary Syndrome 21 and stroke—keeping up the momentum of drug discovery Adjunctive Therapies 5 Angina 2 that has helped cut deaths from these diseases by more Arrhythmia/Atrial Fibrillation 20 than a quarter between 1999 and 2005. All of the medicines Atherosclerosis 18 are either in clinical trials or awaiting approval by the Coronary Artery Disease 11 Heart Attack 16 Food and Drug Administration. Heart Failure 33 Hypertension 36 According to the National Center for Health Statistics, Imaging Agents 10 heart disease has topped the list of killer diseases every Ischemic Disorders 18 Lipid Disorders 26 year but one since 1900. (The exception was 1918, Peripheral Vascular Disease 27 when an influenza epidemic killed more than 450,000 Pulmonary Vascular Disease 16 Stroke Americans.) In 2002, cancer surpassed heart disease as 22 Thrombosis 40 the top killer of Americans under age 85, who account Other 39 for 98.4 percent of the U.S. population. Stroke is the *S ome medicines are listed in more than one category. third leading cause of death. Thanks in large part to new drug treatments, death rates cost of these diseases to American society is more than from heart disease and stroke are falling. According to the $448 billion a year. National Heart, Lung and Blood Institute (NHLBI), if death The medicines in development include 36 for high rates were the same as those of 30 years ago, 815,000 blood pressure, 33 for heart failure, 16 for heart attacks, more Americans would die of heart disease annually and and 22 for stroke. Many of the potential medicines use 250,000 more would die of stroke. This reduction in cutting-edge technologies and new scientific approaches. death rates is “one of the great triumphs of medicine in For example: the past 50 years,” according to cardiologist Dr. Eugene Braunwald of Brigham and Women’s Hospital at • Human stem cells that may restore cardiac function by Harvard University. forming new heart muscle. Much of the progress is due to the development of • A new anticoagulant that regulates clot formation to effective medicines to control both blood pressure and prevent deep vein thrombosis. cholesterol, according to officials at the NHLBI. In • A gene therapy that uses a patient’s own cells to treat addition, treatment of heart attacks has vastly improved. heart failure. Twenty-five years ago, the treatment for heart attacks was simply bed rest. Today, doctors have medicines that can These new medicines promise to continue the already stop a heart attack in mid-stream as well as other high- remarkable progress against heart disease and stroke and tech treatments. to raise the quality of life for patients suffering from these diseases. But, experts warn, the war against heart disease and stroke is not yet won. According to the American Heart Association, every 37 seconds an American dies of cardiovascular disease, and nearly 80 million Americans have one or more types of cardiovascular disease. Many Billy Tauzin people who survive heart attacks develop heart failure, a President and CEO chronic disease that affects 5.3 million Americans. The PhRMA Medicines in Development for Heart Disease and Stroke A CUTE C ORONARY S YNDROME Product Name Sponsor Indication Development Status* Angiomax ® The Medicines Company acute coronary syndrome application submitted bivalirudin Parsippany, NJ (973) 656-1616 apixaban Bristol-Myers Squibb acute coronary syndrome Phase III (factor XA Princeton, NJ (see also stroke, thrombosis) (212) 546-4000 inhibitor) Pfizer (860) 732-5156 New York, NY Arixtra ® GlaxoSmithKline acute coronary syndrome application submitted fondaparinux Rsch. Triangle Park, NC (888) 825-5249 cangrelor The Medicines Company acute coronary syndrome Phase III Parsippany, NJ (800) 388-1183 DX9065a Daiichi Sankyo acute coronary syndrome Phase II Parsippany, NJ (see also coronary artery disease, (973) 359-2600 thrombosis) E5555 Eisai Medical Research acute coronary syndrome/chronic Phase II Ridgefield Park, NJ atherothrombotic disease (888) 422-4743 factor IIa/Xa Bayer HealthCare acute coronary syndrome Phase I inhibitor Pharmaceuticals (888) 842-2937 Wayne, NJ Integrelin ® Schering-Plough early acute coronary syndrome Phase III eptifibatide Kenilworth, NJ (908) 298-4000 M118 Momenta Pharmaceuticals acute coronary syndrome Phase II Cambridge, MA (617) 491-9700 otamixaban sanofi-aventis acute coronary syndrome Phase II (XRP0673) Bridgewater, NJ (800) 633-1610 prasugrel Eli Lilly acute coronary syndrome application submitted (CS-747) Indianapolis, IN (800) 545-5979 Daiichi Sankyo (973) 359-2600 Parsippany, NJ -------------------------------------------------------------------------------------- acute coronary syndrome Phase II (combination therapy) (800) 545-5979 (973) 359-2600 PRT060128 Portola Pharmaceuticals acute coronary syndrome Phase II South San Francisco, CA (see also heart attack) rivaroxaban Bayer HealthCare acute coronary syndrome Phase II Pharmaceuticals (see also stroke, thrombosis) (888) 842-2937 Wayne, NJ Johnson & Johnson Pharmaceutical Reseach & Development Raritan, NJ SCH-530348 Schering-Plough acute coronary syndrome Phase III Kenilworth,NJ (908) 298-4000 * For more information about a specific medicine in this report, please call the telephone number listed. 2 M EDICINES IN D EVELOPMENT FOR Heart Disease and Stroke 2009 A CUTE C ORONARY S YNDROME Product Name Sponsor Indication Development Status TAK-442 Takeda Pharmaceuticals acute coronary syndrome Phase II North America (see also thrombosis) (877) 582-5332 Deerfield, IL Thelin ™ Encysive Pharmaceuticals acute coronary disorders Phase I sitaxentan Houston, TX (see also heart failure, (713) 796-8822 pulmonary vascular disease) ticagrelor AstraZeneca acute coronary syndrome Phase III Wilmington, DE (see also thrombosis) (800) 236-9933 varespladib Anthera Pharmaceuticals acute coronary syndrome Phase II 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 VT-111 Viron Therapeutics acute coronary syndrome Phase II London, ON (see also atherosclerosis, (519) 858-5109 coronary artery disease) Vytorin ™ Merck acute coronary syndrome Phase III ezetimibe/ Whitehouse Station, NJ (800) 672-6372 simvastatin Schering-Plough (908) 298-4000 Kenilworth, NJ A DJUNCTIVE T HERAPIES ; R EVASCULARIZATION Product Name Sponsor Indication Development Status CCX140 ChemoCentryx treatment of vascular restinosis Phase I Mountain View, CA following angioplasty or stenting (650) 210-2900 fibrin patch Omrix Biopharmaceuticals surgical blood loss Phase II New York, NY (212) 887-6500 Ethicon, a Johnson & Johnson Company Somerville, NJ NovoSeven ® Novo Nordisk post-operative hemorrhage in Phase II eptacog alfa Princeton, NJ cardiac surgery (800) 727-6500 rFXIII Novo Nordisk post-operative hemorrhage in Phase I Princeton, NJ cardiac surgery (800) 727-6500 Trinam ® Ark Therapeutics prevention of vascular restinosis Phase III (EG004) London, England following vascular graft surgery A NGINA Product Name Sponsor Indication Development Status ACCLAIM ™ Angiogenix angina pectoris Phase II isosorbide Burlingame, CA (650) 579-6685 mononitrate/ arginine M EDICINES IN D EVELOPMENT FOR Heart Disease and Stroke 2009 3 A NGINA Product Name Sponsor Indication Development Status FGF-1 CardioVascular angina pectoris Phase II (fibroblast growth BioTherapeutics (see also peripheral vascular disease) (702) 248-1174 factor 1) Las Vegas, NV A RRHYTHMIA , A TRIAL F IBRILLATION Product Name Sponsor Indication Development Status Amio-Aqueous ™ Academic Pharmaceuticals supraventricular arrhythmia, Phase III aqueous Lake Bluff, IL ventricular tachycardia (847) 735-1170 amiodarone ATI-2042 ARYx Therapeutics atrial fibrillation Phase II Fremont, CA (510) 585-2200 ATPace ™ Duska Therapeutics diagnosis of bradycardia, Phase II adenosine La Jolla, CA treatment of paroxysmal (858) 551-5700 triphosphate supraventricular tachycardia injection Avapro ® sanofi-aventis atrial fibrillation Phase III irbesartan Bridgewater, NJ (see also heart failure) (800) 633-1610 AZD1305 AstraZeneca atrial fibrillation, left ventricular Phase II Wilmington, DE dysfunction (800) 236-9933 -------------------------------------------------------------------------------------- atrial flutter Phase I/II (800) 236-9933 -------------------------------------------------------------------------------------- arrhythmia Phase I (800) 236-9933 capadenoson Bayer HealthCare atrial fibrillation Phase II Pharmaceuticals (888) 842-2937 Wayne, NJ celivarone sanofi-aventis atrial fibrillation Phase II (SSR149744) Bridgewater, NJ (800) 633-1610 GAP-134 Wyeth Pharmaceuticals arrhythmia Phase I Collegeville, PA (800) 934-5556 idrabiotaparinux sanofi-aventis atrial fibrillation Phase III Bridgewater, NJ (see also thrombosis) (800) 633-1610 idraparinux sanofi-aventis atrial fibrillation Phase III Bridgewater, NJ (see also thrombosis) (800) 633-1610 Lipitor ® Pfizer atrial fibrillation Phase II/III atorvastatin New York, NY (860) 732-5156 Lovaza ® GlaxoSmithKline atrial fibrillation Phase III omega-3 ethylester