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CV Therapeutics 2005 Annual Report

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CV Therapeutics 2005 Annual Report CV Therapeutics 2005 Annual Report Founded in 1990 by Louis Lange, M.D., Ph.D., CV Therapeutics, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing new small molecule therapies for patients suffering from cardiovascular disease — the number one cause of death in the United States. We are dedicated to helping patients with unmet medical needs by bringing new drugs to market. THE VISION OF ONE COMPANY January 27, 2006 The FDA approval of RanexaTM represents the first new pharmaceutical approach to treat chronic angina in more than 20 years in the United States Despite the development of significant new therapies, cardiovascular disease ranks as the number one killer in the United States and today there are over 70 million people in the United States with cardiovascular disease, according to the American Heart Association. Our goal is to address unmet medical needs by developing innovative products, such as Ranexa, to treat patients. THE DEDICATION OF HUNDREDS THE HOPE OF MILLIONS Bringing new drugs to market requires years of support and commitment from many people, including physicians and scientists who serve as investigators or advisors for our programs. Together, their dedication is vital to our goal of improving the quality of treatment for cardiovascular diseases. This pioneering spirit is the foundation for scientific progress, and their contributions are critical for developing potential new drugs that could make an important difference in patients’ lives. CVT / 02 CVT / 03 Ranexa The FDA approval of RanexaTM (ranolazine extended-release tablets) in January 2006 represents the first new pharmaceutical approach to treat chronic angina in the United States in more than 20 years. Ranexa has antianginal and anti-ischemic effects that do not depend upon reductions in heart rate or blood pressure. Ranexa is approved for the treatment of chronic angina in patients who have not achieved an JAN 27, 2006 adequate response with other antianginal drugs and should be used in combination with amlodipine, beta-blockers or nitrates. Complete safety and prescribing information can be found at www.Ranexa.com. In order to potentially broaden the product labeling for Ranexa over time, we are conducting a study of 6,500 patients known as MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36. Under a special protocol assessment agreement with the FDA, if treatment with Ranexa is not associated with an adverse trend in death or arrhythmia, the study could support potential approval of Ranexa as first-line TWELVE MONTHS / TWO PRODUCTS chronic angina therapy. In addition, if the study demonstrates a significant improvement in the time to first occurrence of cardiovascular death, myocardial infarction or recurrent ischemia, Ranexa could gain potential approval for hospital-based and long-term prevention of acute coronary syndromes. ACEON® In August 2005, the FDA expanded the approved indication of ACEON® (perindopril erbumine) Tablets to include reduction of the risk of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease. ACEON®, an angiotensin converting enzyme (ACE) inhibitor, is also indicated for the treatment of essential hypertension. The labeling expansion was based on the EUROPA (EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study. In this study, perindopril AUG 23, 2005 significantly reduced the relative risk of cardiovascular death, nonfatal myocardial infarction or cardiac arrest by 20 percent. Complete safety and prescribing information, including the warning against product use during pregnancy, can be found at www.Aceon.com. CV Therapeutics co-promotes ACEON® with Solvay Pharmaceuticals, Inc. CVT / 04 CVT / 05 From R&D to Commercialization FROM SCIENCE TO PATIENTS Over the past 18 months, CV Therapeutics has evolved from an In March 2006, the American College of Cardiology Annual innovative research and development company with a pipeline based Scientific Sessions in Atlanta provided us with a premier platform to on cutting-edge science into a fully integrated biopharmaceutical establish brand awareness of Ranexa among cardiologists and to company with two approved products and a skilled cardiovascular begin promoting Ranexa. The product is now available in pharmacies sales force. and, for the first time in more than 20 years, physicians in the United States have a new pharmaceutical approach to offer their We began this transformation by entering into an agreement to chronic angina patients. co-promote ACEON® in December 2004. Cardiologists are the primary prescribers of branded tissue-ACE inhibitors like ACEON®, and many While we are devoting significant attention and focus to establishing of these ACEON® prescribers are also potential Ranexa prescribers. CV Therapeutics as a commercial organization, we remain dedicated This overlap provided CV Therapeutics with the opportunity to build to our cutting-edge science based on molecular cardiology. With a commercial sales and marketing team in advance of the Ranexa the MERLIN TIMI-36 trial well underway, regadenoson in late launch and to begin developing relationships with many potential Phase 3 development, and a number of other ongoing clinical and Ranexa customers. In 2005, we recruited and hired our 250-person preclinical programs, our goal remains to bring products to market cardiovascular sales force to complement our regional and district that help physicians address important unmet medical needs for managers, account specialists for managed care, professional program appropriate patients. managers and other essential commercial personnel. Following comprehensive sales training over the summer, we deployed our entire sales team in the fall, in time to capitalize on the expansion of the ACEON® labeling. CVT / 06 CVT / 07 Regadenoson Regadenoson is a selective A2A-adenosine receptor agonist in clinical development for Our Pipeline Our research and development team is working to create new potential product opportunities potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) through our expertise in molecular cardiology, and we have several ongoing clinical and studies. Regadenoson is administered via intravenous bolus and increases coronary blood preclinical programs. flow as if the heart were responding to the demands of physical exercise. The selective action One of our areas of expertise is the field of adenosine receptors. Adenosine is a small of regadenoson on the A -adenosine receptor may potentially avoid some of the side effects 2A molecule that is naturally present in the body and has many actions in different organs. caused by the less specific action of traditional agents when other adenosine receptor There are four types of adenosine receptors: A1, A2A, A2B and A3. Activation of these subtypes are also stimulated. receptors initiates cascades of cellular biochemical events that result in specific changes in MPI studies are conducted to detect areas of insufficient blood perfusion to the heart important cell functions. muscle, which may be caused by blockages in coronary arteries. MPI studies are performed The effects of adenosine serve as the basis for many of our research and development by comparing pictures of the heart at rest and during exercise. In 2002, approximately programs, including our regadenoson, tecadenoson and CVT-6883 clinical programs, as well 7.8 million patients underwent MPI studies. Of those, approximately 3.4 million, or more as some of our preclinical programs. than 40 percent, required a pharmacologic agent to generate maximum coronary blood flow because peripheral vascular disease, arthritis or other limiting medical conditions In 2005, CVT-6883, a selective A2B-adenosine receptor antagonist for the potential treatment prevented them from exercising on the treadmill. of asthma, moved into the clinic. CVT-6883 acts by blocking the A2B-adenosine receptor, which may limit or prevent mast cell activation of the inflammatory events that can lead to In 2005, the first of two Phase 3 trials of regadenoson met its primary endpoint by showing bronchoconstriction and airway hyperreactivity associated with asthma. CVT-6883 could that MPI studies conducted with regadenoson were comparable to MPI studies conducted potentially offer a novel therapeutic approach to asthma. with ADENOSCAN® (adenosine injection). ADENOSCAN® is the market-leading pharmacologic stress agent in the United States for use with MPI and is marketed by our partner Astellas We have numerous preclinical and discovery programs, which focus on various areas such as Pharma US, Inc. We expect data from a second Phase 3 trial of regadenoson in 2006. If late INA inhibition, reverse cholesterol transport, metabolic disorders, dyslipidemia and obesity. successful, we would expect to submit a new drug application to the FDA. Indication/ Discovery/ FDA Compounds/Targets Area of Development Preclinical I II III NDA Approval Chronic Angina d e t (reserved for 2nd line use) e k r a Stable Coronary Artery Disease M ( Hypertension Ranexa™ Chronic Angina (1st line use) Acute Coronary Syndromes Regadenoson Myocardial Perfusion Imaging l a c i Tecadenoson PSVT n i l C Acute Atrial Fibrillation Adentri™ Heart Failure CVT-6883 Asthma Adenosine Receptors Atrial Arrhythmias Lipid Metabolism Diabetes l a Metabolic Syndrome c i n Dyslipidemia i l c Addiction
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