Cardiovascular Drug Discoveries 2008

Date: April 22, 2008
Pages: 314
Price:
US$ 3,410.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: CF3FAB6048FEN
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Cardiovascular Drug Discoveries 2008
This report provides a detailed insight into the current and future market for cardiovascular drugs.

It provides an overview of the marketplace, outlining morbidity and mortality around the world and summarising the leading drugs in terms of sales and US patent expiry.

It examines drug development among major pharmaceutical companies, covering both novel drugs and launched products in development as part of their life cycle management programmes.

For each therapy section the major treatments are discussed in depth, including sales forecasts to 2012 for leading drugs. In addition, a number of new and future treatments have been identified and analysed in order to assess their future market potential.

Extensive tables and charts provide insight into leading cardiovascular markets and products.

Cholesterol and Triglycerides

The global market for drugs used in the management of cholesterol is currently valued at around US$34 billion. Sales of the major branded drugs amounted to around US$27.3 billion in 2007.

The most widely prescribed drugs for cholesterol management are HMG-CoA reductase inhibitors, or statins.

In terms of revenue, Pfizer’s Lipitor (atorvastatin) remains the largest selling drug of any kind worldwide. Lipitor accounts for around 40% of the market for cholesterol management drugs by value. Without a viable replacement in the pipeline, Pfizer is keen to hold onto its Lipitor revenue for as long as possible.

For some time, the company has been embroiled in a worldwide patent litigation battle with Ranbaxy, which is equally keen to launch generic atorvastatin in key markets. While Pfizer should be able to fend off generic competition in the US at least until its basic patent expires in March 2010, Lipitor has also been facing competition from multiple entries of generic simvastatin. During 2007, sales of Lipitor have been squeezed, particularly in the US. For the full year, Pfizer reported a decline of 8.3% in US sales and 1.6% worldwide.

New fixed-dose combinations aimed at improved cholesterol management, or more than one heart disease risk factor, are also likely to gain in popularity. The approval of Abbott’s Simcor (niacin+simvastatin) is just one of several combination products expected over the next few years.

Among the current and upcoming products evaluated with 5-year sales forecasts

Lipitor (atorvastatin) Pfizer
Zocor (simvastatin) Merck & Co
Zetia (ezetimibe) Merck & Co/ Schering-Plough
Crestor (rosuvastatin) AstraZeneca
Vytorin (ezetimibe+simvastatin) Merck & Co/ Schering-Plough
TriCor (fenofibrate) Abbott
Lescol (fluvastatin) Novartis
Niaspan (niacin) Kos Pharmaceutical
Caduet (amlodipine+atorvastatin) Pfizer
Tredaptive (niacin+laropiprant) Merck & Co
Simcor (niacin+simvastatin) Bayer
ABT-335 (SLV348) Abbott

Coronary Artery Disease

The approval of CV Therapeutics’ Ranexa (ranolazine) extended-release tablets by the FDA on 27th January 2006 for the treatment of chronic angina in a restricted patient population, marks the first new pharmaceutical approach to treating angina in the US in more than 25 years. Ranexa has anti-anginal and anti-ischaemic effects that do not depend upon reductions in heart rate or blood pressure.

Espicom has identified 15 drugs in development for atherosclerosis and coronary artery disease. Among these are three launched products in Phase III trials for atherosclerosis indications, including AstraZeneca’s Crestor (rosuvastatin), which has shown promise in atherosclerosis progression. Of the novel candidates in development, we have selected just one for analysis: Generx (alferminogene tadenovec, Ad5FGF-4) from Cardium Therapeutics, which is in Phase III for myocardial ischaemia and associated angina.

In the pipeline…

Cardium Therapeutics is developing Generx (alferminogene tadenovec, Ad5FGF-4) as a potential treatment for myocardial ischaemia (MI - insufficient blood flow within the heart muscle) and associated angina due to coronary heart disease, and represents a new therapeutic class of cardiovascular biologics.

GSK is developing a small-molecule drug for atherosclerosis in collaboration with Human Genome Sciences (HGS). Darapladib (GSK480848) inhibits the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2).

Hypertension

Hypertension is a leading risk factor for coronary heart disease, heart failure, heart attack, stroke and renal insufficiency. Hypertension is generally defined as blood pressure greater than 140/90mmHg. Risk levels are doubled in people with diabetes.

The global hypertension drugs market is currently valued at around US$38.5 billion. The range of drug classes available to treat high blood pressure contributes to the competitive nature of a market in which there were 12 blockbuster drugs in 2007, with combined sales of US$23.7 billion. In terms of revenue, Pfizer’s Norvasc (amlodipine) was the leading hypertension treatment for several years, up to 2006 when its sales peaked at US$4,866 million. Following expiry of the last US patent, however, sales declined in 2007 to US$3,001 million as multiple generics reached the market following FDA ANDA approvals in September 2007. Novartis’ Diovan/Co-Diovan (valsartan) took over as market leader in 2007, with sales of US$5,012 million, an increase of 18.7% over 2006. Merck & Co’s Cozaar (losartan) ranked second, with sales amounting to US$3,350 million, an increase of 5.9% over 2006.

New fixed-dose combinations aimed at more than one heart disease risk factor are also likely to gain in popularity over the next few years. Patients who suffer from both hypertension and high cholesterol levels have a much greater risk of suffering myocardial infarction or stroke than people who only have one of the conditions.

Current and upcoming products evaluated with 5-year sales forecasts

Aprovel (irbesartan) sanofi-aventis
Diovan (valsartan) Novartis
Cozaar (losartan) Merck & Co
Micardis (telmisartan) Boehringer Ingelheim
Atacand (candesartan cilexetil) AstraZeneca/Takeda
Adalat (nifedipine) Bayer
Accupril (quinapril) Pfizer
Coreg (carvedilol) GSK/Roche
Seloken (metoprolol succinate) AstraZeneca
Cardura (doxazosin) Pfizer
Rasilez (aliskiren) Novartis
Bystolic (nebivolol) Mylan/Forest Labs

Pulmonary Arterial Hypertension

Pulmonary hypertension (PH) is defined by the WHO as a mean pulmonary artery pressure above 25 mmHg. Pulmonary arterial hypertension (PAH) is a rare form of PH.

The patient population for PAH is relatively small; an estimated 160,000 globally. The condition is often not diagnosed until it is quite advanced as early symptoms are often similar to other conditions, such as asthma.

Until recently, treatment options were limited, particularly for patients with more severe PAH. There are, however, a number of new and potential entrants into this market:

Thelin (sitaxsentan), an endothelin receptor antagonist which has been approved for PAH in the EU. In the US, it has been the subject of three approvable letters but a further Phase III trial is required prior to approval;

Letairis/Volibris (ambrisentan), type-A selective endothelin receptor antagonist, approved by the FDA for PAH in June 2007. GSK received a positive opinion from the EMEA's CHMP for ambrisentan in February 2008 with approval anticipated by the end of April;

United Therapeutics is currently conducting Phase III clinical trials of an inhaled form of treprostinil, known as Viveta.

New and current products evaluated with 5-year sales forecasts

Tracleer (bosentan) from Actelion, the current market leader, an orally-active endothelin receptor antagonist which has been available in the US since 2001.

Ventavis (iloprost) from CoTherix, an inhalation solution for the treatment of PAH in patients with NYHA Class III or IV symptoms, launched in March 2005.

Revatio (sildenafil) from Pfizer, approved by the US FDA in June 2005 following a priority review, and by the EMEA in November 2005 for PAH.

Thelin (sitaxsentan), an endothelin receptor antagonist which has been approved for PAH in the EU. In the US, it has been the subject of three approvable letters but a further Phase III trial is required prior to approval.

Letairis/Volibris (ambrisentan), type-A selective endothelin receptor antagonist, approved by the FDA for PAH in June 2007.

Atrial Fibrillation

Atrial fibrillation (AF) is a disorder in the rhythm of the atria which reduces the heart’s ability to effectively pump blood. AF can result in a rapid, irregular heart beat and pulse. In addition, blood which is not completely pumped out of the atria may pool and clot, increasing the risk of stroke. Around 15% of strokes occur in people with AF. According to the American Heart Association, around 2.2 million Americans have AF. The risk of developing AF increases with age; as the population ages, the number of people with this condition is likely to increase. By 2025, the number of people in the US with AF is projected to increase to around 3.8 million and by 2050 it could be as high as 5.6 million, according to a study presented at the 2005 ESC annual congress.

Current treatments for AF include drugs, electrical cardioversion to restore sinus rhythm with an electric shock, radiofrequency ablation to destroy tissue that triggers abnormal electrical signals or to block abnormal electrical pathways, surgery and pacemakers to regulate the rhythm.

Drug treatments include Cordarone (amiodarone), Corvert (ibutilide), Tambocor (flecainide), Rythmol (propafenone), Cardioquine (quinidine), Betapace (sotalol) and Tikosyn (dofetilide). These are limited by modest efficacy or potentially serious side effects, including torsades de pointes. The majority of existing drugs have been on the market for 20 years of more and are available generically. Cost is therefore likely to be an issue for new treatments that reach the market, as well as the need to demonstrate superior efficacy and safety.

New products and approaches evaluated

Espicom has identified nine drugs in development for the treatment of atrial fibrillation and other arrhythmias. Of these, three are in late-stage clinical development:
  • sanofi-aventis’ Multaq (dronedarone)
  • Solvay’s Puzlium IV (tedisamil)
  • Astellas Pharma/Cardiome Pharma’s Kynapid (vernakalant iv)

In addition to Multaq, sanofi-aventis is developing celivarone (SSR149744), a back-up compound to dronedarone with similar electrophysiological effects, currently in Phase IIb trials for atrial fibrillation.

A novel approach to treating and preventing atrial and ventricular arrhythmias, through the modulation of GAP junctions, is rotigaptide (GAP-486; ZP123) which is being co-developed by Wyeth and Zealand Pharma. Rotigaptide increases GAP junction conductance in cardiac myocytes, increasing the heart’s ability to transmit signals between muscle cells to maintain natural rhythm. It is the first stable anti-arrhythmic peptide analogue to be advanced into clinical testing.

Thrombosis

Thrombosis is the general term for the formation of a blood clot in the arteries or the veins that obstructs blood flow.

Venous thrombosis, which is usually treated with anticoagulants, is the third most common cardiovascular disorder in the US, affecting almost two million people each year. The most commonly prescribed low molecular weight heparin in the US and major European markets is sanofi-aventis’ Lovenox/Clexane (enoxaparin), which is derived from porcine unfractionated heparin. In 2007, sales of Lovenox increased by 7.3% to €2.6 billion (US$3.6 billion). Sanofi also developed Fraxiparine (nadroparin), a LMWH produced by nitrous acid degradation of heparin from porcine intestinal mucosa. Fraxiparine was acquired by GlaxoSmithKline (GSK) in 2004 in order to satisfy conditions for Sanofi-Synthélabo’s merger with Aventis. In 2007, sales of Fraxiparine declined by 12.0% to £184 million (US$368 million).

Atherothrombosis is treated with antiplatelet drugs which decrease platelet aggregation. By far the largest selling drug in this category is clopidogrel, marketed by sanofi-aventis and Bristol-Myers Squibb as Plavix and Iscover. Clopidogrel is indicated for the prevention of atherothrombotic events in a broad range of patients and can be used in combination with low dose aspirin. In 2007, global sales of Plvix/Iscover amounted to US$8.1 billion.

Current and future products evaluated

Current therapies assessed

Plavix (clopidogrel) sanofi-aventis/BMS
Lovenox (enoxaparin) sanofi-aventis
ReoPro (abciximab) Eli Lilly
Arixtra (fondaparinux) GSK

New and pipeline products assessed

Pradaxa (dabigatran) Boehringer Ingelheim
Prasugrel (CS747) Daiichi Sankyo/Eli Lilly
Rivaroxaban (BAY 59-7939) Bayer/Johnson & Johnson
Apixaban Pfizer/BMS
M118 Momenta

Unique competitor & product evaluation

A key feature of this report is the unique assessment made of products and companies that evaluates not only their pharmacological profile and clinical benefits, but also assesses their chances of succeeding in the market if they are approved.

For a number of promising new and future drugs, Espicom has provided a competitor ratio analysis, based on our assessment of five criteria:
  • Novelty/rational for mechanism of action;
  • Proof of concept/clinical data;
  • Management/clinical expertise;
  • Competition within the marketplace;
  • Risks associated with drug development in therapeutic class.

Each of these criteria attracts up to ten points, resulting in a maximum score of 50 overall. The drugs are tabulated and ranked by total score for comparative purposes and each is discussed in more detail in the relevant section of the report.
FOREWORD

EXECUTIVE SUMMARY

CARDIOVASCULAR DISEASE

Mortality
Prevention and Treatment
Drugs in the Pipeline
Competitor Ratio Analysis

CHOLESTEROL AND TRIGLYCERIDES

The Cholesterol Management Drugs Market
Statins
NICE Guidance on the use of statins
Lipitor (atorvastatin)
Patents, Generic Competition & Litigation
US
Canada
Austria
Denmark
Finland
Ireland
Norway
Spain
UK
Australia
Andean Pact countries
Sales Forecast
Clinical Trials
SPARCL
Imaging studies: ILLUSTRATE and RADIANCE
Pfizer’s response to the ASTEROID trial
TNT
ASCOT
ASCOT-LLA (Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm)
CARDS
IDEAL – atorvastatin versus simvastatin
Atorvastatin+rosiglitazone in diabetic patients
Lescol (fluvastatin)
Patents & Generic Competition
Sales Forecast
Clinical Trials
ALERT
LIPS
Crestor (rosuvastatin)
Patents, Generic Competition & Litigation
Safety Issues
Patient data demonstrate efficacy of Crestor
Sales Forecast
Clinical Trials
ASTEROID
METEOR
MERCURY II
EXPLORER
Effect of rosuvastatin on C-reactive protein and renal function
Crestor in combination with ezetimibe
LDL-C reductions - Crestor versus Pravachol and Zocor
Zocor (simvastatin)
Generic Competition
Sales Forecast
Clinical Trials
SAFARI - simvastatin+fenofibrate
4S
Heart Protection Study
Other Antihyperlipidaemic Agents
Zetia (ezetimibe)
NICE guidance on ezetimibe
Patents, Generic Competition & Litigation
Sales Forecast
Clinical Trials
EXPLORER
Co-administration of ezetimibe+fenofibrate
EASE
TriCor (fenofibrate)
Patents, Litigation & Generic Competition
Lipofen (fenofibrate)
Fenoglide (fenofibrate)
Sales Forecast
Clinical Trials
TriCor (fenofibrate) & WelChol (colesevelam)
Niaspan (niacin)
Patents & Litigation
Sales Forecast
Clinical Trials
Niaspan combined with aspirin
COMPELL
Combination Products
Vytorin (ezetimibe+simvastatin)
FDA issues early communication regarding ongoing review of Vytorin
Patents
Sales Forecast
Clinical Trials
ENHANCE
IMPROVE-IT
Vytorin versus Lipitor (atorvastatin) in Type II diabetes patients
Combined post hoc analysis of three studies
VYVA
Caduet (amlodipine+atorvastatin)
Patents & Generic Competition
Sales Forecast
Clinical Trials
GEMINI AALA
JEWEL
Recent Approval and Drugs in Development
Simcor
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
SEACOAST
Tredaptive (niacin+laropiprant)
Competitor ratio analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Phase III
Tredaptive co-administered with simvastatin
MK-0524B (simvastatin+niacin+laropiprant)
Competitor ratio analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
MK-0452B versus atorvastatin
MK-0452B versus MK-0452A+simvastatin
TriLipix (ABT-335)
Competitor ratio analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Anacetrapib
Competitor ratio analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Outlook
Clinical Trials
Phase IIb
Phase I
AEGR-733
Competitor ratio analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Outlook
Clinical Trials
Phase II
Homozygous Familial Hypercholesterolaemia

HYPERTENSION

The Hypertension Drugs Market
Angiotensin-II Receptor Blockers
Aprovel (irbesartan)
Patents & Generic Competition
Sales Forecast
Clinical Trials
INCLUSIVE
COSIMA
Diovan/Co-Diovan (valsartan/valsartan+HCTZ)
Patents, Generic Competition & Litigation
Sales Forecast
Clinical Trials
NAVIGATOR
AADVANCE
VALUE
Val-HeFT
Cozaar/Hyzaar (losartan/losartan+HCTZ)
Patents & Generic Competition
Sales Forecast
Clinical Trials
LIFE
ELITE II
Micardis/MicardisPlus (telmisartan/telmisartan+HCTZ)
Patents & Generic Competition
Sales Forecast
Clinical Trials
SURGE-2
PRISMA
ONTARGET/TRANSCEND
PROTECTION
PROTECTION Study Programme - AMADEO
PROTECTION Study Programme - DETAIL
PROTECTION Study Programme - ESPRIT
PROTECTION Study Programme - ATHOS
PROTECTION Study Programme - INNOVATION
Atacand (candesartan cilexetil)
Patents & Generic Competition
Sales Forecast
Clinical Trials
HIJ-CREATE
TROPHY
CHARM
DIRECT
Switching from losartan to candesartan cilexetil: an observational study in the UK
Benicar (olmesartan)
Patents & Generic Competition
Sales Forecast
Clinical Trials
MORE
BEST & Treatment of Stage I and Stage II Hypertension Studies
Dihydropyridine Calcium Channel Blockers
Norvasc (amlodipine)
Patents & Generic Competition
Sales Forecast
Clinical Trials
ASCOT
CAFE
Adalat (nifedipine)
Patents & Generic Competition
Sales Forecast
Clinical Trials
TALENT
ACTION
Zanidip (lercanidipine)
Sales Forecast
ACE Inhibitors
Vasotec (enalapril)
Generic Competition
Sales Forecast
Altace/Delix/Tritace (ramipril)
Combinations
Patents & Generic Competition
Sales Forecast
Clinical Trials
Altace+HCTZ
Beta Blockers
Coreg (carvedilol)
OPTIMIZE-HF
Patents & Generic Competition
Sales Forecast
Clinical Trials
MUCHA
COMET
COPERNICUS
Seloken/Toprol-XL (metoprolol succinate)
Patents & Generic Competition
Sales Forecast
Clinical Trials
POISE
Alpha Adreno-Receptor Antagonists
Cardura (doxazosin)
Sales Forecast
Combination Products
Lotrel (amlodipine+benazepril)
Patents & Generic Competition
Sales Forecast
Clinical Trials
ACCOMPLISH
LOGIC, SHIELD and ALERT
Azor (amlodipine+olmesartan)
Zanipress (lercanidipine+enalapril)
Recent Approvals and Drugs in Development
Rasilez/Tekturna (aliskiren)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
ALLAY
Phase III Results
Phase II Results
Bystolic (nebivolol)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Bystolic in African-American patients with Stage I-II HT
Patients with mild-to-moderate HT
Darusentan
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
DAR-201
Cleviprex (clevidipine)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
VELOCITY
ECLIPSE
Ilepatril
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class

CORONARY ARTERY DISEASE

Genetic variations may increase risk of CAD
Angina
Recent Approvals and Drugs in Development
Crestor: first statin to achieve atherosclerosis regression by QCA in a major clinical trial
Ranexa (ranolazine)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Ranolazine in LQT3
MERLIN TIMI-36
ERICA
CARISA
MARISA
Procoralan (ivabradine)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Procoralan versus amlodipine in patients with stable CAD
BEAUTIFUL
Generx (alferminogene tadenovec, Ad5FGF-4)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
AWARE
AGENT-3, AGENT-4
Experimental Stem Cell Therapy

ATRIAL FIBRILLATION

Current Treatments
Cordarone (amiodarone)
Rythmol (propafenone)
Tambocor (flecainide)
Corvert (ibutilide fumarate)
Tikosyn (dofetilide)
Clinical Trials
DIAMOND
Drugs in Development
Multaq (dronedarone)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
EURIDIS and ADONIS
Pulzium (tedisamil)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Vernakalant (RSD1235)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
ACT 1
ACT 3
Phase IIb study of oral vernakalant

PULMONARY ARTERIAL HYPERTENSION

Tracleer (bosentan)
Sales Forecast
Clinical Trials
COMPASS-1 and EARLY
BUILD Programme
BREATHE-5
Paediatric Study
TRAX PMS
Ventavis (iloprost)
Sales Forecast
Clinical Trials
VISION
STEP
Long-term safety and efficacy
ACTIVE
Revatio (sildenafil)
Sales Forecast
Clinical Trials
Australian Trial in Heart Failure
Thelin (sitaxsentan)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Eisenmenger syndrome – observational data
Long-term treatment
STRIDE-2
STRIDE-2X
STRIDE-4
Letairis/Volibris (ambrisentan)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
ARIES
AMB-222
Viveta (treprostinil)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Treprostinil in AERx Essence delivery system
TRIUMPH-1
Inhaled treprostinil as add-on therapy

THROMBOSIS

The Thrombosis Drugs Market
Lovenox (enoxaparin)
Patents & Generic Competition
Sales Forecast
Clinical Trials
ExTRACT-TIMI 25
STEEPLE
SYNERGY
Arixtra (fondaparinux)
Patents & Generic Competition
Sales Forecasts
Clinical Trials
OASIS- 5
OASIS 6
ARTEMIS
FLEXTRA
PEGASUS
Plavix (clopidogrel)
Patents & Generic Competition
Sales Forecast
Clinical Trials
Individualised loading study
BRAVE-3
CHARISMA
ACTIVE
Recent Approval and Drugs in Development
Pradaxa (dabigatran)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
RE-VOLUTION (RE-MODEL, RE-MOBILIZE and RE-NOVATE)
Prasugrel
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
TRITON-TIMI 38
Early-phase data
Rivaroxaban
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
RECORD2
RECORD3
Phase ll studies
Apixaban
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Sales Forecast
Clinical Trials
Phase II
M118
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
Phase I
Abbreviations

SOURCES

Espicom Sources
Others

LIST OF TABLES

Deaths from Ischaemic Heart Diseases in Selected Markets, 2005
Deaths from Acute Myocardial Infarction in Major Markets, 2005
Deaths from Diseases of the Pulmonary Circulation and Other Forms of Heart Disease, 2005
Leading Cardiovascular Drugs by Sales Value, 2006-2007 (US$ Million)
US Patent Expiry for Major Cardiovascular Drugs
Launched Products in Development
Novel Drugs in Development
Competitor Ratio Analysis Summary
Sales of Leading Cholesterol Management Drugs, 2006-2007 (US$ Million)
Sales of Leading Statins, 2003-2007 (US$ Million)
Lipitor Sales, 2003-2012 (US$ Million)
Lipitor US Patents
Lescol Sales, 2003-2007 (US$ Million)
Lescol US Patents
Crestor Sales, 2003-2007 (US$ Million)
Crestor US Patents
Zocor Sales, 2003-2007 (US$ Million)
Zetia Sales, 2003-2007 (US$ Million)
Zetia US Patents
TriCor Sales, 2003-2007 (EUR & US$ Million)
TriCor US Patents
Niaspan Sales, 2003-2007 (US$ Million)
Niaspan US Patents
Vytorin Sales, 2004-2007 (US$ Million)
Vytorin US Patents
Caduet Sales, 2004-2007 (US$ Million)
Caduet US Patents
Drugs in Development for Hypercholesterolaemia and Dyslipidaemia
Sales of Leading Hypertension Drugs, 2006-2007 (US$ Million)
Aprovel/Avapro/Karvea Sales, 2003-2007 (EUR & US$ Million)
Avapro/Avalide US Patents
Diovan/Co-Diovan Sales, 2003-2007 (US$ Million)
Diovan US Patents
Cozaar/Hyzaar Sales, 2003-2007 (US$ Million)
Cozaar/Hyzaar US Patents
Micardis Sales, 2003-2007 (EUR & US$ Million)
Micardis Sales in Japan, 2003-2007 (¥ & US$ Million)
Micardis US Patents
Atacand Sales, 2003-2007 (US$ Million)
Blopress Sales, 2003-2007 (¥ Billion & US$ Million)
Atacand/Atacand Plus US Patents
Benicar/Olmetec Sales, 2004-2007 (¥ Million & US$ Million)
Benicar US Patents
Norvasc Sales, 2003-2007 (US$ Million)
Amlodin Sales, 2003-2007 (¥ Billion & US$ Million)
Adalat Sales, 2003-2007 (EUR & US$ Million)
Adalat US Patents
Zanidip Sales, 2003-2007 (EUR & US$ Million)
Vasotec/Vaseretic Sales, 2003-2007 (US$ Million)
Altace/Delix/Tritace Sales, 2003-2007 (EUR & US$ Million)
Altace US Patents
Coreg/Dilatrend Sales, 2003-2007 (£/CHF & US$ Million)
Coreg US Patents
Seloken ZOK/Toprol-XL Sales, 2003-2007 (US$ Million)
Cardura Sales, 2003-2007 (US$ Million)
Lotrel Sales, 2003-2007 (US$ Million)
Lotrel US Patents
Drugs in Development for Hypertension
Drugs in Development for Atherosclerosis and Coronary Artery Disease
Drugs in Development for Atrial Fibrillation
Drugs in Development for PAH
Tracleer Sales, 2003-2007 (CHF & US$ Million)
Sales of Leading Anticoagulant & Antiplatelet Drugs, 2006-2007 (US$ Million)
Lovenox/Clexane Sales, 2003-2007 (EUR & US$ Million)
Lovenox US Patents
Arixtra Sales, 2004-2007 (£ & US$ Million)
Plavix/Iscover Sales, 2003-2007 (EUR & US$ Million)
Plavix US Patents
Drugs in Development for Thrombosis
List of Figures
Global Sales of Leading Statins, 2003-2007 (US$ Million)
Lipitor Sales, 2003A-2012E (US$ Million)
Lescol Sales 2003A-2012E (US$ Million)
Crestor Sales, 2003A – 2012E (US$ Million)
Zocor Sales 2003A-2012E (US$ Million)
Zetia Sales 2003A-2012E (US$ Million)
TriCor Sales, 2003A-2012E (US$ Million)
Niaspan Sales, 2003A – 2012E (US$ Million)
Vytorin Sales, 2004A-2012E (US$ Million)
Caduet Sales 2004A-2012E (US$ Million)
Simcor Projected Sales, 2008-2012 (US$ Million)
Tredaptive Projected Sales, 2008-2012 (US$ Million)
MK-0524B Projected Sales, 2009-2013 (US$ Million)
TriLipix Projected Sales, 2010-2013 (US$ Million)
Aprovel/Avapro Sales 2003A-2012E (US$ Million)
Diovan/Co-Diovan Sales 2003A-2012E (US$ Million)
Cozaar/Hyzaar Sales 2003A-2012E (US$ Million)
Micardis Sales, 2003A-2012E (US$ Million)
Atacand Sales, 2003A-2012E (US$ Million)
Blopress Sales, 2003A-2012E (¥ Billion)
Benicar/Olmetec Sales 2003A-2012E (US$ Million)
Norvasc Sales, 2003A–2012E (US$ Million)
Amlodin Sales, 2003A-2012E (¥ Billion)
Adalat Sales 2003A-2012E (US$ Million)
Zanidip Sales 2003A-2012E (US$ Million)
Vasotec/Vaseretic Sales 2003A-2012E (US$ Million)
Altace/Tritace Sales 2003A-2012E (US$ Million)
Coreg Sales, 2003A-2012E (US$ Million)
Seloken/Toprol-XL Sales 2003A-2012E (US$ Million)
Cardura Sales 2003A-2012E (US$ Million)
Lotrel Sales, 2003A-2012E (US$ Million)
Rasilez/Tekturna Projected Sales, 2007-2012 (US$ Million)
Bystolic Projected Sales, 2008-2013 (US$ Million)
Darusentan Projected Sales, 2009-2012 (US$ Million)
Cleviprex Projected Sales, 2008-2013 (US$ Million)
Ranexa Sales 2006A-2012E (US$ Million)
Procoralan Sales, 2006E-2012E (US$ Million)
Multaq Projected Sales, 2009E-2014E (US$ Million)
Pulzium Projected Sales 2008E-2013E (US$ Million)
Kynapid Projected Sales 2008E-2013E (US$ Million)
Tracleer Sales, 2003A-2012E (US$ Million)
Ventavis Sales, 2005A-2012E (US$ Million)
Revatio Sales, 2005A-2012E (US$ Million)
Thelin Sales, 2006A-2012E (US$ Million)
Letairis/Volibris Projected Sales, 2008-2012 (US$ Million)
Lovenox Sales, 2003A-2012E (US$ Million)
Arixtra Sales, 2004A-2012E (US$ Million)
Plavix/Iscover Sales, 2003A-2012E (US$ Million)
Pradaxa Projected Sales, 2008-2013 (US$ Million)
Prasugrel Projected Sales, 2008-2013 (US$ Million)
Rivaroxaban Projected Sales, 2009-2014 (US$ Million)
Apixaban Projected Sales, 2010-2014 (US$ Million)
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