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Cardiovascular Drug Discoveries 2008
Espicom Business Intelligence Ltd, April 2008, Pages: 314
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)
INESS INTELLIGENCE
April 2008 iii
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 50
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
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 4
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
Clinical Trials
Individualised loading study BRAVE-3 7
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
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) 4
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).. 174
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) 7
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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