Table of Contents
- About the Disease pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Key metrics
- Anticoagulants
- Antiplatelet Agents
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Antithrombotics segmented by mechanism of action
- Redesigning heparin: the race for ideal coagulation cascade target is
still open
- Antiplatelet agents by drug class
- Antithrombotics segmented by developing company
- Japanese companies in the antithrombotics market
- Key companies involved in the antithrombotics pipeline
- Overview
- AstraZeneca
- Sanofi-Aventis
- CHAPTER 3 PATIENT POTENTIAL
- Definition of antithrombotic market
- Antithrombotic launch indications
- Venous thrombosis
- VTE prophylaxis in patients undergoing major orthopedic surgery
- Treatment and secondary prevention of acute venous thromboembolism
- Arterial thrombosis
- Coronary thrombosis
- Acute coronary syndromes
- Incidence of STEMI
- Incidence of UA and NSTEMI
- Cerebrovascular thrombosis
- Stroke treatment
- Stroke prevention in atrial fibrillation patients (SPAF)
- Peripheral thrombosis
- Peripheral arterial disease (PAD)
- Marketing considerations: unmet needs, barriers to market entry and
uptake
- Anticoagulants
- Unmet needs: parenteral anticoagulants
- Unmet needs: oral anticoagulants
- Unmet need: increased physician awareness of VTE
- Points of consideration: factors influencing market entry and uptake
- Unmet needs summary
- Antiplatelets
- Unmet needs
- Unmet need for rapid onset of action in interventional cardiology
- Unmet need: increased physician awareness for the need of therapy
for PAD
- Points of consideration: factors influencing market entry and uptake
- Unmet needs summary
- CHAPTER 4 R&D APPROACH
- Classification of pipeline products
- Anticoagulants
- Hemostasis and the coagulation cascade
- Indirect thrombin inhibitors
- Unfractionated heparin (UFH)
- Low molecular weight heparin (LMWH)
- Direct thrombin inhibitors (DTIs)
- Factor IXa inhibitors
- Factor Xa inhibitors
- Factor VIIa inhibitors/tissue factor pathway inhibitors
- Anticoagulant activity
- Antiplatelet Agents
- Cyclo-oxygenase (COX) inhibitors: aspirin
- ADP antagonists
- GPIIb/IIIa inhibitors
- PGE-1 antagonists
- PI3-kinase antagonists
- PGH2/TXA2 (TP) receptor antagonists
- Clinical trial design for antithrombotics
- Phase III sample size
- Choice of control drug
- Patient exclusion
- Patient exclusion from efficacy analysis
- Duration of drug intervention
- Pre-operative or post-operative initiation of prophylaxis?
- Dosing interval
- Dose timing
- Clinical trial endpoints for antithrombotics
- Efficacy endpoints
- VTE incidence
- Diagnosis of VTE events
- Central versus local adjudication
- Safety endpoints
- CHAPTER 5 ANTICOAGULANTS LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview of the key anticoagulants in late-stage development
- Pipeline summary
- drug assessment summary
- Comparative forecasts
- Rivaroxaban (BAY-59-7939)
- Drug overview
- Clinical data
- Patient potential
- Marketing factors
- Forecasts to 2016
- Dabigatran etexilate (BIBR-1048) - Rendix
- Drug overview
- Clinical data
- Pharmacokinetics of dabigatran etexilate
- Phase II clinical trial of Dabigatran etexilate in MOS versus
enoxaparin: BISTRO II
- Patient potential
- SPAF - greatest potential for dabigatran etexilate
- Potential device competitor for SPAF indication for high-risk
patients?
- Marketing factors
- Forecast to 2016
- Idraparinux
- Drug overview
- Clinical data
- PERSIST trial
- No significant effect on liver enzymes
- Phase III VAN GOGH trial in PE patients
- Phase III AMADEUS trial
- Patient potential
- Marketing factors
- Strong presence and experience in the AF market
- High price may pose a barrier to uptake
- Lack of antidote raises concerns
- Forecast to 2016
- ART-123
- Drug overview
- Clinical data
- Phase III trials
- Phase I trials
- Prevention of VTE after total hip replacement
- Patient potential
- Marketing factors
- Forecast to 2016
- CHAPTER 6 OTHER ANTICOAGULANTS
- Antithrombin aptamers - NU-172 and ARC1779
- Drug overview
- Preclinical data
- Clinical data
- Apixaban (BMS-562247)
- Drug overview
- Clinical data
- AVE-5026
- Drug overview
- Clinical data
- AZD-0837
- Drug overview
- Clinical data
- AZD-9684
- Drug overview
- Preclinical data
- Biotinylated Idraparinux (SSR-126517)
- Drug overview
- Clinical data
- DU-176b
- Drug overview
- Clinical data
- E-5555
- Drug overview
- Preclinical data
- Clinical data
- Elaprin (Oral heparin) and Oral LMWH
- Drug overview
- Clinical data
- comment
- Flovagatran (TGN-255)
- Drug overview
- Clinical data
- comments
- GSK-813893
- LY-517717
- Drug overview
- Clinical data
- Odiparcil (SB-424323)
- Drug overview
- Clinical data
- Otamixaban (XRP-0673)
- Drug overview
- Clinical data
- PD-348292
- Pegmusirudin (SPP-200; LU-57291)
- Drug overview
- Clinical data
- PRT-54021
- Drug overview
- Clinical data
- REG-1
- Drug overview
- Clinical data
- SCH-530348
- Drug overview
- Preclinical data
- Clinical data
- Sofigatran (MCC-977)
- SR-123781
- Drug overview
- Preclinical data
- Clinical data
- Tanogitran (BIBT-986)
- Drug overview
- Clinical data
- TGN-167
- Drug overview
- Clinical data
- TTP-889
- Drug overview
- Clinical data
- comment
- YM-150
- Drug overview
- Clinical data
- CHAPTER 7 ANTIPLATELET AGENTS: LATE-STAGE ANALYSIS AND FORECASTS
- Overview of the key antiplatelets in late-stage development
- Pipeline summary
- drug assessment summary
- Comparative forecasts
- Prasugrel (CS-747)
- Drug overview
- Clinical data
- Phase IIa: Randomized two-way cross-over, open-label study in
healthy subjects
- Phase IIa : Randomized, partially blind, parallel group dose-ranging
study
- Patient potential
- Marketing factors
- Forecast to 2016
- Cangrelor (AR-C69931)
- Drug overview
- Clinical Data
- Patient potential
- Marketing factors
- Forecast to 2016
- Ticagrelor (AZD-6140)
- Drug overview
- Clinical data
- Patient Potential
- Marketing Factors
- Forecast to 2016
- CHAPTER 8 OTHER ANTIPLATELET AGENTS
- DA-697b
- Drug overview
- Preclinical data
- DG-041
- Drug overview
- Preclinical data
- Clinical data
- Ecraprost
- Drug overview
- Clinical data
- comment
- Liprostin
- Drug overview
- Clinical data
- Parogrelil (NM-702)
- Drug overview
- Clinical data
- PR-15
- Drug overview
- Preclinical data
- Clinical data
- comment
- S-18886
- Drug overview
- Clinical data
- SL-650472
- Drug overview
- Preclinical data
- Clinical data
- BIBLIOGRAPHY
- Epidemiology
- National hospital discharge data
- APPENDIX A
- Methodology
- forecast methodology
- Product forecasts
- Estimated 2006 sales revenue
- Definition of a standard unit (only use if ForeSight model used to
forecast)
- drug assessment summary
- Contributing experts
- APPENDIX B
- About
- Healthcare therapy area capabilities
- About the Disease analysis team
- Key therapy team members
- Disclaimer
- List of Tables
- Table 1: Forecast key pipeline products in Antithrombotics in 2016 ($m)
- Table 2: Anticoagulant agents in the R&D pipeline, 2007
- Table 3: Antiplatelet agents in the R&D pipeline, 2007.
- Table 4: Key players in antithrombotic drug development, 2007
- Table 5: Incidence of arthroplastic knee surgery in the seven major
markets (000s), 2007-2017
- Table 6: Incidence of arthroplastic hip surgery in the seven major
markets (000s), 2007-2017)
- Table 7: Incidence of deep vein thrombosis, pulmonary embolism and
venous thromboembolism in the seven major markets(000s), 2007-2017
- Table 8: Incidence of ST-segment elevation myocardial infarction
(000s), 2007-2017
- Table 9: Incidence of unstable angina and non-ST segment elevation
myocardial infarction in the seven major markets (000s), 2007-2017
- Table 10: Incidence of percutaneous coronary intervention in the seven
major markets (000s), 2007-2017
- Table 11: Incidence of stroke in the seven major markets (000s),
2007-2017
- Table 12: Proportion of atrial fibrillation patients at risk of
developing stroke
- Table 13: Prevalence of chronic atrial fibrillation in the seven major
markets (000s), 2007-2017
- Table 14: Prevalence of peripheral arterial disease in the seven major
markets (000s), 2007-2017
- Table 15: Resistance to key oral antiplatelets
- Table 16: Advantages of direct thrombin inhibitors over heparin
- Table 17: OASIS-5/Michelangelo trial: efficacy
- Table 18: OASIS-5/Michelangelo trial: safety
- Table 19: Key results of CURE substudy
- Table 20: CLARITY/TIMI-28: efficacy outcomes on angiography
- Table 21: CLARITY/TIMI-28: safety outcomes
- Table 22: COMMIT/CCS-2 trial: efficacy endpoints
- Table 23: COMMIT/CCS-2 trial: safety endpoints
- Table 24: COMMIT/CCS-2 trial: time to treatment
- Table 25: COMMIT/CCS-2 trial: thrombolytic background therapy
- Table 26: ARMYDA-2: number of events at 30 days
- Table 27: ARMYDA-2: postprocedural peak biomarker levels
- Table 28: ARMYDA-2: percentage of patients with an elevation of
CKMB/troponin I
- Table 29: ARMYDA-2: number of bleeding events at 30 days
- Table 30: Key efficacy endpoints used in anticoagulant clinical trials
- Table 31: Key safety endpoints used in anticoagulant clinical trials
- Table 32: Key anticoagulants in late-stage development, 2007
- Table 33: Sales forecasts for late-stage anticoagulants in the seven
major markets ($m), 2007-2016
- Table 34: Proportion of AF patients receiving antithrombotic therapy
by level of risk of experiencing stroke
- Table 35: Comparison of fondaparinux with idraparinux
- Table 36: PERSIST trial results
- Table 37: Result of dose-response trial examining ART-123
- Table 38: Key pipeline antiplatelets, 2007
- Table 39: Comparative Sales Forecast for late-stage antiplatelet agents
- Table 40: JUMBO-TIMI 26: number of adverse events
- Table 41: JUMBO-TIMI 26: patient characteristics
- Table 42: JUMBO-TIMI 26: primary endpoint (significant bleeding)
- Table 43: JUMBO-TIMI 26: TIMI major bleeding
- Table 44: JUMBO-TIMI 26: total bleeding episodes (TIMI major/minor and
minimal)
- Table 45: JUMBO-TIMI 26: secondary endpoint (MACE)
- Table 46: JUMBO-TIMI 26: MACE components
- Table 47: drug assessment parameters
- List of Figures
- Figure 1: drug assessment summary of pipeline anticoagulants, ,
2007-2016
- Figure 2: drug assessment summary of pipeline antiplatelets, 2007-2016
- Figure 3: The antithrombotics pipeline by development stage, 2007
- Figure 4: Antithrombotics development pipeline segmented by mechanism
of action, 2007
- Figure 5: Pipeline antithrombotics segmented by developing company,
2007
- Figure 6: Key players in the antithrombotics pipeline with products
segmented by phase of development, 2007
- Figure 7: Overlap of ischemic cardiovascular conditions
- Figure 8: Frequency of disease with symptoms in the three organ
systems and their overlap, from the CAPRIE trial
- Figure 9: Risk of stroke increases with age
- Figure 10: Breakdown of the peripheral arterial disease population by
classification
- Figure 11: The targets of developmental anticoagulants and selected
thrombolytics
- Figure 12: Aspirin inhibits platelet COX-1 irreversibly
- Figure 13: The role of purinergic receptors as targets for
antiplatelets
- Figure 14: GPIIb/IIIa receptor antagonists act directly on the receptor
- Figure 15: CLARITY/TIMI-28: study design
- Figure 16: COMMIT/CCS-2 trial: dual antiplatelet therapy in acute
myocardial infarction
- Figure 17: ARMYDA-2: trial design
- Figure 18: drug assessment summary of pipeline anticoagulants,
2007-2016
- Figure 19: Comparative sales forecast for late-stage anticoagulants in
the seven major markets, 2007-2016
- Figure 20: projected sales for rivaroxaban (BAY-59-7939) in across the
seven major markets ($m), 2007-2016
- Figure 21: projected sales for Rendix (dabigatran etexilate,
BIBR-1048) in across the seven major markets ($m), 2007-2016.
- Figure 22: PERSIST trial design
- Figure 23: Idraparinux Phase III program: VAN GOGH
- Figure 24: Idraparinux Phase III program: AMADEUS
- Figure 25: Is recombinant factor VIIa a valid antidote to idraparinux?
- Figure 26: projected sales for idraparinux in across the seven major
markets ($m), 2007-2016
- Figure 27: projected sales for ART-123 in across the seven major
markets ($m), 2007-2016
- Figure 28: drug assessment summary of pipeline antiplatelet agents,
2007-2016
- Figure 29: Comparative sales forecast for late-stage antiplatelet
agents
- Figure 30: JUMBO-TIMI 26: prasugrel in the setting of percutaneous
coronary intervention
- Figure 31: TRITON-TIMI-38: trial design
- Figure 32: projected sales for prasugrel in across the seven major
markets ($m), 2007-2016
- Figure 33: projected sales for cangrelor in across the seven major
markets ($m), 2007-2016
- Figure 34: Ticagrelor (AZD-6140) is a potent inhibitor of platelet
aggregation
- Figure 35: projected sales for ticagrelor in across the seven major
markets ($m), 2007-2016
- Figure 36: drug assessment summary of pipeline molecular targeted
therapies in development for hematological malignancies, 2007
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