[Report] Antithrombotics Market Research, Trends, Analysis TOC

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
  - Drug overview
- LY-517717
  - Drug overview
  - Clinical data
- Odiparcil (SB-424323)
  - Drug overview
  - Clinical data
- Otamixaban (XRP-0673)
  - Drug overview
  - Clinical data
- PD-348292
  - Drug overview
- 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)
  - Drug overview
- 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
  - About Healthcare
- 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

Pipeline Insight: Antithrombotics - Reaching the untreated prophylaxis market

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