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Published by: Datamonitor
Published: Apr. 9, 2007 - 257 Pages
Table of Contents
ABOUT DATAMONITOR HEALTHCARE
About the Disease pharmaceutical analysis team CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis Datamonitor insight into the antithrombotics market Key metrics Datamonitor pipeline assessment summary 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 Datamonitor 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 Datamonitor comment Flovagatran (TGN-255) Drug overview Clinical data Datamonitor 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 Datamonitor 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 Datamonitor 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 Datamonitor comment Liprostin Drug overview Clinical data Parogrelil (NM-702) Drug overview Clinical data PR-15 Drug overview Preclinical data Clinical data Datamonitor comment S-18886 Drug overview Clinical data SL-650472 Drug overview Preclinical data Clinical data BIBLIOGRAPHY Epidemiology National hospital discharge data
APPENDIX A
Methodology Datamonitor forecast methodology Product forecasts Estimated 2006 sales revenue Definition of a standard unit (only use if ForeSight model used to forecast) Datamonitor drug assessment summary Contributing experts
APPENDIX B
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare's 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: Datamonitor drug assessment parameters
List of Figures
Figure 1: Datamonitor drug assessment summary of pipeline anticoagulants, , 2007-2016
Figure 2: Datamonitor 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: Datamonitor 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: Datamonitor's projected sales for rivaroxaban (BAY-59-7939) in across the seven major markets ($m), 2007-2016
Figure 21: Datamonitor's projected sales for Rendix (dabigatran etexilate, BIBR-1048) in across the seven major markets ($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: Datamonitor's projected sales for idraparinux in across the seven major markets ($m), 2007-2016
Figure 27: Datamonitor's projected sales for ART-123 in across the seven major markets ($m), 2007-2016
Figure 28: Datamonitor 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: Datamonitor's projected sales for prasugrel in across the seven major markets ($m), 2007-2016
Figure 33: Datamonitor's projected sales for cangrelor in across the seven major markets ($m), 2007-2016
Figure 34: Ticagrelor (AZD-6140) is a potent inhibitor of platelet aggregation
Figure 35: Datamonitor's projected sales for ticagrelor in across the seven major markets ($m), 2007-2016
Figure 36: Datamonitor drug assessment summary of pipeline molecular targeted therapies in development for hematological malignancies, 2007
AbstractIntroduction
Novel oral anticoagulants and antiplatelet agents will have a profound impact on the antithrombotics market. Datamonitor expects Bayer's rivaroxaban and Sankyo/Eli Lilly's prasugrel to achieve blockbuster status. Parenteral anticoagulants are not expected to be large revenue generators, due to low clinical unmet need in this market segment and strong competition from current gold standard agents.
Scope
Event-driven sales projections for 2007-16 for key late-stage developmental antithrombotics in the seven major markets Commercial analysis of late-stage developmental compounds in terms of their ability to satisfy unmet clinical needs An overview of the antithrombotics R&D pipeline with a comprehensive assessment of all classes in development Analysis of the potential for developmental antithrombotics with respect to the patient populations for which they are indicated
Highlights
Following the abrupt withdrawal of AstraZeneca's Exanta in February 2006, Bayer Healthcare's rivaroxaban and Boehringer Ingelheim's Rendix are well positioned to profit from patients switching from warfarin, and market growth obtained by recruiting the previously untreated population. The highest selling brands in the antidiabetics market are Lovenox (enoxaparin) and Plavix (clopidogrel), but these agents will be genericized within our forecast period. Consequently, pipeline agents are expected to become significant drivers in the market. Acute Coronary Syndrome is usually the first indication for which novel anticoagulants are approved; this is a quick route to market, while drug companies then prepare to launch their products in more lucrative, chronic treatment markets.
Reasons to Purchase
Understand the factors that will drive the success of next-generation antithrombotics Overcome the barriers to entry generated by lifecycle strategies of key players in the market Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs
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