Edoxaban - Potential Game changer in oral anticoagulant market
1. EXECUTIVE SUMMARY
Market Model for Stroke Prevention in Atrial Fibrillation and DVT
Treatment
Why is Edoxaban a potential Mega Blockbuster
Edoxaban –Market potential
Indication wise
Geography wise
Compared to other oral next generation anticoagulants
Our view on key upcoming Milestones For Edoxaban and Factor Xa class
Estimated launch timelines for new generation anticoagulants–Indication wise/Geographywise
2. EDOXABAN IN SPAF
Background information on Edoxaban (Lixiana)
Edoxaban PK/PD data comparision to other novel oral anticoagulant
Expectations from ENGAGE AF study
ENGAGE AF Clinical trial design comparison to other Clinical trial designs
Analysis of chronology of events happened in completion of ENGAGE AF
Analysis of the reported clinical trial results of Edoxaban
PhII data in Japanese Patient pool
PhII data in Global Patient Pool
PhII data in Taiwan patient pool
Japan- PhII/III clinical data comparision of Edoxaban with other oral anticoagulants
Relative clinical profile and Positioning of Edoxaban compared to Xarelto, Eliquis and Pradaxa in different geographies
3. EDOXABAN MARKET POSITIONING IN SPAF, MARKET MODEL AND PEAK SALES
Estimates based on:
Switch From Warfarin
Warfarin continues to hold itself strong against Pradaxa and
Xarelto– Will the entry of Eliquis / Edoxaban change the scenario?
Switch from Aspirin
Switch/Addition to those on dual antiplatelets
Geographywise clinical data difference and different clinical practise
results in different market leader/market share
Risk to our market share Forecast
4. FACTORS THAT WILL RESTRICT ADOPTION OF NEW GENERATION ORAL
Anticoagulants post launch
Experts view on the hurdles to the adoption of new generation anticoagulants in SPAF at ESC-12
Concomitant Medicines- Donut hole and drug-drug interaction
Availability of antidote for novel oral anticoagulants
Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
Reimbursement status of PT/INR monitoring for warfarin in major countries
Warfarin Genotype testing, its regulatory approval and its reimbursement
5. EDOXABAN IN VTE TREATMENT
Market potential
Treatment duration
Geographywise Prevalence
Edoxaban Clinical Profile compared to Other Factor Xa inhibitor in VTE treatment
Results from PhII BOTTICELI study of Eliquis
Expected data from HOKUSAI VTE study
Pros and Cons of Edoxaban market potential in VTE treatment
ANNEXURE - 1: ANALYSIS OF THE REPORTED PIVOTAL CLINICAL STUDY RESULTS OF NEXT GENERATION ORAL ANTICOAGULANTS (PRADAXA, ELIQUIS, AND XARELTO) IN SPAF
Efficacy and Safety comparision of ROCKET AF, RELY ARISTOTLE AND AVERROES
ROCKET AF, ARISTOTLE & RELY - Cross Trial Comparison Based On CHADS2 Score
ROCKET AF, ARISTOTLE , AVERROES & RELY – Efficacy and Safety comparison – subgroup analysis
GEOGRAPHYWISE NET CLINICAL BENEFIT COMPARISON- Eliquis, Xarelto, Paradaxa
ANNEXURE - 2 ANALYSIS OF THE REPORTED CLINICAL DATA IN VTE TREATMENT
Prolongation of VTE treatment Duration with Xarelto and Pradaxa
Clinical data comparison of Xarelto, Eliquis and Paradaxa in VTE treatment
Market Model for Stroke Prevention in Atrial Fibrillation and DVT
Treatment
Why is Edoxaban a potential Mega Blockbuster
Edoxaban –Market potential
Indication wise
Geography wise
Compared to other oral next generation anticoagulants
Our view on key upcoming Milestones For Edoxaban and Factor Xa class
Estimated launch timelines for new generation anticoagulants–Indication wise/Geographywise
2. EDOXABAN IN SPAF
Background information on Edoxaban (Lixiana)
Edoxaban PK/PD data comparision to other novel oral anticoagulant
Expectations from ENGAGE AF study
ENGAGE AF Clinical trial design comparison to other Clinical trial designs
Analysis of chronology of events happened in completion of ENGAGE AF
Analysis of the reported clinical trial results of Edoxaban
PhII data in Japanese Patient pool
PhII data in Global Patient Pool
PhII data in Taiwan patient pool
Japan- PhII/III clinical data comparision of Edoxaban with other oral anticoagulants
Relative clinical profile and Positioning of Edoxaban compared to Xarelto, Eliquis and Pradaxa in different geographies
3. EDOXABAN MARKET POSITIONING IN SPAF, MARKET MODEL AND PEAK SALES
Estimates based on:
Switch From Warfarin
Warfarin continues to hold itself strong against Pradaxa and
Xarelto– Will the entry of Eliquis / Edoxaban change the scenario?
Switch from Aspirin
Switch/Addition to those on dual antiplatelets
Geographywise clinical data difference and different clinical practise
results in different market leader/market share
Risk to our market share Forecast
4. FACTORS THAT WILL RESTRICT ADOPTION OF NEW GENERATION ORAL
Anticoagulants post launch
Experts view on the hurdles to the adoption of new generation anticoagulants in SPAF at ESC-12
Concomitant Medicines- Donut hole and drug-drug interaction
Availability of antidote for novel oral anticoagulants
Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
Reimbursement status of PT/INR monitoring for warfarin in major countries
Warfarin Genotype testing, its regulatory approval and its reimbursement
5. EDOXABAN IN VTE TREATMENT
Market potential
Treatment duration
Geographywise Prevalence
Edoxaban Clinical Profile compared to Other Factor Xa inhibitor in VTE treatment
Results from PhII BOTTICELI study of Eliquis
Expected data from HOKUSAI VTE study
Pros and Cons of Edoxaban market potential in VTE treatment
ANNEXURE - 1: ANALYSIS OF THE REPORTED PIVOTAL CLINICAL STUDY RESULTS OF NEXT GENERATION ORAL ANTICOAGULANTS (PRADAXA, ELIQUIS, AND XARELTO) IN SPAF
Efficacy and Safety comparision of ROCKET AF, RELY ARISTOTLE AND AVERROES
ROCKET AF, ARISTOTLE & RELY - Cross Trial Comparison Based On CHADS2 Score
ROCKET AF, ARISTOTLE , AVERROES & RELY – Efficacy and Safety comparison – subgroup analysis
GEOGRAPHYWISE NET CLINICAL BENEFIT COMPARISON- Eliquis, Xarelto, Paradaxa
ANNEXURE - 2 ANALYSIS OF THE REPORTED CLINICAL DATA IN VTE TREATMENT
Prolongation of VTE treatment Duration with Xarelto and Pradaxa
Clinical data comparison of Xarelto, Eliquis and Paradaxa in VTE treatment
