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Stroke Prevention in Atrial Fibrillation represents the largest opportunity for the new generation oral anticoagulants, besides a very large prevalence, there is a very clear unmet need. There are 1.7 million patients in the US treated for non-valvular atrial Fibrillation with warfarin, in Europe the prevalence is almost twice and in Japan there are close to million patients. 

About 35% of the AF patients are currently not treated with warfarin because of warfarin related constraints (drug-drug /dietary interactions, difficulty in INR control). Hypothetically assuming a 100% market share shift from warfarin/aspirin/other therapies to new generation oral anticoagulants, the annual market size works out to be $22b (at $3000 as annual cost of therapy). Besides the new generation oral anticoagulants, there is also the watchman device (currently in Phase 3) from Boston Scientific, which as well could be a major contender of market share. 

The recent complete response issued by the USFDA to Eliquis was very much unexpected and has added uncertainty to the forecasts around this class. We see Daiichi Sankyo's Edoxaban and Boston Scientific's watchman device as potentially underestimated threat in the consensus forecasts for the new generation oral anticoagulants. 

This report also has a market model for the new generation oral anti coagulants. The market model has been categorized into three segments 

1) Warfarin Treated Patients 

2) Aspirin Treated Patients 

3) Patients on Dual Anti-platelet therapy / Patients on no therapy. A market model for each of these market segments has been separately prepared for the major geographies (Japan, EU and US). 

The relative market share of new generation coagulants has been assigned based on

1) A thorough / detailed assessment of the pros and cons of Edoxaban success in ENGAGE AF and its expected clinical profile

2) A thorough / detailed assessment of the pros and cons of Watchman Device Success in ongoing PREVAIL trial and its expected clinical profile

3) Relative merits and demerits of the newer treatment options

4) Existing market dynamics with regard to patient's / physician propensity to switch to new generation oral anticoagulants

5) Availability of Antidotes 
 


Date: 31 Aug 2012 | Type: Therapeutic Class Overviews - TC12101001
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WILL WARFARIN CONTINUE AS A MAINSTAY TREATMENT IN THE ERA OF NEXT GENERATION ORAL ANTICOAGULANTS

Pradaxa: With first mover advantage, Will it be the Leader in SPAF?

Xarelto: Is it the future mainstay anticoagulant therapy?      

Eliquis and Edoxaban: Would they be able to differentiate enough?

In the coming months, there are major regulatory and clinical milestones with regard to the new generation of oral anticoagulants (Pradaxa, Xarelto, Eliquis and Edoxaban), which will have wide ranging impact on the treatment paradigm in several therapeutic areas encompassing - stroke prevention in atrial fibrillation / DVT Treatment / VTE prevention in medically ill patients and Acute coronary syndrome.

This therapy class report analyses the practical issues in the adoption of new generation anticoagulants, major upcoming milestones, clinical trial design/data and cost-effectiveness of recently launched and upcoming molecules. This report will provide insightful information about the performance of molecules in oral anticoagulation arena in all the indications (SPAF, VTE, ACS) and the way these newer drugs will be positioned to garner the benefits against Aspirin/Warfarin/Lovenox are discussed.


Date: 27 Aug 2011 | Type: Therapeutic Class Overviews - TC11083101
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Xarelto 10mg/once daily is the first among the oral anticoagulants to win a USFDA approval for prevention of DVT (Deep Vein Thrombosis) in patients following hip or knee surgery.  Earlier Pradaxa has failed to get an approval as it failed to show net clinical benefit over Lovenox.  VTE prevention post orthopedic surgery is a small market~ $500m and despite entry of Lovenox generics, we anticipate Xarelto should be able to carve a decent share (~ 50%), driven by the robust efficacy demonstrated in clinical trials. Both Eliquis and Pradaxa have failed to show net clinical benefit over Lovenox US regimen in clinical trials for VTE prevention.


Date: 13 Jul 2011 | Type: Essentials - ME11071301
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EINSTEIN-DVT study (n=3400, up to 12 months) - exploring once daily pill Xarelto (rivaroxaban, UR, BAY/JNJ) in DVT treatment has met both the primary endpoint and secondary endpoint. The results are in line with our expectation as discussed in our report “Next generation oral anticoagulants- An eventful 2H-2010” - dated 1st June 2010. Positive data from EINSTEIN-DVT practically clears safety related concerns associated with Xarelto and increases the probability of a successful outcome from ROCKET AF study. Detailed data will be discussed at the European Society of Cardiology - ESC on August 31st. AVERROES trial, which compares BMY/PFE apixaban with aspirin in patients not eligible/willing to take warfarin, will also be discussed at ESC, but the study may not hold much relevance if Xarelto is able to demonstrate superiority over warfarin in the ROCKET AF trials. ROCKET AF trial will report data in 4Q-2010 We are highly optimistic about a positive outcome from ROCKET AF study and believe apixaban would fail to compare with Xarelto’s efficacy while compliance (apixaban twice daily vs. Xarelto once daily) would further let it down in the competitive landscape. In the EINSTEIN-DVT study, Xarelto has demonstrated an overall relative risk reduction compared to current standard of care (Lovenox followed by warfarin) in the treatment of DVT and has shown superiority to standard of care in delivering net clinical benefit. The secondary endpoint of the study was reduction in clinically relevant bleeding and reduction in deaths and vascular events. The safety was in line with what has been observed in previous studies
Date: 05 Aug 2010 | Type: Deep Dive - MMM10111705
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