Late-stage anti-coagulant data from BMS / Pfizer's apixaban and Bayer / Johnson & Johnson's Xarelto will be presented at this year's European Society of Cardiology (ESC) Congress. These data should shed more light on how the products will be adopted by this highly lucrative market.
The anti-coagulant market is becoming increasingly competitive. We expect three products to dominate this space through 2016, Boehringer Ingelheim's Pradaxa, Bayer / Johnson & Johnson's Xarelto, and BMS / Pfizer's apixaban, all of which we forecast to clear annual sales of $2B by 2015. Gaining a label for the treatment to prevent stroke in patients with atrial fibrillation (AF) holds the largest commercial opportunity for these anti-coagulants. Pradaxa, Xarelto, and apixaban are at different stages of development, offer different attributes, and we expect them to fight to take market share from each other. Data on apixaban and Xarelto will be presented at the Congress that should shed more light on how the products will be adopted by the market.
BMS / Pfizer will present data from the AVERROES trial, which investigated the use of apixaban to prevent stroke in patients with AF who had failed or were unsuitable for warfarin treatment. In addition to a low renal clearance, positive data from this trial will provide apixaban with a further differentiating factor; it is the only anti-coagulant to be studied in this specific population. In AF, apixaban is also being studied in the ARISTOTLE trial (due to complete in April 2011) where warfarin is the comparator. AF data for Xarelto from the Phase III ROCKET AF trial is expected to be presented at the American Heart Association (AHA) conference in November. Boehringer Ingelheim presented AF data (the RE-LY trial) for Pradaxa at last year's ESC congress.
Bayer / Johnson & Johnson will report data from Xarelto's Phase III EINSTEIN DVT trial. This study evaluated Xarelto treatment in patients with established deep vein thrombosis (DVT) but without symptoms of pulmonary embolism (PE). As well forming the basis for a regulatory submission in this indication, data from the EINSTEIN DVT trial should confirm the drug's long term safety profile and support a US label for the shorter-term VTE primary prophylaxis indication. We believe the FDA did not approve Xarelto for VTE primary prophylaxis on the basis of safety concerns; Xarelto was launched in the EU for this indication in 2008. The potential for long term Xarelto use in the DVT treatment setting will significantly add to the agent's commercial potential, although we note that the drug's anticipated approval for stroke prevention in AF holds the greater sales opportunity.