Bayer Seeks Approval for Xarelto - Analyst Blog

Recently, Germany's Bayer (BAYRY) filed an application with the European Medicines Agency (EMA), seeking approval from the European regulatory body to market  its blood thinner Xarelto (rivaroxaban) in Europe. Clearance has been sought to market the drug, co-developed with Johnson & Johnson (JNJ), for preventing stroke in patients with an erratic heartbeat. This cardiac rhythm disorder is referred to as atrial fibrillation (AF). European approval has also been sought to market Xarelto to treat patients suffering from deep vein thrombosis (DVT), and for the prevention of recurrent DVT and pulmonary embolism (PE).

Clearance to market Xarelto in Europe for preventing stroke in AF patients has been sought on the basis of the pivotal, double-blind, late-stage study (n=14,264), data from whom were presented at the annual meeting of the American Heart Association late last year.

The randomized, double-blind study, known as ROCKET-AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation), revealed that treatment with Xarelto was more effective than warfarin (the current standard of care) for the prevention of stroke and embolism in AF patients. Data from the study also demonstrated that treatment with Xarelto did not increase bleeding compared to the standard therapy.

European clearance for Xarelto for the other indications was sought based on results from other late-studies which demonstrated the benefit of Bayer's blood thinner.

Apart from seeking European approval, clearance from the US Food and Drug Administration (FDA) has also been sought to market Xarelto for preventing stroke and systemic embolism in non-valvular AF patients in the US. The US approval, like the European approval, was sought on the basis of data from the ROCKET-AF study. On approval, Johnson & Johnson will market the drug in the US.  Bayer is exclusively responsible for the marketing of Xarelto in countries outside the US.

We believe that Xarelto's approval in Europe and the US would be a major boost to Bayer's top line since the candidate offers multi-billion dollar sales potential.

However, Xarelto would face intense competition in the anti-coagulant market.  We note that Bristol-Myers (BMY)/Pfizer (PFE) are making rapid strides with the development of their late-stage candidate apixaban for the same indication as targeted by Xarelto. Moreover, the FDA's approval of Boehringer Ingelheim's Pradaxa (approved on October 19, 2010) has intensified competition in the market.

We upgraded Bayer to 'Outperform' based on its strong third quarter 2010 results and the positive outlook maintained by the company.

 

 

 
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