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Data from Bayer/JNJ's Xarelto Study

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Bayer’s (BAYRY) HealthCare segment recently announced that it will present data from a Xarelto clinical program at the XXIVth Congress of the International Society on Thrombosis and Haemostasis soon.

Xarelto is marketed by Johnson & Johnson (JNJ) in the US and by Bayer outside the US.

Data will be presented from the pivotal EINSTEIN program which consists of three phase III studies on Xarelto in comparison to the dual-drug regimen of low molecular weight heparin (:LMWH) and vitamin K antagonist (:VKA) in patients suffering from deep vein thrombosis (:DVT) and pulmonary embolism (:PE) and the prevention of recurrent DVT and PE. Bayer and Johnson & Johnson enrolled over 100,000 patients for the program around the world.

Results from the studies confirmed the effectiveness of Xarelto as a monotherapy for the treatment of DVT and PE. Results further revealed that Xarelto had a lower rate and severity of major bleeding in comparison to dual-drug therapy of LMWH and VKA. Xarelto was also found to be more cost-effective compared to dual-drug therapy for treating PE and for the secondary prevention of venous blood clots.

We note that Xarelto is already approved for several indications in the US including stroke prevention in nonvalvular atrial fibrillation, DVT, PE and reducing the risk of recurrent DVT and PE. In the first quarter of 2013, Xarelto sales increased 269% year over year to €155 million.

Bayer and Johnson & Johnson are looking to expand Xarelto’s indication further. Successful label expansion will boost the sales potential of the drug.

However, earlier in the year, Bayer and Johnson & Johnson received a huge setback when the US Food and Drug Administration (:FDA) issued a second complete response letter for the supplemental New Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for the reduction of the risk of secondary cardiovascular events in patients suffering from acute coronary syndrome.

Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile, other stocks such as Jazz Pharmaceuticals Public Ltd (JAZZ) and Novo Nordisk (NVO) currently look more attractive. While Jazz Pharma carries a Zacks Rank #1 (Strong Buy), Novo Nordisk carries a Zacks Rank #2 (Buy).

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