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Bayer’s (BAYRY - Analyst Report) HealthCare segment and partner Johnson & Johnson (JNJ - Analyst Report) recently received a huge setback from the US Food and Drug Administration (FDA) when the regulatory body issued a complete response letter (CRL) to the supplemental New Drug Application (sNDA) of Xarelto.

The companies are looking to get Xarelto approved for the reduction of risk of stent thrombosis in patients suffering from acute coronary syndrome (ACS). Bayer now intends to work with Johnson & Johnson on the issues raised in the CRL.

Bayer/Johnson & Johnson’s sNDA submission was based on encouraging data from a global late-stage study (ATLAS ACS 2-TIMI 51). Results from the study revealed that there was a significant reduction in cardiovascular events in patients treated with a combination of Xarelto (2.5 mg twice daily) and standard antiplatelet therapy versus those treated only with standard antiplatelet therapy.

We note that Bayer/Johnson & Johnson are no strangers to setbacks regarding the ACS indication in the US. In Mar 2013, the companies received a second CRL from the FDA for Xarelto’s (2.5 mg twice daily) sNDA submission for the reduction of the risk of secondary cardiovascular events in patients suffering from ACS. The initial CRL for this indication was issued in Jun 2012, after which Bayer and Johnson & Johnson had resubmitted the sNDA for blood-thinner Xarelto in Sep 2012.

Xarelto is however approved for several indications in the US including stroke prevention in nonvalvular atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE) and reduction of the risk of recurrent DVT and PE.

Meanwhile, in May this year, Xarelto was approved in the EU for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an ACS in adults suffering from elevated cardiac biomarkers at a dose of 2.5 mg twice-daily (BID) in combination with antiplatelet therapy.

In the first quarter of 2013, Xarelto sales increased 269% year over year to €155 million. We note that Xarelto is marketed by Johnson & Johnson in the US and by Bayer outside the US.

Bayer, a large-cap pharma company, presently carries a Zacks Rank #4 (Sell). Meanwhile, other large-cap stocks such as Novo Nordisk (NVO - Analyst Report) currently look more attractive with a Zacks Rank #2 (Buy). Other pharma stocks such as Jazz Pharmaceuticals (JAZZ - Analyst Report) carry a Zacks Rank #1 (Strong Buy).

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