Bayer Looks to Expand Xarelto Label (revised)

Bayer (BAYRY - Analyst Report) and partner Janssen Research and Development (JRD) are seeking approval to market their co-developed blood thinner, Xarelto, to reduce the risk of cardiovascular events in patients suffering from acute coronary syndrome (ACS). JRD, which holds the U.S. rights to the drug, filed an sNDA with the U.S. Food and Drug Administration (FDA) last week.

In addition, Bayer HealthCare submitted for EU marketing authorization for the same indication, secondary prevention after an acute coronary syndrome. Bayer develops the drug outside of the U.S.

ACS refers to a heart disease, which results in the blockage of a coronary artery via a blood clot. The disease, which reduces the supply of blood to the heart, is one of the leading causes of death in the US. Bayer has co-developed Xarelto with Johnson & Johnson (JNJ - Analyst Report).

Bayer is seeking FDA approval of Xarelto for the indication on the basis of 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. Moreover, there was a more than 30% reduction in the rate of cardiovascular death and the occurrence of all-cause mortality in the Xarelto arm. Bayer is also seeking approval for Xarelto in Europe for the indication.

This development comes close on the heels of the European approval of Xarelto for stroke prevention in atrial fibrillation (SPAF) and the treatment of deep vein thrombosis (DVT). While atrial fibrillation refers to a common form of cardiac rhythm disorder, DVT refers to the obstruction of a blood vessel courtesy a blood clot. The drug was approved for the indications in the EU in December 2011.

Xarelto has also been approved for a few indications in the US last year. In November 2011, the FDA cleared Xarelto for the lucrative SPAF indication. Furthermore, in July, the FDA cleared the drug for the prevention of DVT , which may cause pulmonary embolism in patients undergoing knee or hip replacement surgery. Consequently, if Xarelto is cleared for the additional indication - reduction of cardiovascular events following ACS – then the sales potential of the drug would be boosted further.

Our Recommendation

Currently, we have a long-term Neutral recommendation on Bayer, which is in line with the Zacks #3 Rank (Hold rating) carried by the stock in the short run. Our stance is similar on Johnson & Johnson.

(We are reissuing this article to correct a mistake. The original article, issued earlier today, is no longer to be relied upon.)

Read the full analyst report on BAYRY

Read the full analyst report on JNJ