) and partner,
Johnson & Johnson
) Janssen Research and Development unit recently received some
encouraging news with the European Commission (EC) clearing their
blood thinner Xarelto in the EU for an additional indication.
The clearance from the EC will allow the HealthCare unit of Bayer
to market Xarelto in the EU for the treatment of pulmonary
embolism (PE) and prevent recurrent deep vein thrombosis (DVT)
and PE in adults. We note that thrombosis refers to the formation
of a blood clot inside a blood vessel, thereby blocking a vein
(venous thrombosis) or artery (arterial thrombosis).
Following the approval, Xarelto became the first novel oral
anticoagulant to be cleared in the EU for the indication.
Approval was based on data from a global phase III study
(EINSTEIN-PE: n=4,833). Bayer stated in its press release that
Xarelto is approved for the indication in more than 20 countries
We are encouraged by Bayer/Johnson & Johnson's label
expansion efforts for Xarelto, which is already approved for
multiple indications, including the lucrative stroke prevention
in nonvalvular atrial fibrillation (SPAF) indication. Successful
label expansion should boost the sales potential of the drug.
We remind investors that earlier in the month, Bayer announced
the US approval of Xarelto for treating DVT, PE and reducing the
risk of recurrent DVT and PE. The US Food and Drug Administration
(FDA) reviewed the marketing application, filed in May 2012, for
Xarelto for the indication on a priority basis. Applications for
priority review designated drugs are reviewed by the FDA within
six months of submission as against the usual ten months.
We have an Outperform recommendation on Bayer. The stock carries
a Zacks #2 Rank (Buy rating) in the short run. We have a Neutral
recommendation on Johnson & Johnson. The stock carries a
Zacks #3 Rank (Hold rating) in the short run.
BAYER A G -ADR (BAYRY): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
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