) HealthCare segment recently received encouraging news when the
European Commission approved its oral anticoagulant Xarelto
(rivaroxaban) in combination with standard antiplatelet therapy.
The combination is approved for the prevention of
atherothrombotic events (myocardial infarction, cardiovascular
death or stroke) after an acute coronary syndrome (ACS) in adults
having elevated cardiac biomarkers.
Bayer mentioned in its press release that with the approval,
Xarelto became the only novel oral anticoagulant to be approved
for the prevention of elevated cardiac biomarkers after an ACS
The approval does not surprise us as in Mar 2013, the European
Committee for Medicinal Products for Human Use (CHMP) gave a
positive recommendation on Xarelto's approval in this
Xarelto's approval was based on positive results from the
phase III ATLAS ACS 2-TIMI 51 study (n>15,500). Results from
the study showed that the risk of cardiovascular death,
myocardial infarction or stroke in patients after an ACS was
lower in patients in the Xarelto arm compared to those who
received standard antiplatelet therapy alone.
Xarelto is marketed by
Johnson & Johnson
) in the US and by Bayer outside the US.
We note that Xarelto is already approved for several
indications in the US including stroke prevention in nonvalvular
atrial fibrillation, deep vein thrombosis (DVT), pulmonary
embolism (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.
We remind investors that earlier in the year, Bayer and
Johnson & Johnson received a huge setback from the US Food
and Drug Administration (FDA) when it 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
Bayer presently carries a Zacks Rank #3 (Hold). Meanwhile,
other stocks such as
Jazz Pharmaceuticals Public Ltd
Alexion Pharmaceuticals Inc.
) currently look more attractive. While Jazz Pharma carries a
Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2
ALEXION PHARMA (ALXN): Free Stock Analysis
BAYER A G -ADR (BAYRY): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
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