) HealthCare segment and partner
Johnson & Johnson
) 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.
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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
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
) currently look more attractive with a Zacks Rank #2 (Buy).
Other pharma stocks such as
) carry a Zacks Rank #1 (Strong Buy).