Investors in the pharma/biotech sector eagerly wait for
pipeline updates as they play an important role in deciding
whether or not to invest in a particular company. Pipelines are
of prime importance as far as pharma/biotech companies are
concerned. These companies spend a significant amount in
advancing their pipelines.
The HealthCare segment at
) and partner,
Johnson & Johnson
) received yet another setback from the U.S. Food and Drug
Administration (FDA) regarding Xarelto.
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The FDA issued complete response letters (CRLs) in response to
the supplemental New Drug Applications (sNDA) submitted by the
companies seeking approval of Xarelto in combination with
standard antiplatelet therapy to bring down the risk of
thrombotic cardiovascular events and stent thrombosis in patients
suffering from acute coronary syndrome (ACS). The news did not
come as a surprise as last month, the FDA's Cardiovascular and
Renal Drugs Advisory Committee had voted against the approval of
Xarelto in combination with standard antiplatelet therapy to
reduce the risk of thrombotic cardiovascular events (heart
attack, stroke or cardio-vascular death) in patients suffering
We note that Bayer and Johnson & Johnson have earlier been
subject to a series of setbacks regarding the ACS indication of
Xarelto in the U.S. In Jun 2013, the companies received a CRL for
Xarelto's sNDA for the reduction of risk of stent thrombosis in
patients suffering from ACS.
Before that in Mar 2013, the companies received another 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
Xarelto is however approved for several indications in the U.S.
including stroke prevention in nonvalvular atrial fibrillation,
deep vein thrombosis (DVT), pulmonary embolism (PE) and reduction
of the risk of recurrent DVT and PE.
We are highly disappointed with Xarelto's latest CRL. Bayer and
Johnson & Johnson have been really struggling with Xarelto's
ACS indication in the U.S. Further setbacks may jeopardize the
drug's future in the U.S. for this indication. Bayer recorded
Xarelto sales of €259 million for the third quarter of 2013.
Meanwhile, in May last 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.
Bayer currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks include
Alexion Pharmaceuticals, Inc.
). While Alexion holds a Zacks Rank #1 (Strong Buy), Actelion
carries a Zacks Rank #2 (Buy).