The HealthCare unit of
Bayer
(
BAYRY
) recently filed an application with the European Medicines Agency
(EMA) seeking marketing approval for its blood thinner, Xarelto,
for an additional indication in the EU. Bayer is looking to get the
drug approved for treating pulmonary embolism (PE) and preventing
the recurrence of deep vein thrombosis (DVT) and PE in
adults.
The HealthCare unit of Bayer has co-developed Xarelto with the
Janssen Research and Development unit of
Johnson & Johnson
(
JNJ
). While Johnson & Johnson is exclusively responsible for the
marketing of Xarelto in the US, Bayer is responsible for the same
in ex-US markets.
Bayer is seeking European approval for the indication on the
basis of encouraging data from a phase III study (EINSTEIN-PE:
n=4,833). Data from the study proved Xarelto to be as efficient as
the current standard of care (
Sanofi
's (
SNY
) Lovenox) in reducing recurrent symptomatic VTE. Results further
revealed that while the overall bleeding rates were similar in
patients in both the cohorts, patients treated with Xarelto
experienced lower rates of major bleeding compared to those treated
with Lovenox.
We note that Bayer/Johnson & Johnson are also looking to get
Xarelto approved in the US for reducing the risk of cardiovascular
events in patients suffering from acute coronary syndrome (ACS).
ACS refers to a heart disease, which results in the blockage of a
coronary artery via a blood clot. Xarelto is under priority review
for the indication. Successful label expansion of Xarelto, already
approved for multiple indications including the lucrative stroke
prevention in non-valvular atrial fibrillation indication, would
further boost the top lines of the companies.
Neutral on Bayer, Johnson & Johnson
Currently, we have Neutral recommendations for both Bayer
and Johnson & Johnson in the long run. However, the short-term
ratings differ. While Bayer carries a Zacks #2 Rank ("Buy" rating),
Johnson & Johnson carries a Zacks #3 Rank ("Hold" rating) in
the short run.
BAYER A G -ADR (
BAYRY
): Free Stock Analysis Report
JOHNSON & JOHNS (
JNJ
): Free Stock Analysis Report
SANOFI-AVENTIS (
SNY
): Free Stock Analysis Report
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