Pipeline updates are highly awaited events in the
pharma/biotech sector 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.
ACTELION LTD (ALIOF): Get Free Report
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Earlier in the week, the HealthCare segment at
) announced the initiation of the phase III EINSTEIN CHOICE study
(n=2,850) on Xarelto. The study will evaluate two doses (10 mg or
20 mg) of Xarelto versus acetylsalicylic acid (ASA) for the
long-term, secondary prevention of symptomatic venous
thromboembolism (VTE), including deep vein thrombosis (DVT) and
pulmonary embolism (PE).
The EINSTEIN CHOICE study will evaluate whether once-daily
Xarelto is superior to ASA in the prevention of fatal or
non-fatal symptomatic recurrent VTE, in patients who have
finished anticoagulant treatment for 6 to 12 months for their
index DVT or PE event.
We note that Xarelto is jointly developed by Bayer and
Johnson & Johnson
). The drug is marketed by Johnson & Johnson in the U.S. and
by Bayer outside the U.S. Xarelto is approved for several
indications including stroke prevention in nonvalvular atrial
fibrillation, DVT, PE and reduction of the risk of recurrent DVT
and PE. Bayer recorded Xarelto sales of €259 million for the
third quarter of 2013.
Although Bayer and Johnson & Johnson has progressed well with
Xarelto in several indications, they have really struggled with
Xarelto in the acute coronary syndrome (ACS) indication in the
U.S. Last week, the U.S. Food and Drug Administration (FDA)
issued complete response letters (CRLs) to Xarelto's supplemental
New Drug Applications (sNDA) in combination with standard
antiplatelet therapy to reduce the risk of thrombotic
cardiovascular events and stent thrombosis in patients suffering
from ACS. The news came as a huge dissapoinment for both the
companies. Bayer and Johnson & Johnson have earlier been
subject to a series of setbacks regarding the ACS indication of
Xarelto in the U.S.
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).