The HealthCare segment of
) recently announced positive results from a phase I study on
prothrombin complex concentrates (PCCs). The study evaluated
three- and four-factor PCCs in 34 healthy adults.
Results from the phase I study revealed that three- and
four-factor PCCs can be used to reverse the anticoagulant effect
measured by coagulation assays in patients treated with blood
thinner Xarelto (20mg twice daily). The study further revealed
that the three-factor PCC was more effective than the four-factor
PCC on reversing Xarelto-induced changes in thrombin generation.
Bayer stated in its press release that currently there are no
approved reversal agents for Xarelto. In Feb 2013, Bayer along
Johnson & Johnson
) collaborated with
Portola Pharmaceuticals Inc.
) to evaluate the potential ability of PRT4445 in reversing the
anticoagulant activity of Xarelto in emergency situations.
We note that Xarelto is marketed by Johnson & Johnson in the
US and by Bayer outside the US.
Meanwhile, Bayer and Johnson & Johnson received a huge
setback from the US Food and Drug Administration (FDA) last
month, when the US regulatory body issued a complete response
letter (CRL) to the supplemental New Drug Application (sNDA) of
Xarelto for the reduction of risk of stent thrombosis in patients
suffering from acute coronary syndrome (ACS).
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.
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).
BAYER A G -ADR (BAYRY): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
PORTOLA PHARMA (PTLA): Free Stock Analysis
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