Bayer Announces Positive Phase I Data - Analyst Blog
08 Juillet 2013 - 11:00PM
Zacks
The HealthCare segment of
Bayer (BAYRY) 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 with
partner Johnson & Johnson (JNJ) collaborated
with Portola Pharmaceuticals Inc. (PTLA) 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 Novo
Nordisk (NVO) currently look more attractive with a Zacks
Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
PORTOLA PHARMA (PTLA): Free Stock Analysis Report
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